Gao 2012

Methods	Study design: parallel group randomised controlled trial. Study dates: January 2008 to March 2009. Setting: academic hospital. Country: China.
Participants	Inclusion criteria: men aged ≥ 18 years with symptoms of CP within previous 3 months and pain or discomfort in pelvic region for ≥ 6 weeks and total score of ≥ 12 on NIH‐CPSI. Exclusion criteria: urinary tract infection; bacteriuria; history of urethritis with discharge 4 weeks before study entry; history of epididymitis or sexually transmitted infection; residual volume > 50 mL resulting from bladder outlet obstruction by urodynamic evaluation; indication for, or history of, prostate surgery, including prostate biopsy; history of urogenital cancer; neurological disease affecting bladder; treatment with phytotherapeutic agents, alpha‐blockers or antimicrobial substances with prostatic penetration 4 weeks before study entry; treatment with agents influencing intraprostatic hormone metabolism 6 months before study entry and unmarried or with no children. Sample size: 159 (105 included type III CP/CPPS). Age (mean, years): Group 1: 35.9 for type IIIa, 36.7 for type IIIb; Group 2: 36.5 for type IIIa, 35.6 for type IIIb; Group 3: 34.7 for type IIIa, 39.3 for type IIIb. Baseline NIH‐CPSI score (mean): Group 1: 20.9 for type IIIa, 20.2 for type IIIb; Group 2: 20.0 for type IIIa, 21.1 for type IIIb; Group 3: 22.4 for type IIIa, 21.7 for type IIIb. Sex: men.
Interventions	Group 1 (n = 30): tamsulosin 0.2 mg once daily + clarithromycin 0.25 g twice daily for 6 weeks. Group 2 (n = 32): 60‐min treatment with TRFH (ZRL‐II‐A cavity intervention treatment instrument (Shanghai Songhang Industry, Co. Ltd., Shanghai, China), temperature 40‐43 °C) every day for 5 days. Group 3 (n = 43): TRFH combined with tamsulosin + clarithromycin.
Outcomes	Prostatitis symptoms How measured: NIH‐CPSI. Time points measured: pretreatment and 6 weeks. Time points reported: pretreatment and 6 weeks. Subgroups: no subgroup relevant to the review.
Funding sources	Not stated.
Declarations of interest	Not stated.
Notes	Other outcomes included changes in malondialdehyde, superoxide dismutase, nitrogen monoxide and zinc (for the study of inflammation).
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Quote: 'randomly divided into 3 treatment groups based on the order of their arrival.' No information available. Wrote to authors.
Allocation concealment (selection bias)	Unclear risk	No information available. Wrote to authors.
Blinding of participants and personnel (performance bias) Subjective outcomes	High risk	Blinding was not likely for the comparison of Group 1 with Groups 2 and 3. Blinding not specified for any comparison.
Blinding of outcome assessment (detection bias) All outcomes	High risk	Blinding was not likely for the comparison of Group 1 with Groups 2 and 3. Blinding not specified for any comparison. Self‐reported outcome.
Incomplete outcome data (attrition bias) All outcomes	Low risk	All outcomes: outcome data available for all randomised participants.
Selective reporting (reporting bias)	Unclear risk	Protocol not available.
Other bias	Low risk	No other sources of bias detected.