Therapeutic effect of combined acupuncture and moxibustion for patients with benign prostatic hyperplasia: study protocol of a randomized controlled trial

Abstract Background Combined acupuncture and moxibustion have shown benefits for a variety of illnesses. However, few studies have reported the therapeutic effect of this combined therapy for benign prostatic hyperplasia. Here, we report the study protocol of a randomized controlled clinical trial investigating the therapeutic effect of this combined therapy by comparing with the effect of conventional medical treatments. Methods A single-center, two-arm designed, randomized controlled clinical trial will commence in Shanghai Fourth People’s Hospital, China. Two hundred participants with moderate to severe benign prostatic hyperplasia will be recruited and assigned to the combined therapy group and the conventional western medicine group in a ratio of 1:1. They will be treated for 18 weeks and assessed after 8- and 18-weeks treatment. The primary outcome is the International prostate symptom score (IPSS), the Aging Male Symptoms score (AMS); secondary outcomes include constitution in Chinese Medicine Questionnaire (CCMQ), post-voiding residual urine volume, maximum flow rate (Qmax) and average flow rate (Qave), voided volume (VV), voiding time and time to maximum flow, the change of urgency/24 h, the change of voiding frequency/24 h, the change of nocturnal frequency/24 h, the change of urge urinary incontinence frequency/24 h. Discussion The result of this trial will confirm whether combined acupuncture and moxibustion is effective in managing benign prostatic hyperplasia as well as the superiority of inferiority of this therapy to conventional medical treatments. Trial registration: chictr.org.cn, ID: ChiCTR2000030504/ChiMCTR2000003082.