Integrative Medicine Research最新文献

{"title":"Herbal decoctions for dysmenorrhea under universal health coverage pilot project: Evidence from a nationwide claims database in the Republic of Korea","authors":"Kyeore Bae ,&nbsp;Minjung Park ,&nbsp;Junhyeok Yi","doi":"10.1016/j.imr.2025.101152","DOIUrl":"10.1016/j.imr.2025.101152","url":null,"abstract":"<div><h3>Background</h3><div>Despite its high prevalence, dysmenorrhea is an underestimated gynecological disorder. To enhance the service coverage, the Pilot Project for Expanding National Health Insurance (NHI) Coverage to Herbal Decoctions (HDs) was implemented in the Republic of Korea from November 2020. This study aimed to assess the effectiveness and safety of HDs for dysmenorrhea at a nationwide level. Additionally, its impact on accessibility was explored.</div></div><div><h3>Methods</h3><div>This retrospective observational study used claims data from the pilot project (November 1, 2020, to April 28, 2024). A linear mixed-effects model was used to estimate symptom improvement during the HD exposure period. Time series data decomposition and structural change points detection were performed using NHI statistics on dysmenorrhea patient counts for those who received medical services between 2014 and 2023.</div></div><div><h3>Results</h3><div>Among 39,574 participants, a descriptive analysis of 7016 suggested a tendency to receive HD treatment for moderate-to-severe symptoms. Effectiveness analysis demonstrated that HD significantly reduced symptom severity over time (β = –0.072, <em>p</em> &lt; 0.001). Adverse events were reported by 0.58 % of the patients, mostly involving gastrointestinal symptoms. Following the initiation of the pilot project, a significant increase in the number of patients with dysmenorrhea receiving traditional Korean medicine (TKM) services was observed.</div></div><div><h3>Conclusion</h3><div>The nationwide pilot project showed clinical effectiveness and a manageable safety profile of HDs for dysmenorrhea. The universal health coverage initiative appeared to have improved the accessibility of TKM services for managing dysmenorrhea. Further robust research utilizing nationwide real-world data is required to validate these findings.</div></div>","PeriodicalId":13644,"journal":{"name":"Integrative Medicine Research","volume":"14 3","pages":"Article 101152"},"PeriodicalIF":2.8,"publicationDate":"2025-05-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144195483","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Effect of acupoint catgut embedding for simple obesity in adults: A randomized controlled double-blind trial","authors":"Qiwang Yang ,&nbsp;Nenggui Xu ,&nbsp;Lidong Guo ,&nbsp;Hui Li ,&nbsp;Xiaoyan Li ,&nbsp;Qingmei Zeng ,&nbsp;Wenyue Zhang ,&nbsp;Shiping Li ,&nbsp;Wei Yi","doi":"10.1016/j.imr.2025.101151","DOIUrl":"10.1016/j.imr.2025.101151","url":null,"abstract":"<div><h3>Background</h3><div>Acupoint catgut embedding (ACE) is considered an effective treatment for simple obesity, though high-quality clinical evidence remains lacking. To establish a solid evidence base in obesity management, well-designed studies are needed to verify both the short- and long-term efficacy and safety of ACE.</div></div><div><h3>Methods</h3><div>In this randomized controlled, double-blind trial, 120 patients with simple obesity were initially allocated to verum ACE (<em>n</em> = 60) or sham ACE group (<em>n</em> = 60) .One participant allocated to the verum group was excluded during screening for failing to meet BMI criteria (&lt;24 kg/m²), resulting in a final cohort of 59 verum and 60 sham cases completing the 12-week intervention and 12-week follow-up. The primary outcome was the change in body weight from baseline to week 12. Secondary outcomes included body weight change at 12-week follow-up, cumulative weight change by week 24, changes in body mass index (BMI), body fat status, body circumference, and appetite indicators.</div></div><div><h3>Results</h3><div>After the 12-week treatment, both groups showed varying degrees of weight loss, with the verum ACE group experiencing a significantly greater reduction compared to the sham group. At the 12-week follow-up, the visceral fat grade of the verum group was significantly greater than that of sham group. The waist, upper arm, and thigh girths in the verum group decreased significantly more than that in sham group; the reduction degree of waist-hip ratio was significantly better than that in the sham group at all time points. Additionally, the cumulative reduction in appetite factors was significantly higher in the verum group compared to the sham group.</div></div><div><h3>Conclusion</h3><div>ACE can significantly reduce body weight, and is both long-lasting and safe. It also has beneficial effects on fat distribution, body circumference, and appetite, making it a promising complementary therapy for simple obesity.</div></div><div><h3>Trial registration</h3><div>Chinese Clinical Trial Registry, ChiCTR2100046693.</div></div>","PeriodicalId":13644,"journal":{"name":"Integrative Medicine Research","volume":"14 2","pages":"Article 101151"},"PeriodicalIF":2.8,"publicationDate":"2025-05-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144105933","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Evaluating and ranking guidelines on traditional and integrative medicine globally: Establishment of the International STAR-TIM Committee","authors":"Xuan Yu ,&nbsp;Yishan Qin ,&nbsp;Janne Estill ,&nbsp;Hui Liu ,&nbsp;Xu Wang ,&nbsp;Zhaoxiang Bian ,&nbsp;Yaolong Chen ,&nbsp;on behalf of STAR Secretariat","doi":"10.1016/j.imr.2025.101150","DOIUrl":"10.1016/j.imr.2025.101150","url":null,"abstract":"<div><div>To further enhance the quality and transparency of practice guidelines and consensus statements, the Scientific, Transparent, and Applicable Rankings (STAR) working group was officially established and commenced its work in 2021. The STAR tool contains 39 items grouped into 11 domains, with each domain and item assigned to a weight that reflects its importance. In 2021–2022, a total of 266 Chinese Traditional and Integrative Medicine (TIM) guidelines and consensus statements met the inclusion criteria for STAR evaluation. After evaluating these TIM guidelines and consensus statements, the highest STAR score achieved was 96.5 (out of 100), with a median score 23.3 and a mean score of 32.0. As the number of TIM guidelines and consensus statements published globally continues to increase, the STAR Secretariat aims to establish an International STAR Specialty Committee for TIM. Utilizing the integrated STAR evaluation system and large language models, the committee seeks to enhance the efficiency of evaluations without compromising accuracy. This initiative aims to conduct evaluations of international TIM guidelines and consensus statements, thereby improving their quality and transparency. Additionally, it will assess the importance and necessity of developing the International STAR-TIM Extension.</div></div>","PeriodicalId":13644,"journal":{"name":"Integrative Medicine Research","volume":"14 2","pages":"Article 101150"},"PeriodicalIF":2.8,"publicationDate":"2025-05-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144067947","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Acupuncture and moxibustion in integrative oncology and new progress in China","authors":"Ming Yang ,&nbsp;Yue Chen ,&nbsp;Yuxiang Wan ,&nbsp;Chen Shen ,&nbsp;Jinchang Huang","doi":"10.1016/j.imr.2025.101149","DOIUrl":"10.1016/j.imr.2025.101149","url":null,"abstract":"<div><div>Acupuncture and moxibustion are increasingly gaining recognition in the clinical and research fields of integrative oncology. This review synthesizes findings from clinical guidelines, systematic reviews, meta-analyses, and randomized controlled trials (RCTs) of acupuncture and moxibustion for cancer care. Clinical evidence highlights acupuncture’s efficacy in managing symptoms such as hot flashes, pain, insomnia, fatigue, and constipation. Acupuncture also demonstrates potential effects in reducing chemotherapy and radiotherapy-induced side effects. Recent advancements in China shows integrated therapies combining acupuncture with chemotherapy to enhance therapeutic outcomes. Additionally, laboratory studies reveal the potential of acupuncture and moxibustion to modulate the tumor microenvironment, boost chemotherapy efficacy, and strengthen immunity. Despite these promising results, there is a pressing need for well-designed trials and real-world studies to evaluate the long-term effects of standardized acupuncture and moxibustion treatments in cancer care.</div></div>","PeriodicalId":13644,"journal":{"name":"Integrative Medicine Research","volume":"14 2","pages":"Article 101149"},"PeriodicalIF":2.8,"publicationDate":"2025-04-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143937531","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Comparative effectiveness and safety of acupuncture vs metformin in insulin-resistant polycystic ovary syndrome women: A network meta-analysis of RCTs","authors":"Wen-Li Yan ,&nbsp;Zun-Qi Kan ,&nbsp;Li-Qiong Wang ,&nbsp;Zhen-Ping Yu ,&nbsp;Cun-Zhi Liu ,&nbsp;Shi-Yan Yan ,&nbsp;Na-Na Yang","doi":"10.1016/j.imr.2025.101148","DOIUrl":"10.1016/j.imr.2025.101148","url":null,"abstract":"<div><h3>Background</h3><div>The purpose of this study was to conduct a network meta-analysis (NMA) comparing the effectiveness and safety of traditional acupuncture with metformin. This study aims to identify an effective and safe alternative treatment for women with polycystic ovary syndrome (PCOS) complicated by insulin resistance (IR).</div></div><div><h3>Methods</h3><div>We searched PubMed, EMBASE, Web of Science, Cochrane, ClinicalTrials.gov, and relevant citations for eligible randomized controlled trials (RCTs) published up to August 12, 2024. Data extraction and bias assessment were performed by two independent reviewers, and Bayesian NMA was performed using the GeMTC package, with a random effects model. The NMA compared the effectiveness and safety of acupuncture with metformin which were measured using the Homeostasis Model Assessment Insulin Resistance (HOMA-IR) index, fasting plasma glucose, fasting insulin, and the incidence of adverse events (AEs).</div></div><div><h3>Results</h3><div>We included 12 RCTs (<em>n</em> = 870). Four RCTs compared acupuncture with metformin, six compared metformin with control interventions (blank control or placebo), and two compared acupuncture with sham acupuncture. Acupuncture (Mean difference (MD): -0.76, 95 % credible interval (CrI): -1.42, -0.03) and metformin (MD: -0.74, 95 % CrI: -1.28, -0.17) significantly reduced the IR level (HOMA-IR). No statistical difference was observed between both treatment methods in improving glucose metabolism; however, acupuncture had fewer AEs (risk ratio: 0.13, 95 % CrI: 0.01, 0.68). Acupuncture all ranked high in terms of surface under the cumulative ranking curve across all outcomes, thus demonstrating better effectiveness and safety potential.</div></div><div><h3>Conclusions</h3><div>Acupuncture may be a potential alternative for PCOS women with IR, as it is equally effective, easier to perform, and relatively safer than metformin. Further trials are necessary to confirm these findings owing to the current lack of sufficient evidence.</div><div><em>Protocol registration</em>: PROSPERO, CRD42024581934.</div></div>","PeriodicalId":13644,"journal":{"name":"Integrative Medicine Research","volume":"14 2","pages":"Article 101148"},"PeriodicalIF":2.8,"publicationDate":"2025-04-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144067946","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Patient Experiences of Integrative health CarE [PEICE]: A cross-sectional study","authors":"Matthew J Leach ,&nbsp;Simon DuBois ,&nbsp;Reine DuBois","doi":"10.1016/j.imr.2025.101147","DOIUrl":"10.1016/j.imr.2025.101147","url":null,"abstract":"<div><h3>Background</h3><div>Although consumer demand and practitioner interest in integrative health care (IHC) have amplified over the past few decades, the patient experience of IHC still remains poorly understood. This study aimed to explore patient’s experiences of receiving care within an IHC setting in Australia.</div></div><div><h3>Methods</h3><div>Adults that had accessed an IHC setting within the past 12 months were invited to participate in a national, cross-sectional study. Individuals meeting the inclusion criteria were asked to complete the 57-item Integrative Healthcare Experience Tool (iHEET), online.</div></div><div><h3>Results</h3><div>A total of 327 participants completed the iHEET (82.3 % female; 92.9 % aged 30 years or older). Participants reported a generally favourable experience of IHC, as indicated by an overall IHC experience score of 4.19 ± 0.90 (mean ± SD). Mean experience subscores were high for 8 of the 12 IHC experience domains (i.e. respectful, personalised, patient-centred, holistic, interdisciplinary, evidence-based, communicative, wellness-focussed), and moderate for 4 of the 12 domains (i.e. non-hierarchical, collaborative, coordinated, accessible).</div></div><div><h3>Conclusion</h3><div>The findings of this novel study suggest IHC practice in Australia closely aligns with the philosophy and framework of IHC, and is mostly congruent with what patients want from an IHC service. Notwithstanding, there are several areas where IHC services could improve in order to optimise the patient experience. These areas include providing care that is more visibly collaborative and coordinated, and enabling equitable access to services for diverse patient populations.</div></div>","PeriodicalId":13644,"journal":{"name":"Integrative Medicine Research","volume":"14 2","pages":"Article 101147"},"PeriodicalIF":2.8,"publicationDate":"2025-04-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143937533","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"A nationwide retrospective cohort study of the association between acupuncture exposure and clinical outcomes of idiopathic Parkinson’s disease using health insurance claim data in South Korea","authors":"Ye-Chae Hwang ,&nbsp;Jungkuk Lee ,&nbsp;Dongwoo Kang ,&nbsp;Han-Gyul Lee ,&nbsp;Seungwon Kwon ,&nbsp;Seung-Yeon Cho ,&nbsp;Seong-Uk Park ,&nbsp;Woo-Sang Jung ,&nbsp;Sang-Kwan Moon ,&nbsp;Jung-Mi Park ,&nbsp;Jungtae Leem ,&nbsp;Chang-Nam Ko","doi":"10.1016/j.imr.2025.101146","DOIUrl":"10.1016/j.imr.2025.101146","url":null,"abstract":"<div><h3>Background</h3><div>Idiopathic Parkinson’s disease (IPD) has been associated with increased global mortality. While acupuncture has been reported to slow IPD progression, its effect on mortality remains unclear. This study investigated the association between acupuncture exposure and mortality, causes of death, and prognosis in patients with IPD.</div></div><div><h3>Methods</h3><div>Using customized cohort data from the National Health Insurance Service (NHIS), we analyzed patients newly diagnosed with IPD without disabilities between 2012 and 2016. Patients were classified into an acupuncture group (≥six sessions within 1 year of diagnosis) and a non-acupuncture group. Propensity score matching (PSM) was applied, and Cox proportional hazards models were used for survival analysis. During a 6-year follow-up, hazard ratios (HRs) were estimated for overall and cause-specific mortality, emergency room visits, fractures, and the first deep brain stimulation (DBS) procedure, using the non-acupuncture group as the reference.</div></div><div><h3>Results</h3><div>After PSM, 6394 patients were included in each group. The HR for mortality in the acupuncture group was 0.887 (95 % CI: 0.813−0.967), indicating a significantly lower mortality risk. Deaths due to neoplasms and digestive diseases were also lower in the acupuncture group. No significant differences were observed between groups in fracture risk, emergency room visits, or DBS procedures.</div></div><div><h3>Conclusions</h3><div>Acupuncture exposure was associated with a reduced mortality rate in patients with IPD. These findings suggest potential benefits of integrating acupuncture into IPD management, though further long-term randomized controlled trials are needed to confirm these results.</div></div>","PeriodicalId":13644,"journal":{"name":"Integrative Medicine Research","volume":"14 2","pages":"Article 101146"},"PeriodicalIF":2.8,"publicationDate":"2025-04-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143937532","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Comparative efficacy of moxibustion in chemotherapy-induced leukopenia: A Bayesian network meta-analysis","authors":"Zun-Yuan Li ,&nbsp;Chun-Lan Chen ,&nbsp;Xiao-Yan Li ,&nbsp;Wen-Ge Huo ,&nbsp;Yan Yang ,&nbsp;Yu-Hong Guo ,&nbsp;Zhi-Dan Liu","doi":"10.1016/j.imr.2025.101145","DOIUrl":"10.1016/j.imr.2025.101145","url":null,"abstract":"<div><h3>Background</h3><div>Moxibustion has been applied in various clinical treatments, including chemotherapy-induced leukopenia. Using a Bayesian network meta-analysis, this study assessed a wide range of published data to identify the most efficient and effective method of moxibustion therapy for treating chemotherapy-induced leukopenia.</div></div><div><h3>Methods</h3><div>PubMed, EMBASE, and eight other databases plus two clinical trial registration platforms were searched from their respective inception date to January 2024. All randomized controlled trials (RCTs) of moxibustion for chemotherapy-induced leukopenia were included. The primary outcome indicator was white blood cell count, and the secondary outcome was the Karnofsky performance status score. Stata (version 17.0) and the gemtc package (version 1.0–0) of R (version 4.3.1) were used to perform the network meta-analysis. This study is registered in the International Prospective Register of Systematic Reviews (PROSPERO) database, registration number CRD42023402588.</div></div><div><h3>Results</h3><div>Thirty RCTs with 2282 total patients involving 12 types of moxibustion-related therapies were identified. Results of the surface under the cumulative ranking curve revealed the following treatments as most effective for leukopenia: thunder-fire moxibustion combined with medication (95.9 %), grain-sized moxibustion combined with medication (76.2 %), and herb-separated moxibustion (76.0 %). Grain-sized moxibustion combined with medication (76.5 %) ranked first in improving Karnofsky performance status scores.</div></div><div><h3>Conclusion</h3><div>Thunder-fire moxibustion combined with medication appears to be the most effective treatment for chemotherapy-induced leukopenia.</div></div><div><h3>Protocol registration</h3><div>PROSPERO, CRD42023402588.</div></div>","PeriodicalId":13644,"journal":{"name":"Integrative Medicine Research","volume":"14 2","pages":"Article 101145"},"PeriodicalIF":2.8,"publicationDate":"2025-04-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143878663","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Therapeutic effects of singing bowls: A systematic review of clinical studies","authors":"Yiqing Cai ,&nbsp;Guoyan Yang ,&nbsp;Yibo Liu ,&nbsp;Xiangyun Zou ,&nbsp;Heng Yin ,&nbsp;Xinyan Jin ,&nbsp;Xuehan Liu ,&nbsp;Chenlu Wang ,&nbsp;Nicola Robinson ,&nbsp;Jianping Liu","doi":"10.1016/j.imr.2025.101144","DOIUrl":"10.1016/j.imr.2025.101144","url":null,"abstract":"<div><h3>Background</h3><div>Singing bowl has traditionally been utilized to promote healing and relaxation. This systematic review aimed to analyze all available clinical evidence, and determine any beneficial or adverse effects of singing bowl in any population.</div></div><div><h3>Methods</h3><div>Databases searched included PubMed, Embase, the Cochrane Library, PsyINFO, CINAHL, CNKI, VIP, Wanfang, Sinomed from database inception to July 2024. Clinical studies of singing bowl therapy, regardless of research type, population, and intervention were included. The risk of bias of randomized controlled trials (RCTs) was assessed using the Cochrane tool. Data from randomized trials were analyzed and presented as the mean difference with 95 % confidence interval, and the results from two or more separate trials with same study type that evaluated similar populations, interventions, comparisons and outcomes were statistical pooled using meta-analysis by Stata.16 software.</div></div><div><h3>Results</h3><div>Nineteen clinical studies originated from eight countries and published between 2008 and 2024 were identified. Half were RCTs (9), the remainder included case series studies (7), randomized crossover studies (2) and non-RCT (1). Evidence showed that singing bowl has been applied to a wide range of conditions, including the elderly, surgery, Parkinson's disease, pain, cancer, neurological function, sleep disorder, depression, anxiety, autism spectrum disorder, as well as physiological and psychological function, and it has mainly focused on outcomes related to mental health.</div></div><div><h3>Conclusion</h3><div>Singing bowl may have potential to alleviate anxiety, depression, improve quality of sleep and cognitive function in various patient groups, and change autistic behavior. It also shows potential benefits in physiological improvements like electroencephalography.</div></div><div><h3>Protocol registration</h3><div>PROSPERO, CRD42025639808.</div></div>","PeriodicalId":13644,"journal":{"name":"Integrative Medicine Research","volume":"14 2","pages":"Article 101144"},"PeriodicalIF":2.8,"publicationDate":"2025-04-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143882755","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Traditional Vietnamese herbal medicine TD0015 in Knee Osteoarthritis: A Phase-II randomized controlled trial","authors":"Nguyen Thi Thu Ha ,&nbsp;Duong Trong Nghia ,&nbsp;Ha Thi Viet Nga ,&nbsp;Trinh Thi Lua ,&nbsp;Nguyen Thi Bich Hong ,&nbsp;Nguyen Thi Hanh ,&nbsp;Nguyen Kim Ngoc ,&nbsp;Nguyen Lam Vuong","doi":"10.1016/j.imr.2025.101143","DOIUrl":"10.1016/j.imr.2025.101143","url":null,"abstract":"<div><h3>Background</h3><div>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.</div></div><div><h3>Methods</h3><div>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).</div></div><div><h3>Results</h3><div>The mean age was around 60 years, and &gt;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.</div></div><div><h3>Conclusions</h3><div>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.</div></div><div><h3>Trial registration</h3><div>ClinicalTrials.gov, NCT06657495.</div></div>","PeriodicalId":13644,"journal":{"name":"Integrative Medicine Research","volume":"14 2","pages":"Article 101143"},"PeriodicalIF":2.8,"publicationDate":"2025-03-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143833570","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}