Zhongguo quanke yixue (Mar 2023)
Outcome Measures Used in Randomized Controlled Trials of Acupuncture for Chronic Nonspecific Low Back Pain
Abstract
Background As an important treatment for chronic nonspecific low back pain (CNSLBP) , the effect of acupuncture on CNSLBP has been studied by numerous randomized controlled trials (RCTs) with the development of research on acupuncture. However, there are some problems in the selection of outcome indicators, which severely hinder the generation of high-quality clinical evidence. Objective To describe the outcome measures used in RCTs of acupuncture for CNSLBP, providing a basis for the carrying out of relevant research. Methods Four Chinese databases (CNKI, VIP, Wanfang Data and SinoMed) and three English databases (PubMed, Embase and Cochrane Library) were systematically searched for literature on CNSLBP treated with acupuncture published from January 1, 2017 to March 15, 2022, and the NSLBP core outcome set (COS) used in studies published from database inception to March 15, 2022. According to the enrolment criteria to analyze the following aspects: basic characteristics, classification of clinical outcome indicators, use of composite indicators, and the application of TCM Criteria for Diagnosis and Treatment of Diseases & Syndromes (hereinafter referred to as TCMCDTDS) . In addition, 11 studies published from database inception to March 15, 2022 were enrolled to analyze their basic characteristics and use of COSs of NSLBP. In addition, to analyze the studies' basic characteristics and use of NSLBP COS. The similarities and differences between COSs of NSLBP and outcome measures in the RCTs in recent five years were compared. Results Of the included 49 RCTs, four are in English and the other 45 are in Chinese, involving 4 272 cases aged from 18 to 69 years (2 049 in the treatment group, and 2 223 in the control group) . The course of CNSLBP was reported in 38 RCTs. A total of 33 outcome indicators were used in all the RCTs, divided into assessing pain, dysfunction, quality of life, activities of daily living, treatment safety, patient satisfaction, disease recognition, psychological status indicators, and other indicators. The outcome indicator number in one RCT were from 1 to 8. The outcomes were measured twice in 42 RCTs, namely before and after treatment. Safety was reported in only two RCTs. The indicator of "effective rate" in the TCMCDTDS was used in 77.55% (38/49) of the RCTs. The COSs of NSLBP in the aforementioned 11 studies include indicators assessing pain, dysfunction, quality of life, psychological status, social functioning and patient satisfaction. Three of the studies graded the domains of outcome measures in terms of importance, four covered patient satisfaction indicators, five covered psychological assessment indicators, nine used different measurement tools for different outcomes, and one used COSs of NSLBP treated with TCM. Conclusion The COSs of NSLBP used in studies and outcome measures in the included RCTs have similarities in the contents involving pain level, dysfunction, quality of life, psychological status and patient satisfaction, and differences in the selection of the type of outcome domain, direction of attention, and measurement tools. The RCTs used both primary and secondary outcome measures, had unclear measurement time points, great heterogeneity in the number of used outcome measures, and non-standard application of outcome measures, and valued efficacy outcomes but undervalued safety indicators. In view of this, we put forward the recommendation on the use of outcome measures for future relevant studies: according to the research characteristics, choosing the recognized outcome measures with reference to available COSs of NSLBP and common measurement tools.
Keywords
