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Efficacy of Acupuncture for Chronic Spontaneous Urticaria : A Randomized Controlled Trial
Hui Zheng1, Xian-Jun Xiao2, Yun-Zhou Shi1
1Acupuncture 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.).
Background:
The effectiveness of acupuncture for patients with chronic spontaneous urticaria (CSU), reported in a few small-scale studies, is not convincing.
Objective:
To investigate whether acupuncture leads to better effects on CSU than sham acupuncture or waitlist control.
Design:
A multicenter, randomized, sham-controlled trial. (Chinese Clinical Trial Registry: ChiCTR1900022994).
Setting:
Three teaching hospitals in China from 27 May 2019 to 30 July 2022.
Participants:
330 participants diagnosed with CSU.
Intervention:
Participants 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).
Measurements:
The 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.
Results:
The 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.
Limitation:
Lack of complete blinding, self-reported outcomes, limited generalizability because antihistamine use was disallowed, and short follow-up period.
Conclusion:
Compared 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 Source:
The National Key R&D Program of China and the Science and Technology Department of Sichuan Province.
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