[Status of outcome measures in randomized controlled trials of kidney-tonifying and blood-activating method in treatment of knee osteoarthritis].

This study assesses the status of outcome measures in the randomized controlled trial(RCT) involving the kidney-tonif-ying and blood-activating method for treating knee osteoarthritis(KOA), aiming to establish a theoretical foundation for the development of a core set of outcome measures in traditional Chinese medicine(TCM) treatment of KOA. The relevant articles were retrieved from CNKI, Wanfang, VIP, SinoMed, PubMed, EMbase, Cochrane Library, and Web of Science, in addition to ClinicalTrials.gov and the China Clinical Trial Registration Center, with the time interval from inception to August 2023. The RCT of treating KOA with the kidney-tonifying and blood-activating method was included. Two assessors independently conducted literature screening, data collection, and qualitative analysis to compile the outcome measure results. A total of 350 RCTs were included, involving 165 outcome measures with the total frequency of 1 462. These outcome measures were categorized into six domains: symptom and sign measures(23) with the frequency of 718(49.1%), TCM symptom and syndrome measures(3) with the frequency of 53(3.6%), physical examination measures(130) with the frequency of 506(34.6%), quality of life measures(4) with the frequency of 20(1.3%), long-term efficacy measures(2) with the frequency of 6(0.4%), and safety measures(3) with the frequency of 159(10.9%). Additionally, 53 studies used TCM syndrome and symptom scores as indicators of efficacy, employing eight distinct measurement tools. The RCTs involving the kidney-tonifying and blood-activating method for treating KOA had a variety of problems, such as unclear prio-ritization of outcome measures, diversity in measurement tools, absence of standardized assessment criteria for specific measures, and non-standardized usage. These problems affected the research quality and reliability. Hence, it is advisable to draw upon international expertise, improve research design, and merge TCM efficacy characteristics with clinical research to establish a core set of KOA outcome measures aligned with TCM principles.

Baduanjin exercise for chronic non-specific low back pain: protocol for a series of N-of-1 trials.

INTRODUCTION: Chronic non-specific low back pain (CNLBP) is one of the most common health problems worldwide. According to the clinical guideline released by the American College of Physicians, exercise has been recommended for the treatment of chronic LBP. In recent years, traditional Chinese medicine (TCM) is becoming increasingly popular for the management of chronic LBP. Baduanjin exercise is one of the exercise therapies in TCM. N-of-1 trial is a randomised cross-over self-controlled trial suitable for patients with this chronic disease. A series of similar N-of-1 trials can be pooled to estimate the overall and individual therapeutic effects synchronously by hierarchical Bayesian analysis. And N-of-1 trials are considered as a good tool for evaluating the therapeutic effect of TCM. Therefore, this study aims to conduct a series of N-of-1 trials with hierarchical Bayesian analysis for assessing whether Baduanjin exercise is effective and safe for CNLBP. METHODS AND ANALYSIS: This study conducts a series of N-of-1 trials on Baduanjin exercise for the management of CNLBP. Fifty participants will receive 1-3 treatment cycles. They will be randomised into a Baduanjin exercise or waiting list group for a week during the two periods of each treatment cycle. The primary outcome is the 10-point Visual Analogue Scale. The secondary outcomes include the Oswestry Disability Index, the Japanese Orthopaedic Association Back Pain Evaluation Questionnaire and the Short Form Health Survey 12. Statistical analysis will be conducted with WinBUGS V.1.4.3 software. Overall and individual therapeutic effects will be estimated synchronously by hierarchical Bayesian analysis. ETHICS AND DISSEMINATION: This study is approved by the Medical Ethics Committee of Tianjin University of TCM (reference number TJUTCM-EC20220005). Our findings will be published in a peer-reviewed journal or international conference. TRIAL REGISTRATION NUMBER: ChiCTR2200063307.

Acupuncture for the Treatment of Knee Osteoarthritis: An Overview of Systematic Reviews.

BACKGROUND: Acupuncture has been widely used in the clinical management of osteoarthritis of the knee (KOA). Many systematic reviews (SRs) and meta-analyses (MAs) have reported its effectiveness in relieving pain. This overview aimed to summarize SRs and MAs on the effectiveness and safety of acupuncture for KOA and evaluate their methodological and evidence quality of the included SRs and MAs. METHODS: We conducted a comprehensive literature search for SRs and MAs in four Chinese and four international databases from their inception until August 2021. Two researchers independently searched the reviews, extracted the data, and cross-checked the data. The Assessing the Methodological Quality of Systematic Reviews 2 (AMSTAR 2) tool was used to evaluate the methodological quality of the included SRs and MAs. The Grades of Recommendations, Assessment, Development, and Evaluation (GRADE) system was used to assess the quality of evidence for the outcomes of the included SRs and MAs. RESULTS: A total of 14 SRs and MAs were included. The evaluation results of the AMSTAR 2 tool showed that the methodological quality of all the 14 SRs and MAs was critically low. The principal causes are the lack of a pre-registration proposal and a list of excluded studies and justify the exclusions, the report on the sources of funding, and the reasons for the study designs for inclusion. The results of the GRADE evaluation showed 25 of 46 outcomes were very low-level evidence. Seventeen were of low level, four were of moderate level and none were of high level. Most outcomes were downgraded in quality of evidence mainly because of publication bias and imprecision. CONCLUSION: The existing evidence suggests that acupuncture seems to be an effective and safe therapy for KOA. However, the deficiencies in the methodological quality and quality of evidence of the included SRs/MAs have limited the reliability of the conclusions. Therefore, further rigorous and comprehensive studies are warranted to verify the effectiveness and safety of acupuncture in KOA.