Objective

2

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.

Methods

2

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.

Results

2

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.

Conclusion

2

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.