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Traditional Vietnamese herbal medicine TD0015 in Knee Osteoarthritis: A Phase-II randomized controlled trial
IF 2.8 4区 医学 Q2 INTEGRATIVE & COMPLEMENTARY MEDICINE Pub Date : 2025-03-31 DOI: 10.1016/j.imr.2025.101143
Nguyen Thi Thu Ha , Duong Trong Nghia , Ha Thi Viet Nga , Trinh Thi Lua , Nguyen Thi Bich Hong , Nguyen Thi Hanh , Nguyen Kim Ngoc , Nguyen Lam Vuong

Background

Knee osteoarthritis (KOA) is a leading cause of disability among older adults worldwide. Traditional medicine offers a promising treatment for KOA with fewer side effects compared to current treatments such as non-steroidal anti-inflammatory drugs and corticosteroids. This study aimed to evaluate the safety and efficacy of TD0015, a herbal formulation based on the Duhuo Jisheng decoction, in treating KOA.

Methods

This randomized, double-blind, placebo-controlled trial enrolled 108 patients with KOA. Participants were randomly assigned in a 1:1:1 ratio to receive TD0015 5 g, TD0015 7.5 g, or placebo daily for 60 days. Efficacy endpoints included changes in Western Ontario and McMaster Universities Osteoarthritis index (WOMAC), Visual Analogue Scale (VAS), Lequesne index, heel-buttock distance, and knee flexion and extension range of motion. Safety was assessed by adverse events (AEs).

Results

The mean age was around 60 years, and >80 % were females. Both TD0015 treatment groups significantly improved the WOMAC, VAS, Lequesne score, heel-buttock distance, and knee flexion and extension during the treatment period. At the 90-day follow-up, the mean percentage improvement in WOMAC scores was 74.5 % ± 13.4 %, 83.9 % ± 14.8 %, and 7.4 % ± 31.5 % in the TD0015 5 g, TD0015 7.5 g, and placebo groups, respectively, which corresponds to a 67.1 % (95 % CI: 56.3–77.9) and 76.5 % (95 % CI: 65.6–87.4) improvement in the TD0015 5 g and TD0015 7.5 g groups, compared to placebo. No AEs were reported in any group.

Conclusions

The Vietnamese herbal medicine TD0015 is safe, efficacious, and well-tolerated in treating KOA. Further studies are required to confirm the long-term efficacy and safety of TD0015.

Trial registration

ClinicalTrials.gov, NCT06657495.
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引用次数: 0
Exploring the intersection of brain-computer interfaces and traditional, complementary, and integrative medicine 探索脑机接口与传统医学、补充医学和综合医学的交叉点
IF 2.8 4区 医学 Q2 INTEGRATIVE & COMPLEMENTARY MEDICINE Pub Date : 2025-03-31 DOI: 10.1016/j.imr.2025.101142
Jeremy Y. Ng
Brain-computer interfaces (BCIs) represent a transformative innovation in healthcare, enabling direct communication between the brain and external devices. This educational article explores the potential intersection of BCIs and traditional, complementary, and integrative medicine (TCIM). BCIs have shown promise in enhancing mind-body practices such as meditation, while their integration with energy-based therapies may offer novel insights and measurable outcomes. Emerging advancements, including artificial intelligence-enhanced BCIs, hold potential for improving personalization and expanding the therapeutic efficacy of TCIM interventions. Despite these opportunities, integrating BCIs with TCIM presents considerable ethical, cultural, and practical challenges. Concerns related to informed consent, cultural sensitivity, data privacy, accessibility, and regulatory frameworks must be addressed to ensure responsible implementation. Interdisciplinary collaboration among relevant stakeholders, including TCIM and conventional practitioners, researchers, and policymakers among other relevant stakeholders is crucial for developing integrative healthcare models that balance innovation with patient safety and respect for diverse healing traditions. Future directions include expanding evidence bases to validate TCIM practices through BCI-enhanced research, fostering equitable access to neurotechnological advancements, and promoting global ethical guidelines to navigate complex sociocultural dynamics. BCIs have the potential to revolutionize TCIM, offering novel solutions for complex health challenges and fostering a more inclusive, integrative approach to healthcare, provided that they are utilized responsibly and ethically.
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引用次数: 0
Patients Receiving Integrative Medicine Effectiveness Registry (PRIMIER) of the BraveNet practice-based research network: Results of the chronic pain cohort
IF 2.8 4区 医学 Q2 INTEGRATIVE & COMPLEMENTARY MEDICINE Pub Date : 2025-03-25 DOI: 10.1016/j.imr.2025.101141
Jeffery A. Dusek , Qi Gao , Ryung S. Kim , Donald I. Abrams , Benjamin Kligler , Natalie L. Dyer , Kathryn Hansen , Eric J. Roseen , M. Diane McKee , the PRIMIER Writing Group*

Background

An increasing number of clinics are providing integrative medicine for chronic pain, creating a need for real-world, practice-based research. Our purpose was to conduct a multi-site prospective, practice-based, observational evaluation of patient reported outcomes in chronic pain patients.

Methods

This study took place at seventeen BraveNet Practice Based Research Network integrative medicine clinics. Chronic pain patients receiving personalized, integrative medicine interventions at BraveNet clinics were eligible. Participants completed the Patient Reported Outcomes Measurement Information System-29, Perceived Stress Scale-4, and the Patient Activation Measure at the index/baseline visit and at 2, 4, 6, and 12 months. Diagnostic and billing codes were extracted data from patients’ health records. Linear mixed-model and multi-variate analyses evaluated changes from index visit through 12 months.

Results

A total of 4883 patients enrolled, 3658 qualified and 967 of them endorsed chronic pain, completed at least two outcomes at 2 time points, had evaluable electronic health record data, and had at least one integrative medicine visit during the study period. Participants had a mean age of 51.6 years (SD 13.88) and were mostly white (81.8 %), female (78.3 %), educated (≥ college degree: 70.1 %). Significant improvements were observed on all 7 Patient Reported Outcomes Measurement Information System subscales, Perceived Stress Scale, and Patient Activation Measure scores at 12 months.

Conclusions

Chronic pain patients receiving care at integrative medicine clinics reported significant improvement over time in multiple domains of pain and quality of life. Future research with more sites and a common set of outcomes would further guide clinical practice.

Trial Registration

Clinical Trials.gov NCT01754038
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引用次数: 0
Non-pharmacological interventions involving traditional Chinese medicine for assisted reproductive technology: A group consensus
IF 2.8 4区 医学 Q2 INTEGRATIVE & COMPLEMENTARY MEDICINE Pub Date : 2025-03-10 DOI: 10.1016/j.imr.2025.101137
Xinyue Li , Hye Won Lee , Tianyi Zhou , Nicola Robinson , Xiao-Yang Mio Hu , Momir Dunjić , Fangfang Wang , Rong Zhang , Consensus Panel , Yuhang Zhu , Fan Qu

Background

Assisted reproductive technologies (ART) are being increasingly utilized for mitigating fertility problems. Nonpharmacological interventions of traditional Chinese medicine (TCM) are widely used as an adjunct to ART, which may improve the rate of pregnancy. Currently, no standard treatment guidelines or consensus are available for non-pharmacological interventions of TCM for patients undergoing ART. The aim of this study was to establish a consensus on the use of non-pharmacological TCM interventions during the ART treatment cycle.

Methods

This study utilized existing data and developed a consensus among a panel of experts on non-pharmacological interventions of TCM for ART. Through face-to-face or online contact, the listed recommendations were revised one by one, and a consensus was reached when >70 % of the experts agreed with the recommendation. The writing group of the expert panel then created the first draft of the expert consensus based on the discussion in the first round. The second round was held to reach a consensus on content improvements based on the opinions of the experts in the previous round.

Results

After the literature search, a total of 873 related articles were retrieved, and 59 studies were ultimately included according to the inclusion and exclusion criteria. After two rounds of the survey, a total of 24 experts from 18 Chinese provinces across China and five international experts from the United Kingdom, Korea, and Serbia provided vital insight and support for the formulation of this consensus. The consensus outlines eight non-pharmacological interventions for seven different stages of the ART cycle and three major complications during ART, involving 23 items of clinical practice recommendations.

Conclusions

Expert consensus provides a foundation for integrating non-pharmacological TCM interventions into clinical practice during ART. As more high-quality, large-scale, multicenter clinical trials are conducted, these recommendations may be refined and updated to better inform clinical guidelines and improve patient outcomes in ART.
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引用次数: 0
Integrative medicine and perinatal outcomes among women giving birth: A national population-based study in South Korea
IF 2.8 4区 医学 Q2 INTEGRATIVE & COMPLEMENTARY MEDICINE Pub Date : 2025-02-28 DOI: 10.1016/j.imr.2025.101135
Seongju Kim , Jiae Choi , Hye Won Lee , Sunju Park

Background

The aim of this study was to examine the effects of integrative medicine (IM) on perinatal outcomes and health care utilization in women who gave birth in Korea.

Methods

This study used National Health Insurance Sharing Service (NHISS) claims data and established a retrospective cohort of all women who gave birth in Korea from January to December 2021. The women were categorized into IM and conventional medicine (CM) groups according to the nature of their health institution visits before delivery. To assess the risk of adverse perinatal outcomes between the two groups, a logistic regression model was used to estimate the odds ratio (OR) and the corresponding 95 % confidence interval (CI).

Results

A total of 171,136 women were divided into the IM (n = 91,902) and CM (n = 79,234) groups. Among the 9,608,545 claims analyzed, respiratory system disease was the most common primary diagnosis, followed by genitourinary system diseases. In the IM group, 19,153 claims were associated with infertility diagnosis codes, with the most frequent primary diagnoses being female infertility associated with anovulation and female infertility of other origins. Compared with the CM group, the IM group had significantly greater rates of assisted reproductive technology (ART) use (aOR, 1.25 [95 % CI, 1.21, 1.29]; P < 0.0001) and cesarean delivery (aOR, 1.08 [95 % CI, 1.06, 1.11]; P < 0.0001).

Conclusion

The study findings support that dual health care system use is not associated with the health outcomes of women who gave birth. The findings are expected to be valuable for establishing national health and medical policies or promoting health care utilization for women who give birth in South Korea.
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引用次数: 0
Exploring the potential of acupuncture practice education using artificial intelligence
IF 2.8 4区 医学 Q2 INTEGRATIVE & COMPLEMENTARY MEDICINE Pub Date : 2025-01-23 DOI: 10.1016/j.imr.2025.101123
Kyeong Han Kim , Hyein Jeong , Gyeong Seo Lee , Seung-Hee Lee
Generative artificial intelligence (AI) is being applied in various areas such as education, clinical practice, and research within the medical field. This review explores the potential use of AI models in acupuncture practice education. Recent and relevant findings were searched from literature. Active research on the use of AI in acupuncture education, particularly in areas such as acupoint selection and acupuncture manipulation, is ongoing. Additionally, AI-powered educational tools are being developed in the field of traditional medicine. The development of AI-driven educational tools for acupuncture education holds significant potential to enhance the effectiveness and efficiency of traditional medicine education.
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引用次数: 0
Concerns about the use of verum acupuncture points in sham acupuncture studies for pain conditions: Findings and insights from network meta-analysis
IF 2.8 4区 医学 Q2 INTEGRATIVE & COMPLEMENTARY MEDICINE Pub Date : 2025-01-10 DOI: 10.1016/j.imr.2025.101122
Boram Lee , Chan-Young Kwon , Hye Won Lee , Arya Nielsen , L Susan Wieland , Tae-Hun Kim , Stephen Birch , Terje Alraek , Myeong Soo Lee
{"title":"Concerns about the use of verum acupuncture points in sham acupuncture studies for pain conditions: Findings and insights from network meta-analysis","authors":"Boram Lee ,&nbsp;Chan-Young Kwon ,&nbsp;Hye Won Lee ,&nbsp;Arya Nielsen ,&nbsp;L Susan Wieland ,&nbsp;Tae-Hun Kim ,&nbsp;Stephen Birch ,&nbsp;Terje Alraek ,&nbsp;Myeong Soo Lee","doi":"10.1016/j.imr.2025.101122","DOIUrl":"10.1016/j.imr.2025.101122","url":null,"abstract":"","PeriodicalId":13644,"journal":{"name":"Integrative Medicine Research","volume":"14 1","pages":"Article 101122"},"PeriodicalIF":2.8,"publicationDate":"2025-01-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143143504","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Acupuncture-related therapy for chronic cough: A systematic review and meta-analysis
IF 2.8 4区 医学 Q2 INTEGRATIVE & COMPLEMENTARY MEDICINE Pub Date : 2025-01-02 DOI: 10.1016/j.imr.2025.101121
Boram Lee , Chan-Young Kwon , Yoon Kyoung Jeong , Na-Yeon Ha , Kwan-Il Kim , Beom-Joon Lee , Jun-Hwan Lee

Background

Despite the high prevalence and socioeconomic burden of chronic cough, there has been an unmet medical need. Acupuncture may be promising for treating chronic cough with various pathophysiologies involving several neurotransmission mechanisms. We aimed to systematically compile evidence on the effect and safety of acupuncture-related therapy for chronic cough.

Methods

Through a search of 11 databases, randomized controlled trials (RCTs) published until February 15, 2024 that evaluated the effect of acupuncture-related therapy at acupuncture points (including acupuncture, acupoint herbal patching, and moxibustion) for patients with chronic cough were identified and analyzed without restrictions on the cause of cough or age. When there were two or more studies that measured the same outcome measures, a meta-analysis was performed, and the certainty of evidence was evaluated based on the GRADE methodology.

Results

A total of 30 RCTs with 2835 participants were included. When acupuncture-related therapy was implemented in addition to conventional treatment including medicine and lifestyle guidance according to symptoms and causes, cough severity, cough-related quality of life, and the total effective rate (TER) were significantly improved with no difference in the incidence of adverse events. Furthermore, compared with conventional treatment, acupuncture-related therapy significantly improved cough severity and the TER. The certainty of the evidence was generally moderate due to the risk of bias. The most frequently used acupuncture points in the included studies were BL13, GV14, CV17, and EX-B1.

Conclusion

Acupuncture-related therapy might be an effective and safe treatment for patients with chronic cough of various causes with complex pathophysiologies.

Protocol registration

PROSPERO, CRD42024518115. PROSPERO (CRD42024518115).
{"title":"Acupuncture-related therapy for chronic cough: A systematic review and meta-analysis","authors":"Boram Lee ,&nbsp;Chan-Young Kwon ,&nbsp;Yoon Kyoung Jeong ,&nbsp;Na-Yeon Ha ,&nbsp;Kwan-Il Kim ,&nbsp;Beom-Joon Lee ,&nbsp;Jun-Hwan Lee","doi":"10.1016/j.imr.2025.101121","DOIUrl":"10.1016/j.imr.2025.101121","url":null,"abstract":"<div><h3>Background</h3><div>Despite the high prevalence and socioeconomic burden of chronic cough, there has been an unmet medical need. Acupuncture may be promising for treating chronic cough with various pathophysiologies involving several neurotransmission mechanisms. We aimed to systematically compile evidence on the effect and safety of acupuncture-related therapy for chronic cough.</div></div><div><h3>Methods</h3><div>Through a search of 11 databases, randomized controlled trials (RCTs) published until February 15, 2024 that evaluated the effect of acupuncture-related therapy at acupuncture points (including acupuncture, acupoint herbal patching, and moxibustion) for patients with chronic cough were identified and analyzed without restrictions on the cause of cough or age. When there were two or more studies that measured the same outcome measures, a meta-analysis was performed, and the certainty of evidence was evaluated based on the GRADE methodology.</div></div><div><h3>Results</h3><div>A total of 30 RCTs with 2835 participants were included. When acupuncture-related therapy was implemented in addition to conventional treatment including medicine and lifestyle guidance according to symptoms and causes, cough severity, cough-related quality of life, and the total effective rate (TER) were significantly improved with no difference in the incidence of adverse events. Furthermore, compared with conventional treatment, acupuncture-related therapy significantly improved cough severity and the TER. The certainty of the evidence was generally moderate due to the risk of bias. The most frequently used acupuncture points in the included studies were BL13, GV14, CV17, and EX-B1.</div></div><div><h3>Conclusion</h3><div>Acupuncture-related therapy might be an effective and safe treatment for patients with chronic cough of various causes with complex pathophysiologies.</div></div><div><h3>Protocol registration</h3><div>PROSPERO, CRD42024518115. PROSPERO (CRD42024518115).</div></div>","PeriodicalId":13644,"journal":{"name":"Integrative Medicine Research","volume":"14 1","pages":"Article 101121"},"PeriodicalIF":2.8,"publicationDate":"2025-01-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143143019","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Effect of acupressure on smoking cessation in young smokers with nicotine dependence: a mixed methods study
IF 2.8 4区 医学 Q2 INTEGRATIVE & COMPLEMENTARY MEDICINE Pub Date : 2024-12-30 DOI: 10.1016/j.imr.2024.101120
Ying-Ying Zhang , Yi-Jie Liu , Yuan Wang , Chen Shen , Shi-Bing Liang , Nicola Robinson , Hai-Fa Qiao , Jian-Ping Liu

Background

Acupressure has been widely used for quitting smoking for a long time in China. This study explores the feasibility and effects of acupressure on smoking cessation in young smokers with nicotine dependence to inform policy and decision-making.

Methods

This was a single group study using pre/post-test design. Participants received four weeks of auricular acupressure treatment, led by a registered acupuncturist. Smoking cravings, nicotine dependence, withdrawal symptoms, and cigarettes per day (CPD) were recorded before and after treatment. Changes in outcomes were analyzed at 2 weeks and 4 weeks using SPSS software version 22.0. Semi-structured interviews were conducted with participants to explore their experience and attitude towards auricular acupressure. Thematic analysis was applied to analyze the data.

Results

A total of 20 participants completed this study. A significant reduction was observed in smoking cravings (F = 11.02, P < 0.05), nicotine dependence (F = 11.09, P < 0.05), withdrawal symptoms (F = 11.19, P < 0.05), and CPD (F = 19.03, P < 0.05) over sessions. Additionally, withdrawal symptoms decreased significantly from 2 weeks to 4 weeks (P < 0.05) of acupressure treatment. Three inter-related themes emerged from interviews: personal and external resources, psychological and physical effects of acupressure, and satisfaction with acupressure for smoking cessation.

Conclusion

The quantitative and qualitative data suggest that acupressure maybe effective in decreasing nicotine dependence and smoking cravings. However, this was a pilot and single arm study, these effects need to be further verified. The study supports the feasibility and safety of introducing acupressure therapy for smoking cessation in young smokers.
{"title":"Effect of acupressure on smoking cessation in young smokers with nicotine dependence: a mixed methods study","authors":"Ying-Ying Zhang ,&nbsp;Yi-Jie Liu ,&nbsp;Yuan Wang ,&nbsp;Chen Shen ,&nbsp;Shi-Bing Liang ,&nbsp;Nicola Robinson ,&nbsp;Hai-Fa Qiao ,&nbsp;Jian-Ping Liu","doi":"10.1016/j.imr.2024.101120","DOIUrl":"10.1016/j.imr.2024.101120","url":null,"abstract":"<div><h3>Background</h3><div>Acupressure has been widely used for quitting smoking for a long time in China. This study explores the feasibility and effects of acupressure on smoking cessation in young smokers with nicotine dependence to inform policy and decision-making.</div></div><div><h3>Methods</h3><div>This was a single group study using pre/post-test design. Participants received four weeks of auricular acupressure treatment, led by a registered acupuncturist. Smoking cravings, nicotine dependence, withdrawal symptoms, and cigarettes per day (CPD) were recorded before and after treatment. Changes in outcomes were analyzed at 2 weeks and 4 weeks using SPSS software version 22.0. Semi-structured interviews were conducted with participants to explore their experience and attitude towards auricular acupressure. Thematic analysis was applied to analyze the data.</div></div><div><h3>Results</h3><div>A total of 20 participants completed this study. A significant reduction was observed in smoking cravings (<em>F</em> = 11.02, <em>P</em> &lt; 0.05), nicotine dependence (<em>F</em> = 11.09, <em>P</em> &lt; 0.05), withdrawal symptoms (<em>F</em> = 11.19, <em>P</em> &lt; 0.05), and CPD (<em>F</em> = 19.03, <em>P</em> &lt; 0.05) over sessions. Additionally, withdrawal symptoms decreased significantly from 2 weeks to 4 weeks (<em>P</em> &lt; 0.05) of acupressure treatment. Three inter-related themes emerged from interviews: personal and external resources, psychological and physical effects of acupressure, and satisfaction with acupressure for smoking cessation.</div></div><div><h3>Conclusion</h3><div>The quantitative and qualitative data suggest that acupressure maybe effective in decreasing nicotine dependence and smoking cravings. However, this was a pilot and single arm study, these effects need to be further verified. The study supports the feasibility and safety of introducing acupressure therapy for smoking cessation in young smokers.</div></div>","PeriodicalId":13644,"journal":{"name":"Integrative Medicine Research","volume":"14 1","pages":"Article 101120"},"PeriodicalIF":2.8,"publicationDate":"2024-12-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143143503","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Common adverse events of herbal formulas for developing reporting forms for clinical practice and research: An overview of systematic reviews
IF 2.8 4区 医学 Q2 INTEGRATIVE & COMPLEMENTARY MEDICINE Pub Date : 2024-12-28 DOI: 10.1016/j.imr.2024.101118
Eunbyul Cho , Sungha Kim , Mi Ju Son

Background

Previous research has mainly focused on the adverse events (AEs) of individual medicinal plants rather than those of herbal formulas. This study investigated AEs associated with herbal formulas composed of two or more herbs by summarizing existing systematic reviews (SRs). We aimed to identify common AEs to develop a comprehensive reporting form for clinical practice and research, improving herbal medicine safety monitoring in South Korea.

Methods

Four international (MEDLINE, EMBASE, CENTRAL, CINAHL) and three Korean databases (KISS, ScienceON, OASIS) were searched for SRs on AEs associated with herbal formulas from inception to September 13, 2024. Inclusion criteria were SRs focusing on AEs of herbal formulas composed of two or more herbs. Two researchers independently conducted the search, selection, and data extraction. Methodological and reporting quality were evaluated using A MeaSurement Tool to Assess systematic Reviews 2 and the Preferred Reporting Items for Systematic Reviews and Meta-Analyses 2020 checklist. AEs were classified using the System Organ Class of the Medical Dictionary for Regulatory Activities.

Results

Thirteen SRs were selected. The most frequently reported organ system was hepatobiliary (9 SRs), followed by nervous and gastrointestinal systems (3 SRs each). Common symptoms in primary studies were nausea (n = 102), diarrhea (n = 80), and vomiting (n = 70). Causality was analyzed in 7 SRs using various scales. The methodological quality of the included SRs was critically low.

Conclusions

Our findings provide a foundation for developing a standardized AE reporting form for herbal formulas. Further high-quality reports with specific patient conditions, herbal constituents, and causality assessments are required to enhance herbal medicine safety monitoring and understanding.

Protocol registration

PROSPERO, CRD42023478440.
{"title":"Common adverse events of herbal formulas for developing reporting forms for clinical practice and research: An overview of systematic reviews","authors":"Eunbyul Cho ,&nbsp;Sungha Kim ,&nbsp;Mi Ju Son","doi":"10.1016/j.imr.2024.101118","DOIUrl":"10.1016/j.imr.2024.101118","url":null,"abstract":"<div><h3>Background</h3><div>Previous research has mainly focused on the adverse events (AEs) of individual medicinal plants rather than those of herbal formulas. This study investigated AEs associated with herbal formulas composed of two or more herbs by summarizing existing systematic reviews (SRs). We aimed to identify common AEs to develop a comprehensive reporting form for clinical practice and research, improving herbal medicine safety monitoring in South Korea.</div></div><div><h3>Methods</h3><div>Four international (MEDLINE, EMBASE, CENTRAL, CINAHL) and three Korean databases (KISS, ScienceON, OASIS) were searched for SRs on AEs associated with herbal formulas from inception to September 13, 2024. Inclusion criteria were SRs focusing on AEs of herbal formulas composed of two or more herbs. Two researchers independently conducted the search, selection, and data extraction. Methodological and reporting quality were evaluated using A MeaSurement Tool to Assess systematic Reviews 2 and the Preferred Reporting Items for Systematic Reviews and Meta-Analyses 2020 checklist. AEs were classified using the System Organ Class of the Medical Dictionary for Regulatory Activities.</div></div><div><h3>Results</h3><div>Thirteen SRs were selected. The most frequently reported organ system was hepatobiliary (9 SRs), followed by nervous and gastrointestinal systems (3 SRs each). Common symptoms in primary studies were nausea (<em>n</em> = 102), diarrhea (<em>n</em> = 80), and vomiting (<em>n</em> = 70). Causality was analyzed in 7 SRs using various scales. The methodological quality of the included SRs was critically low.</div></div><div><h3>Conclusions</h3><div>Our findings provide a foundation for developing a standardized AE reporting form for herbal formulas. Further high-quality reports with specific patient conditions, herbal constituents, and causality assessments are required to enhance herbal medicine safety monitoring and understanding.</div></div><div><h3>Protocol registration</h3><div>PROSPERO, CRD42023478440.</div></div>","PeriodicalId":13644,"journal":{"name":"Integrative Medicine Research","volume":"14 1","pages":"Article 101118"},"PeriodicalIF":2.8,"publicationDate":"2024-12-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143143505","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
期刊
Integrative Medicine Research
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