Efficacy of acupuncture in improving the quality of life of patient’s with moderate or severe acne vulgaris: protocol for a randomized controlled trial
Abstract Background Acne vulgaris (AV) is a common chronic dermatologic disease that tends to impair the quality of life of patients. None of the previous clinical trials of acupuncture therapy for AV used the quality of life as a primary outcome or employed a sham acupuncture control arm. Methods/design Participants with AV will be randomly assigned to acupuncture or sham acupuncture groups (1:1 allocation). All participants will receive 4-week treatment comprising of a total of 12 sessions (3 sessions per week). The primary outcome will be change from baseline in the Skindex-16 scale total score at treatment completion. The secondary outcomes will be Skindex-16 subscale scores, the Dermatology Life Quality Index scale total score, the total lesion count and inflammatory lesion count, itch and pain assessment using the visual analogue scale score, patient expectations of acupuncture, patient satisfaction with treatment, and the blinding of the effect of sham acupuncture. Follow-up evaluation will be performed at weeks 16 and 28. All outcome analyses will be performed in the intention-to-treat population. Discussion This is the first randomized controlled trial which will compare the effect of acupuncture versus sham acupuncture in improving the quality of life of patients with moderate or severe acne vulgaris (AV). The limitation of the design of this trial is that the sample size of a single center trial, which may lead to potential overestimation of the effect of acupuncture. Meanwhile, due to the characteristics of acupuncture, the acupuncturists will not be blinded and the use of non-acupoints and minimal acupuncture without any manipulation, which may introduce an element of bias and cause some biological effect.