Trends in the design quality of randomized clinical trials on acupotomy over the past 21 years and influencing factors: a CONSORT-based systematic review from 2003 to 2024

Acupotomy is an innovative combination of acupuncture with surgical treatment that is widely used for pain-related conditions. There has been an increasing number of randomized controlled trials (RCTs) in acupotomy, their design and reporting quality remain inconsistent. Additionally, these RCTs have not been systematically evaluated in accordance with the Consolidated Standards for Reporting of Trials (CONSORT) framework.

A systematic search was performed in China National Knowledge Infrastructure (CNKI) and PubMed until January 2024 to identify eligible acupotomy RCTs using keywords related to “Acupotomy” and “RCT.” Each study was assessed based on the 2010 CONSORT guidelines. Descriptive statistics, nonparametric tests, and regression analyses were conducted to compare the quality scores and examine potential influencing factors.

We included 141 studies; among them, 93 and 48 RCTs were from the CNKI and PubMed, respectively. The mean quality scores of CNKI- and PubMed-indexed RCTs were 42.5 (median, 42; range, 24–74) and 53.4 (median, 49; range, 33–82). Further, the mean scores of each item and proportion of studies with excellent scores were higher in PubMed-indexed studies than in CNKI-indexed studies (2.1, 41.1% vs. 1.7, 32.3%). Among the 25 items, PubMed-indexed RCTs had higher scores in 23 (92%) items, with 13 items showing significant differences. Regarding the impacting factors, the number of authors, sample size, and funding were correlated with nine, four, and nine items, respectively. There were no significant differences among hospitals at different levels. The municipal gross domestic product per capita positively affected the total score.

The quality of RCTs on acupotomy has improved over two decades. Domestic articles covered a broader regional scope, while international trials demonstrated better adherence to the CONSORT guidelines. These findings highlight the need to improve awareness regarding trial design, ensure adherence to reporting standards, and support research teams through training and funding.