RESUMEN
INTRODUCTION: Both acupuncture and moxibustion have been used for thousands of years in China for diverse conditions. But there are few reports on their combined effect in managing benign prostatic hyperplasia (BPH). To answer this question, we designed a prospectively study and the present protocol described details of this randomized controlled trial (RCT). METHODS: In this RCT, an estimated number of 200 patients with BPH will be enrolled from Shanghai Fourth People's Hospital, China. They will be assigned to either the combined therapy group or the conventional western medicine group in a ratio of 1:1. The International Prostate Symptom Score (IPSS) will be assessed as the primary outcome, other parameters, including the post-voiding residual urine volume, maximum flow rate (Qmax), and average flow rate (Qave), voiding time, and time to maximum flow, are secondary outcomes. DISCUSSION: Results of this study will provide the theoretical basis for clinicians to select combined therapy or conventional western medicine treatments for BPH patients based on the efficacy of these therapies. TRIAL REGISTRATION: chictr.org.cn, ID: ChiCTR2000030504/ChiMCTR2000003082. http://www.chictr.org.cn/edit.aspx?pid=47719&htm=4, Registered on 5th March 2020.