Background: Acupuncture has promising effects on chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS), but high-quality evidence is scarce.
Objective: To assess the long-term efficacy of acupuncture for CP/CPPS.
Design: Multicenter, randomized, sham-controlled trial. (ClinicalTrials.gov: NCT03213938).
Setting: Ten tertiary hospitals in China.
Participants: Men with moderate to severe CP/CPPS, regardless of prior exposure to acupuncture.
Intervention: Twenty sessions of acupuncture or sham acupuncture over 8 weeks, with 24-week follow-up after treatment.
Measurements: The primary outcome was the proportion of responders, defined as participants who achieved a clinically important reduction of at least 6 points from baseline on the National Institutes of Health Chronic Prostatitis Symptom Index at weeks 8 and 32. Ascertainment of sustained efficacy required the between-group difference to be statistically significant at both time points.
Results: A total of 440 men (220 in each group) were recruited. At week 8, the proportions of responders were 60.6% (95% CI, 53.7% to 67.1%) in the acupuncture group and 36.8% (CI, 30.4% to 43.7%) in the sham acupuncture group (adjusted difference, 21.6 percentage points [CI, 12.8 to 30.4 percentage points]; adjusted odds ratio, 2.6 [CI, 1.8 to 4.0]; P < 0.001). At week 32, the proportions were 61.5% (CI, 54.5% to 68.1%) in the acupuncture group and 38.3% (CI, 31.7% to 45.4%) in the sham acupuncture group (adjusted difference, 21.1 percentage points [CI, 12.2 to 30.1 percentage points]; adjusted odds ratio, 2.6 [CI, 1.7 to 3.9]; P < 0.001). Twenty (9.1%) and 14 (6.4%) adverse events were reported in the acupuncture and sham acupuncture groups, respectively. No serious adverse events were reported.
Limitation: Sham acupuncture might have had certain physiologic effects.
Conclusion: Compared with sham therapy, 20 sessions of acupuncture over 8 weeks resulted in greater improvement in symptoms of moderate to severe CP/CPPS, with durable effects 24 weeks after treatment.
Primary funding source: China Academy of Chinese Medical Sciences and the National Administration of Traditional Chinese Medicine.