Efficacy and safety of acupuncture for patients with chronic urticaria: study protocol of a randomized, sham-controlled pilot trial

BACKGROUND: Chronic urticaria (CU) is a refractory skin disease with long duration and a high recurrence rate. Acupuncture has been widely used for the treatment of CU in clinical practice in China. However, until now, there has been no appropriately designed randomized controlled trial (RCT) to provide explicit evidence about the effectiveness of acupuncture for the treatment of CU worldwide. Therefore, we plan to conduct a pilot study to explore its effectiveness and safety and determine the feasibility of studying acupuncture in a future, full-scale, RCT of CU. METHODS/DESIGN: This randomized, sham-controlled, participant-blinded and assessor-blinded pilot trial is underway in China. A total of 60 participants with CU will be randomly assigned to two groups in a 1:1 ratio: one treated with real acupuncture and the other with sham acupuncture, for 10 sessions over 2 weeks. The experimental group will receive acupuncture on a fixed prescription of acupoints, whereas the control group will receive sham acupuncture, namely minimal acupuncture on non-acupuncture points. The primary outcome will be the urticaria activity score (UAS). The secondary outcomes will include a visual analogue scale (VAS) score for itching intensity, the Dermatology Life Quality Index (DLQI), the Hamilton Depression Scale (HAMD), the Hamilton Anxiety Scale (HAMA), the humoral immunity index, serum total IgE, and adverse events. The UAS, VAS for itching and the DLQI will be conducted at baseline and at 1, 2, 3, and 4 weeks after randomization. The HAMD, HAMA, humoral immunity index, and serum total IgE will be assessed at baseline and at 2 weeks after randomization. Adverse events will be summarized at 1 week and 2 weeks after randomization. DISCUSSION: The pilot study mainly aims to investigate trial feasibility, and confirm basic information about its effects and safety. Results of this trial will help clarify whether the acupuncture treatment is beneficial for symptom improvement in patients with CU. The finding of this study will provide preliminary evidence on the effectiveness and safety of acupuncture for CU. TRIAL REGISTRATION: Acupuncture-Moxibustion Clinical Trial Registry, AMCTR-ICR-18000190. Registered on 19 June 2018. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (10.1186/s13063-019-3433-1) contains supplementary material, which is available to authorized users.