Analysis of Randomized Controlled Trials Outcome Indicators of Acupuncture for Knee Osteoarthritis

Abstract

Background Traditional Chinese acupuncture has been widely applied for the treatment of knee osteoarthritis (KOA) with outstanding efficacy. However, recognized and unified outcome indicators remain to be absent, which impedes the translation of research into high-quality clinical evidence. Therefore, the establishment of core outcome indicators for acupuncture in KOA is conducive to enhance the scientific rigor, rationality, and feasibility of clinical research programs in traditional Chinese medicine (TCM) , provide higher quality evidence-based basis for clinical research. Objective To analyze the current status of the application of outcome indicators in randomized controlled trials (RCTs) of acupuncture for KOA, so as to provide a basis for the assessment method of clinical efficacy. Methods PubMed, Cochrane Library, Embase, Web of Science, CNKI, Wanfang, VIP and SinoMed were searched for clinical RCTs of acupuncture in the treatment of KOA from 2003 to 2022. Two researchers screened and extracted the characteristics of literature. The indicator domain, measurement tools and the time point of measurement of RCTs of acupuncture for KOA were analyzed. Results A total of 131 papers were included, with a sample size of 22 726 cases and 89 outcome indicators, which were classified into 40 (44.9%) items for symptoms and signs, 22 (24.7%) items for physical and chemical examinations, 5 (5.6%) items for quality of life, 5 (5.6%) items for psychological state, 3 (3.4%) items for satisfaction evaluation, 2 (2.2%) items for safety indicators, and 12 (13.5%) items for other indicators. Among the 131 articles, 23 measurement time points were included in the 131 articles, ranging from 1 hour to 3 years after treatment, 106 (80.9%) articles used "clinical efficacy" as the outcome indicator, 23 (17.6%) articles used safety evaluation and adverse event reports. Conclusion There are some problems in the use of outcome indicators in the RCTs of acupuncture for KOA, such as large variation in the use of outcome indicators, confounding of primary and secondary indicators, abuse of index combination, irregular use of composite indexes, inadequate safety evaluation, irregular measurement time points, insufficient evaluation of long-term prognosis, and failing to reflect the characteristics of TCM intervention of acupuncture. Future research should combine treatment based on syndrome differentiation characteristics of TCM, to evaluate the efficacy of acupuncture in the treatment of KOA by using scientific and reasonable outcome indicators. It is urgent to establish the core indicators set of TCM in the treatment of KOA, and to construct a standardized and recognized COS-TCM.

Keywords

• osteoarthritis, knee|acupuncture|randomized controlled trial|outcome measures|core outcome set