@Article{info:doi/10.2196/67392,
author="Ren, Dongsheng
and Tan, Judan
and Zhou, Yuling
and Luo, Zhenchun",
title="Efficacy of DaXianXiong Decoction in Preventing the Progression of Acute Pancreatitis Severity: Protocol for a Randomized Controlled Trial",
journal="JMIR Res Protoc",
year="2025",
month="Apr",
day="29",
volume="14",
pages="e67392",
keywords="acute pancreatitis",
keywords="traditional Chinese medicine",
keywords="protocol",
keywords="severe acute pancreatitis",
keywords="prevent",
abstract="Background: Low- and middle-income countries are facing an increase in the incidence of acute pancreatitis (AP)---characterized by rapid onset, fast progression, high rate of severity, and high mortality. Progression of AP into severe AP (SAP) results in a series of complications such as organ dysfunction, local abscesses, pseudocysts, and necrosis. Although the treatment of AP is primarily supportive, including fluid resuscitation and organ support, there is still a lack of consensus on the optimal management regimen for fluid therapy, and strategies to promote gastrointestinal recovery remain limited. As no effective intervention measure has yet been developed, supportive therapy remains the primary approach for the early treatment of AP. DaXianXiong decoction is a widely used traditional Chinese medicine formulation; however, limited research has been conducted on its clinical efficacy. Objective: This study aims to evaluate the efficacy and safety of DaXianXiong decoction in preventing AP from progressing to SAP, assessing its impact on SAP incidence, clinical severity scores, inflammation markers, and gastrointestinal function, and providing evidence for AP management. Methods: This study is a randomized, double-blind, placebo-controlled, single-center clinical trial. The primary outcomes will include the incidence of SAP, modified computed tomography severity index score, APACHE II (Acute Physiology and Chronic Health Evaluation II) score, modified Marshall score, and levels of the inflammation factor. The secondary outcomes will include the effect of the gastrointestinal dysfunction treatment. Evaluations will be conducted at baseline; 24 hours after the intervention; and on days 3, 7, and 28 after the intervention in both groups. A total of 60 eligible patients will be randomly allocated in a 1:1 ratio to the intervention group and the control group. Both groups will receive standard Western medical treatment for pancreatitis. The intervention group will additionally receive DaXianXiong decoction, while the control group will receive a placebo similar to the decoction. Results: This study has been funded by the Performance Incentive Project of Scientific Research Institutions in Chongqing. The trial was registered in April 2024, and data analysis is expected to be completed by April 2025. The study results will be presented at both national and international conferences and published in peer-reviewed journals. Conclusions: This trial will help us assess the effectiveness and safety of DaXianXiong decoction in patients with AP and provide clinical evidence on the efficacy and safety of DaXianXiong decoction in preventing the progression of AP to SAP. By evaluating its impact, the findings will contribute to the understanding of DaXianXiong decoction as an adjunct therapy in AP management and may offer a novel complementary treatment strategy for AP, potentially improving patient outcomes and reducing complications. Trial Registration: Chinese Clinical Trial Registry ChiCTR2300076885; https://www.chictr.org.cn/showproj.html?proj=207084 International Registered Report Identifier (IRRID): DERR1-10.2196/67392 ",
doi="10.2196/67392",
url="https://www.researchprotocols.org/2025/1/e67392",
url="http://www.ncbi.nlm.nih.gov/pubmed/40098229"
}


@Article{info:doi/10.2196/65958,
author="Wang, Bin
and Zhang, Xiaodong
and Lu, Ping
and Sun, Pingping
and He, Tianxiang",
title="Impact of Tai Chi Therapy on Fatigue and Cognitive Function in Individuals With Chronic Fatigue Syndrome: Protocol for a Pilot Randomized Controlled Trial",
journal="JMIR Res Protoc",
year="2025",
month="Apr",
day="25",
volume="14",
pages="e65958",
keywords="Tai Chi",
keywords="chronic fatigue syndrome",
keywords="cognitive impairment",
keywords="ANT",
keywords="N-Back",
keywords="fatigue",
keywords="cognitive function",
keywords="cognitive",
keywords="protocol",
keywords="protocols",
keywords="randomized controlled trial",
keywords="RCT",
keywords="controlled trial",
keywords="controlled trials",
keywords="psychosomatic disorder",
keywords="cognition",
keywords="therapy",
keywords="efficacy",
keywords="safety",
keywords="CFS",
keywords="intervention",
keywords="data analysis",
abstract="Background: Chronic fatigue syndrome (CFS) is a psychosomatic disorder characterized by persistent fatigue, primarily involving physical and mental exhaustion, with greater emphasis on the latter. This leads to a deterioration in concentration and memory. These symptoms affect cognitive functions, including attention and memory, to varying degrees. Previous research has shown that Tai Chi can help reduce fatigue in individuals with CFS. However, the relationship between alleviating CFS-related fatigue through Tai Chi and its impact on cognitive functions remains unclear. The effects of Tai Chi on cognitive functions in individuals with CFS have not been clinically validated, and its efficacy and safety have yet to be examined through large-scale randomized controlled trials. Therefore, this protocol outlines a pilot randomized, parallel, single-blind clinical trial designed to evaluate the impact of Tai Chi therapy on fatigue and cognitive functions in individuals with CFS, using both subjective and objective assessments. Objective: This pilot study aims to explore the preliminary efficacy and safety of Tai Chi in reducing fatigue and improving cognitive function in patients with CFS, and to generate data to inform future large-scale trials. Methods: We will conduct a randomized, analyst-blinded, parallel-controlled trial with a 12-week intervention period and a 4-week follow-up. Enrolled patients will be randomly assigned to either the Tai Chi group (30 patients) or the health education group (30 patients). The Tai Chi group will receive the 24-style simplified Tai Chi intervention, while the control group will receive a health education intervention. Following the 12-week intervention, a 4-week follow-up will be conducted. The Tai Chi group will train 3 times per week, consisting of 2 in-person sessions at the Physical Education Center of Shanghai University of Traditional Chinese Medicine and 1 self-directed session guided online by an instructor. The primary outcome measure is the 20-item Multi-Dimensional Fatigue Inventory (MFI-20). The secondary outcome measures include the Montreal Cognitive Assessment (MoCA), Pittsburgh Sleep Quality Index (PSQI), Attention Network Test (ANT), working memory performance (N-Back task), and magnetic resonance imaging. Results: The research protocol and informed consent form were approved by the Shanghai Clinical Research Ethics Committee on March 18, 2024 (approval number SECCR2024-22-01). Participant recruitment began in April 2024. All interventions and concurrent data collection will be completed by October 2025, and the 4-week postintervention follow-up assessments will be finalized by the end of October 2025. Data management is still ongoing; therefore, data analysis has not yet been performed. Conclusions: As a pilot trial, the findings of this study will provide preliminary clinical evidence on the role of Tai Chi in improving cognitive function in patients with CFS and will serve as a foundation for designing future large-scale trials. Trial Registration: China Clinical Trials Registry ChiCTR2400082268; https://tinyurl.com/2tkr7j7x International Registered Report Identifier (IRRID): DERR1-10.2196/65958 ",
doi="10.2196/65958",
url="https://www.researchprotocols.org/2025/1/e65958"
}


@Article{info:doi/10.2196/63933,
author="Cai, Zijie
and Meng, ChunXue
and Wang, Fei
and Tang, ChunZhi
and Zhang, Jing
and Zhang, Qian
and Guo, Bin",
title="Efficacy And Safety of Acupoint Catgut Embedding for Perennial Allergic Rhinitis: Protocol for a Randomized Clinical Trial",
journal="JMIR Res Protoc",
year="2025",
month="Apr",
day="21",
volume="14",
pages="e63933",
keywords="acupoint thread embedding",
keywords="catgut embedding",
keywords="allergic rhinitis",
keywords="loratadine",
abstract="Background: Allergic rhinitis (AR) is a noninfectious chronic inflammatory disease of the nasal mucosa characterized mainly by itching, sneezing, nasal congestion, and rhinorrhea. It is mediated by immunoglobulin E (IgE). AR is one of the most common allergic diseases globally, affecting 10\% to 20\% of the population worldwide, with some regions even reaching rates as high as 50\%, posing a global health issue. The prevalence of AR has been increasing since the 1960s, with a significant increase in recent years. At present, modern medicine---including desensitization therapy, the use of antiallergic drugs, antihistamines, hormones, and other treatments---can improve symptoms or regulate the immune system. However, both short- and long-term efficacy remain limited, as symptoms often recur after treatment cessation, and long-term drug use is associated with toxicity and side effects. Objective: Acupoint catgut embedding (ACE) therapy is widely used to treat AR in China. ACE therapy has been reported to be effective in managing the symptoms of AR, but the evidence faces methodological limitations. Therefore, we designed a parallel-arm, randomized controlled, multicentered, placebo-controlled, and single-blinded trial to evaluate the efficacy and safety of ACE therapy for AR. Methods: This study will be a parallel-group, patient-blind, placebo-controlled randomized controlled trial conducted in the Third Affiliated Hospital of Sun Yat-sen University, Ningxia Chinese Medicine Research Center, and the Affiliated Hospital of Shanxi University of Traditional Chinese Medicine. The trial consists of a 4-week treatment period, along with a 3-month follow-up. After providing written informed consent, eligible participants will be randomized at a ratio of 1: 1 into one of 2 groups: the ACE group receiving treatment and the sham ACE group. Both groups will receive conventional loratadine treatment. Results: The funding began in January 2022. The study was initiated on February 1, 2025, and will end in February 2026. Patient recruitment has already started, and the study results will be released in March 2026. Conclusions: We expect that this research will provide important insights into the efficacy of ACE treatment for AR and generate robust data for the foundation of future research in this field. Trial Registration: Chinese Clinical Trial Registry ChiCTR2500095634; https://www.chictr.org.cn/historyversionpubEN.html?regno=ChiCTR2500095634 International Registered Report Identifier (IRRID): PRR1-10.2196/63933 ",
doi="10.2196/63933",
url="https://www.researchprotocols.org/2025/1/e63933"
}


@Article{info:doi/10.2196/67737,
author="Liu, Hongji
and Dai, Yan
and Yu, Ming
and Zeng, Jian
and Wang, Chao
and Tan, Sa
and Xiong, Ming
and Zhang, Ran
and Yu, Xuemeng
and Shi, Mingsong
and Yan, Xing
and Lai, Fengming",
title="Effects and Safety of Press-Needle Therapy for Improving Visual Function and Eye Blood Circulation in Patients With Glaucoma With Controlled Intraocular Pressure: Study Protocol for a Multicenter Randomized Controlled Trial",
journal="JMIR Res Protoc",
year="2025",
month="Apr",
day="1",
volume="14",
pages="e67737",
keywords="press needle",
keywords="press-needle therapy",
keywords="needling technique",
keywords="glaucoma",
keywords="acupuncture",
keywords="visual function",
keywords="eye blood circulation",
keywords="randomized controlled trial",
keywords="traditional Chinese medecine",
abstract="Background: Glaucoma is the leading cause of irreversible blindness worldwide, causing continuous and progressively worsening damage to visual function, which leads to vision loss. Optic nerve protection is an important treatment for glaucoma with controlled intraocular pressure (GPCI), but to date, there is no universally accepted effective optic nerve protection agent. Acupuncture can protect the optic nerve by increasing blood flow to the eye. However, fear of pain or the limitations of treatment place and time lead to poor patient compliance. Press-needle therapy is a characteristic of traditional Chinese medicine (TCM) external treatment methods; its safety is high, the effect is fast and lasting, it is easy to conduct, and it has high patient compliance. Objective: The objective of the trial is to evaluate the safety and clinical efficacy of press-needle therapy and investigate whether it can improve visual function by regulating eye blood circulation in patients with GPCI. Methods: In total, 192 participants aged 18-75 years with GPCI from the Mianyang Central Hospital, the Mianyang Hospital of Traditional Chinese Medicine, and the Mianyang Wanjiang Eye Hospital will participate in this study. Participants will be allocated to 2 treatment groups (experimental and control groups) in a ratio of 1:1 and will undergo press-needle therapy and sham press-needle therapy, respectively, for the same 4-week period. Primary outcomes will include the best-corrected visual acuity (BCVA), optical coherence tomography angiography (OCTA), color Doppler flow imaging (CDFI), and visual field assessment results. Secondary outcomes will include the intraocular pressure (IOP) and traditional Chinese medicine (TCM) clinical symptom scales. The primary outcomes and safety assessments will be measured at baseline and 4 weeks thereafter, while the secondary outcomes will be measured at baseline and 1, 2, 3, and 4 weeks thereafter. Results: Recruitment and data collection began in February 2023. The final outcomes are expected in September 2025. As of October 2024, the project had recruited 220 eligible participants, of whom 192 (87.3\%) will complete the study, exceeding initial projections for the study time frame. The remainder of the participants will provide the ability to explore cross-level interactions that could not be statistically powered at the outset. The strengths of the project include rigorous data collection, good retention rates, and high compliance rates. Conclusions: This study will provide data on the effects of press-needle therapy on visual function and ocular circulation in patients with GPCI, and these results will help demonstrate whether acupuncture can improve patients' visual function by regulating ocular circulation, thus providing a clinical and theoretical basis for the wider application of acupuncture therapy in GPCI. Trial Registration: Chinese Clinical Trial Registry ChiCTR2300067862?https://tinyurl.com/mrxd58x9 International Registered Report Identifier (IRRID): DERR1-10.2196/67737 ",
doi="10.2196/67737",
url="https://www.researchprotocols.org/2025/1/e67737"
}


@Article{info:doi/10.2196/60801,
author="Rajput, Shivshankar
and Mata, Shweta
and Saxena, Upma
and Ota, Sarada
and Gupta, Bharti",
title="Ayurveda Management of Menorrhagia (Raktapradara): Protocol for a Randomized Controlled Trial",
journal="JMIR Res Protoc",
year="2025",
month="Mar",
day="31",
volume="14",
pages="e60801",
keywords="Ashokarishta",
keywords="Trinakantamani pishti",
keywords="tranexamic acid",
keywords="menorrhagia",
keywords="Raktapradara",
abstract="Background: In India, heavy menstrual bleeding or menorrhagia (Raktapradara) constitutes about 15\% to 20\% of all gynecological admissions in an institution. Of these, 43\% of patients are aged 20-40 years. This condition is worsening because of the high prevalence of anemia among Indian women. Menorrhagia can have a significant impact on women's lives. Medical treatment is usually the first choice in excessive bleeding, but it reduces menstrual blood loss by only 50\%, and up to 50\% of women undergo surgical treatment within 5 years. However, none of these treatments proved their definite efficacy in spite of the high price and side effects. This condition presents a major financial burden on health care services. In Ayurveda, encouraging work has been done on the compound drug Ashokarishta, and the drug Trinakantamani pishti is indicated in Ayurvedic classics and the Ayurvedic Formulary of India. Also, these medicines have been used in Ayurvedic practice for a long time. However, no clinical trial has been carried out on these formulations. Objective: The primary objective is to evaluate the efficacy of Ayurvedic intervention in the management of menorrhagia, and the secondary objective is to assess the efficacy of Ayurvedic intervention on the quality of life of the women with menorrhagia. Methods: This ongoing study is an open-label, interventional, randomized controlled trial, with a sample size of 140 in the treatment and control groups combined (including 20\% dropouts), and will be carried out within the duration of 36 months. Participants in the treatment group will receive Ayurvedic treatment, that is, 20 mL of Ashokarishta, 250 mg of Trinakantamani pishti, and 1 iron and folic acid tablet (100 mg of elemental iron and 1.5 mg of folic acid) twice a day orally for 3 months. Participants in the control group will receive a 500-mg tranexamic acid tablet thrice a day for 7 days from the first day of menses for 3 cycles and 1 iron and folic acid tablet twice a day orally for 3 months. The primary outcomes are changes in the amount of uterine bleeding evaluated by the Pictorial Blood Loss Assessment Chart, changes in the duration of bleeding, and attainment of a normal quantity of blood loss during the interval of cycles. The secondary outcome is changes in the Menorrhagia Impact Questionnaire. Results: As of December 2024, a total of 79 patients have been enrolled. Data analysis should be completed by February 2026. The study will be reported following standard guidelines for reporting randomized controlled trials. Clinical results will be disseminated through conferences and peer-reviewed publications in a relevant journal. Conclusions: The Ayurvedic approach may provide an evidence-based therapeutic tactic for the management of menorrhagia. Trial Registration: Clinical Trial Registry India CTRI/2023/05/052929; https://tinyurl.com/3cd6mxrn International Registered Report Identifier (IRRID): DERR1-10.2196/60801 ",
doi="10.2196/60801",
url="https://www.researchprotocols.org/2025/1/e60801"
}


@Article{info:doi/10.2196/58951,
author="Zhao, Yanchun
and Huang, Ting
and Chen, Yanli
and Li, Songmei
and Zhao, Juan
and Han, Xu
and Ni, Qing
and Su, Ning",
title="Evaluation of the Clinical Nursing Effects of a Traditional Chinese Medicine Nursing Program Based on Care Pathways for Patients With Type 2 Diabetes: Protocol for a Randomized Controlled Clinical Trial",
journal="JMIR Res Protoc",
year="2025",
month="Mar",
day="31",
volume="14",
pages="e58951",
keywords="type 2 diabetes",
keywords="traditional Chinese medicine",
keywords="TCM nursing program",
keywords="clinical pathway",
keywords="application research",
keywords="diabetes",
keywords="diabetes mellitus",
keywords="research protocol",
keywords="nursing",
keywords="nursing program",
keywords="nursing care",
keywords="chronic disease",
keywords="disease monitoring",
keywords="prevalence",
keywords="China",
keywords="adult",
keywords="patient recovery",
keywords="psychological care",
keywords="health education",
keywords="quality of life",
keywords="blood glucose",
keywords="self-care",
keywords="medication",
keywords="control group",
keywords="patient satisfaction",
abstract="Background: To improve the performance of health care institutions, reduce overmedication, and minimize the waste of medical resources, China is committed to implementing a clinical pathway management model. This study aims to standardize nursing practices, foster clinical thinking in nurses, and promote patient recovery. Objective: The purpose of this study is to evaluate the clinical effects of a traditional Chinese medicine (TCM) nursing program based on nursing pathways for patients with type 2 diabetes mellitus (T2DM). Methods: This study uses a prospective, randomized, single-blind, parallel-controlled design. Based on sample size calculations, the study will include 594 patients with diabetes, with 2 groups of 297 patients: an observation group will receive a TCM nursing program based on clinical pathways, while a control group will receive routine care. Both groups will be evaluated before and after the intervention using assessment indicators. The primary outcome is the quality of life score, measured by a diabetes-specific quality of life questionnaire. Secondary outcomes include hospital stay duration, medical expenses, health knowledge, blood glucose control, symptom scores, and patient satisfaction. Results: This study was funded in August 2021 and has received approval from the Ethics Committee of Guang'anmen Hospital, China Academy of Chinese Medical Sciences (2022-022-KY-01). The trial is ongoing, with the first patient enrolled in September 2022. The study is expected to conclude in April 2025. To date, 380 patients have been recruited, with 202 randomized into the study, though no statistical analysis of the data has yet been conducted. A single-blind method is used; nurses are aware of group assignments and intervention plans, while patients remain blinded. Final results are planned for release in the first quarter of 2025. Conclusions: This study seeks to integrate existing national standardized nursing protocols with clinical pathways to implement more efficient and higher-quality nursing practices. The goal is to standardize nursing procedures, enhance patients' quality of life, and improve self-care and medication adherence after discharge. Trial Registration: International Traditional Medicine Clinical Trial Registry ITMCTR2022000048; https://tinyurl.com/y4jd68h4 International Registered Report Identifier (IRRID): DERR1-10.2196/58951 ",
doi="10.2196/58951",
url="https://www.researchprotocols.org/2025/1/e58951"
}


@Article{info:doi/10.2196/69120,
author="Saskovets, Marina
and Saponkova, Irina
and Liang, Zilu",
title="Effects of Sound Interventions on the Mental Stress Response in Adults: Scoping Review",
journal="JMIR Ment Health",
year="2025",
month="Mar",
day="24",
volume="12",
pages="e69120",
keywords="mental stress",
keywords="anxiety",
keywords="sound therapy",
keywords="music therapy",
keywords="psychoacoustics",
keywords="expressive sounds",
keywords="stress reduction",
keywords="stress management",
keywords="stress relief",
keywords="stress markers",
keywords="relaxation",
keywords="personalized therapy",
keywords="PRISMA",
abstract="Background: This scoping review examines the effects of various sound interventions, including music, natural sounds, and speech, on the stress response in adults. Objective: The review aims to identify key therapeutic factors, including sound type, individual listener characteristics, and environmental influences. It also synthesizes evidence on physiological responses to sound interventions and highlights current research gaps. Methods: We conducted a comprehensive search using databases such as PubMed, Web of Science, Scopus, and PsycINFO, focusing on studies from 1990 to 2024. Eligible studies included randomized controlled trials, clinical trials, and laboratory experiments that measured stress through physiological markers (eg, heart rate variability and cortisol) and self-reports. A total of 34 studies were included, and thematic analysis was conducted to identify recurring themes in the findings. Results: The findings suggest that music, especially classical and self-selected pieces, effectively reduces physiological stress markers, including cortisol levels, heart rate variability, and blood pressure. Nonmusical sounds, such as nature sounds and calming voices, also demonstrate potential for stress relief, although research in this area remains limited. While most sound interventions showed positive effects, some studies reported adverse effects, indicating that sound can both alleviate and induce stress. The outcomes were substantially affected by contextual factors such as personal preferences, delivery methods, cultural context, and emphasizing the importance of personalized interventions. Conclusions: Sound interventions offer promising, noninvasive methods for stress reduction. This review suggests that future research should address gaps in the study of nonmusical sound interventions and further investigate the neural mechanisms underlying stress responses to sound. International Registered Report Identifier (IRRID): RR2-10.2196/54030 ",
doi="10.2196/69120",
url="https://mental.jmir.org/2025/1/e69120"
}


@Article{info:doi/10.2196/65789,
author="Wang, Mengmeng
and Wang, Lianxin
and Liu, Fumei
and Chen, Renbo
and Wang, Zhifei
and Cui, Xin
and Li, Yuanyuan
and Xie, Yanming",
title="Clinical Safety of Pudilan Xiaoyan Oral Liquid for the Treatment of Upper Respiratory Tract Infection in the Real World: Protocol for a Prospective, Observational, Registry Study",
journal="JMIR Res Protoc",
year="2025",
month="Mar",
day="21",
volume="14",
pages="e65789",
keywords="Pudilan Xiaoyan oral liquid",
keywords="PDL",
keywords="upper respiratory tract infection",
keywords="URTI",
keywords="registry",
keywords="adverse drug reaction",
abstract="Background: Pudilan Xiaoyan oral liquid (PDL) is a proprietary Chinese medicine preparation widely used for upper respiratory tract infection, known for its significant therapeutic effects. However, the safety profiles reported in several observational studies vary, and these studies primarily focus on efficacy rather than specifically addressing safety concerns, thus representing inadequate safety monitoring. Objective: This study aimed to investigate the incidence of adverse drug reactions (ADRs) associated with PDL and explore the factors contributing to these reactions. Methods: The study is a prospective, observational, multicenter, hospital-based surveillance study. A total of 17 hospitals from China are involved. The study is expected to enroll a large sample of 10,000 patients aged between 18 and 80 years with upper respiratory tract infection who were prescribed PDL. The patients' data, including demographics, medical history, diagnostic information, medication details, adverse events, and laboratory test results, will be monitored. The occurrence of ADRs will be recorded. The primary outcome is the incidence of ADR. Secondary outcomes are the ratio of patients whose body temperature return to the normal range (cases of body temperature normalization and the duration for achieving normal body temperature within a 3-day period will be documented) and changes in liver and kidney function (occurrence of drug-induced liver injury and acute kidney injury). Descriptive analyses will be performed for the primary and secondary outcomes. A cohort, nested, case-control study design will be used. If one patient has an ADR, then 4 patients without ADRs will be matched as the control group according to gender, age within 5 years, drug batch, and other factors, at a ratio of 1?4 to compare the symptoms related to ADRs. The differences of ADR incidence among the possible influencing factors will be compared separately to find the factors with large differences. Then, synthetic minority oversampling technique and group least absolute shrinkage and selection operator methods will be used to identify factors influencing the occurrence of ADRs. Finally, propensity scoring methods will be used to control for confounding variables. The progress of each subcenter will be closely monitored, and the incidence of ADR will be systematically calculated. Furthermore, the characteristics and influencing factors of ADR will be analyzed, along with an investigation into its geographical distribution. Results: The study began on July 17, 2019. Due to the limited number of eligible patients, missed follow-ups, and the huge clinical burden caused by public health events in 2019, the final case will be enrolled on August 30, 2025. Conclusions: This study will obtain safety results of PDL in the real world and provide guidance on the clinical safety of traditional Chinese medicine formulations. Trial Registration: ClinicalTrials.gov NCT04031651; https://clinicaltrials.gov/study/NCT04031651 International Registered Report Identifier (IRRID): DERR1-10.2196/65789 ",
doi="10.2196/65789",
url="https://www.researchprotocols.org/2025/1/e65789"
}


@Article{info:doi/10.2196/57905,
author="Kaur, Harleen
and Sachdeva, Jyoti
and Bawaskar, Ramesh
and Goyal, Twinkle",
title="Comparative Evaluation of Effectiveness of Standard of Care Alone and in Combination With Homoeopathic Treatment in COVID-19--Related Rhino-Orbito-Cerebral Mucormycosis (ROCM): Protocol for a Single Blind, Randomized Controlled Trial",
journal="JMIR Res Protoc",
year="2025",
month="Mar",
day="19",
volume="14",
pages="e57905",
keywords="Rhino-orbital-cerebral mucormycosis, randomized controlled trial, homoeopathy, fungus, CE-MRI PNS mucormycosis",
keywords="India",
keywords="medical care",
keywords="mortality rate",
keywords="conventional therapy",
keywords="ethical",
keywords="mortality",
keywords="survival",
keywords="recovery",
keywords="homoeopathic medicines",
keywords="management",
abstract="Background: Rhino-orbital-cerebral mucormycosis (ROCM) is the most common (45\%-74\%) mucormycosis in India. With contemporary medical care, ROCM has a mortality rate of 40\%-50\% and 70\% of survivors are left with residual defects. Recently, several cases of mucormycosis in people with COVID-19 have been increasingly reported worldwide, from India, due to immune dysregulation caused by SARS-CoV-2. To reduce the high mortality rate and residual defect in most survivors under the guidelines of the Ministry of AYUSH, the Government of India recommended homoeopathy as an add-on therapy to maximize the effectiveness of standard treatment in conventional therapy. Objective: This study aimed to evaluate the role of existing homoeopathic treatment as an adjuvant therapy in patients with COVID-19--related ROCM and enhancing the survival of the patients hospitalized due to COVID-19 infection and to access the initial treatment response and duration required for significant or complete recovery in patients receiving adjuvant treatment. Methods: This superiority, randomized controlled clinical trial would include two parallel comparator groups A and B. Group A would be the experimental group and would receive homoeopathic treatment along with the standard line of treatment as per investigational medicinal product (IMP) and group B would be the control arm and would receive standard line of treatment as per IMP along with identical placebo. Allocation would be 1:1 through randomization. Based on the inclusion and exclusion criteria, 36 participants per arm would be screened. Participants would be assessed clinically twice a day and magnetic resonance imagery or endoscopy cum-biopsy would be assessed on days 1, 14, and 28. Laboratory investigations may vary as per demand of disease conditions. Results: In India, the COVID-19 pandemic, particularly during the second wave, resulted in a surge of mucormycosis cases among patients with COVID-19. At the time this protocol was being developed, there was a significant spike in mucormycosis cases in India, particularly in Mumbai (June 2021). However, by the time the Central Council for Research in Homoeopathy obtained the necessary approvals and ethical clearance for the study, the incidence of mucormycosis had drastically declined (September 2021). As a result, the study was not initiated and registered. The authors feel it is their ethical responsibility to share the reviewed protocol with the medical community as a reference for future work. Conclusions: This study aims to evaluate the role of existing homoeopathic medicines as an adjuvant therapy in managing COVID-19--related ROCM, potentially contributing to the use of homoeopathy as an evidence-based medical approach. The protocol can also serve as a valuable resource for clinicians and researchers addressing mucormycosis cases unrelated to COVID-19, particularly in immunocompromised patients. It would help ensure preparedness, whether or not sufficient evidence is available, in the event of a future health emergency. International Registered Report Identifier (IRRID): PRR1-10.2196/57905 ",
doi="10.2196/57905",
url="https://www.researchprotocols.org/2025/1/e57905"
}


@Article{info:doi/10.2196/58897,
author="Tseng, Liang-Wei
and Lu, Yi-Chin
and Tseng, Liang-Chi
and Chen, Yu-Chun
and Chen, Hsing-Yu",
title="Performance of ChatGPT-4 on Taiwanese Traditional Chinese Medicine Licensing Examinations: Cross-Sectional Study",
journal="JMIR Med Educ",
year="2025",
month="Mar",
day="19",
volume="11",
pages="e58897",
keywords="artificial intelligence",
keywords="AI language understanding tools",
keywords="ChatGPT",
keywords="natural language processing",
keywords="machine learning",
keywords="Chinese medicine license exam",
keywords="Chinese medical licensing examination",
keywords="medical education",
keywords="traditional Chinese medicine",
keywords="large language model",
abstract="Background: The integration of artificial intelligence (AI), notably ChatGPT, into medical education, has shown promising results in various medical fields. Nevertheless, its efficacy in traditional Chinese medicine (TCM) examinations remains understudied. Objective: This study aims to (1) assess the performance of ChatGPT on the TCM licensing examination in Taiwan and (2) evaluate the model's explainability in answering TCM-related questions to determine its suitability as a TCM learning tool. Methods: We used the GPT-4 model to respond to 480 questions from the 2022 TCM licensing examination. This study compared the performance of the model against that of licensed TCM doctors using 2 approaches, namely direct answer selection and provision of explanations before answer selection. The accuracy and consistency of AI-generated responses were analyzed. Moreover, a breakdown of question characteristics was performed based on the cognitive level, depth of knowledge, types of questions, vignette style, and polarity of questions. Results: ChatGPT achieved an overall accuracy of 43.9\%, which was lower than that of 2 human participants (70\% and 78.4\%). The analysis did not reveal a significant correlation between the accuracy of the model and the characteristics of the questions. An in-depth examination indicated that errors predominantly resulted from a misunderstanding of TCM concepts (55.3\%), emphasizing the limitations of the model with regard to its TCM knowledge base and reasoning capability. Conclusions: Although ChatGPT shows promise as an educational tool, its current performance on TCM licensing examinations is lacking. This highlights the need for enhancing AI models with specialized TCM training and suggests a cautious approach to utilizing AI for TCM education. Future research should focus on model improvement and the development of tailored educational applications to support TCM learning. ",
doi="10.2196/58897",
url="https://mededu.jmir.org/2025/1/e58897"
}


@Article{info:doi/10.2196/56849,
author="Lin, Lien-Cheng
and Wang, Wei-Hsun
and Chang, Wei-Kai
and Gao, Jyun-Liang
and Yang, Ru-Chang
and Hsu, Po-Chi
and Lo, Lun-Chien",
title="Evaluation of the Efficacy of the Traditional Chinese Medicine Formulation Ru-Yi-Jin-Huang-Saan on Colles Fracture After Surgery: Protocol for a Randomized, Double-Blind, Placebo-Controlled Trial",
journal="JMIR Res Protoc",
year="2025",
month="Mar",
day="5",
volume="14",
pages="e56849",
keywords="traditional Chinese medicine",
keywords="Ru-Yi-Jin-Huang-Saan",
keywords="external application",
keywords="Colles fracture",
keywords="Patient-Rated Wrist Evaluation",
keywords="PRWE",
keywords="PRWE score",
keywords="surgeries",
keywords="fracture",
keywords="randomized controlled trial",
keywords="RCT",
keywords="alternative treatment",
keywords="postoperative",
keywords="protocol",
keywords="Western medicine",
keywords="wrist evaluation",
keywords="pain relief medication",
abstract="Background: Colles fracture, a common wrist injury, often requires surgical intervention. After surgery, patients may experience persistent pain and reduced wrist function, potentially resulting in long-term disability. In clinical practice, traditional Chinese medicine practitioners frequently use Ru-Yi-Jin-Huang-Saan (RYJHS) to treat such patients in Taiwan. RYJHS is a traditional Chinese herbal formula with a history spanning centuries, primarily used topically for the treatment of bone fractures and the promotion of healing. However, there is currently a lack of substantial clinical evidence supporting its efficacy in the management of postsurgical Colles fractures. To the best of our knowledge, there are no studies evaluating the clinical effectiveness of RYJHS. Objective: This study aims to investigate the therapeutic potential of RYJHS in postsurgical Colles fracture cases. An additional objective is to provide an alternative treatment option for postoperative patients unable to take anti-inflammatory and pain relief medications. Methods: This is a protocol for a randomized, double-blind, placebo-controlled trial. A total of 100 postoperative patients with Colles fracture, aged 20-80 years, will be recruited for this study. They will be randomly assigned to either the experimental or control group in a 1:1 allocation ratio. Both groups will receive standard postoperative Colles fracture treatment. The primary outcome measure will assess wrist functional recovery using the Patient-Rated Wrist Evaluation score. Secondary outcomes will include C-reactive protein levels and ultrasound measurements of wrist swelling. All of these examinations will be assessed at baseline, 3 days after surgery, and 6 days after surgery. In addition, the Dyshidrotic Eczema Area and Severity Index will be used to monitor for adverse skin reactions. Results: This protocol was registered at ClinicalTrials.gov on December 6, 2022. It was performed in accordance with the approved guidelines and regulations of the participating institutions. Recruitment began in May 2023, with data collection expected to conclude in May 2025. Study completion is expected in December 2025. Conclusions: This is the first protocol discussing the assessment of the therapeutic efficacy and safety of topical traditional Chinese medicine in patients after fracture surgery. The protocol will establish an integrated care model combining both traditional Chinese medicine and Western medicine for postsurgical fracture cases. Trial Registration: ClinicalTrials.gov NCT05638360; https://clinicaltrials.gov/ct2/show/NCT05638360 International Registered Report Identifier (IRRID): DERR1-10.2196/56849 ",
doi="10.2196/56849",
url="https://www.researchprotocols.org/2025/1/e56849",
url="http://www.ncbi.nlm.nih.gov/pubmed/40053806"
}


@Article{info:doi/10.2196/69417,
author="Li, Yadi
and Zhou, Jianlong
and Wei, Zheng
and Liang, Lizhu
and Xu, Hualing
and Lv, Caihong
and Liu, Gang
and Li, Wenlin
and Wu, Xin
and Xiao, Yunhui
and Sunzi, Kejimu",
title="Efficacy and Safety of Acupuncture for Post--COVID-19 Insomnia: Protocol for a Systematic Review and Meta-Analysis",
journal="JMIR Res Protoc",
year="2025",
month="Mar",
day="3",
volume="14",
pages="e69417",
keywords="acupuncture",
keywords="traditional Chinese medicine",
keywords="post--COVID-19 condition",
keywords="long COVID-19",
keywords="insomnia",
keywords="sleep disorder",
keywords="depression",
keywords="complementary and alternative medicine",
keywords="treatment",
keywords="public health",
keywords="study protocol",
keywords="systematic review",
abstract="Background: The COVID-19 pandemic has had a profound global impact, leading to a range of persistent sequelae referred to as post--COVID-19 condition or ``long COVID'' that continue to affect patients worldwide. Among these sequelae, post--COVID-19 insomnia (PCI) has emerged as a significant issue. Conventional treatments, including cognitive behavioral therapy and pharmacological interventions, face limitations such as variable efficacy, potential side effects, and substantial costs. Recently, acupuncture has gained traction due to its efficacy, cost-effectiveness, and safety profile. Objective: This study aims to conduct a meta-analysis and systematic review evaluating the efficacy and safety of acupuncture for the treatment of PCI to delineate the optimal modality, intervention frequency, and duration for achieving the most beneficial outcomes, thereby providing a comprehensive understanding of acupuncture's role in managing PCI, contributing to evidence-based clinical practice, and informing clinical decision-making. Methods: Electronic searches will be performed in 12 databases from inception to October 2024 without language restrictions. This includes both English databases (PubMed, Cochrane Library, Web of Science, Embase, OVID and Scopus), as well as Chinese databases (China National Knowledge Infrastructure, Wan-Fang Data, Chinese Biomedical Literature Database, Chinese Scientific Journal Database, Duxiu Database and the Chinese Clinical Trial Registry Center). Randomized controlled trials on acupuncture for PCI will be included. Primary outcomes will include the response rate and insomnia severity; secondary outcomes will include the Traditional Chinese Medicine Symptom Scale (TCMSS) and adverse event rates. Data synthesis will use risk ratios for dichotomous data and mean differences for continuous data. Study selection, data extraction, and quality assessment will be conducted independently by 2 reviewers. Methodological quality of eligible studies will be evaluated following the Cochrane Handbook for Systematic Reviews of Interventions (version 6.3). Meta-analysis will be performed with RevMan 5.3. Results: Based on the data on response rate, insomnia severity, TCMSS score, and adverse event rates, this study will provide an evidence-based review of the efficacy and safety of acupuncture for PCI treatment. Conclusions: This systematic review will present the current evidence for acupuncture for PCI, aiming to inform clinical practices and decision-making and to enhance the understanding of acupuncture's role in managing PCI. Furthermore, it will identify research gaps and suggest potential areas for future investigation. Trial Registration: PROSPERO CRD42024499284; https://www.crd.york.ac.uk/prospero/display\_record.php?RecordID=499284 International Registered Report Identifier (IRRID): DERR1-10.2196/69417 ",
doi="10.2196/69417",
url="https://www.researchprotocols.org/2025/1/e69417",
url="http://www.ncbi.nlm.nih.gov/pubmed/40053784"
}


@Article{info:doi/10.2196/59856,
author="Sun, Wen
and He, Jingwei
and Wang, Wenqin
and Lu, Chen
and Lin, Yating
and Dou, Yalan
and Yan, Weili
and Yu, Jian",
title="Auricular Acupressure Versus an Intermittent Low-Carbohydrate Diet in Children With Overweight or Obesity With Gastric-Heat and Dampness-Obstruction Syndrome: Protocol for a Randomized Controlled Trial",
journal="JMIR Res Protoc",
year="2025",
month="Mar",
day="3",
volume="14",
pages="e59856",
keywords="children with obesity",
keywords="traditional Chinese medicine",
keywords="TCM auricular acupressure treatment",
keywords="intermittent low carbohydrate diet",
keywords="study protocol",
abstract="Background: Childhood obesity frequently persists into adulthood and is associated with an increased risk and earlier onset of cardiovascular disease in later life. Behavioral change strategies have been proposed as the first-line weight management approach for children and adolescents with obesity. Nonpharmacological interventions, such as traditional Chinese medicine (TCM) auricular acupressure treatment and intermittent low-carbohydrate diet (ILCD), are increasingly being investigated in the young obese population. However, there is limited high-quality evidence about effectiveness and safety in weight control and reducing cardiometabolic risk in the pediatric population. Objective: This study aimed to compare the effect of cardiometabolic risk reduction between TCM auricular acupressure treatment (TAAT) and ILCD in children with overweight or obesity with gastric-heat and dampness-obstruction syndrome. Methods: This is a randomized controlled trial. Eligible participants are children with overweight or obesity and enrolled at the obesity clinic of the department of TCM at a tertiary children's hospital. Eligible participants must meet the following criteria: (1) be aged between 6 and 18 years, (2) be overweight, and (3) have gastric-heat and dampness-obstruction syndrome. Recruited children will be randomized 3:1 to receive either TAAT or a self-administered ILCD for 1 month: 150 in the TAAT group and 50 in the ILCD group. The primary outcome is the change in body weight from the beginning of treatment to the end of 1 month. Secondary outcomes included body weight, waist circumference, waist-to-height ratio, BMI, blood pressure, body fat content, indexes of liver and renal function, indexes of glucose metabolism, gut microbiota, and TCM syndrome scores at the end of 1 month and 3 months, respectively. Primary statistical analyses were conducted using the intention-to-treat strategy. A generalized linear model was used to compare the difference in weight change between the groups, with the baseline body weight as the covariate, to obtain the estimate of the mean difference in body weight change and its 95\% CI, using Gaussian for family function and identity for link function. Results: The study protocol was approved by the institutional ethical committee and registered on ClinicalTrials.gov on May 5, 2023, before recruitment. Recruitment began in June 2023 and is expected to be completed by December 2025. As of November 2024, we have enrolled 112 participants. Conclusions: This randomized controlled trial will provide evidence on the treatment effects and safety of TAAT versus ILCD among children with overweight or obesity with gastric-heat and dampness-obstruction syndrome, in reducing body weight and improving cardiometabolic risks. Exploratory aims include potential underlying mechanisms of the 2 kinds of interventions, based on biosamples. Trial Registration: ClinicalTrials.gov NCT05847478. https://clinicaltrials.gov/study/NCT05847478 International Registered Report Identifier (IRRID): DERR1-10.2196/59856 ",
doi="10.2196/59856",
url="https://www.researchprotocols.org/2025/1/e59856",
url="http://www.ncbi.nlm.nih.gov/pubmed/40053799"
}


@Article{info:doi/10.2196/58197,
author="Kakar, Monika
and Rathi, Renu
and Balakrishnan, Deepthi
and Rathi, Bharat",
title="Evaluation of Comparative Efficacy of Polyherbal Steam Inhalation Versus Polyherbal Nasal Fumigation (Dhoopana) in Children With Rhinitis (Pratishyaya): Protocol for an Open-Label Randomized Controlled Trial",
journal="JMIR Res Protoc",
year="2025",
month="Feb",
day="21",
volume="14",
pages="e58197",
keywords="pratishyaya",
keywords="Ayurveda",
keywords="allergic rhinitis",
keywords="rhinitis",
keywords="dhoopana",
keywords="nasal fumigation",
keywords="steam inhalation",
keywords="polyherbal",
keywords="vasa",
keywords="nirgundi",
keywords="nilgiri",
keywords="tulsi",
keywords="sneezing",
keywords="nasal cavity",
keywords="nasal decongestants",
keywords="evaluation",
keywords="efficacy",
keywords="child",
keywords="adolescent",
keywords="randomized controlled trial",
abstract="Background: Rhinitis is a condition characterized by inflammation of the nasal mucosa. It causes obstruction and congestion in the nasal cavity. Clinically, it resembles pratishyaya (rhinitis) in Ayurveda, which is caused by accumulation and downward movement of the tridoshas (3 elements, named vata, pitta, and kapha) in the nasal cavity. Rhinitis is one of the most common diseases among children. There is no role for antibiotics in rhinitis, and nasal decongestants have also not been found to be effective in its management. In Ayurveda, dhoopana (nasal fumigation) is mentioned in the pratishyaya treatment protocol. However, we have found no previous study regarding its efficacy. The efficacy of tulsi, vasa, nirgundi, and nilgiri is already proven when they are used for steam inhalation in respiratory tract infections. Therefore, in this study, a dhoopana of a polyherbal formulation containing tulsi, vasa, nirgundi, and nilgiri will be compared with the inhalation of steam containing arka (a liquid obtained by distillation) of tulsi, vasa, nirgundi, and nilgiri leaves in children with pratishyaya. Objective: We aim to evaluate the efficacy of polyherbal steam inhalation as a standard control against dhoopana in children aged 7 to 14 years with pratishyaya. Methods: A total of 70 participants fulfilling the inclusion criteria were selected and distributed into 2 groups of 35 each. The intervention group received dhoopana and the control group received polyherbal steam inhalation, both twice daily for 7 days. The primary outcome measure was the change in Total Nasal Symptom Score and a modified cold spatula test. At the same time, the association between prakriti (body constitution) and the prevalence of pratishyaya in children was analyzed as a secondary outcome. Assessments were performed on days 3, 5, and 7, with a follow-up time of 28 days. Appropriate descriptive and inferential statistics will be used for data analysis. Results: As of November 2024, we have completed our enrollment of 70 patients, with 35 patients in each group. Data analysis will be completed by February 2025, and we expect results to be published in March 2025. Conclusions: We anticipate that polyherbal nasal fumigation will be found to be equally as effective as polyherbal steam inhalation in the management of acute rhinitis in the pediatric population. This study may provide a standardized, herbal, safe, and cost-effective treatment for rhinitis in children in the form of dhoopana. International Registered Report Identifier (IRRID): DERR1-10.2196/58197 ",
doi="10.2196/58197",
url="https://www.researchprotocols.org/2025/1/e58197"
}


@Article{info:doi/10.2196/66838,
author="Shin, Hyeonsang
and Seong, Woohyun
and Woo, Yeonju
and Kim, Joo-Hee
and Park, Kwang-Rak
and Lee, Hyuk Dong",
title="Neural Mechanism of Cognitive Reserve in Acupuncture Stimulation: Protocol for a Randomized, Placebo-Controlled Functional Near-Infrared Spectroscopy Trial",
journal="JMIR Res Protoc",
year="2025",
month="Feb",
day="19",
volume="14",
pages="e66838",
keywords="cognitive reserve",
keywords="acupuncture",
keywords="dementia",
keywords="mild cognitive impairment",
keywords="neuroimaging",
keywords="fNIRS",
keywords="brain connectivity",
keywords="neural mechanism",
keywords="RCT",
keywords="randomized controlled trial",
abstract="Background: Dementia is a clinical syndrome characterized by a progressive decline in various cognitive domains. Since there is still no treatment for dementia, early diagnosis and prevention are the best approaches. In this context, the cognitive reserve (CR) concept has received considerable attention in dementia research with regard to prognosis. It originates from discrepancies between the degree of brain pathology and clinical manifestations. Acupuncture, as a complementary intervention, has long been widely applied in neurological diseases in East Asia. At the macroscale level, how acupuncture stimulation affects neural activity concerning CR in normal aging and dementia is largely unknown. Objective: The aim of this study is to investigate the acute neural mechanisms of acupuncture stimulation concerning CR in the normal aging group and the group with cognitive impairment using neuroimaging methods. Methods: This study is a randomized, placebo-controlled trial. Participants without (n=30) and with cognitive impairment (n=30) will be randomly assigned to the verum or sham acupuncture groups. The verum acupuncture group will receive acupuncture stimulation at acupoints related to cognitive function and gain deqi sensation. The sham acupuncture group will receive superficial needling at nonacupoints not related to cognitive function. Each group will undergo cognitive function tests, functional near-infrared spectroscopy imaging before and after acupuncture stimulation, and an assessment of CR. The primary outcomes will be differences in resting brain activities according to disease status, differences in resting brain connectivity before and after acupuncture stimulation between the 2 groups, and changes in brain activity in relation to the CR index. The secondary outcomes will be brain connectivity or network metrics associated with CR and differences in neural activity between the cognitive task and resting states. Results: The recruitment began in August 2023; to date, there have been 50 participants, divided into 20 in the group with cognitive impairment and 30 in the unimpaired group. The recruitment process will continue until February 2025. Conclusions: CR refers to the individual susceptibility to age-related brain changes and pathologies in cognitive impairment, and it is a factor affecting the trajectories of the disease. Although acupuncture is a widely used intervention for various neurological diseases, including dementia, its mechanism associated with CR at the macroscale has not been clearly identified. This study could contribute to identifying the neural mechanisms of acupuncture stimulation associated with CR using neuroimaging methods and provide a basis for future longitudinal research. Trial Registration: Clinical Research Information Service of the Republic of Korea KCT0008719; https://tinyurl.com/ydv5537n International Registered Report Identifier (IRRID): DERR1-10.2196/66838 ",
doi="10.2196/66838",
url="https://www.researchprotocols.org/2025/1/e66838"
}


@Article{info:doi/10.2196/57918,
author="Makhija, Deepa
and Mata, Sunita
and Sharma, Abha
and Kachare, Kalpana
and Manathottathil, Aparna
and Jain, Seema
and Jameela, Sophia
and Rao, Chandrasekhara Bhogavalli
and Rana, Rakesh
and Tripathi, Arunabh
and Rana, Kiran
and Joshi, Vandana
and Singh, Anukampa
and Srikanth, Narayanam
and Acharya, Rabinarayan",
title="Effectiveness of Composite Ayurveda Regimen in a Black Box Design for the Management of Rheumatoid Arthritis: Protocol of a Single Arm, Community-Based Study",
journal="JMIR Res Protoc",
year="2025",
month="Feb",
day="18",
volume="14",
pages="e57918",
keywords="rheumatoid arthritis",
keywords="Amavata",
keywords="Ayush-SG (coded drug)",
keywords="Rasnasaptak Kashaya",
abstract="Background: Rheumatoid arthritis (RA) is an autoimmune disease that affects joints and can have extra-articular manifestations. RA usually tends to be progressive and leads to substantial health care burdens, both in terms of disability and economic costs. Despite the various treatment modalities available, there is still an urgent need for safe and effective medicine based on the pattern of disease presentation. The increasing interest in complementary and alternative medicine has created a demand for extensive research in this area. Objective: This clinical study is designed to evaluate the effectiveness and tolerability of a composite Ayurveda regimen in RA. Methods: The study is a single-arm (pre-post design), community-based interventional study with a black box design being conducted at 6 study centers. A total of 240 participants aged between 18 and 65 years, diagnosed with RA as per the 2010 American College of Rheumatology and the European League Against Rheumatism criteria are recruited as per the selection criteria. All the participants received Ayush-SG and Rasnasaptak Kashaya for 84 days along with customized treatment as per the disease presentation and associated complaints. The outcome measures include the change in disease activity score (DAS)-28 with erythrocyte sedimentation rate, disease-specific biochemical and inflammatory markers, Disability Index score, change in the participant's assessment of pain and frequency of use of conventional analgesics or nonsteroidal anti-inflammatory drugs from baseline. The tolerability of interventions is assessed through the occurrence of adverse events. Categorical variables will be analyzed with McNemar chi-square test, and continuous variables will be assessed using the paired t test or Wilcoxon test for pre-post assessment. The level of significance will be 5\%. Results: The recruitment of participants was initiated in December 2023. The participant recruitment was completed in March 2024 and out of 240 participants enrolled, 222 (92.5\%) completed the study up to the last follow-up. Data verification, compilation, and analysis are under process. After data analysis, the study's findings will be published in a peer-reviewed journal. Conclusions: This interventional study that incorporates the black box approach may provide a strong framework for managing RA. This design is a more reliable method for evaluating the effectiveness and tolerability of the composite Ayurveda regimen in RA. Trial Registration: Clinical Trial Registry-India CTRI/2023/06/054203; https://tinyurl.com/4prvwr6z International Registered Report Identifier (IRRID): DERR1-10.2196/57918 ",
doi="10.2196/57918",
url="https://www.researchprotocols.org/2025/1/e57918"
}


@Article{info:doi/10.2196/63481,
author="Fu, Guojing
and Chen, Yunmeng
and Liang, Xiao
and Guo, Chunli
and Fan, Xueming
and Gong, Xiao
and Chen, Wenjie
and Teng, Jing
and Tang, Jun
and Liao, Xing
and Wei, Jingjing
and Zhang, Yunling",
title="Core Outcome Set Development for Tension-Type Headache Treatment Using Traditional Chinese Medicine: Protocol for a Delphi Consensus Study",
journal="JMIR Res Protoc",
year="2025",
month="Feb",
day="5",
volume="14",
pages="e63481",
keywords="tension-type headache",
keywords="core outcome set",
keywords="traditional Chinese medicine",
keywords="systematic review",
keywords="Delphi",
keywords="protocol",
abstract="Background: Tension-type headache (TTH) is the most common type of headache and the second most common health-related complaint among children and adults. Traditional Chinese medicine (TCM) offers unique therapeutic benefits in treating TTH. However, the lack of standardized evidence---such as inconsistencies in outcome selection and reporting in clinical studies, a lack of consensus on outcomes and measures, high risks of selective reporting bias, and missing data---has limited the development of robust evidence supporting the efficacy of TCM in treating TTH. Therefore, establishing a core outcome set (COS) is crucial for standardizing TCM clinical studies for TTH, thereby enhancing the quality and comparability of research findings. Objective: This study aims to develop a COS for future clinical studies on the treatment of TTH with TCM. Methods: The COS will be developed through the following 3 stages. First, systematic reviews and semistructured interviews will be conducted to identify potential essential outcomes, which will be evaluated by the steering committee to finalize a preliminary list of outcomes. Data will be processed using thematic analysis to ensure comprehensive coverage of relevant outcomes. Second, a 2-round Delphi survey will be conducted, inviting stakeholders, including health care experts and patients with tension-type headaches, to determine the importance of each outcome. Statistical analysis will be used to assess the level of consensus and prioritize outcomes based on predefined criteria. Third, a face-to-face consensus meeting will be held to finalize the COS and recommend measurement times for each outcome. Key outcomes will be interpreted based on their clinical relevance and feasibility of measurement, ensuring the COS is comprehensive and applicable in clinical settings. Results: The protocol has been registered in PROSPERO, with the review commencing on October 1, 2024, and anticipated results by November 15, 2024. The systematic reviews will be finalized, followed by the Delphi survey and consensus conference in late 2024 and early 2025. The COS findings will be reported per COS-STAR (Core Outcome Set--STAndards for Reporting) guidelines, published in an international journal, presented at conferences, and disseminated to participants for clinical application. Conclusions: This study is necessary as developing a COS for future TCM clinical studies in the treatment of TTH can maximize the value of data from individual trials and provide high-quality research evidence. Trial Registration: Core Outcome Measures in Effectiveness Trials Initiative 1473; https://tinyurl.com/3ts62s2p International Registered Report Identifier (IRRID): PRR1-10.2196/63481 ",
doi="10.2196/63481",
url="https://www.researchprotocols.org/2025/1/e63481"
}


@Article{info:doi/10.2196/63063,
author="Shankar KM, Pratap
and Puthan Purayil, Indu
and Binitha, Palengara
and Rai, Kumar Amit
and Jameela, Sophia
and Ahmad, Azeem
and Bhogavalli, Rao Chandra Sekhara
and Srikanth, Narayanam
and Acharya, Rabinarayan",
title="Efficacy and Safety of Murivenna Anal Infiltration Compared to Diltiazem Topical Application in Chronic Anal Fissure: Protocol for a Prospective, Randomized, Open-Label Clinical Trial",
journal="JMIR Res Protoc",
year="2025",
month="Feb",
day="3",
volume="14",
pages="e63063",
keywords="chronic anal fissure",
keywords="murivenna anal infiltration",
keywords="Ayurveda",
keywords="efficacy",
keywords="anal infiltration",
keywords="murivenna",
keywords="diltiazem",
keywords="app",
keywords="chronic",
keywords="study protocol",
keywords="randomized clinical trial",
keywords="proctologic condition",
keywords="proctologic",
keywords="pain",
keywords="quality of life",
keywords="well-being",
keywords="surgical intervention",
keywords="defecation",
keywords="cessation of bleeding",
keywords="treatment",
abstract="Background: Anal fissure is a common proctologic condition that causes significant pain and anguish to patients, significantly impacting their quality of life and well-being. There are various treatment options for anal fissure, ranging from pharmacological agents that reduce anal sphincter tone to surgical interventions for cases resistant to medical management. Ayurvedic treatments have shown potential for the therapeutic management of anal fissure. Objective: This clinical study aims to analyze the efficacy and safety of murivenna anal infiltration compared to diltiazem topical application in chronic anal fissure. Methods: This is an open-labeled, randomized, controlled parallel group clinical trial with a sample size of 66 participants to be randomized and allocated in a 1:1 ratio to 2 groups. The intervention group will be treated with murivenna anal infiltration, and the control group will be treated with topical application of diltiazem for a period of 4 weeks. The primary outcome will be the proportion of participants demonstrating complete healing after 4 weeks of treatment. The secondary outcomes will be the proportion of participants demonstrating complete healing after 7 days and 14 days of treatment, change in pain at or after defecation, cessation of bleeding, and any recurrence during the study period. Any adverse events will also be recorded during the trial period. Results: The project was funded in July 2023, and the study period is 24 months. Participant recruitment started in December 2023. As of August 2024, we have enrolled 50 participants. The data analysis will be complete by June 2025, and the results are expected to be published by August 2025. Conclusions: High recurrence rates, adverse effects, incomplete healing, and the negative impact on patients' daily activities and quality of life underscore the need for alternative therapeutic options. Ayurveda offers potential for more sustainable relief with fewer adverse effects. Murivenna oil is a time-tested medicated oil effectively used by Ayurvedic physicians for various ulcers of traumatic and pathological origin. This study will provide scientific evidence on the efficacy and safety of murivenna anal infiltration; further, it can be incorporated into the cost-effective management of chronic anal fissure. Trial Registration: Clinical Trials Registry India CTRI/2023/09/057330; https://tinyurl.com/y4ut9e8p International Registered Report Identifier (IRRID): DERR1-10.2196/63063 ",
doi="10.2196/63063",
url="https://www.researchprotocols.org/2025/1/e63063"
}


@Article{info:doi/10.2196/65471,
author="Chen, Shu-Cheng
and Lo, Kwai-Ching
and Li, Han
and Wong, Pong-Ming
and Pang, Lok-Yi
and Qin, Jing
and Yeung, Wing-Fai",
title="Parental Experiences of Administering Pediatric Tuina for Sleep and Appetite in Early School-Aged Children With Attention-Deficit/Hyperactivity Disorder: Qualitative Study in Hong Kong",
journal="JMIR Pediatr Parent",
year="2025",
month="Jan",
day="30",
volume="8",
pages="e65471",
keywords="pediatric massage",
keywords="child",
keywords="traditional Chinese medicine",
keywords="TCM",
keywords="ADHD",
keywords="qualitative study",
keywords="complementary medicine",
keywords="attention deficit",
keywords="hyperactivity",
keywords="massage",
keywords="tuina",
keywords="tui na",
keywords="mental health",
keywords="sleep",
keywords="appetite",
keywords="parent",
keywords="parenting",
keywords="interview",
keywords="focus group",
keywords="anmo",
keywords="attention-deficit/hyperactivity disorder",
abstract="Background: Previous research suggested that parent-administered pediatric tuina could improve symptoms of attention-deficit/hyperactivity disorder (ADHD), such as sleep quality and appetite. Objective: This study aimed to explore the experiences and perceptions of parents administering pediatric tuina to school-aged children with ADHD in Hong Kong. Methods: This qualitative study was embedded in a pilot randomized controlled trial on parent-administered pediatric tuina for improving sleep and appetite in school-aged children diagnosed with ADHD. Purposive sampling was used to invite 12 parents who attended a pediatric tuina training program and delivered the intervention to their children at home for at least 8 weeks. Data were collected through semistructured focus group interviews and individual interviews, which were audio-recorded, transcribed verbatim, and analyzed using thematic analysis. Results: Two main themes emerged: (1) effects of parent-administered pediatric tuina and (2) parents' experience of administering pediatric tuina. Parents reported significant improvements in children's sleep quality, appetite, behavior, mental state, and academic performance. Facilitators provided professional guidance and applied a user-friendly course design. Challenges included difficulties in mastering techniques, locating acupuncture points, and time management. Participants suggested the need for more traditional Chinese medicine pattern diagnostic sessions, real-time supervision methods, and extended follow-up to better observe long-term effects. Conclusions: Parent-administered pediatric tuina was perceived to improve children's sleep quality and appetite significantly, along with other aspects of well-being. Professional guidance and a structured training program facilitated implementation, and challenges highlighted the need for more frequent diagnostic sessions, real-time supervision, and extended follow-up. Trial Registration: ClinicalTrials.gov NCT06007742; https://clinicaltrials.gov/study/NCT06007742 ",
doi="10.2196/65471",
url="https://pediatrics.jmir.org/2025/1/e65471"
}


@Article{info:doi/10.2196/63314,
author="Zhang, Liuren
and Chu, Linchen
and Sundaram, E. Maria
and Zhou, Yi
and Sun, Xiu
and Wei, Zheng
and Fu, Chuanxi",
title="Identifying Preferred Features of Influenza Vaccination Programs Among Chinese Clinicians Practicing Traditional Chinese Medicine and Western Medicine: Discrete Choice Experiment",
journal="JMIR Public Health Surveill",
year="2025",
month="Jan",
day="20",
volume="11",
pages="e63314",
keywords="influenza vaccination program",
keywords="traditional Chinese medicine",
keywords="clinicians",
keywords="vaccine",
keywords="health care worker",
keywords="hospital-acquired",
keywords="effectiveness",
keywords="antiviral",
keywords="cross-sectional study",
abstract="Background: Achieving high vaccine coverage among clinicians is crucial to curb the spread of influenza. Traditional Chinese medicine (TCM), rooted in cultural symbols and concepts without direct parallels in modern Western medicine, may influence perspectives on vaccination. Therefore, understanding the preferences of TCM clinicians towards influenza vaccines is of great importance. Objective: To understand preferences for features of influenza vaccination programs and identify the optimal influenza vaccination program among clinicians practicing TCM and Western medicine. Methods: We conducted a discrete choice experiment with a national sample of 3085 Chinese clinicians from various hospital levels (n=1013 practicing TCM) from January to May 2022. Simulations from choice models using the experimental data generated the coefficients of preference and predicted the uptake rate of different influenza vaccination programs. Clinicians were grouped by vaccine preference classification through a latent class analysis. Results: All included attributes significantly influenced clinicians' preferences for choosing an influenza vaccination program. An approximate hypothetical 60\% increase of vaccine uptake could be obtained when the attitude of the workplace changed from ``no notice'' to ``encouraging of vaccination''; there was an approximate hypothetical 35\% increase of vaccine uptake when vaccination campaign strategies changed from ``individual appointment'' to ``vaccination in a workplace setting.'' In the entire sample, about 30\% (946/3085) of clinicians preferred free vaccinations, while 26.5\% (819/3085) comprehensively considered all attributes, except vaccination campaign strategies, when making a decision about choosing an influenza vaccination program. Clinicians who practiced TCM, worked in tertiary hospital, or had at least a postgraduate degree exhibited a lower preference for free vaccinations. Clinicians who practiced Western medicine, worked in primary hospital, or had at most a bachelor's degree had a higher preference for vaccinations in workplace settings. Conclusions: Offering a range of influenza vaccination programs targeting the preferred attributes of different clinician groups could potentially encourage more clinicians, including those practicing TCM, to participate in influenza vaccination programs. ",
doi="10.2196/63314",
url="https://publichealth.jmir.org/2025/1/e63314"
}


@Article{info:doi/10.2196/62930,
author="Bevilacqua, Roberta
and Maranesi, Elvira
and Benadduci, Marco
and Cortellessa, Gabriella
and Umbrico, Alessandro
and Fracasso, Francesca
and Melone, Giovanni
and Margaritini, Arianna
and La Forgia, Angela
and Di Bitonto, Pierpaolo
and Potenza, Ada
and Fiorini, Laura
and La Viola, Carlo
and Cavallo, Filippo
and Leone, Alessandro
and Caroppo, Andrea
and Rescio, Gabriele
and Marzorati, Mauro
and Cesta, Amedeo
and Pelliccioni, Giuseppe
and Riccardi, Renato Giovanni
and Rossi, Lorena",
title="Exploring Dance as a Therapeutic Approach for Parkinson Disease Through the Social Robotics for Active and Healthy Ageing (SI-Robotics): Results From a Technical Feasibility Study",
journal="JMIR Aging",
year="2025",
month="Jan",
day="14",
volume="8",
pages="e62930",
keywords="Parkinson disease",
keywords="rehabilitation",
keywords="Irish dancing",
keywords="balance",
keywords="gait",
keywords="socially interacting robot",
abstract="Background: Parkinson disease (PD) is a progressive neurodegenerative disorder characterized by motor symptoms. Recently, dance has started to be considered an effective intervention for people with PD. Several findings in the literature emphasize the necessity for deeper exploration into the synergistic impacts of dance therapy and exergaming for PD management. Moreover, socially engaging robotic platforms equipped with advanced interaction and perception features offer potential for monitoring patients' posture and enhancing workout routines with tailored cues. Objective: This paper presents the results of the Social Robotics for Active and Healthy Ageing (SI-Robotics) project, aimed at designing an innovative rehabilitation program targeted at seniors affected by (early-stage) PD. This study therefore aims to assess the usefulness of a dance-based rehabilitation program enriched by artificial intelligence--based exergames and contextual robotic assistance in improving motor function, balance, gait, and quality of life in patients with PD. The acceptability of the system is also investigated. Methods: The study is designed as a technical feasibility pilot to test the SI-Robotics system. For this study, 20 patients with PD were recruited. A total of 16 Irish dance--based rehabilitation sessions of 50 minutes were conducted (2 sessions per week, for 8 wks), involving 2 patients at a time. The designed rehabilitation session involves three main actors: (1) a therapist, (2) a patient, and (3) a socially interacting robot. To stimulate engagement, sessions were organized in the shape of exergames where an avatar shows patients the movements they should perform to correctly carry out a dance-based rehabilitation exercise. Results: Statistical analysis reveals a significant difference on the Performance-Oriented Mobility Assessment scale, both on balance and gait aspects, together with improvements in Short Physical Performance Battery, Unified Parkinson Disease Rating Scale--III, and Timed Up and Go test, underlying the usefulness of the rehabilitation intervention on the motor symptoms of PD. The analysis of the Unified Theory of Acceptance and Use of Technology subscales provided valuable insights into users' perceptions and interactions with the system. Conclusions: This research underscores the promise of merging dance therapy with interactive exergaming on a robotic platform as an innovative strategy to enhance motor function, balance, gait, and overall quality of life for patients grappling with PD. Trial Registration: ClinicalTrials.gov NCT05005208; https://clinicaltrials.gov/study/NCT05005208 ",
doi="10.2196/62930",
url="https://aging.jmir.org/2025/1/e62930"
}


@Article{info:doi/10.2196/46497,
author="Xian, Xuechang
and Zhang, Xiaoran
and Zheng, Danhe
and Wang, Yanlin",
title="Mental Health Benefits of Listening to Music During COVID-19 Quarantine: Cross-Sectional Study",
journal="JMIR Form Res",
year="2024",
month="Dec",
day="16",
volume="8",
pages="e46497",
keywords="COVID-19",
keywords="quarantine",
keywords="social connectedness",
keywords="sense of security",
keywords="mental well-being",
keywords="cross-sectional study",
keywords="contagion",
keywords="treatment",
keywords="music",
keywords="security",
keywords="mental health",
keywords="questionnaire",
keywords="China",
keywords="intervention",
keywords="relaxation",
keywords="meditation",
keywords="mental illness",
keywords="stimuli",
keywords="environmental",
abstract="Background: COVID-19 has posed a significant global threat to public health due to its high contagion risk and lack of effective treatment. While quarantine measures have been crucial in controlling the virus' spread, they have also contributed to negative impacts on individuals' mental health. Music listening has emerged as a potential coping mechanism, yet it remains unclear whether mental well-being varies across music preferences. Objective: This study examined individuals' music-listening preferences in the context of COVID-19 quarantine and assessed the mediation pathways linking 5 types of music to mental health levels, mediated by perceived social connectedness as well as sense of security. Methods: A web-based survey was conducted among people with quarantine experience in September 2022, in mainland China. A total of 712 valid questionnaires were returned and 596 samples were finally included in our study for mediation analysis. Results: The results revealed that the vast majority (596/623, 96\%) of respondents had music-listening experiences during the COVID-19 quarantine, with pop music emerging as the most popular preference among respondents, while quyi was the least listened-to genre. Additionally, listening to music across 5 different genres appeared as a significant parameter indirectly linked to mental health through perceived social connectedness. Specifically, engaging with quyi was associated with higher levels of perceived social connectedness and sense of security, which in turn correlated with improved mental well-being. Conversely, individuals listening to jazz reported lower social connectedness and sense of security, which was subsequently linked to increased mental health problems. The potential reasons for these findings and implications are discussed. Conclusions: This study significantly contributes to the understanding of the mechanisms behind music-listening preferences in stressful environments. Specifically, our findings highlight the mediating roles of perceived social connectedness and sense of security in the relationship between music preferences and mental health outcomes during the quarantine period. These insights provide valuable guidance for developing interventions that use music to enhance mental health, thereby broadening the scope of studies on environmental stimuli and their impact on mental well-being. ",
doi="10.2196/46497",
url="https://formative.jmir.org/2024/1/e46497"
}


@Article{info:doi/10.2196/60283,
author="Muenster, Mika Roxana
and Gangi, Kai
and Margolin, Drew",
title="Alternative Health and Conventional Medicine Discourse About Cancer on TikTok: Computer Vision Analysis of TikTok Videos",
journal="J Med Internet Res",
year="2024",
month="Dec",
day="9",
volume="26",
pages="e60283",
keywords="misinformation",
keywords="social media",
keywords="TikTok",
keywords="alternative health",
keywords="cancer",
keywords="computer vision",
abstract="Background: Health misinformation is abundant online and becoming an increasingly pressing concern for both oncology practitioners and patients with cancer. On social media platforms, including the popular audiovisual app TikTok, the flourishing alternative health industry is further contributing to the spread of misleading and often harmful information, endangering patients' health and outcomes and sowing distrust of the medical community. The prevalence of false and potentially dangerous treatments on a platform that is used as a quasi--search engine by young people poses a serious risk to the health of patients with cancer. Objective: This study seeks to examine how cancer discourse on TikTok differs between alternative health and conventional medicine videos. It aims to look beyond mere facts and falsehoods that TikTok users may utter to understand the visual language and format used in the support of both misleading and truthful narratives, as well as other messages. Methods: Using computer vision analysis and subsequent qualitative close reading of 831 TikTok videos, this study examined how alternative health and conventional medicine videos on cancer differ with regard to the visual language used. Videos were examined for the length of time and prominence in which faces are displayed, as well as for the background setting, location, and dominant color scheme. Results: The results show that the alt-health and conventional health samples made different use of the audiovisual affordances of TikTok. First, videos from the alternative health sample were more likely to contain a single face that was prominently featured (making up at least 7.5\% of the image) for a substantial period of time (35\% of the shots), with these testimonial-style videos making up 28.5\% (93/326) of the sample compared to 18.6\% (94/505) of the conventional medicine sample. Alternative health videos predominantly featured cool tones (P<.001) and were significantly more likely to be filmed outdoors (P<.001), whereas conventional medicine videos were more likely to be shot indoors and feature warm tones such as red, orange, or yellow. Conclusions: The findings of this study contribute to an increased understanding of misinformation as not merely a matter of individual falsehoods but also a phenomenon whose effects might be transported through emotive as well as rational means. They also point to influencer practices and style being an important contributing factor in the declining health of the information environment around cancer and its treatment. The results suggest that public health efforts must extend beyond correcting false statements by injecting factual information into the online cancer discourse and look toward incorporating both visual and rational strategies. ",
doi="10.2196/60283",
url="https://www.jmir.org/2024/1/e60283"
}


@Article{info:doi/10.2196/63281,
author="Gaba, Ann
and Bennett, Richard",
title="Health-Related Messages About Herbs, Spices, and Other Botanicals Appearing in Print Issues and Websites of Legacy Media: Content Analysis and Evaluation",
journal="JMIR Form Res",
year="2024",
month="Dec",
day="4",
volume="8",
pages="e63281",
keywords="legacy media",
keywords="health applications",
keywords="health communication",
keywords="botanical products",
keywords="content analysis",
abstract="Background: Legacy media are publications that existed before the internet. Many of these have migrated to a web format, either replacing or in parallel to their print issues. Readers place an economic value on access to the information presented as they pay for subscriptions and place a higher degree of trust in their content. Much has been written about inaccurate and misleading health information in social media; however, the content and accuracy of information contained in legacy media has not been examined in detail. Discussion of herbs, spices, and other botanicals has been absent from this context. Objective: The objectives of this study were to (1) identify the health associations of botanical products mentioned in legacy media targeted to a range of demographic groups and (2) evaluate these health associations for accuracy against published scientific studies. Methods: In total, 10 popular magazines targeting a range of gender, race/ethnicity, and sexual orientation demographic groups were selected for analysis. Relevant content was extracted and coded over 1 year. Associations between specific botanical products and health factors were identified. For the most frequent botanical--health application associations, a PubMed search was conducted to identify reviews corresponding to each item's indicated applications. Where no systematic reviews were available, single research studies were sought. Results: A total of 237 unique botanical products were identified. There were 128 mentions of these in the print issues and 1215 on the websites. In total, 18 health applications were identified and used to categorize the indicated uses for the various products individually and as general categories. The most frequently mentioned applications were skin care, with 913 mentions, immunity enhancement, with 705 mentions, gastrointestinal health and probiotics, with 184 mentions, and cognitive function (stress and mental health), with 106 mentions. Comparison to published literature evaluating the efficacy of these functions identified positive support for aloe vera, argan oil, chamomile, jojoba oil, lavender, rosemary, and tea tree oil in skin care. Berries, ginger, turmeric, and green tea had the strongest evidence for a role in immunity enhancement. Ginger and oats were supported as having a role in gastrointestinal health. Finally, berries, lavender, ashwagandha, and cannabidiol were supported as having a role in managing stress. Other frequently mentioned items such as aloe vera, ashwagandha, or mushrooms for immunity were less strongly supported. Conclusions: Comparison of the most prevalent associations between botanical products and health applications to published literature indicates that, overall, these associations were consistent with current scientific reports about the health applications of botanical products. While some products had a greater degree of research support than others, truly egregious falsehoods were absent. Therefore, legacy media may be considered a credible source of information to readers about these topics. ",
doi="10.2196/63281",
url="https://formative.jmir.org/2024/1/e63281"
}


@Article{info:doi/10.2196/66430,
author="Peng, L. Mary
and Monin, Joan
and Ovchinnikova, Polina
and Levi, Amanda
and McCall, Terika",
title="Psychedelic Art and Implications for Mental Health: Randomized Pilot Study",
journal="JMIR Form Res",
year="2024",
month="Dec",
day="3",
volume="8",
pages="e66430",
keywords="digital art",
keywords="mental health",
keywords="psychedelic art",
keywords="well-being",
keywords="pilot trial",
keywords="digital health tool",
keywords="art therapy",
abstract="Background: Psychedelic art (PA) emerged in the 1960s during the psychedelic era; then characterized by visuals induced by the ingestion of psychedelic drugs, it is now an art form known for its vibrant colors, distorted forms, and intricate patterns. Building upon the existing research on art viewing as an effective means to improving physiological and psychological well-being, viewing PA is postulated to evoke positive emotions and provide a meditative experience, contributing to improved mental well-being. Objective: This study aims to investigate how digitally rendered PA influences viewers' perceived emotional, mental, and physical states compared to imagery of natural scenery, offering insights into potential applications in mental health care and well-being. Methods: Overall, 102 participants age 18 to 35 years were randomly assigned to either the experimental group viewing 300 seconds of PA imagery (50/102, 49\%) or the control group viewing 300 seconds of scenic imagery (52/102, 51\%), after which every participant completed a survey that gathered qualitative data on the perceived impact of viewing their given imagery on their physical, mental, and emotional states through open-ended questions. Thematic analysis was conducted to identify the patterns of experiences reported by the participants. Results: Qualitative analysis unveiled a greater intensity and diversity of emotional, mental, and physical impacts induced by PA compared to natural scenery, including the sense of relaxation and peace, anxiety and stress alleviation, joy, thrill and sense of euphoria, sensations of awe and wonder, hypnotizing effect, holistic meditative effect, provocation of creative thoughts, induced hyperawareness of bodily states, and transitions from induced overstimulation or anxious thoughts to feelings of calmness. Conclusions: The preliminary findings of this study suggest that PA is a rich and complex form of visual art that has the potential to facilitate healing and promote well-being and mental health. PA presents promising avenues for integration into mental health care, therapeutic practices, digital health, health care environment, and medical research. ",
doi="10.2196/66430",
url="https://formative.jmir.org/2024/1/e66430"
}


@Article{info:doi/10.2196/49328,
author="Zhou, Weiqiang
and Liu, Dongliang
and Yi, Zhaoxu
and Lei, Yang
and Zhang, Zhenming
and Deng, Yu
and Tan, Ying",
title="Web-Based Platform for Systematic Reviews and Meta-Analyses of Traditional Chinese Medicine: Platform Development Study",
journal="JMIR Form Res",
year="2024",
month="Nov",
day="22",
volume="8",
pages="e49328",
keywords="evidence-based medicine",
keywords="information science",
keywords="medical librarian",
keywords="web development",
keywords="web design",
keywords="meta-analysis",
keywords="traditional Chinese medicine",
keywords="systematic review",
keywords="review methodology",
keywords="Chinese medicine",
keywords="traditional medicine",
abstract="Background: There are many problems associated with systematic reviews of traditional Chinese medicine (TCM), such as considering ``integrated traditional Chinese and Western medicine'' or treatment methods as intervention measures without considering the differences in drug use, disregarding dosage and courses of treatment, disregarding interindividual differences in control groups, etc. Classifying a large number of heterogeneous intervention measures into the same measure is easy but results in inaccurate results. In April 2023, Cochrane launched RevMan Web to digitalize systematic reviews and meta-analyses. We believe that this web-based working model helps solve the abovementioned problems. Objective: This study aims to (1) develop a web-based platform that is more suitable for systematic review and meta-analysis of TCM and (2) explore the characteristics and future development directions of this work through the testing of digital workflow. Methods: We developed TCMeta (Traditional Chinese Medicine Meta-analysis)---a platform focused on systematic reviews of TCM types. All systematic review--related work can be completed on the web, including creating topics, writing protocols, arranging personnel, obtaining literature, screening literature, inputting and analyzing data, and designing illustrations. The platform was developed using the latest internet technology and can be continuously modified and updated based on user feedback. When screening the literature on the platform, in addition to the traditional manual screening mode, the platform also creatively provides a query mode where users input keywords and click on Search to find literature with the same characteristics; this better reflects the objectivity of the screening with higher efficiency. Productivity can be improved by analyzing data and generating graphs digitally. Results: We used some test data in TCMeta to simulate data processing in a systematic review. In the literature screening stage, researchers could rapidly screen 19 sources of literature from among multiple sources with the manual screening mode. This traditional method could result in bias due to differences in the researchers' cognitive levels. The query mode is much more complex and involves inputting of data regarding drug compatibility, dosage, syndrome type, etc; different query methods can yield very different results, thus increasing the stringency of screening. We integrated data analysis tools on the platform and used third-party software to generate graphs. Conclusions: TCMeta has shown great potential in improving the quality of systematic reviews of TCM types in simulation tests. Several indicators show that this web-based mode of working is superior to the traditional way. Future research is required to focus on validating and refining the performance of TCMeta, emphasizing the ability to handle complex data. The system has good scalability and adaptability, and it has the potential to have a positive impact on the field of evidence-based medicine. ",
doi="10.2196/49328",
url="https://formative.jmir.org/2024/1/e49328"
}


@Article{info:doi/10.2196/60942,
author="Chun, Elizabeth
and Joseph, Richard
and Pojednic, Rachele",
title="Whole-Body Cryotherapy Reduces Systemic Inflammation in Healthy Adults: Pilot Cohort Study",
journal="Interact J Med Res",
year="2024",
month="Nov",
day="22",
volume="13",
pages="e60942",
keywords="cold therapy",
keywords="C-reactive protein",
keywords="fasting glucose",
keywords="HbA1c",
keywords="inflammation",
keywords="lipid metabolism",
keywords="whole-body cryotherapy",
keywords="cryotherapy",
keywords="retrospective",
keywords="reactive protein",
keywords="biomarker",
keywords="adult",
keywords="systemic inflammation",
abstract="Background: Chronically elevated inflammation is implicated in many conditions, including obesity, metabolic syndrome, and cardiovascular disease, and has been associated with increased mortality risk. Whole-body cryotherapy (W-BC) is a promising modality to treat inflammation with demonstrated benefits for clinical subpopulations including those with arthritis, obesity, and type 2 diabetes. However, it is unclear whether the benefit from W-BC extends to healthy individuals prior to chronic disease--related inflammation. In addition, the long-term durability of W-BC effect is unknown. Objective: This study investigates the inflammatory response to W-BC in healthy adults with a biomarker of inflammation, high-sensitivity C-reactive protein (hsCRP), and clinical biomarkers of metabolism including fasting glucose, hemoglobin A1c (HbA1c), low-density lipoprotein (LDL) and high-density lipoprotein (HDL), and triglycerides. Methods: Fifteen individuals (n=9 female) participated in frequent recreational W-BC (3 minutes of cold exposure at --110 {\textcelcius}) over approximately 9 months and had blood draws at baseline plus follow-up visits. Biomarkers were modeled as linear functions of W-BC sessions received in the month prior to blood draw. Results: The mean amount of W-BC received was 6.78 (SD 4.26) times per month with the cumulative total ranging from 13 to 157 W-BC sessions over the course of the study. On average, participants completed 1-2 sessions per week throughout the intervention. The number of W-BC sessions were associated with decreased hsCRP (--0.14 mg/L in hsCRP per W-BC session; P<.01) and with durability of up to 9 months. Increased W-BC was also associated with a downward trend in fasting glucose. This trend failed to reach significance at 1 month (--0.73 mg/dL in fasting glucose per W-BC session; P<.10) but was significant for 2- and 3-month windows (P<.05). HbA1c was increased significantly after 9 months (P<.01); however, the change occurred within normal ranges (difference=0.13\% and <5.7\%) and was not clinically significant. There was no association between W-BC and LDL cholesterol, HDL cholesterol, or triglycerides (P>.10), although LDL trended lower over the time period examined (P=.07). Conclusions: These results suggest that W-BC beneficially impacts systemic inflammation by lowering hsCRP levels in healthy individuals and may also have some modulating effect on fasting glucose. ",
doi="10.2196/60942",
url="https://www.i-jmr.org/2024/1/e60942",
url="http://www.ncbi.nlm.nih.gov/pubmed/39576692"
}


@Article{info:doi/10.2196/51833,
author="Yewale, Prasad
and Rathi, Renu
and Mate, Swapnali",
title="Study to Evaluate the Comparative Efficacy of Medhya Rasayana (Pharmacological) Versus Nonpharmacological Interventions in Management of Gadget Addiction in Children: Protocol for Parallel, Triple-Arm, Randomized Clinical Trial",
journal="JMIR Res Protoc",
year="2024",
month="Nov",
day="11",
volume="13",
pages="e51833",
keywords="addiction",
keywords="Ayurveda",
keywords="gadget addiction",
keywords="children",
keywords="Kaumarbhritya",
keywords="Medhya Rasayana",
keywords="yoga",
keywords="complementary and alternative medicine",
abstract="Background: Gadget addiction is a common behavioral problem among children. It is known to hamper social and academic life as well as adversely affect the lives of children. Ayurveda offers many therapeutic modalities and Ayurvedic medicines that can be used in the management of gadget addiction in children. The purpose of this study is to evaluate and compare the effectiveness of nonpharmacological therapies and the pharmaceutical intervention Medhya Rasayana in treating childhood gadget addiction. Objective: This study aims to provide a detailed description of the study methodology that will be used to compare the efficacy of nonpharmacological versus pharmaceutical interventions in the treatment of children's gadget addiction. Methods: A randomized, parallel, triple-arm interventional study will be conducted on diagnosed participants of gadget addiction with an age group of 6- to 16-year-old children, which will be selected and equally distributed in 2 groups. Group P will be given Medhya Rasayana (pharmacological intervention), group N will be nonpharmacological Ayurveda intervention, and group C (cognitive behavioral therapy) will be an external group. The Study duration is 180 days with assessment at baseline, midpoint, and endpoint Appropriate statistical techniques, such as ANOVA and regression analysis, will be used to examine the data and evaluate the efficacy of the 3 groups' interventions. We will perform subgroup analysis according to initial addiction severity, gender, and age. Primary outcome measures include a reduction in gadget addiction and changes in the psychosocial well-being of participants. Standardized questionnaires and instruments will be used to collect data. Results: In December 2023, the randomized controlled study got underway. Since participants may begin at any time, our goal is for everyone to be finished by December 2024. Conclusions: This research will provide crucial new information about the relative effectiveness of Ayurveda nonpharmacological therapies and Medhya Rasayana in treating children's gadget addiction. The results will guide evidence-based treatments aimed at reducing the negative impact of excessive gadget use on this susceptible population's psychosocial development. In the end, the findings are meant to help policy makers and medical professionals create sensible plans to deal with the rising issue of childhood gadget addiction. International Registered Report Identifier (IRRID): PRR1-10.2196/51833 ",
doi="10.2196/51833",
url="https://www.researchprotocols.org/2024/1/e51833"
}


@Article{info:doi/10.2196/58186,
author="Mundada, Pallavi
and Makhija, Deepa
and Mata, Sunita
and Kachare, Kalpana
and Manathottathil, Aparna
and Sharma, Abha
and Rao, Sekhara Bhogavalli Chandra
and Rana, Rakesh
and Tripathi, Arunabh
and Rana, Kiran
and Joshi, Vandana
and Raturi, Ashish
and Singh, Anukampa
and Srikanth, N.
and Acharya, Rabinarayan",
title="Effectiveness of Ayush Rasayana A and B on the Quality of Life of Older Adults: Protocol for a Cluster Randomized Controlled Trial",
journal="JMIR Res Protoc",
year="2024",
month="Nov",
day="11",
volume="13",
pages="e58186",
keywords="Ayush Rasayana A",
keywords="Ayush Rasayana B",
keywords="cluster-randomized trial",
keywords="geriatrics",
keywords="Ayurveda",
keywords="quality of life",
keywords="complementary and alternative medicine",
abstract="Background: With advancing age among older adults, the associated debilities increase, indicating a deteriorating health status as there is a gradual loss of muscle mass, strength, and functionality. Ayush Rasayana A and B are coded Ayurvedic medicines developed from herbal extracts. This study has been planned to prevent debilitating conditions and improve the quality of life (QOL) in older adults. Objective: This study aimed to assess the effectiveness of Ayush Rasayana A and B on the QOL, quality of sleep, and functionality of older adults, along with the tolerability of the intervention. Methods: This was a multicenter, open-label, cluster randomized controlled trial conducted with 720 participants aged 60 to 75 years. The participants were divided into 2 groups (intervention and control), with both receiving Ayurvedic ancillary treatment for 3 months. The intervention group additionally received 10 g of Ayush Rasayana A orally once daily at bedtime for 6 days, followed by 1.5 g of Ayush Rasayana B orally twice daily before food for the remaining 84 days. The assessment criteria included the Older People's Quality of Life Questionnaire Brief, Katz Index of Independence in Activities of Daily Living, Pittsburgh Sleep Quality Index, Five Times Sit-to-Stand Test, and shoulder and scapular movements. Any change in hematological and biochemical parameters and occurrence of treatment-emergent adverse events were also assessed during the study period. Results: The recruitment of the participants started in December 2023, and the final follow-up was completed in April 2024. Out of the total 720 enrolled participants, 686 (95.3\%) completed the study up to the last follow-up. Conclusions: This study may provide evidence-based data to establish preventive treatment protocols for enhancing the QOL and functionality among older adults. The study results may also be helpful for the planning of interdisciplinary health policies for improving the health conditions of different populations International Registered Report Identifier (IRRID): DERR1-10.2196/58186 ",
doi="10.2196/58186",
url="https://www.researchprotocols.org/2024/1/e58186"
}


@Article{info:doi/10.2196/55870,
author="Shi, JiaNi
and Li, Peiqi
and Wu, Yifan
and Li, Jiawei
and Zhang, Yuchen
and Xiao, Bin",
title="Efficacy of Electroacupuncture in the Treatment of Mild to Moderate Female Stress Urinary Incontinence: Protocol for a Systematic Review and Network Meta-Analysis",
journal="JMIR Res Protoc",
year="2024",
month="Nov",
day="4",
volume="13",
pages="e55870",
keywords="stress urinary incontinence",
keywords="electroacupuncture",
keywords="drugs",
keywords="pelvic floor muscle training",
keywords="systematic review",
keywords="network meta-analysis",
abstract="Background: Stress urinary incontinence (SUI), the most common form of urinary incontinence, is a condition that affects many women. It is characterized by involuntary urine leakage during activities that increase abdominal pressure, such as sneezing, coughing, or physical exertion, according to the International Continence Society. SUI affects patients' quality of life and causes depression and emotional disorders, which negatively influences physical and mental health. The participants in the studies in this review comprised women with mild to moderate SUI, because there are more female patients than male patients, and most patients with severe SUI are treated surgically. Moreover, after retrieval, there were no systematic reviews or network meta-analyses (NMAs) of conservative treatments, such as electroacupuncture (EA), in women with mild to moderate SUI. Objective: This study aims to investigate the efficacy of electroacupuncture among women with mild to moderate SUI using an NMA. Methods: Randomized clinical trials related to conservative treatments for SUI will be searched in 5 English and 3 Chinese literature databases: EMBASE, PubMed, Cochrane, Web of Science, ClinicalTrials.gov, Chinese National Knowledge Infrastructure (CNKI), WanFang, and the Chinese BioMedical Literature Database. The search period for these 8 electronic databases will be from 2002 to 2022. The PROSPERO database and the International Platform of Registered Systematic Review and Meta-Analysis Protocols (INPLASY) database will also be searched. Two reviewers will independently complete the research selection. After screening the studies, 2 other researchers will extract the data, and the quality of the included studies will be evaluated according to the quality standards specified in the Cochrane Collaboration Tool (version 2). The primary outcomes will be the change in urine leakage determined by a 1-hour pad test and International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF) scores at baseline and at the conclusion of the follow-up. The secondary outcomes will be 72-hour incontinence episodes, residual bladder volume, effective rate, urodynamic indexes, and other reported measurements. Stata (version 14.0; StataCorp) and Review Manager (RevMan version 5.3; Cochrane) will be implemented for data synthesis and meta-analysis. Results: The results are not yet accessible because this is a protocol for a systematic review and meta-analysis. The protocol was registered on INPLASY on February 22, 2023. By April 6, 2023, we had completed the literature search of the 8 databases and completed the selection and data extraction of the articles. Conclusions: The results of this systematic review will demonstrate the efficacy of EA among women with mild to moderate SUI. The results will provide evidence for clinicians and guideline makers to choose suitable treatments for SUI. Trial Registration: International Platform of Registered Systematic Review and Meta-Analysis Protocols (INPLASY) 202320098; https://inplasy.com/inplasy-2023-2-0098/ International Registered Report Identifier (IRRID): DERR1-10.2196/55870 ",
doi="10.2196/55870",
url="https://www.researchprotocols.org/2024/1/e55870"
}


@Article{info:doi/10.2196/56869,
author="Farapti, Farapti
and Putri, Amara Sheila
and Furqonia, Wulida Annisaa
and Rejeki, Sri Purwo
and Miftahussurur, Muhammad",
title="High Potassium Diet Rich in Spices and Herbs-Salt Substitution (HPSH-SS) for Blood Pressure Reduction in Older Adults: Protocol for Diet Concept and Randomized Controlled Trial",
journal="JMIR Res Protoc",
year="2024",
month="Oct",
day="29",
volume="13",
pages="e56869",
keywords="sodium",
keywords="potassium",
keywords="spices and herbs",
keywords="blood pressure",
keywords="hypertension",
keywords="elderly",
keywords="vascular",
keywords="kidney",
keywords="gerontology",
keywords="aging",
keywords="protocol study",
keywords="dietary",
keywords="phytochemical",
keywords="anti-hypertensive",
keywords="Indonesia",
keywords="molecular mechanism",
keywords="control group",
keywords="oxidative stress",
abstract="Background: Hypertension increases with age, often due to high sodium (Na) and low potassium (K) intake. Reducing salt and increasing K intake is challenging, especially for older adults due to taste preferences. Culinary herbs and spices, rich in K, offer a potential solution. The High Potassium Diet Rich in Spices and Herbs-Salt Substitution (HPSH-SS) diet has not yet been studied for its effectiveness in lowering blood pressure. Objective: This study aims to create an HPSH-SS diet, analyze its effects on blood pressure in older adults, and study the molecular mechanism occurring in the kidneys and blood vessels influenced by this diet. Methods: This study consists of 2 phases. The first phase involved formulating and assessing the HPSH-SS diet tailored for older adults. The intervention group (IG) received a diet of 1800 kcal/day, with 3500 mg K and 1500 mg Na, while the control group (CG) received 1500 mg K and 2000 mg Na. The diet was administered for 14 days and standardized using the NutriSurvey program and biochemistry analysis by atomic absorbance spectrophotometry (AAS). The second phase was a 14-day parallel randomized controlled trial (RCT) with the older adult participants divided into IG and CG. Primary outcomes included blood pressure; serum potassium; aldosterone; F2 isoprostane; nitric oxide plasma levels; and urine analysis of Na, K, and the Na/K ratio. Confounding variables were controlled through randomization and stratified analysis. Results: The menu formulation and organoleptic assessment of the HPSH-SS diet began in mid-2022 and was approved by the Ethics Committee of the Faculty of Public Health at Universitas Airlangga (78/EA/KEPK/2022) on May 11, 2022. The diet was standardized to achieve daily nutritional values of 1800 kcal energy, 3500 mg K, and 1500 mg Na. K and Na contents were analyzed using AAS from several participants' spice diet menus. Recruitment for the RCT started in March 2023, with approval from the Health Research Ethics Committee Universitas Airlangga School of Medicine, Surabaya (35/EC/KEPK/FKUA/2023). The study was registered from February 9, 2023, to February 9, 2024. Between March and June 2023, 64 participants were recruited, with 32 participants in the IG and CG. The intervention and data collection will take place over 1 year. Data management is in progress, and data analysis is yet to be performed. Conclusions: This RCT protocol hypothesizes that the diet will increase serum K, plasma aldosterone, and nitric oxide levels; decrease plasma F2 isoprostane; increase urinary Na and K levels; lower the urinary Na/K ratio; and reduce systolic and diastolic blood pressure. If effective, it will offer valuable insights into dietary strategies for blood pressure regulation in older adults. International Registered Report Identifier (IRRID): DERR1-10.2196/56869 ",
doi="10.2196/56869",
url="https://www.researchprotocols.org/2024/1/e56869",
url="http://www.ncbi.nlm.nih.gov/pubmed/39470696"
}


@Article{info:doi/10.2196/55792,
author="Ruela, Oliveira Ludmila
and Moura, Castro Caroline de
and Shieu, Bianca
and Cho, Yu-Min
and Yeh, Hsing Chao
and Pimentel, Fernandes Franklin
and Stefanello, Juliana",
title="Auricular Therapy to Control Pain in Women With Breast Cancer: Protocol for Systematic Review and Meta-Analysis",
journal="JMIR Res Protoc",
year="2024",
month="Oct",
day="15",
volume="13",
pages="e55792",
keywords="breast neoplasms",
keywords="cancer pain",
keywords="pain",
keywords="auricular acupuncture",
keywords="auricular therapy",
keywords="systematic review",
keywords="meta-analysis",
abstract="Background: The increased incidence of breast cancer implies the appearance of frequent symptoms associated with disease and treatments, such as pain. For the management of this issue, auricular therapy has been used in a complementary manner, especially for its safety and analgesic action. Objective: This systematic review aims to summarize available evidence on the effects of auricular therapy on pain in women undergoing breast cancer treatment. Methods: This is a systematic review that includes randomized controlled trials that evaluated the effects of auricular therapy on pain in women with breast cancer, as compared with other interventions (sham or placebo auricular therapy, other nonpharmacological interventions, and routine pain treatments) during the treatment of the disease. Pain, whether induced or not by cancer treatments, is the main outcome to be evaluated. The search for the studies was performed in the following databases: MEDLINE through PubMed, CINAHL, CENTRAL, Embase, Web of Science, Scopus, VHL, TCIM Americas Network, CNKI, and Wanfang Data. The reviewers have independently evaluated the full texts, and in the near future, they will extract the data and assess the risk of bias in the included studies. The certainty of the evidence will be assessed using the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE), and a meta-analysis will be carried out to evaluate the intervention, considering the homogeneity of the results, using the Cochran Q test and quantified by the Higgins inconsistency index. The guidelines of the PRISMA-P (Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols) have been respected in the elaboration of this protocol. Results: The records screening stage has been completed, and the synthesis and meta-analysis were conducted in February 2024. We hope to have finished the preparation of the paper for publication by September 2024. Review reporting will follow standard guidelines for reporting systematic reviews. The results will be published in peer-reviewed scientific journals. Conclusions: This review will compile the strength of evidence for the use of auricular therapy in the management of pain in women with breast cancer during the treatment of the disease, identifying gaps in the available evidence as well as assisting health professionals in indicating the intervention for clinical practice. Trial Registration: PROSPERO CRD42022382433; https://www.crd.york.ac.uk/prospero/display\_record.php?RecordID=382433 International Registered Report Identifier (IRRID): DERR1-10.2196/55792 ",
doi="10.2196/55792",
url="https://www.researchprotocols.org/2024/1/e55792"
}


@Article{info:doi/10.2196/57888,
author="Liao, Yi-Fang
and Lee, Yu-Chen
and Lin, Hui-Ju
and Shao, Yi-Ching",
title="Acupuncture as Adjuvant Therapy for Glaucoma: Protocol for a Randomized Controlled Trial",
journal="JMIR Res Protoc",
year="2024",
month="Oct",
day="8",
volume="13",
pages="e57888",
keywords="acupuncture",
keywords="open-angle glaucoma",
keywords="optical coherence tomography",
keywords="intraocular pressure",
keywords="glaucoma",
keywords="adjuvant therapy",
keywords="optic neuropathy",
keywords="disease progression",
keywords="ophthalmic disorders",
keywords="optic",
keywords="conventional treatment",
keywords="efficacy",
keywords="adjunctive therapy",
abstract="Background: Glaucoma is a chronic progressive optic neuropathy that necessitates lifelong treatment to reduce the decline of the optic nerve. Due to the extended and continuous treatments required for patients, complementary therapies are often considered alongside conventional treatments to enhance the effectiveness of the treatment. Acupuncture has demonstrated the potential to lower intraocular pressure in previous clinical trials, making it a promising glaucoma intervention. Objective: The primary objective of this study is to conduct a single-center randomized control trial involving patients with glaucoma. Acupuncture will be evaluated as an adjunctive therapy. The trial aims to explore its effectiveness for glaucoma. Methods: In this single-center randomized controlled trial, participants (N=50) with primary open-angle glaucoma will be randomly assigned to the treatment group, receiving ophthalmic acupuncture with ``De Qi'' sensation, or the control group, receiving minimum acupuncture stimulation on nonophthalmic acupoints. The intervention will consist of weekly acupuncture treatments for a total of 6 sessions. Participants will be assessed at 8 time points, which are baseline, during the intervention (6 times), and at a 3-month follow-up. The primary outcome measure is a change in the intraocular pressure before and after each acupuncture treatment. Secondary outcomes will include measurements of heart rate and blood pressure before and after acupuncture, best-corrected visual acuity, visual field, optical coherence tomography, optical coherence tomography angiography, the Glaucoma Symptom Scale, and the Glaucoma Quality of Life-15 questionnaire. Results: Recruitment of participants for the trial commenced on June 28, 2023. A total of 10 participants have been enrolled to test the feasibility of the experiment. We anticipate that the preliminary data from this trial will be completed by December 2025. Conclusions: This trial uses rigorous methodology and comprehensive outcome measurements to assess the clinical efficacy of acupuncture as an adjunctive therapy for glaucoma, providing valuable insights for future clinical treatment guidelines. Trial Registration: ClinicalTrials.gov NCT05753137; https://clinicaltrials.gov/study/NCT05753137 International Registered Report Identifier (IRRID): DERR1-10.2196/57888 ",
doi="10.2196/57888",
url="https://www.researchprotocols.org/2024/1/e57888",
url="http://www.ncbi.nlm.nih.gov/pubmed/39378079"
}


@Article{info:doi/10.2196/63852,
author="Jiang, Changzheng
and Huang, Hongye
and Chen, Lechun
and Jiang, Jingjing
and Zhang, Huanzhen
and Chen, Jincheng
and Chen, Shuijin
and Lin, Zhigang",
title="Functional Magnetic Resonance Imaging Analysis of the Clinical Effect and Cerebral Mechanism of Tuina in Lumbar Disc Herniation: Protocol for a Randomized Controlled Parallel Group Trial",
journal="JMIR Res Protoc",
year="2024",
month="Sep",
day="30",
volume="13",
pages="e63852",
keywords="fMRI",
keywords="functional magnetic resonance imaging",
keywords="lumbar disc herniation",
keywords="Tuina",
keywords="traction",
keywords="transcutaneous electrical nerve stimulation",
keywords="cerebral mechanism",
abstract="Background: Lumbar disc herniation (LDH) has become a serious public health and socioeconomic problem. Tuina is a Chinese medicine treatment method based on meridian acupuncture theory and modern anatomy. Tuina can relieve pain and muscle tension and improve functional disorders; this massage is performed by pressing, kneading, pushing, pulling, and shaking the skin, muscles, and bones. However, the mechanism of action and the effect of Tuina as an external treatment on the activities of the central nervous system to relieve LDH pain is unclear. Therefore, we performed functional magnetic resonance imaging (fMRI), which is widely used in pain-related research, as it can detect the effects of different types of pain on brain activity. Objective: Our randomized controlled parallel-group trial aims to compare the effects of Tuina with those of transcutaneous electrical nerve stimulation (TENS) with traction in patients with LDH. Methods: This trial will be conducted between May 2024 and April 2025 in the Rehabilitation Hospital affiliated to Fujian University of Traditional Chinese Medicine. Seventy-six participants with LDH will be enrolled for this trial and randomly assigned to 2 groups: Tuina intervention group and TENS with traction intervention group. Participants in both groups will receive treatment for 14 days. fMRI will be performed for the main pain measurements by assessing the effect of the intervention on brain activity before and after the end of the intervention. Short-Form McGill Pain Questionnaire, pressure pain thresholds, and the Oswestry disability index will be used to reflect the degree of pain and lumbar dysfunction, and the results will be used as secondary outcome measurements. Results: The study protocol has been approved by the ethics review committee of The Rehabilitation Hospital affiliated to Fujian University of Traditional Chinese Medicine. This study was registered on May 1, 2024, with the Chinese Clinical Trial Registry. Data collection began on May 2024 and is expected to end on April 2025. Currently, data from this trial are in the collection phase, and no data analysis has been performed. As of July 1, 2024, we have collected data from 21 patients. The results of this trial are expected to be submitted for publication in September 2025. Conclusions: This clinical trial will compare the effectiveness of Tuina with that of TENS with traction in the treatment of patients with LDH and will show the cerebral mechanism of Tuina in LDH treatment by using fMRI. The results of our trial will be helpful in clarifying the cerebral mechanism of Tuina in the treatment of LDH and provide a solid foundation for Tuina therapy research. Trial Registration: Chinese Clinical Trial Registry ChiCTR2400083784; https://www.chictr.org.cn/showproj.html?proj=225157 International Registered Report Identifier (IRRID): DERR1-10.2196/63852 ",
doi="10.2196/63852",
url="https://www.researchprotocols.org/2024/1/e63852"
}


@Article{info:doi/10.2196/56063,
author="Mata, Shweta
and Rajput, Shivshankar
and Tuli, Preet Isha
and Mundada, Pallavi
and Gupta, Bharti
and Srikanth, Narayanam
and Acharya, Rabinarayanan",
title="Ayurveda Management of Allergic Rhinitis: Protocol for a Randomized Controlled Trial",
journal="JMIR Res Protoc",
year="2024",
month="Sep",
day="25",
volume="13",
pages="e56063",
keywords="allergic rhinitis",
keywords="AR",
keywords="Anu Taila Nasya",
keywords="fluticasone propionate nasal spray",
keywords="Naradiya Laxmivilas Rasa",
keywords="randomized controlled trial",
keywords="Shrishadi Kwath",
abstract="Background: Allergic rhinitis (AR) is the inflammation of the membranes lining the nose due to allergen exposure and is characterized by sneezing, nasal congestion, itching of the nose, or postnasal discharge. The prevalence varies worldwide, perhaps due to the geographic and aeroallergen differences, with 10\% to 30\% of the world's population experiencing AR. In this study, Anu Taila Nasya, Naradiya Laxmivilas Rasa, and Shirishadi Kwath will be compared to a fluticasone nasal spray. Objective: The primary aim is to assess the efficacy of Ayurvedic management for AR (or vataja pratishyaya) by comparing it to a conventional control group. The secondary aims are to determine the mean change in the nasal endoscopy index and the mean change in the laboratory tests. Methods: This ongoing study is an open-label randomized controlled interventional trial, with a sample size of 90 both in the trial and standard control group (including dropouts, 20\%), and will be carried out for 24 months. Participants in the trial group will receive Ayurvedic treatment, that is, Anu Taila Nasya (6 drops in each nostril for 7 days for 3 consecutive weeks), Naradiya Laxmivilas Rasa (250 mg twice per day), and Shirishadi Kwath (40 ml twice per day for 45 days). The participants in the control group will receive a fluticasone propionate nasal spray (2 sprays once per day for 45 days). The primary outcome will include the mean change in the Control of Allergic Rhinitis and Asthma Test score, and the secondary outcomes will include the mean change in the nasal endoscopy index (assessment of nasal membrane color, pale or hyperemia; rhinorrhea, watery or yellow; and inferior turbinate swelling, hypertrophy) and the mean change in the laboratory tests. Results: As of May 2024, 72 patients have been enrolled in both groups. Data analysis should be completed by February 2025. The study will be reported following standard guidelines for reporting randomized controlled trials. Clinical results will be disseminated through conferences and peer-reviewed publication in a relevant journal. Conclusions: The Ayurvedic approach could be an evidence-based therapeutic tactic for the management of AR. Trial Registration: Clinical Trials Registry India CTRI/2023/06/053395; https://tinyurl.com/564d2zz8 International Registered Report Identifier (IRRID): DERR1-10.2196/56063 ",
doi="10.2196/56063",
url="https://www.researchprotocols.org/2024/1/e56063"
}


@Article{info:doi/10.2196/55089,
author="V, Kumar Krishna
and Thomas, V. Sanjeev
and C Nair, Murugan
and Nair, G. Parvathy
and L, M. Nisha
and S, Anuradha
and Tripathi, Arunabh
and Mundada, Pallavi
and Yadav, Babita
and Rao, S. B. C.
and D, Sudhakar
and N, Srikanth",
title="Ayurvedic Management of Presbycusis (Project TOPMAC): Protocol for an Exploratory Randomized Controlled Trial",
journal="JMIR Res Protoc",
year="2024",
month="Sep",
day="23",
volume="13",
pages="e55089",
keywords="presbycusis",
keywords="Karnapurana",
keywords="Kshirabala Taila",
keywords="Rasayana",
keywords="Withania somnifera (L.) Dunal",
keywords="age-related hearing loss",
keywords="hearing loss",
keywords="sensorineural",
keywords="auditory information",
keywords="older adults",
keywords="older adult",
keywords="geriatrics",
keywords="tinnitus",
keywords="population-based",
keywords="cognitive deterioration",
keywords="topical oil pooling",
keywords="efficacy",
keywords="TOPMAC",
keywords="intervention",
keywords="hearing status",
keywords="effectiveness",
keywords="Ayurveda",
abstract="Background: Presbycusis is characterized by sensorineural hearing loss in both ears at high frequencies, which affects more than half of the older adults by the age of 75 years and is often accompanied by tinnitus and cognitive deterioration. Unfortunately, there are no treatments available to restore hearing loss. Treatment mainly focuses on improving the quality of life and communication with hearing aids. Traditional medicine like Ayurveda also explains ailments of a similar nature as Badhirya and advises using drugs with antiaging and neuroprotective activity for treatment. In Ayurveda, Badhirya and Karnanada (senile deafness with tinnitus) are due to vitiation of Vata Dosha. Treatments such as topical oil pooling (Karnapurana) are usually advised to counter Vata, improve hearing capacity, and reduce tinnitus. Kshirabala Taila, a medicated oil formulation prepared with Sida cordifolia Linnaeus, is one of the most preferred oils for topical oil pooling in such conditions, as it has a definitive indication for sensory dysfunctions. Drugs like Withania somnifera (L.) Dunal (Ashwagandha) are also used, as they ameliorate neurodegeneration and help to improve cognitive dysfunction. Objective: We propose an exploratory randomized controlled trial study for evaluating the efficacy of TOPMAC (Topical Oil Pooling with Kshirabala Taila and Supplementation of Ashwagandha Churna) in tinnitus suppression and hearing and cognitive function protection in patients aged 60-75 years with mild to moderate presbycusis. Methods: A parallel, 2-group, exploratory randomized controlled trial will be conducted in an Indian Ayurvedic research center at its outpatient service. Participants (N=60) with mild to moderate presbycusis will be recruited by screening. Participants will be randomized (computer-generated 1:1) to receive either basic treatment and health education (BTHE) or BTHE+TOPMAC for 24 weeks. The primary objective is to compare the efficacy of TOPMAC with that of BTHE in the protection of hearing function. The secondary objective is to compare the efficacy of TOPMAC with that of BTHE in tinnitus suppression and cognitive function protection. Results: This project was funded in January 2023. The institutional ethics committees at National Ayurveda Research Institute for Panchakarma (3/1/2020/NARIP/Tech/2036) and Institute for Communicative and Cognitive Neuro Sciences (IEC006) approved this study. The first patient was enrolled in September 2023; 22 participants were enrolled as of August 2024. The data analysis is yet to start, and the results are expected to be published by January 2025. Conclusions: If this exploratory trial is proven effective, it will steer the setting of a definitive randomized controlled trial to test whether the TOPMAC intervention can be incorporated as a cost-effective integrative approach for managing presbycusis. The Indian government has already launched a National Program for Prevention and Control of Deafness to benefit the deaf population. TOPMAC may later be considered for integration with the national program. Trial Registration: Clinical Trials Registry India CTRI/2023/04/051485; https://tinyurl.com/2h2hry3n International Registered Report Identifier (IRRID): DERR1-10.2196/55089 ",
doi="10.2196/55089",
url="https://www.researchprotocols.org/2024/1/e55089"
}


@Article{info:doi/10.2196/60104,
author="Du, Yan
and Wei, Gao-Xia
and He, Yichao
and Ning, Hongting
and Roberts, Penny
and Golob, Edward
and Yin, Zenong",
title="Current Evidence of the Application of Music in Tai Chi Exercise: Scoping Review",
journal="Asian Pac Isl Nurs J",
year="2024",
month="Sep",
day="19",
volume="8",
pages="e60104",
keywords="Tai Chi",
keywords="exercise",
keywords="music",
keywords="synergetic effects",
keywords="review",
keywords="scoping review",
keywords="thematic analysis",
keywords="health outcome",
keywords="motivation",
keywords="performance",
keywords="dissemination",
keywords="implementation",
keywords="public health",
keywords="data extraction",
abstract="Background: Music has frequently been used in movement exercises to enhance health benefits. However, scientific evidence regarding the application of music to Tai Chi practice is limited. Objective: This scoping review aims to understand how music has been used in Tai Chi practice and whether music could be applied to Tai Chi practice to help optimize its benefits. Methods: PubMed, CINAHL, CNKI, and Weipu databases were searched. We included studies that compare Tai Chi practice experience or health outcomes between individuals practicing Tai Chi with music and those practicing Tai Chi without music. Studies published through September 2022 were identified. Two researchers (YD and YH) independently performed study selection and data extraction. Thematic analysis was used to summarize and categorize the findings of the included studies. Results: Seven studies were included in this review. All 7 included studies are experimental studies. Practicing Tai Chi with music might lead to positive perceptions of Tai Chi practice (eg, motivation, concentration, enjoyment, compliance, and performance) and higher evaluations of Tai Chi instructional quality, especially for Tai Chi beginners. The effects of incorporating music into Tai Chi practice on health outcomes are inconclusive due to the heterogeneities of the sample size, and the intervention components, lengths, and frequencies of the included studies. Conclusions: Applying music to Tai Chi practice may result in positive Tai Chi practice experience and adherence, particularly for beginners, which could help improve the dissemination and implementation of Tai Chi interventions for public health. However, whether applying music to Tai Chi practice leads to synergetic effects on health outcomes needs further investigation. ",
doi="10.2196/60104",
url="https://apinj.jmir.org/2024/1/e60104"
}


@Article{info:doi/10.2196/57287,
author="Kulkarni, Pandurang Satyajit
and Parwe, Shweta",
title="Evaluation of Comparative Efficacy of Levothyroxine Versus Kshar Basti and Kanchanar Guggul in the Treatment of Hypothyroidism: Protocol for a Randomized Controlled Trial",
journal="JMIR Res Protoc",
year="2024",
month="Sep",
day="10",
volume="13",
pages="e57287",
keywords="ayurveda",
keywords="complementary and alternative medicine",
keywords="hypothyroidism",
keywords="levothyroxine",
keywords="rectal enema",
keywords="massage therapy",
keywords="sudation",
abstract="Background: The thyroid gland is an endocrine gland that has an impact on the body's general metabolism. Thus, the secretions of the thyroid gland can modify the overall metabolism of the entire body. The prevalence of hypothyroidism is increasing quickly, with rates of 2\%-5\% in affluent countries and 11\% in India. Individuals diagnosed with hypothyroidism need to take medication for the rest of their lives, resulting in significant stress. Therefore, conducting a study in this area is imperative. Objective: This study aims to assess the effectiveness of the therapeutic enema (Kshar Basti) and oral Kanchanar Guggul in the treatment of hypothyroidism. Methods: The trial group (n=45) will receive a therapeutic enema (Kshar Basti) followed by oral Ayurvedic drugs for 180 days. The control group (n=45) will be given levothyroxine tablets at a dosage of 1.6 {\textmu}g/kg/day for the same duration. The objective is to examine the alterations in thyroid stimulating hormone (TSH) levels before and after the treatment. Results: Any deviation of the serum TSH by more than 20\% from the initial values, while keeping triiodothyronine (T3), and thyroxine (T4) levels within the normal range, will be deemed statistically significant. Consequently, we anticipate a statistically significant variation in serum TSH levels between the therapeutic enema and Kanchanar Guggul treatments. Presently, the drug preparation operations are in progress. We expect to start enrolling patients in June 2024, do data analysis in December 2025, and acquire results by early 2026, marking the end of this trial. Conclusions: This study will evaluate the efficacy of the therapeutic enema, specifically Kshar Basti, in treating hypothyroidism. Furthermore, more research can determine the efficacy of a therapeutic enema (Kshar Basti) in treating overt hypothyroidism and hypothyroidism during pregnancy. Trial Registration: Clinical Trials Registry India CTRI/2023/05/052389; https://ctri.nic.in/Clinicaltrials/pmaindet2.php?EncHid=Nzk1NjY=\&Enc=\&userName=052389 International Registered Report Identifier (IRRID): PRR1-10.2196/57287 ",
doi="10.2196/57287",
url="https://www.researchprotocols.org/2024/1/e57287"
}


@Article{info:doi/10.2196/38542,
author="Basheer, Aneesh
and Agarwal, Ayush
and Mishra, Biswamohan
and Gupta, Anu
and Padma Srivastava, Vasantha Madakasira
and Kirubakaran, Richard
and Vishnu, Venugopalan",
title="Use of Bacopa monnieri in the Treatment of Dementia Due to Alzheimer Disease: Systematic Review of Randomized Controlled Trials",
journal="Interact J Med Res",
year="2022",
month="Aug",
day="1",
volume="11",
number="2",
pages="e38542",
keywords="Bacopa monnieri",
keywords="Brahmi",
keywords="Ayurveda",
keywords="Ayurvedic",
keywords="alternative medicine",
keywords="traditional medicine",
keywords="complementary medicine",
keywords="herb",
keywords="dementia",
keywords="systematic review",
keywords="Alzheimer's disease",
keywords="Alzheimer disease",
keywords="mild cognitive impairment",
keywords="cognition",
keywords="neuroprotection",
keywords="memory",
keywords="cognitive",
keywords="treatment",
keywords="therapy",
keywords="clinical outcome",
keywords="memory scale",
keywords="neurology",
keywords="neurodegenerative disease",
keywords="randomized controlled trial",
keywords="RCT",
abstract="Background: Bacopa monnieri, a herb that has been used for many centuries in India, has shown neuroprotective effects in animal and in vitro studies; human studies on patients with Alzheimer disease have been inconclusive. Objective: The primary objective of this review was to determine the clinical efficacy and safety of B. monnieri in persons with mild, moderate, or severe dementia, or mild cognitive impairment, due to Alzheimer disease. Methods: We searched PubMed, Embase, Cochrane Library, clinical trial registries (World Health Organization, Australia-New Zealand, United States, and South Africa), the metaRegister of Controlled Trials, and CINAHL. We intended to include all randomized and quasi-randomized controlled trials that compared B. monnieri, its extract or active ingredients (at any dosage), with a placebo or a cholinesterase inhibitor among adults with dementia due to Alzheimer disease and in those with mild cognitive impairment due to Alzheimer disease. Results: Our comprehensive search yielded 5 eligible studies. A total of 3 studies used B. monnieri in combination with herbal extracts while the remaining 2 used B. monnieri extracts only. Two studies compared B. monnieri with donepezil while the others used a placebo as the control. There was considerable variation in the B. monnieri dose used (ranging between 125 mg to 500 mg twice daily) and heterogeneity in treatment duration, follow-up, and outcomes. The major outcomes were Mini-Mental State Examination scores reported in 3 trials, Cognitive subscale scores of the Alzheimer's Disease Assessment Scale in 1 study, and a battery of cognitive tests in 2 studies. Using the Cochrane risk-of-bias tool, overall, we judged all 5 studies to be at high risk of bias. While all studies reported a statistically significant difference between B. monnieri and the comparator in at least one outcome, we rated the overall quality of evidence for the Alzheimer's Disease Assessment Scale-Cognitive Subscale, Postgraduate Institute Memory Scale, Mini-Mental State Examination, and Wechsler Memory Scale to be very low due to downgrading by 2 levels for high risk of bias and 1 more level for impreciseness due to small sample sizes and wide CIs. Conclusions: There was no difference between B. monnieri and the placebo or donepezil in the treatment of Alzheimer disease based on very low certainty evidence. No major safety issues were reported in the included trials. Future randomized controlled trials should aim to recruit more participants and report clinically meaningful outcomes. Trial Registration: PROSPERO CRD42020169421; https://www.crd.york.ac.uk/prospero/display\_record.php?RecordID=169421 ",
doi="10.2196/38542",
url="https://www.i-jmr.org/2022/2/e38542",
url="http://www.ncbi.nlm.nih.gov/pubmed/35612544"
}


@Article{info:doi/10.2196/34292,
author="Regueiro, Cristina
and Codesido, Laura
and Garc{\'i}a-Nimo, Laura
and Zarraqui{\~n}os, Sara
and Remedios, David
and Rodr{\'i}guez-Blanco, Arturo
and Sinde, Esteban
and Fern{\'a}ndez-de-Ana, Catalina
and Cubiella, Joaqu{\'i}n",
title="Effect of the Nutraceutical Micodigest 2.0 on the Complication Rate of Colorectal Cancer Surgery With Curative Intent: Protocol for a Placebo-Controlled Double-blind Randomized Clinical Trial",
journal="JMIR Res Protoc",
year="2022",
month="May",
day="16",
volume="11",
number="5",
pages="e34292",
keywords="colorectal cancer",
keywords="surgery complications",
keywords="gut microbiota",
keywords="inflammatory pattern",
keywords="nutritional status",
keywords="nutraceutical",
keywords="postsurgery",
keywords="colorectal",
keywords="cancer",
keywords="colon",
abstract="Background: Most colorectal cancer patients diagnosed are candidates for surgical resection with curative intent, although colorectal surgery is associated with some complications that could be life-threatening. Antibiotic prophylaxis is commonly used for the prevention of infectious postoperative complications. However, this intervention can change the composition of intestinal microbiota and promote adverse inflammatory outcomes in colorectal cancer patients. The combination of different fungal extracts could be beneficial because of their role in gut microbiota modulation and their anti-inflammatory activity. Objective: Based on this hypothesis, we have designed a double-bind, randomized clinical trial to evaluate the effect of the nutraceutical fungal extract Micodigest 2.0 on complications of surgery for colorectal cancer resection. Methods: Colorectal cancer candidates for surgery will be considered for inclusion in the study. After evaluation by the multidisciplinary tumor board, patients who meet selection criteria will be screened, stratified according to tumor location, and randomly allocated to be treated with Micodigest 2.0 or placebo. Treatment will be continued until admission for surgery (4-6 weeks). Participants will undergo a medical and clinical evaluation including baseline and preadmission quality of life, microbiome composition, inflammatory and nutritional status, adverse events, and adherence assessments. The main end point of the study is the surgery complication rate. We will evaluate complications using the Clavien-Dindo classification. It will be necessary to recruit 144 patients to find a relevant clinical difference. We will also evaluate the effect of the nutraceutical on microbiome composition, inflammatory response, nutritional status, and quality of life, as well as the effect of these variables on surgical complications. Results: This study was funded in 2020 by the Center for Industrial Technology Development. Recruitment began in September 2021 and is expected to be completed in September 2022. Data will be analyzed and the results will be disseminated in 2023. Conclusions: The results of this protocol study could help to reduce surgery complications in patients with colorectal cancer using the new treatment Micodigest. This study could also identify new features associated with colorectal surgery complications. In summary, this study trial could improve the management of colorectal cancer patients. Trial Registration: Clinical Trials.gov NCT04821258; https://clinicaltrials.gov/ct2/show/NCT04821258 International Registered Report Identifier (IRRID): DERR1-10.2196/34292 ",
doi="10.2196/34292",
url="https://www.researchprotocols.org/2022/5/e34292",
url="http://www.ncbi.nlm.nih.gov/pubmed/35576566"
}


@Article{info:doi/10.2196/25589,
author="Massey, Heather
and Gorczynski, Paul
and Harper, Mark C.
and Sansom, Lisa
and McEwan, Kieren
and Yankouskaya, Alla
and Denton, Hannah",
title="Perceived Impact of Outdoor Swimming on Health: Web-Based Survey",
journal="Interact J Med Res",
year="2022",
month="Jan",
day="4",
volume="11",
number="1",
pages="e25589",
keywords="open water swimming",
keywords="blue space",
keywords="blue gym",
keywords="mental health",
keywords="physical health",
abstract="Background: Outdoor swimming in lakes, lidos (outdoor pools), rivers, and the sea has grown in popularity in many countries, including the United Kingdom. Many anecdotal accounts indicate improvements in medical conditions, which are considered a consequence of outdoor swimming. Objective: The aim of this study is to better understand outdoor swimmers' perceptions of their health and the extent to which participation impacted their existing self-reported symptoms. Methods: A survey was conducted to investigate outdoor swimming behaviors and reports of any diagnosed medical conditions. Medical conditions were coded into categories, and descriptive statistics were generated regarding the outdoor swimmers' behaviors and the effect that outdoor swimming had on their medical symptoms if any. The medical categories were clustered into five larger categories based on their prevalence in the current sample: mental health; musculoskeletal and injury; neurological; cardiovascular and blood disease; and other, which comprises inflammatory, immune, endocrine, and respiratory conditions. Results: In total, 722 outdoor swimmers responded, of whom 498 (68.9\%) were female. The probability of outdoor swimming having some positive impact on health across all medical categories was 3.57 times higher compared with no impact (B=1.28, 95\% CI 0.63-1.91; P<.001), 44.32 times higher for the mental health category (B=3.79, 95\% CI 2.28-5.30; P<.001), 5.25 times higher for musculoskeletal and injury category (B=1.66, 95\% CI 0.52-2.79; P=.004), and 4.02 times higher for the other category (B=1.39, 95\% CI 0.27-2.51; P=.02). Overall, outdoor swimming was associated with perceived reductions in symptoms of poor mental health ($\chi$22=25.1; P<.001), musculoskeletal and injury ($\chi$22=8.2; P=.04), cardiovascular and blood ($\chi$22=14.7; P=.006), and other conditions ($\chi$22=18.2; P<.001). Conclusions: Physical activity in the form of outdoor swimming is perceived to have positive impacts on health and is associated with perceived symptom reductions in mental health, musculoskeletal and injury, and cardiovascular and blood conditions. This study cannot provide causal relationships or provide mechanistic insights. However, it does provide a starting point for more targeted prospective intervention research into individual conditions or categories of conditions to establish the impact in those who choose to start outdoor swimming. ",
doi="10.2196/25589",
url="https://www.i-jmr.org/2022/1/e25589",
url="http://www.ncbi.nlm.nih.gov/pubmed/34982711"
}


@Article{info:doi/10.2196/25648,
author="Murat-Ringot, Audrey
and Souquet, Jean Pierre
and Subtil, Fabien
and Boutitie, Florent
and Preau, Marie
and Piriou, Vincent",
title="The Effect of Foot Reflexology on Chemotherapy-Induced Nausea and Vomiting in Patients With Digestive or Lung Cancer: Randomized Controlled Trial",
journal="JMIR Cancer",
year="2021",
month="Nov",
day="5",
volume="7",
number="4",
pages="e25648",
keywords="cancer",
keywords="randomized controlled trial",
keywords="foot reflexology",
keywords="nausea and vomiting",
keywords="chemotherapy",
keywords="complementary and alternative medicine",
abstract="Background: Cancer is a chronic disease with an incidence of 24.5 million and 9.6 million deaths worldwide in 2017. Lung and colorectal cancer are the most common cancers for both sexes and, according to national and international recommendations, platinum-based chemotherapy is the reference adjuvant treatment. This chemotherapy can be moderately to highly emetogenic. Despite antiemetic therapy, chemotherapy-induced nausea and vomiting (CINV) may persist. Moreover, cancer patients are increasingly interested in alternative and complementary medicines and have expressed the desire that nonpharmacological treatments be used in hospitals. Among alternative and complementary medicines, foot reflexology significantly decreases the severity of CINV in patients with breast cancer. Objective: The primary aim of this study was to assess the benefits of foot reflexology as a complement therapy to conventional treatments regarding the severity of acute CINV in patients with digestive or lung cancer. The secondary objectives assessed were the frequency and severity of delayed CINV, quality of life, anxiety, and self-esteem. Methods: This study was conducted between April 2018 and April 2020 in the Hospices Civils de Lyon, France. This was an open-label randomized controlled trial. Participants were randomized into two groups: the intervention group (ie, conventional care with foot reflexology; n=40) and the control group (ie, conventional care without foot reflexology; n=40). Foot reflexology sessions (30 minutes each) were performed on outpatients or inpatients. Eligible participants were patients with lung or digestive cancer with an indication for platinum-based chemotherapy. Results: The severity of acute nausea and vomiting was assessed with a visual analog scale during the second cycle of chemotherapy. A significant increase of at least 2 points was observed for the control group (7/34, 21\%; P=.001). Across all cycles, the foot reflexology group showed a trend toward less frequent delayed nausea (P=.28), a significantly less frequent consumption of antiemetic drugs (P=.04), and no significant difference for vomiting (P=.99); there was a trend toward a perception of stronger severity for delayed nausea in the control group (P=.39). Regarding quality of life and anxiety, there was no significant difference between the intervention group and the control group (P=.32 and P=.53, respectively). Conclusions: This study's results indicate that foot reflexology provides significantly better management of acute nausea severity and decreased consumption of antiemetic drugs in patients with lung or digestive cancer. In order to fulfill patients' desires to use nonpharmacological treatments and complementary and alternative medicines in hospitals, foot reflexology could be provided as a complementary intervention to conventional antiemetic drugs. Foot reflexology did not result in adverse effects. To assess the benefits of foot reflexology in routine practice, a larger study with several health care centers would be needed with a cluster randomized controlled trial. Trial Registration: ClinicalTrials.gov NCT03508180; https://clinicaltrials.gov/ct2/show/NCT03508180 International Registered Report Identifier (IRRID): RR2-10.2196/17232 ",
doi="10.2196/25648",
url="https://cancer.jmir.org/2021/4/e25648",
url="http://www.ncbi.nlm.nih.gov/pubmed/34738909"
}


@Article{info:doi/10.2196/28383,
author="Reid, Amanda
and Kresovich, Alex",
title="Copyright as a Barrier to Music Therapy Telehealth Interventions: Qualitative Interview Study",
journal="JMIR Form Res",
year="2021",
month="Aug",
day="13",
volume="5",
number="8",
pages="e28383",
keywords="telehealth",
keywords="music therapy",
keywords="diffusion of innovations",
keywords="COVID-19",
keywords="copyright law",
keywords="fair use",
abstract="Background: Music therapy is a multifaceted discipline that harnesses the power of music to treat a wide range of patient populations. A therapist who plays music in a private room for a patient is not subject to copyright restrictions on public performances. However, in the wake of the COVID-19 pandemic, music therapy is no longer strictly confined to the face-to-face setting. This study explores music therapists' perceptions of copyright law with respect to their ability to provide mediated services to their clients. Objective: The objectives of our study were two-fold. The first was to investigate whether concerns about copyright law are hampering the diffusion of telehealth innovations, and the second was whether these concerns are causing music therapists to avoid therapeutically beneficial telehealth interventions. Methods: Semistructured interviews were conducted with credentialed music therapists (n=18) in the United States between May 2020 and June 2020. With participants' consent, we used video conference technology to record and transcribe the in-depth interviews. The median interview length was 45 (SD 16.37) minutes. This theoretically informed study employed thematic analysis of the interview data. Results: The COVID-19 pandemic accelerated the adoption of telehealth interventions to facilitate therapy outside of private face-to-face environments: environments where music therapy practices are largely shielded from copyright infringement concerns. Five main themes emerged, including therapists' uncertainty about permissible uses of music and therapists' erring on the side of caution causing lost opportunities for care. Our interview data suggest music therapists have altered telehealth interventions in suboptimal ways to avoid copyright liability in a physically distanced environment. Conclusions: Some music therapists ``drag their feet'' on offering therapeutically appropriate telehealth services to clients because of copyright concerns. Our findings suggest innovative mediated therapies were shied away from or abandoned. These findings offer a novel contribution to the public health literature by highlighting copyright law as an unexpected and unwelcome barrier to the diffusion of music therapy practices in technology-mediated settings. ",
doi="10.2196/28383",
url="https://formative.jmir.org/2021/8/e28383",
url="http://www.ncbi.nlm.nih.gov/pubmed/34319241"
}


@Article{info:doi/10.2196/25703,
author="Srikanth, N.
and Rana, Rakesh
and Singhal, Richa
and Jameela, Sophia
and Singh, Rajeshwari
and Khanduri, Shruti
and Tripathi, Arunabh
and Goel, Sumeet
and Chhatre, Leena
and Chandra, Ashwin
and Rao, S. B. C.
and Dhiman, S. K.",
title="Mobile App--Reported Use of Traditional Medicine for Maintenance of Health in India During the COVID-19 Pandemic: Cross-sectional Questionnaire Study",
journal="JMIRx Med",
year="2021",
month="May",
day="7",
volume="2",
number="2",
pages="e25703",
keywords="AYUSH Sanjivani app",
keywords="COVID-19",
keywords="traditional medicine",
keywords="Ayurveda",
keywords="Siddha",
keywords="Unani",
keywords="homeopathy",
abstract="Background: India follows a pluralistic system for strategic and focused health care delivery in which traditional systems of medicine such as Ayurveda, yoga and naturopathy, Unani, Siddha, Sowa Rigpa, and homoeopathy (AYUSH) coexist with contemporary medicine, and this system functions under the Ministry of AYUSH (MoA). The MoA developed a mobile app, called AYUSH Sanjivani, to document the trends of the use of AYUSH-based traditional and holistic measures by the public across India. Analysis of the data generated through this app can help monitor the extent of the use of AYUSH measures for maintenance of health during the COVID-19 pandemic and aid effective health promotion and communication efforts focused on targeted health care delivery during the pandemic. Objective: The purpose of the study was to determine the extent of use of AYUSH measures by the public in India for maintenance of health during the COVID-19 pandemic as reported through the AYUSH Sanjivani mobile app. Methods: Cross-sectional analysis of the data generated through the Ayush Sanjivani app from May 4 to July 31, 2020, was performed to study the pattern and extent of the use of AYUSH-based measures by the Indian population. The responses of the respondents in terms of demographic profile, use pattern, and benefits obtained; the association between the use of AYUSH-based measures and symptomatic status; and the association between the duration of use of AYUSH-based measures and the outcome of COVID-19 testing were evaluated based on bivariate and multivariate logistic regression analysis. Results: Data from 723,459 respondents were used for the analysis, among whom 616,295 (85.2\%) reported that they had been using AYUSH measures for maintenance of health during the COVID-19 pandemic. Among these 616,295 users, 553,801 (89.8\%) either strongly or moderately agreed to have benefitted from AYUSH measures. Ayurveda and homeopathic measures and interventions were the most preferred by the respondents across India. Among the 359,785 AYUSH users who described their overall improvement in general health, 144,927 (40.3\%) rated it as good, 30,848 (8.6\%) as moderate, and 133,046 (40.3\%) as slight. Respondents who had been using AYUSH measures for less than 30 days were more likely to be COVID-19--positive among those who were tested (odds ratio 1.52, 95\% CI 1.44-1.60). The odds of nonusers of AYUSH measures being symptomatic if they tested positive were greater than those of AYUSH users (odds ratio 4.01, 95\% CI 3.61-4.59). Conclusions: The findings of this cross-sectional analysis assert that a large proportion of the representative population practiced AYUSH measures across different geographic locations of the country during the COVID-19 pandemic and benefitted considerably in terms of general well-being, with a possible impact on their quality of life and specific domains of health. ",
doi="10.2196/25703",
url="https://xmed.jmir.org/2021/2/e25703",
url="http://www.ncbi.nlm.nih.gov/pubmed/34032815"
}


@Article{info:doi/10.2196/26564,
author="Mamo, Andrina
and Szeto, D. Mindy
and Mirhossaini, Roya
and Fortugno, Andrew
and Dellavalle, P. Robert",
title="Tetrahydrocannabinol and Skin Cancer: Analysis of YouTube Videos",
journal="JMIR Dermatol",
year="2021",
month="May",
day="4",
volume="4",
number="1",
pages="e26564",
keywords="THC",
keywords="tetrahydrocannabinol",
keywords="skin cancer",
keywords="YouTube",
keywords="cannabis",
keywords="social media",
keywords="internet",
abstract="Background: Cannabis oil is being used topically by patients with skin cancer as a homeopathic remedy, and has been promoted and popularized on social media, including YouTube. Although topical cannabinoids, especially tetrahydrocannabinol (THC), may have antitumor effects, results from a sparse number of clinical trials and peer-reviewed studies detailing safety and efficacy are still under investigation. Objective: We sought to assess the accuracy, quality, and reliability of THC oil and skin cancer information available on YouTube. Methods: The 10 most-viewed videos on THC oil and skin cancer were analyzed with the Global Quality Scale (GQS), DISCERN score, and useful/misleading criteria based on presentation of erroneous and scientifically unproven information. The videos were also inspected for source, length, and audience likes/dislikes. Top comments were additionally examined based on whether they were favorable, unfavorable, or neutral regarding the video content. Results: All analyzed videos (10/10, 100\%) received a GQS score of 1, corresponding to poor quality of content, and 9/10 (90\%) videos received a DISCERN score of 0, indicating poor reliability of information presented. All 10 videos were also found to be misleading and not useful according to established criteria. Top comments were largely either favorable (13/27, 48\%) or neutral (13/27, 48\%) toward the content of the videos, compared to unfavorable (1/27, 4\%). Conclusions: Dermatologists should be aware that the spread of inaccurate information on skin cancer treatment currently exists on popular social media platforms and may lead to detrimental consequences for patients interested in pursuing alternative or homeopathic approaches. ",
doi="10.2196/26564",
url="https://derma.jmir.org/2021/1/e26564",
url="http://www.ncbi.nlm.nih.gov/pubmed/37632811"
}


@Article{info:doi/10.2196/27406,
author="Liu, Hang Xiao
and Jin, Fan
and Hsu, Jeffrey
and Li, Nan Di
and Chen, Wei",
title="Comparing Smartphone Apps for Traditional Chinese Medicine and Modern Medicine in China: Systematic Search and Content Analysis",
journal="JMIR Mhealth Uhealth",
year="2021",
month="Mar",
day="24",
volume="9",
number="3",
pages="e27406",
keywords="mHealth",
keywords="traditional Chinese medicine",
keywords="modern medicine",
keywords="mobile apps",
keywords="app",
keywords="comparison",
keywords="content analysis",
keywords="China",
keywords="health care",
keywords="development",
abstract="Background: Traditional Chinese medicine (TCM) is an integral part of mainstream medicine in China, with theories and practices that are completely different from modern medicine. TCM should not be ignored or confused with modern medicine in the analysis of the Chinese health care system, including the analysis of mobile health (mHealth) apps. To date, differences between TCM apps and modern medicine apps have not be systematically investigated. Objective: The aim of this study was to systematically compare the quality of apps for TCM and modern medicine in China. Methods: In December 2020, we searched iOS (iTunes) and Android (Tencent, Oppo, and Huawei app stores) platforms for all mHealth apps and then categorized them as TCM or modern medicine apps if they were included in the final analysis. The included apps were downloaded on smartphones and assessed by 2 reviewers on the following 4 aspects: (1) data in the app stores, including user ratings, download counts, cost, target users, and year of last update; (2) functionality; (3) quality of the app content as determined by the Mobile App Rating Scale (MARS); and (4) analysis of the app privacy and security. Results: In total, 658 apps were analyzed, including 261 TCM medicine apps and 397 modern medicine apps. The average download count of modern medicine apps (approximately 5 million) was more than 10 times that of TCM apps (approximately 400,000). Regarding functionalities, 64.7\% (257/397) of modern medicine apps provided telemedicine (74/261, 28.4\% in TCM apps), 62.7\% (249/397) provided registration (70/261, 26.8\% in TCM apps), and 45.6\% (181/397) provided communication (38/261, 14.6\% in TCM apps). A larger proportion of TCM apps provided prescription and medication management (144/261, 55.2\% in TCM apps versus 168/397, 42.3\% in modern medicine apps). The majority of modern medicine apps (329/397, 82.9\%) combined ?3 functionalities compared with one-third of TCM apps (93/261, 34.6\%). We then selected 81 top apps for quality and safety assessment (41 TCM apps and 40 modern medicine apps). Of these, the mean overall MARS score of TCM apps (2.7, SD 0.5) was significantly lower than modern medicine apps (3.6, SD 0.4). Almost all modern medicine apps (38/40, 95\%) addressed privacy and security by providing a privacy policy and describing how to protect personal data, but less than half of the TCM apps (18/41, 44\%) described this information (P<.001). Conclusions: The different functionalities reflect the distinct innate characteristics of these two medical systems. Although great progress has been made and the Chinese mHealth market size is large, there still exist many opportunities for future development, especially for TCM. ",
doi="10.2196/27406",
url="https://mhealth.jmir.org/2021/3/e27406",
url="http://www.ncbi.nlm.nih.gov/pubmed/33759786"
}


@Article{info:doi/10.2196/20236,
author="Jang, Soobin
and Kim, Dongsu
and Yi, Eunhee
and Choi, Gunhee
and Song, Mideok
and Lee, Eun-Kyoung",
title="Telemedicine and the Use of Korean Medicine for Patients With COVID-19 in South Korea: Observational Study",
journal="JMIR Public Health Surveill",
year="2021",
month="Jan",
day="19",
volume="7",
number="1",
pages="e20236",
keywords="telemedicine",
keywords="telehealth",
keywords="herbal medicine",
keywords="Korean medicine",
keywords="COVID-19",
keywords="Korea",
keywords="pandemic",
keywords="guideline",
keywords="infectious disease",
abstract="Background: COVID-19 was first reported in Wuhan, China, in December 2019, and it has since spread worldwide. The Association of Korean Medicine (AKOM) established the COVID-19 telemedicine center of Korean medicine (KM telemedicine center) in Daegu and Seoul. Objective: The aim of this study was to describe the results of the KM telemedicine center and the clinical possibility of using herbal medicines for COVID-19. Methods: All procedures were conducted by voice call following standardized guidelines. The students in the reception group obtained informed consent from participants and they collected basic information. Subsequently, Korean Medicine doctors assessed COVID-19--related symptoms and prescribed the appropriate herbal medicine according to the KM telemedicine guidelines. The data of patients who completed the program by June 30, 2020, were analyzed. Results: From March 9 to June 30, 2020, 2324 patients participated in and completed the KM telemedicine program. Kyung-Ok-Ko (n=2285) was the most prescribed herbal medicine, and Qingfei Paidu decoction (I and II, n=2053) was the second most prescribed. All COVID-19--related symptoms (headache, chills, sputum, dry cough, sore throat, fatigue, muscle pain, rhinorrhea, nasal congestion, dyspnea, chest tightness, diarrhea, and loss of appetite) improved after treatment (P<.001). Conclusions: The KM telemedicine center has provided medical service to 10.8\% of all patients with COVID-19 in South Korea (as of June 30, 2020), and it is still in operation. We hope that this study will help to establish a better health care system to overcome COVID-19. ",
doi="10.2196/20236",
url="http://publichealth.jmir.org/2021/1/e20236/",
url="http://www.ncbi.nlm.nih.gov/pubmed/33342765"
}


@Article{info:doi/10.2196/22324,
author="Yeh, Bo-Yan
and Liu, Geng-Hao
and Lee, Tzung-Yan
and Wong, May-Kuen Alice
and Chang, Hen-Hong
and Chen, Yu-Sheng",
title="Efficacy of Electronic Acupuncture Shoes for Chronic Low Back Pain: Double-Blinded Randomized Controlled Trial",
journal="J Med Internet Res",
year="2020",
month="Oct",
day="26",
volume="22",
number="10",
pages="e22324",
keywords="acupuncture",
keywords="electronic acupuncture shoes",
keywords="low back pain",
keywords="medical device",
keywords="self-treatment",
keywords="mHealth",
abstract="Background: Chronic low back pain is a common problem and is associated with high costs, including those related to health care and indirect costs due to absence at work or reduced productivity. Previous studies have demonstrated that acupuncture or electroacupuncture can relieve low back pain. Electronic acupuncture shoes (EAS) are a novel device designed in this study. This device combines the properties of acupuncture and transcutaneous electrical nerve stimulation for clinical use. Objective: The aim of this study was to evaluate the efficacy of EAS in patients with chronic low back pain. Methods: In this prospective double-blinded randomized controlled study, the data of 83 patients who experienced chronic low back pain were analyzed. Patients came to our clinic for 20 visits and underwent assessment and treatment. Patients were randomly allocated to receive either EAS plus placebo nonsteroidal anti-inflammatory drugs (NSAIDs) (EAS group, n=42) or sham EAS plus NSAIDs (NSAID group, n=41). The visual analog scale (VAS) score and range of motion were assessed at baseline, before and after each EAS treatment, and 2 weeks after the last treatment. The time for achieving pain remission was recorded. Quality of life was assessed at the 2nd, 14th, and 20th visits. Results: After 6 weeks of treatment, the treatment success rate in each visit in the EAS group was higher than that in the NSAID group, as revealed by the intention-to-treat (ITT) and per-protocol (PP) analyses, but significant differences were observed only during the 16th visit in the ITT analysis (EAS group: 31/37, 84\% and NSAID group: 21/34, 62\%; P=.04). The change in the VAS score from baseline in each visit in the EAS group was greater than that in the NSAID group, as revealed by the ITT and PP analyses, and significant differences were observed in the 5th visit and 9th visit in the ITT analysis (P=.048 and P=.048, respectively). Significant differences were observed in the left rotation in the 2nd visit and 4th visit (P=.049 and P=.03, respectively). No significant differences were observed in the VAS score before and after treatment in each visit and in the quality of life in both groups. Conclusions: EAS might serve as a reliable alternative therapeutic tool for patients with chronic low back pain who are contraindicated for oral NSAIDs. Trial Registration: ClinicalTrials.gov NCT02468297https://clinicaltrials.gov/ct2/show/NCT02468297 ",
doi="10.2196/22324",
url="http://www.jmir.org/2020/10/e22324/",
url="http://www.ncbi.nlm.nih.gov/pubmed/33104004"
}


@Article{info:doi/10.2196/17096,
author="Cheng, Ya-Wen Vivian
and Huang, Chiu-Mieh
and Liao, Jung-Yu
and Hsu, Hsiao-Pei
and Wang, Shih-Wen
and Huang, Su-Fei
and Guo, Jong-Long",
title="Combination of 3-Dimensional Virtual Reality and Hands-On Aromatherapy in Improving Institutionalized Older Adults' Psychological Health: Quasi-Experimental Study",
journal="J Med Internet Res",
year="2020",
month="Jul",
day="23",
volume="22",
number="7",
pages="e17096",
keywords="three-dimensional",
keywords="virtual reality",
keywords="aromatherapy",
keywords="older adult",
keywords="happiness",
keywords="stress",
keywords="sleep quality",
keywords="meditation",
keywords="life satisfaction",
abstract="Background: In Taiwan, which has one of the most rapidly aging populations in the world, it is becoming increasingly critical to promote successful aging strategies that are effective, easily usable, and acceptable to institutionalized older adults. Although many practitioners and professionals have explored aromatherapy and identified its psychological benefits, the effectiveness of combining 3-dimensional (3D) virtual reality and hands-on aromatherapy remains unknown. Objective: A quasi-experimental trial was designed to evaluate the effectiveness of this combination in lowering perceived stress and promoting happiness, sleep quality, meditation experience, and life satisfaction among institutionalized older adults in Taiwan. Methods: A total of 60 institutionalized elderly participants either received the combined intervention or were in a control group. Weekly 2-hour sessions were implemented over 9 weeks. The outcome variables were happiness, perceived stress, sleep quality, meditation experience, and life satisfaction, which were assessed at baseline and after the intervention. Results: Generalized estimating equation (GEE) analyses indicated that the experimental group showed significant post-intervention improvements in terms of scores for happiness, perceived stress, sleep quality, meditation experience, and life satisfaction (n=48; all P<.001). Another GEE analysis showed that the significant improvements in the 5 outcome variables persisted in participants aged 80 years and older (n=35; all P<.001). Conclusions: This is the first trial to explore the effectiveness of a combination of 3D virtual reality and hands-on aromatherapy in improving older adults' psychological health. The results are promising for the promotion of psychological health in institutionalized older adults. Trial Registration: ClinicalTrials.gov NCT04324216; https://clinicaltrials.gov/ct2/show/NCT04324216. ",
doi="10.2196/17096",
url="http://www.jmir.org/2020/7/e17096/",
url="http://www.ncbi.nlm.nih.gov/pubmed/32706660"
}


@Article{info:doi/10.2196/17232,
author="Murat-Ringot, Audrey
and Souquet, Jean Pierre
and Chauvenet, Marion
and Rentler, Charlotte
and Subtil, Fabien
and Schott, Anne-Marie
and Preau, Marie
and Piriou, Vincent",
title="The Effects of Foot Reflexology on Chemotherapy-Induced Nausea and Vomiting in Patients with Digestive System or Lung Cancer: Protocol for a Randomized Controlled Trial",
journal="JMIR Res Protoc",
year="2020",
month="Jul",
day="14",
volume="9",
number="7",
pages="e17232",
keywords="cancer",
keywords="randomized controlled trial",
keywords="foot reflexology",
keywords="nausea",
keywords="vomiting",
keywords="chemotherapy",
abstract="Background: The side effects of chemotherapy, specifically chemotherapy-induced nausea and vomiting, are a concern for patients. To relieve these side effects, antiemetic drugs are recommended. However, some patients report that these drugs are not sufficiently effective. Moreover, patients with chronic disease, including cancer, are increasingly interested in complementary and alternative medicines, and express the desire for nonpharmacological treatments to be used in hospitals. Foot reflexology is a holistic approach that is reported to significantly reduce the severity of chemotherapy-induced nausea and vomiting in patients with breast cancer. Some of the chemotherapy treatments for patients with lung and digestive system cancer are moderately or highly emetic. Objective: The primary objective of this study is to assess the benefits of foot reflexology, together with conventional treatments, on the severity and frequency of chemotherapy-induced nausea and vomiting in patients with lung or digestive system cancer. The secondary objectives to be assessed are quality of life, anxiety, and self-esteem. Methods: This study is an open-label randomized controlled trial conducted over 22 months (18 months intervention and 4 months follow-up). Eligible participants are patients with a lung or digestive system cancer with an indication for platinum-based chemotherapy. Participants are randomized into two groups: conventional care with foot reflexology and conventional care without foot reflexology. Foot reflexology sessions (30 minutes) are performed on an outpatient or inpatient basis. It was estimated that 40 participants per group will be required. The benefits of foot reflexology will be assessed by comparing the relative change in the severity of nausea and vomiting, as assessed by a visual analogue scale, and the frequency of these side effects between the two groups. The secondary objectives will be assessed with the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire; Hospital and Anxiety Depression Scale; and Body Image Questionnaire. Results: This study was approved by the regional ethics committee ({\^I}le de France X CPP) on April 3, 2018 (No. ID RCB 2018-A00571-54). Enrollment started in June 2018. Data analysis will be performed during the second quarter of 2020 and results will be published in the last quarter of 2020. Conclusions: The lack of knowledge regarding the efficacy and safety of foot reflexology limits oncologists to recommend it for this use. This study will provide evidence of the benefits of foot reflexology. If efficacy is confirmed, foot reflexology may be a promising complement to conventional antiemetic drugs. Trial Registration: Clinicaltrials.gov NCT03508180; https://www.clinicaltrials.gov/ct2/show/NCT03508180. International Registered Report Identifier (IRRID): DERR1-10.2196/17232 ",
doi="10.2196/17232",
url="https://www.researchprotocols.org/2020/7/e17232",
url="http://www.ncbi.nlm.nih.gov/pubmed/32449505"
}


@Article{info:doi/10.2196/16018,
author="Wang, Chun Zhi
and Zhang, Ping Shi
and Yuen, Chi Pong
and Chan, Wa Kam
and Chan, Yi Yi
and Cheung, Hoi Chun
and Chow, Ho Chi
and Chua, Kit Ka
and Hu, Jun
and Hu, Zhichao
and Lao, Beini
and Leung, Chuen Chun
and Li, Hong
and Zhong, Linda
and Liu, Xusheng
and Liu, Yulong
and Liu, Zhenjie
and Lun, Xin
and Mo, Wei
and Siu, Yuen Sheung
and Xiong, Zhoujian
and Yeung, Fai Wing
and Zhang, Yun Run
and Zhang, Xuebin",
title="Intra-Rater and Inter-Rater Reliability of Tongue Coating Diagnosis in Traditional Chinese Medicine Using Smartphones: Quasi-Delphi Study",
journal="JMIR Mhealth Uhealth",
year="2020",
month="Jul",
day="9",
volume="8",
number="7",
pages="e16018",
keywords="mobile health",
keywords="smartphone",
keywords="traditional Chinese medicine",
keywords="telemedicine",
keywords="tongue image",
keywords="machine learning",
keywords="oral disease",
keywords="Gwet AC2",
keywords="COVID-19",
abstract="Background: There is a growing trend in the use of mobile health (mHealth) technologies in traditional Chinese medicine (TCM) and telemedicine, especially during the coronavirus disease (COVID-19) outbreak. Tongue diagnosis is an important component of TCM, but also plays a role in Western medicine, for example in dermatology. However, the procedure of obtaining tongue images has not been standardized and the reliability of tongue diagnosis by smartphone tongue images has yet to be evaluated. Objective: The first objective of this study was to develop an operating classification scheme for tongue coating diagnosis. The second and main objective of this study was to determine the intra-rater and inter-rater reliability of tongue coating diagnosis using the operating classification scheme. Methods: An operating classification scheme for tongue coating was developed using a stepwise approach and a quasi-Delphi method. First, tongue images (n=2023) were analyzed by 2 groups of assessors to develop the operating classification scheme for tongue coating diagnosis. Based on clinicians' (n=17) own interpretations as well as their use of the operating classification scheme, the results of tongue diagnosis on a representative tongue image set (n=24) were compared. After gathering consensus for the operating classification scheme, the clinicians were instructed to use the scheme to assess tongue features of their patients under direct visual inspection. At the same time, the clinicians took tongue images of the patients with smartphones and assessed tongue features observed in the smartphone image using the same classification scheme. The intra-rater agreements of these two assessments were calculated to determine which features of tongue coating were better retained by the image. Using the finalized operating classification scheme, clinicians in the study group assessed representative tongue images (n=24) that they had taken, and the intra-rater and inter-rater reliability of their assessments was evaluated. Results: Intra-rater agreement between direct subject inspection and tongue image inspection was good to very good (Cohen $\kappa$ range 0.69-1.0). Additionally, when comparing the assessment of tongue images on different days, intra-rater reliability was good to very good ($\kappa$ range 0.7-1.0), except for the color of the tongue body ($\kappa$=0.22) and slippery tongue fur ($\kappa$=0.1). Inter-rater reliability was moderate for tongue coating (Gwet AC2 range 0.49-0.55), and fair for color and other features of the tongue body (Gwet AC2=0.34). Conclusions: Taken together, our study has shown that tongue images collected via smartphone contain some reliable features, including tongue coating, that can be used in mHealth analysis. Our findings thus support the use of smartphones in telemedicine for detecting changes in tongue coating. ",
doi="10.2196/16018",
url="https://mhealth.jmir.org/2020/7/e16018",
url="http://www.ncbi.nlm.nih.gov/pubmed/32459647"
}


@Article{info:doi/10.2196/17580,
author="Hosseini, Ahmad Seyed
and Jamshidnezhad, Amir
and Zilaee, Marzie
and Fouladi Dehaghi, Behzad
and Mohammadi, Abbas
and Hosseini, Mohsen Seyed",
title="Neural Network--Based Clinical Prediction System for Identifying the Clinical Effects of Saffron (Crocus sativus L) Supplement Therapy on Allergic Asthma: Model Evaluation Study",
journal="JMIR Med Inform",
year="2020",
month="Jul",
day="6",
volume="8",
number="7",
pages="e17580",
keywords="asthma",
keywords="machine learning",
keywords="clinical predictor system",
keywords="neural networks",
keywords="supplement therapy",
keywords="saffron",
keywords="Crocus sativus L",
abstract="Background: Asthma is commonly associated with chronic airway inflammation and is the underlying cause of over a million deaths each year. Crocus sativus L, commonly known as saffron, when used in the form of traditional medicines, has demonstrated anti-inflammatory effects which may be beneficial to individuals with asthma. Objective: The objective of this study was to develop a clinical prediction system using an artificial neural network to detect the effects of C sativus L supplements on patients with allergic asthma. Methods: A genetic algorithm--modified neural network predictor system was developed to detect the level of effectiveness of C sativus L using features extracted from the clinical, immunologic, hematologic, and demographic information of patients with asthma. The study included data from men (n=40) and women (n=40) individuals with mild or moderate allergic asthma from 18 to 65 years of age. The aim of the model was to estimate and predict the level of effect of C sativus L supplements on each asthma risk factor and to predict the level of alleviation in patients with asthma. A genetic algorithm was used to extract input features for the clinical prediction system to improve its predictive performance. Moreover, an optimization model was developed for the artificial neural network component that classifies the patients with asthma using C sativus L supplement therapy. Results: The best overall performance of the clinical prediction system was an accuracy greater than 99\% for training and testing data. The genetic algorithm--modified neural network predicted the level of effect with high accuracy for anti--heat shock protein (anti-HSP), high sensitivity C-reactive protein (hs-CRP), forced expiratory volume in the first second of expiration (FEV1), forced vital capacity (FVC), the ratio of FEV1/FVC, and forced expiratory flow (FEF25\%-75\%) for testing data (anti-HSP: 96.5\%; hs-CRP: 98.9\%; FEV1: 98.1\%; FVC: 97.5\%; FEV1/FVC ratio: 97\%; and FEF25\%-75\%: 96.7\%, respectively). Conclusions: The clinical prediction system developed in this study was effective in predicting the effect of C sativus L supplements on patients with allergic asthma. This clinical prediction system may help clinicians to identify early on which clinical factors in asthma will improve over the course of treatment and, in doing so, help clinicians to develop effective treatment plans for patients with asthma. ",
doi="10.2196/17580",
url="https://medinform.jmir.org/2020/7/e17580",
url="http://www.ncbi.nlm.nih.gov/pubmed/32628613"
}


@Article{info:doi/10.2196/17821,
author="Liu, Ziqing
and He, Haiyang
and Yan, Shixing
and Wang, Yong
and Yang, Tao
and Li, Guo-Zheng",
title="End-to-End Models to Imitate Traditional Chinese Medicine Syndrome Differentiation in Lung Cancer Diagnosis: Model Development and Validation",
journal="JMIR Med Inform",
year="2020",
month="Jun",
day="16",
volume="8",
number="6",
pages="e17821",
keywords="traditional Chinese medicine",
keywords="syndrome differentiation",
keywords="lung cancer",
keywords="medical record",
keywords="deep learning",
keywords="model fusion",
abstract="Background: Traditional Chinese medicine (TCM) has been shown to be an efficient mode to manage advanced lung cancer, and accurate syndrome differentiation is crucial to treatment. Documented evidence of TCM treatment cases and the progress of artificial intelligence technology are enabling the development of intelligent TCM syndrome differentiation models. This is expected to expand the benefits of TCM to lung cancer patients. Objective: The objective of this work was to establish end-to-end TCM diagnostic models to imitate lung cancer syndrome differentiation. The proposed models used unstructured medical records as inputs to capitalize on data collected for practical TCM treatment cases by lung cancer experts. The resulting models were expected to be more efficient than approaches that leverage structured TCM datasets. Methods: We approached lung cancer TCM syndrome differentiation as a multilabel text classification problem. First, entity representation was conducted with Bidirectional Encoder Representations from Transformers and conditional random fields models. Then, five deep learning--based text classification models were applied to the construction of a medical record multilabel classifier, during which two data augmentation strategies were adopted to address overfitting issues. Finally, a fusion model approach was used to elevate the performance of the models. Results: The F1 score of the recurrent convolutional neural network (RCNN) model with augmentation was 0.8650, a 2.41\% improvement over the unaugmented model. The Hamming loss for RCNN with augmentation was 0.0987, which is 1.8\% lower than that of the same model without augmentation. Among the models, the text-hierarchical attention network (Text-HAN) model achieved the highest F1 scores of 0.8676 and 0.8751. The mean average precision for the word encoding--based RCNN was 10\% higher than that of the character encoding--based representation. A fusion model of the text-convolutional neural network, text-recurrent neural network, and Text-HAN models achieved an F1 score of 0.8884, which showed the best performance among the models. Conclusions: Medical records could be used more productively by constructing end-to-end models to facilitate TCM diagnosis. With the aid of entity-level representation, data augmentation, and model fusion, deep learning--based multilabel classification approaches can better imitate TCM syndrome differentiation in complex cases such as advanced lung cancer. ",
doi="10.2196/17821",
url="https://medinform.jmir.org/2020/6/e17821",
url="http://www.ncbi.nlm.nih.gov/pubmed/32543445"
}


@Article{info:doi/10.2196/17608,
author="Zhang, Hong
and Ni, Wandong
and Li, Jing
and Zhang, Jiajun",
title="Artificial Intelligence--Based Traditional Chinese Medicine Assistive Diagnostic System: Validation Study",
journal="JMIR Med Inform",
year="2020",
month="Jun",
day="15",
volume="8",
number="6",
pages="e17608",
keywords="traditional Chinese medicine",
keywords="TCM",
keywords="disease diagnosis",
keywords="syndrome prediction",
keywords="syndrome differentiation",
keywords="natural language processing",
keywords="NLP",
keywords="artificial intelligence",
keywords="AI",
keywords="assistive diagnostic system",
keywords="convolutional neural network",
keywords="CNN",
keywords="machine learning",
keywords="ML",
keywords="BiLSTM-CRF",
abstract="Background: Artificial intelligence--based assistive diagnostic systems imitate the deductive reasoning process of a human physician in biomedical disease diagnosis and treatment decision making. While impressive progress in this area has been reported, most of the reported successes are applications of artificial intelligence in Western medicine. The application of artificial intelligence in traditional Chinese medicine has lagged mainly because traditional Chinese medicine practitioners need to perform syndrome differentiation as well as biomedical disease diagnosis before a treatment decision can be made. Syndrome, a concept unique to traditional Chinese medicine, is an abstraction of a variety of signs and symptoms. The fact that the relationship between diseases and syndromes is not one-to-one but rather many-to-many makes it very challenging for a machine to perform syndrome predictions. So far, only a handful of artificial intelligence--based assistive traditional Chinese medicine diagnostic models have been reported, and they are limited in application to a single disease-type. Objective: The objective was to develop an artificial intelligence--based assistive diagnostic system capable of diagnosing multiple types of diseases that are common in traditional Chinese medicine, given a patient's electronic health record notes. The system was designed to simultaneously diagnose the disease and produce a list of corresponding syndromes. Methods: Unstructured freestyle electronic health record notes were processed by natural language processing techniques to extract clinical information such as signs and symptoms which were represented by named entities. Natural language processing used a recurrent neural network model called bidirectional long short-term memory network--conditional random forest. A convolutional neural network was then used to predict the disease-type out of 187 diseases in traditional Chinese medicine. A novel traditional Chinese medicine syndrome prediction method---an integrated learning model---was used to produce a corresponding list of probable syndromes. By following a majority-rule voting method, the integrated learning model for syndrome prediction can take advantage of four existing prediction methods (back propagation, random forest, extreme gradient boosting, and support vector classifier) while avoiding their respective weaknesses which resulted in a consistently high prediction accuracy. Results: A data set consisting of 22,984 electronic health records from Guanganmen Hospital of the China Academy of Chinese Medical Sciences that were collected between January 1, 2017 and September 7, 2018 was used. The data set contained a total of 187 diseases that are commonly diagnosed in traditional Chinese medicine. The diagnostic system was designed to be able to detect any one of the 187 disease-types. The data set was partitioned into a training set, a validation set, and a testing set in a ratio of 8:1:1. Test results suggested that the proposed system had a good diagnostic accuracy and a strong capability for generalization. The disease-type prediction accuracies of the top one, top three, and top five were 80.5\%, 91.6\%, and 94.2\%, respectively. Conclusions: The main contributions of the artificial intelligence--based traditional Chinese medicine assistive diagnostic system proposed in this paper are that 187 commonly known traditional Chinese medicine diseases can be diagnosed and a novel prediction method called an integrated learning model is demonstrated. This new prediction method outperformed all four existing methods in our preliminary experimental results. With further improvement of the algorithms and the availability of additional electronic health record data, it is expected that a wider range of traditional Chinese medicine disease-types could be diagnosed and that better diagnostic accuracies could be achieved. ",
doi="10.2196/17608",
url="http://medinform.jmir.org/2020/6/e17608/",
url="http://www.ncbi.nlm.nih.gov/pubmed/32538797"
}


@Article{info:doi/10.2196/12536,
author="Lognos, B{\'e}atrice
and Carbonnel, Fran{\c{c}}ois
and Boulze Launay, Isabelle
and Bringay, Sandra
and Guerdoux-Ninot, Estelle
and Mollevi, Caroline
and Senesse, Pierre
and Ninot, Gregory",
title="Complementary and Alternative Medicine in Patients With Breast Cancer: Exploratory Study of Social Network Forum Data",
journal="JMIR Cancer",
year="2019",
month="Nov",
day="27",
volume="5",
number="2",
pages="e12536",
keywords="complementary and alternative medicine (CAM)",
keywords="nonpharmacological interventions",
keywords="cancer",
keywords="social network",
keywords="forum",
keywords="patient",
abstract="Background: Patients and health care professionals are becoming increasingly preoccupied in complementary and alternative medicine (CAM) that can also be called nonpharmacological interventions (NPIs). In just a few years, this supportive care has gone from solutions aimed at improving the quality of life to solutions intended to reduce symptoms, supplement oncological treatments, and prevent recurrences. Digital social networks are a major vector for disseminating these practices that are not always disclosed to doctors by patients. An exploration of the content of exchanges on social networks by patients suffering from breast cancer can help to better identify the extent and diversity of these practices. Objective: This study aimed to explore the interest of patients with breast cancer in CAM from posts published in health forums and French-language social media groups. Methods: The retrospective study was based on a French database of 2 forums and 4 Facebook groups between June 3, 2006, and November 17, 2015. The extracted, anonymized, and compiled data (264,249 posts) were analyzed according to the occurrences associated with the NPI categories and NPI subcategories, their synonyms, and their related terms. Results: The results showed that patients with breast cancer use mainly physical (37.6\%) and nutritional (31.3\%) interventions. Herbal medicine is a subcategory that was cited frequently. However, the patients did not mention digital interventions. Conclusions: This exploratory study of the main French forums and discussion groups indicates a significant interest in CAM during and after treatments for breast cancer, with primarily physical and nutritional interventions complementing approved treatments. This study highlights the importance of accurate information (vs fake medicine), prescription and monitoring of these interventions, and the mediating role that health professionals must play in this regard. ",
doi="10.2196/12536",
url="http://cancer.jmir.org/2019/2/e12536/",
url="http://www.ncbi.nlm.nih.gov/pubmed/31774404"
}


@Article{info:doi/10.2196/ijmr.9803,
author="Chen, T. Annie
and Taylor-Swanson, Lisa
and Buie, W. Ronald
and Park, Albert
and Conway, Mike",
title="Characterizing Websites That Provide Information About Complementary and Integrative Health: Systematic Search and Evaluation of Five Domains",
journal="Interact J Med Res",
year="2018",
month="Oct",
day="10",
volume="7",
number="2",
pages="e14",
keywords="complementary and integrative health",
keywords="online information quality",
keywords="website quality",
keywords="website content",
keywords="acupuncture",
keywords="massage",
keywords="homeopathy",
keywords="reiki",
keywords="yoga",
abstract="Background: In recent years, there has been an increase in the utilization of complementary and integrative health (CIH) care, and an increase in information-seeking behavior focused on CIH. Thus, understanding the quality of CIH information that is available on the internet is imperative. Although there have been a limited number of studies evaluating the quality of websites providing information about specific CIH-related topics, a broad evaluation of CIH websites has not been conducted. Objective: This study was designed to fill that gap. We set out to assess website quality in 5 CIH domains: (1) acupuncture, (2) homeopathy, (3) massage, (4) reiki, and (5) yoga. This study aimed to 1) characterize the websites by type and quality; 2) evaluate website characteristics which may affect readers' perceptions, specifically message content, structural features, and presentation style, and 3) investigate the extent to which harms, benefits and purposes of use are stated on websites. Methods: This study employed a systematic search strategy to identify websites in each of the target domains to be evaluated. The websites were then classified by type, and a set of checklists focusing on quality, message content, structural features, and presentation style was used to evaluate the websites. Lastly, we performed content analysis to identify harms, benefits, and perceived purposes of use. Results: There were similarities across domains regarding their overall quality and their message content. Across all domains, a high proportion of websites received strong scores in terms of ownership, currency, interactivity and navigability. Scores were more variable concerning authorship, balanced presentation of information and the use of sources of information. However, there were differences regarding their structural features and presentation style. Acupuncture and reiki sites tended to include more external links, and yoga, fewer. There was variation across domains in the extent to which the websites contained domain-specific terminology. Websites tended to provide an extensive list of potential benefits, while reporting of harms was scarce. Conclusions: This is the first study to perform a multidimensional assessment of websites in multiple CIH domains. This review showed that while there are similarities among websites of different CIH domains, there are also differences. The diverse distribution of website types suggests that, regardless of CIH domain, the public encounters information through many different types of media, and it would be useful to consider how the presentation of this content may differ depending on the medium. The characteristics for which variability exist are areas that warrant greater attention from researchers, policy makers, clinicians and patients. There is also a need to better understand how individuals may interact with CIH websites, and to develop tools to assist people to interpret the CIH-related information that they encounter. ",
doi="10.2196/ijmr.9803",
url="http://www.i-jmr.org/2018/2/e14/",
url="http://www.ncbi.nlm.nih.gov/pubmed/30305254"
}