• Hui Zheng, Xian-Jun Xiao, Yun-Zhou Shi, Lei-Xiao Zhang, Wei Cao, Qian-Hua Zheng, Feng Zhong, Ping-Sheng Hao, Ying Huang, Ming-Ling Chen, Wei Zhang, Si-Yuan Zhou, Yan-Jun Wang, Chuan Wang, Li Zhou, Xiao-Qin Chen, Zuo-Qin Yang, Zi-Hao Zou, Ling Zhao, Fan-Rong Liang, and Ying Li.
• Acupuncture and Tuina School, Chengdu University of Traditional Chinese Medicine, Chengdu, China (H.Z., Y.-Z.S., W.C., Q.-H.Z., S.-Y.Z., Z.-H.Z., L.Z., F.-R.L., Y.L.).
• Ann. Intern. Med. 2023 Dec 1; 176 (12): 161716241617-1624.

BackgroundThe effectiveness of acupuncture for patients with chronic spontaneous urticaria (CSU), reported in a few small-scale studies, is not convincing.ObjectiveTo investigate whether acupuncture leads to better effects on CSU than sham acupuncture or waitlist control.DesignA multicenter, randomized, sham-controlled trial. (Chinese Clinical Trial Registry: ChiCTR1900022994).SettingThree teaching hospitals in China from 27 May 2019 to 30 July 2022.Participants330 participants diagnosed with CSU.InterventionParticipants were randomly assigned in a 1:1:1 ratio to receive acupuncture, sham acupuncture, or waitlist control over an 8-week study period (4 weeks for treatment and another 4 weeks for follow-up).MeasurementsThe primary outcome was the mean change from baseline in the Weekly Urticaria Activity Score (UAS7) at week 4. Secondary outcomes included itch severity scores, self-rated improvement, and Dermatology Life Quality Index scores.ResultsThe mean change in UAS7 (range, 0 to 42) for acupuncture from baseline (mean score, 23.5 [95% CI, 21.8 to 25.2]) to week 4 (mean score, 15.3 [CI, 13.6 to 16.9]) was -8.2 (CI, -9.9 to -6.6). The mean changes in UAS7 for sham acupuncture and waitlist control from baseline (mean scores, 21.9 [CI, 20.2 to 23.6] and 22.1 [CI, 20.4 to 23.8], respectively) to week 4 (mean scores, 17.8 [CI, 16.1 to 19.5] and 20.0 [CI, 18.3 to 21.6], respectively) were -4.1 (CI, -5.8 to -2.4) and -2.2 (CI, -3.8 to -0.5), respectively. The mean differences between acupuncture and sham acupuncture and waitlist control were -4.1 (CI, -6.5 to -1.8) and -6.1 (CI, -8.4 to -3.7), respectively, which did not meet the threshold for minimal clinically important difference. Fifteen participants (13.6%) in the acupuncture group and none in the other groups reported adverse events. Adverse events were mild or transient.LimitationLack of complete blinding, self-reported outcomes, limited generalizability because antihistamine use was disallowed, and short follow-up period.ConclusionCompared with sham acupuncture and waitlist control, acupuncture produced a greater improvement in UAS7, although the difference from control was not clinically significant. Increased adverse events were mild or transient.Primary Funding SourceThe National Key R&D Program of China and the Science and Technology Department of Sichuan Province.

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