PURPOSE: We investigated the effectiveness of acupuncture in patients with chronic prostatitis/chronic pelvic pain syndrome. MATERIALS AND METHODS: We performed this 32-week randomized, controlled trial with 8 weeks of treatment followed by 24 weeks of followup to compare acupuncture with sham acupuncture. Participants with chronic prostatitis/chronic pelvic pain syndrome were randomly assigned to acupuncture or noninvasive sham acupuncture. The primary outcome was the change in the NIH-CPSI (National Institutes of Health Chronic Prostatitis Symptom Index) total score from baseline to week 8. Secondary outcomes were the NIH-CPSI subscale scores, pain severity, the I-PSS (International Prostate Symptom Score), the global response rate and satisfaction assessment. RESULTS: A total of 68 participants 18 to 50 years old were enrolled and included in intent to treat analyses. Baseline characteristics were comparable in the 2 groups. The reduction in the NIH-CPSI total score differed significantly between the 2 groups at weeks 8, 20 and 32 with a difference of -5.7 (95% CI -7.8 to -3.7), -6.7 (95% CI -8.9 to -4.5) and -7.4 (95% CI -9.8 to -5.1), respectively (each p < 0.001). All differences were greater than the 4-point minimal clinically important difference. No significant difference was found between the groups in NIH-CPSI pain and quality of life subscale scores or in I-PSS at week 4 (each p > 0.05). For all other secondary outcomes the acupuncture group was statistically better than the sham acupuncture group. CONCLUSIONS: Acupuncture showed clinical and long-lasting benefits compared with sham acupuncture for chronic prostatitis/chronic pelvic pain syndrome. Randomized controlled trials with larger sample sizes are needed in the future.

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