Has the design quality of randomized controlled trials of Acupotomy improved over the past 18 years? -- CONSORT statement-based literature study from 2006 to 2024

Abstract

Acupotomy, originally named ‘Nine Needles’ in Ling Shu, was invented as a new type of TCM instrument in 1976, an innovative combination of acupuncture and surgical treatment. Its forward development is related to the Clinical effectiveness and safety. RCTs are gold standards in clinical practice and were welcomed in Acupotomy recently. The CONSORT Statement is set to guide the designing, analysis and interpretation of trials. But there haven’t been many Acupotomy RCTs until now, with few on quality evaluation, therefore design quality of Acupotomy RCTs is still weakness. This study aims to assess design quality of acupotomy RCTs by CONSORT statement, to analyze the overall quality status and influencing factors. PubMed database was used to search keywords like ‘Acupotomy’ and ‘Randomized Controlled Trial’. All 48 Acupotomy RCTs published from January 2006 to January 2024 were included. The CONSORT(2010) was used for quality assessment. 48 studies were included for analysis, with 39 articles from Grade 3A hospitals and 9 from non-Grade 3A hospitals. Scores of RCTs ranged from 33 to 82, the mean score of 53.1 and median of 49. Grade 3A and non-Grade 3A hospitals differed significantly only in item 8, no studies reported item 18, and items 11, 14, and 23 had the highest frequency of reporting as failed. Based on 48 Acupotomy RCTs included, the publication time associated with the quality of reports. The number of authors and possession of funding were the most important factors affecting the total score. Number of beds, hospitals’ grade, sample sizes, and region GDP/PP did not relate to the total score. Among 25 items, Ancillary analyses, Blinding, Recruitment were the worst-performing items. Therefore, updating and standardizing the use of CONSORT can help to improve quality of RCTs, and cross-team communication and cooperation could promote the use of CONSORT.