Efficacy and Safety of Deep Acupuncture at Qugu Point (CV2) for Benign Prostatic Hyperplasia: Study Protocol for a Randomized Controlled Trial
Abstract
Background: Benign prostatic hyperplasia (BPH) is one of the most common urological disease and often associated with lower urinary tract symptoms (LUTS) in elderly men. Chinese acupuncturists found that deep acupuncture at Qugu point (CV2) can effectively relieve urination difficulties and improve quality of life of patients with troublesome BPH/LUTS. However, there are currently insufficient scientific evidence and well-designed trials to support its effect as well as safety in the treatment of BPH/LUTS. Therefore, this study protocol is designed to evaluate the effectiveness and safety of deep acupuncture at CV2 for men with BPH/LUTS.Methods: A single-center, randomized, subject-and assessor-blinded, placebo-controlled trial will be conducted in an outpatient acupuncture department in Beijing, China. A total of 120 subjects (50-80 yr) will be randomized to one of three balanced groups: deep acupuncture group 1 (deep acupuncture at CV2 with needle tip reaching the prostate capsule), deep acupuncture group 2 (deep acupuncture at CV2 with needle tip 10mm away from the prostate capsule), and sham acupuncture group (sham acupuncture with non-penetrating needle) in a ratio of 1:1:1. The study period for each subject will be 4 months, including 4 weeks baseline observation period, 4 weeks intervention period, and 8 weeks follow-up period. All subjects will receive 10 treatments during the intervention period. Subjects in deep acupuncture groups will be measured the needle depth…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 120 participants or records.
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