Analysis of status quo on the outcome indexes in randomized controlled trials of acupuncture for polycystic ovary syndrome

Abstract

To analyze the application and status quo of the outcome indexes in randomized controlled trials (RCTs) of acupuncture for polycystic ovary syndrome (PCOS) so as to provide a favorable reference for the construction of the core outcome set. RCTs of acupuncture for PCOS were searched in databases, i. e. CNKI, Wanfang, VIP, SinoMed, PubMed, EMbase, Cochrane Library and Web of Science, from January 1st, 2018 to June 28th, 2023. The relevant outcome indexes were extracted, collected and analyzed to collate the index domains of acupuncture for PCOS. A total of 60 articles were included, involving 123 outcome indexes. The outcome indexes of the physical and chemical detection were the highest in frequency (65.79%), followed by the symptoms/signs (23.37%), safety events (4.02%), TCM syndrome (3.10%), quality of life (1.86%) and the long-term prognosis (1.86%). None of the RCTs included the indexes for the economic evaluation. Regarding the status quo of outcome indexes, the primary outcome index was not distinguished from secondary one, the types of outcome indexes were various, the effect evaluation was not specified, and the assessment of quality of life and safety was ignored. The status quo of the outcome indexes in RCTs of acupuncture for PCOS is not conducive to pooling and comparing the data and the results among the different trials. It is recommended to structure the core outcome index set consistent with the therapeutic characteristics of TCM so as to improve the standardization of the clinical design of acupuncture and the quality of evidence in the trials.