Analysis of the outcome measures in randomized controlled trials of acupuncture for chronic urticaria

To analyze the current status of outcome measures adopted in randomized controlled trials (RCTs) of acupuncture for chronic urticaria (CU), and provide the references for the design of subsequent clinical studies and the construction of core outcome set in acupuncture treatment of CU.

The RCTs of acupuncture for CU were searched from China Journal Full-text Database (CNKI), Wanfang Data Knowledge Service Platform (Wanfang), VIP Information Chinese Journal Service Platform (VIP), SinoMed, PubMed, EMbase, Cochrane Library and Web of Science, from the inception to November 30, 2024. The outcomes were extracted and analyzed.

A total of 60 articles were included, and 6 indexes domains were extracted, including TCM syndromes, symptoms/signs, physiological and chemical indexes, quality of life, long-term prognosis and safety events. Ninety-four outcomes were included, with a total application frequency of 539 times, and the top 3 indexes with the most application frequency were symptoms/signs (69.0%), safety events (10.8%) and quality of life (8.3%). The current application of outcome indexes in RCTs of acupuncture for CU showed the unclear distinction between primary and secondary outcomes, non-standardized names of outcome indexes, inconsistent criteria of efficacy evaluation, large disparity in treatment duration and evaluation time points, low attention to long-term prognosis, and neglect of ethical review, trial registration, safety evaluation and economic assessment.

It is recommended to establish a core outcome set for acupuncture treatment of CU, so as to improve the standardization of clinical research design and promote the development of clinical studies of acupuncture.