Objective:

2

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:

2

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:

2

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.

Conclusion:

2

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)