Quality Evaluation of Randomized Controlled Trials on the Treatment of Cervical Spondylosis with TCM Manipulation

Abstract

Background TCM manipulation is an important way for the treatment of cervical spondylosis. A large number of randomized controlled trials (RCTs) about TCM manipulation for cervical spondylosis have been published as relevant research develops. However, various levels of qualities of these RCTs may be non-beneficial to the promotion of TCM manipulation and the generation of high-quality clinical evidence. Objective To evaluate the quality of RCTs of TCM manipulation for cervical spondylosis. Methods We searched RCTs of TCM manipulation for cervical spondylosis in databases of CNKI, Wanfang Data, VIP, SinoMed, PubMed, Embase and Cochrane Library from inception to June 2021. RCTs enrollment and data extraction were performed by two researchers, separately. Quality assessment was conducted using the PEDro Rating Scale, The Cochrane Collaboration's tool for assessing risk of bias, and the CONSORT 2010 Statement and other six indicators (whether the RCT is multicenter, with ethical approval, informed consent, quality control for intervention, efficacy assessment criteria, and acknowledgement) . Results Finally, 81 RCTs were included, of which 28 were published from 2006 to 2014, annually averaged 3.11, other 53 were published from 2015 to 2021, annually averaged 7.57. By the PEDro Rating Scale, the quality of only 7 (8.6%) RCTs was rated as high-quality (≥7 points) . By the Cochrane Collaboration's tool for assessing risk of bias, the percentage of RCTs with high risk of bias was the least, followed by that of those with low risk of bias. Most of RCTs had unclear risk of bias due to reported incomplete information. By the CONSORT 2010 Statement, the rates of title, abstract, methods, results, discussion and other information reported by the included RCTs were insufficient. By other six indicators, the rate of RCTs with a multicenter design, ethical approval, quality control for intervention, and acknowledgement was low. Conclusion The quality of current RCTs about TCM manipulation for cervical spondylosis is generally low. The improvement recommendation for relevant researchers is writing RCTs about the TCM manipulation for cervical spondylosis standardly in accordance with the PEDro Rating Scale, the Cochrane Collaboration's tool for assessing risk of bias, and the CONSORT 2010 Statement.

Keywords

• cervical spondylosis|musculoskeletal manipulations|tcm manipulation|randomized controlled trial|pedro scale|cochrane bias risk assessment tool|consort statement|quality evaluation