In individuals battling with chronic spontaneous urticaria, active acupuncture eases symptoms, enhances the quality of life, and addresses depression and anxiety.

A randomized, sham-controlled pilot trial was conducted to assess whether it is practical to carry out a comprehensive randomized controlled trial (RCT) to assess the fundamental data and evaluate the safety of acupuncture as a potential treatment for individuals suffering from chronic spontaneous urticaria (CSU).

Overall, 80 individuals diagnosed with CSU were enrolled in the study. They were allocated randomly to two groups: one group (n=41) received active acupuncture, following a predetermined set of acupoints, while the other group (n=39) underwent sham acupuncture, where superficial acupuncture was applied to non-acupuncture points. This allocation was done using a completely randomized design.

Each volunteer in both groups was given five sessions every week for two weeks, and they were then monitored for an additional two weeks. The study's feasibility was evaluated based on several factors, including the occurrence of adverse events (AEs), adherence to the treatment protocol, participant retention, and the rates of participant recruitment and randomization.

The major clinical endpoint assessed was the alteration in weekly urticaria activity scores (UAS7) from baseline following the two-week treatment. The Hamilton Anxiety Scale (HAMA), the Hamilton Depression Scale (HAMD), the Dermatology Life Quality Index (DLQI), and the Visual Analogue Scale (VAS) score for itching intensity were the secondary endpoints ascertained.

The recruitment rate was 24.02%, and all participants were successfully randomized (100%). There was a loss rate of 6.25%, and no noticeable AEs were reported in either group. At week 2, the active acupuncture group showed a mean decrease of -8.63 in the UAS7 total score from baseline, while the sham acupuncture group had a decrease of -6.21.

The between-group difference was -2.42, indicating a modest advantage for the active acupuncture group. Regarding alterations in the DLQI, VAS for itching intensity, HAMA, and HAMD, there was a slight improvement in the active acupuncture group in comparison with the sham acupuncture group. But, these differences were not significant.

Active acupuncture proved to be a more beneficial treatment than sham acupuncture for patients with CSU.