Abstract

To evaluate the quality of randomized controlled trials (RCTs) of acupuncture on female urinary incontinence (UI). We searched for related RCTs of acupuncture on female UI from seven databases (PubMed, Embase, Cochrane library, Web of Science, Medline, ClinicalKey, and Clinical trials). We applied CONSORT (2010year) and STRICTA criteria to evaluate the relevant factors of included RCTs. Two trained researchers scored independently, and concordance was assessed by Cohen's к-statistic. The median and interquartile range summarized the CONSORT and STRICTA scores of the included studies. In addition, two independent sample t tests were used to assess the differences in the study quality between the 2000-2010 and the 2011-2022years. A total of 25 RCTs were finally included, and the scores were consistent between different assessors. The average CONSORT score was 10.50 (IQR 9.0-15.0) (total score was 25.0). Overall, the studies generally included scientific background (24/25, 96%), inclusion and exclusion criteria (24/25, 96%), outcome indicators (24/25, 96%), randomization methods (21/25, 84%), generalizability (19/25, 76%), and financial support (15/25, 60%). Most lacked sample size calculation (5/25, 20%), type of randomization (5/25, 20%), blinding (6/25, 24%), case screening period and follow-up (4/25, 16%), and study registration (6/25, 24%), etc. The average STRICTA score was 3.380 (IQR 3.02-3.95) (total score was 6.0). There had a lack of education on treatment methods for patients (3/25, 12%) and the qualification of acupuncturists (6/25, 24%). The overall quality of RCTs on acupuncture treatment of female UI was suboptimal. It is still necessary to improve the research methods, especially the application of random methods, blinding, the interpretation of treatment, and the identification qualification of acupuncturists.

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