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Acupuncture for Patients with Chronic Spontaneous Urticaria: A Randomized, Sham-Controlled Pilot Trial

  • Acupuncture Research
  • Published:
Chinese Journal of Integrative Medicine Aims and scope Submit manuscript

Abstract

Objective

To determine the feasibility of conducting a full-scale randomized controlled trial (RCT) and investigate the basic information and safety of acupuncture for patients with chronic spontaneous urticaria (CSU).

Methods

A total of 80 participants with CSU from July 2018 to July 2019 were randomly assigned to receive active acupuncture (n=41) on a fixed prescription of acupoints or sham acupuncture (n=39) with superficial acupuncture on non-acupuncture points through the completely randomized design. Patients in both groups received 5 sessions per week for 2 weeks, and participants were followed for a further 2 weeks. Feasibility was assessed by recruitment and randomization rates, retention of participants, treatment protocol adherence, and the incidence of adverse events (AEs). The clinical primary outcome was the changes from baseline weekly urticaria activity scores (UAS7) after treatment at 2 weeks. Secondary outcomes included the Visual Analogue Scale (VAS) score of itching intensity, Dermatology Life Quality Index (DLQI), Hamilton Depression Scale (HAMD), and Hamilton Anxiety Scale (HAMA).

Results

A total of 80 participants were enrolled. The recruitment rate of 24.02%, randomization rate of 100%, a loss rate of 6.25%, and no obvious AEs were observed in either group. The decrease from baseline in the mean UAS7 total score at week 2 in the active acupuncture group was −8.63 (95%CI, −11.78 to −5.49) and −6.21 (95%CI, −9.43 to −2.98) in the sham acupuncture group for a between-group difference of −2.42 (95% CI, −6.93 to 2.07). The change in the DLQI, VAS of itching intensity, HAMA, and HAMD were a slightly better improvement trend in the active acupuncture group than the sham acupuncture group, but the between-group difference was not significant.

Conclusions

Active acupuncture had a better improvement trend in alleviating symptoms, improving quality of life and regulating the mood of anxiety and depression in patients with CSU than sham acupuncture. (Registration Nos. AMCTR-ICR-18000190 and ChiCTR2100054776)

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Acknowledgments

The authors thank Pro. George David Baxter, and Dr. Liu LZ for their guidance on the article during the Visiting Ph.D. Researcher in Otago, New Zealand, and the patients and their families agreed to sign informed consent to the publication of their case details for their participation in this study.

Author information

Authors and Affiliations

  1. Department of Acupuncture and Moxibustion, Chengdu University of Traditional Chinese Medicine, Chengdu, 610075, China

    Yun-zhou Shi, Shu-guang Yu, Hui Zheng, Qian-hua Zheng, Si-yuan Zhou, Lei-xiao Zhang, Xian-jun Xiao, Wei Cao & Ying Li

  2. Dermatology Department of Affiliated Hospital of Chengdu University of Traditional Chinese Medicine, Chengdu, 610075, China

    Ying Huang

Authors
  1. Yun-zhou Shi
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  2. Shu-guang Yu
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Contributions

Shi YZ, Yu SG, Zheng H, Zheng QH, Zhou SY, and Li Y designed this study; Huang Y, Shi YZ, and Zhang LX recruited the participants; Shi YZ, Zhang LX, and Xiao XJ performed acupuncture treatments; Cao W conducted clinical assessments. Shi YZ wrote the draft; Zheng H, Zheng QH, and Li Y revised the manuscript.

Corresponding author

Correspondence to Ying Li.

Ethics declarations

The authors have no conflicts of interest to declare.

Additional information

Supported by the National Key Research and Development Program of the Ministry of Science and Technology of the People’s Republic of China-Key Project “Research on Modernization of Traditional Chinese Medicine”—“International Cooperation Research on Evaluation of Acupuncture Advantage Diseases” (No. 2017YFC1703605)

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Shi, Yz., Yu, Sg., Zheng, H. et al. Acupuncture for Patients with Chronic Spontaneous Urticaria: A Randomized, Sham-Controlled Pilot Trial. Chin. J. Integr. Med. 29, 924–931 (2023). https://doi.org/10.1007/s11655-023-3741-x

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  • DOI: https://doi.org/10.1007/s11655-023-3741-x

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