| Methods | Study design: parallel group randomised trial. Study dates: February 2004 to July 2005. Setting: academic hospitals, outpatient. Country: Malaysia and US. | |
| Participants | Inclusion criteria: men aged ≥ 20 years with NIH‐CPSI total score ≥ 15 (scale 0‐43) and symptoms for ≥ 3 months within preceding 6 months. Exclusion criteria: bacterial prostatitis, urinary tract infection within 1 year, any traditional or complementary alternative medicine (traditional Chinese medicine) treatment within 6 weeks or any consensus CP/CPPS exclusion criterion (Propert 2002). Sample size: 89. Age (years): Group 1: 40.9 (SD 11.0); Group 2: 42.8 (SD 9.4). Baseline NIH‐CPSI score: Group 1: 24.8 (SD 6.2); Group 2: 25.2 (SD 5.8). Sex: men. | |
| Interventions | Group 1 (n = 45): 4 acupoints prepared, then sterile, disposable stainless steel needles (Suzhou Huan‐Qiu Acupuncture Medical Supplies, Suzhou, China) placed perpendicularly in 30‐min sessions in acupoints (CV1‐Guan Yuan, CV4‐Huiyin, SP6‐Sanyinjiao and SP9‐Yinlingquan), twice weekly for 10 weeks. Group 2 (n = 45): sham acupuncture included same number, duration and frequency of sessions as the acupuncture group at non‐acupoints (15 mm to the left). Cointerventions: no use of medications or supplemental therapies known to affect immune function during study. | |
| Outcomes | Prostatitis symptoms How measured: NIH‐CPSI (continuous and dichotomous). Dichotomous: responders defined as those who had a drop of 6 points in NIH‐CPSI score. Time points measured: baseline, and 5, 10, 14, 22 and 34 weeks. Time points reported: baseline and 10 weeks; additionally, responder rate reported at 34 weeks. Other time points presented graphically. Urinary symptoms How measured: IPSS. Time points measured: baseline, and 5, 10, 14, 22 and 34 weeks. Time points reported: baseline and 10 weeks. Sexual dysfunction How measured: International Index of Erectile Function. Time points measured: baseline, and 5, 10, 14, 22 and 34 weeks. Time points reported: baseline and 10 weeks. Adverse events How measured: narratively. | |
| Funding sources | NIH Grants DK065266 and DK38955, National Institutes of Health, Bethesda, MD. | |
| Declarations of interest | None. | |
| Notes | 90 participants randomised but 1 in acupuncture arm did not receive intervention (not analysed in results). Clinical Trial registry: NCT00260637. | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Quote: 'computer generated, random, variable block design.' |
| Allocation concealment (selection bias) | Unclear risk | No information provided. |
| Blinding of participants and personnel (performance bias) Subjective outcomes | Low risk | Participants blinded. Quote: 'Because acupuncturists could not be blinded to the treatment assignment, they were deliberately excluded from examining and enrolling participants, and from all outcome assessments.' |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote: 'Sham points were 15 mm away from the acupuncture points. These measures ensured credibility, because three quarters of the sham group thought they had received acupuncture.' |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | All outcomes: outcome data available for 44/45 participants allocated to acupuncture and 45/45 participants allocated to sham procedure. |
| Selective reporting (reporting bias) | Low risk | All outcomes reported. |
| Other bias | Low risk | No other sources of bias identified. |