Zeng 2012

Methods	Study design: parallel group randomised trial. Study dates: August 2009 to May 2011. Setting: academic hospital. Country: China.
Participants	Inclusion criteria: aged > 18 years with type IIIb CP/CPPS refractory to other treatments, with pelvic pain or discomfort defined as pain in bladder, groin, genitals or lower abdomen or perineal or perianal areas (or a combination) without clear abnormalities on urological examination for minimum 3 months, NIH‐CPSI total score > 15 and pain domain score > 4, and the ability to communicate, understand and comply with the requirements of study. Exclusion criteria: chronic urethritis, urinary stones, bacterial or inflammatory CP/CPPS, seminal vesiculitis, bladder cancer, prostate cancer, urethral strictures, neurogenic bladder dysfunction, restricted mobility and antimicrobial or anti‐inflammatory medication within the 4 weeks prior to enrolment in the study. Participants were also excluded from analysis if they had a documented history of prostatic intraepithelial neoplasia on biopsy, serum prostate‐specific antigen levels in excess of 4 ng/mL, history of prostate surgery or radiotherapy, acute urinary retention or an indwelling catheter. Sample size: 80. Age (years): ESWT group: 48.7 (SD 12.1). Sham group: 46.3 (SD 10.2). Baseline NIH‐CPSI score: Group 1: 30.5 (SD 4.7); Group 2: 29.3 (SD 4.1). Sex: men.
Interventions	Group 1 (n = 40): participants received 20,000 ESWT (HB‐ESWT‐01, Haibin Medical Equipment Co. Ltd., China) impulses in 10 sessions over 2 weeks. Shock waves were applied directly to perineal area in which the pain was localised (from anus to scrotum). Starting energy density 0.06 mJ/mm2 and frequency 2 Hz used for all treatments. The energy density was gradually increased until it reached the maximum possible tolerable pain level reported by participant. This energy density was recorded during 1st session and used in all subsequent sessions. Group 2 (n = 40): sham ESWT, which was conducted by setting energy level to 0 (no shockwave energy transmission), under conditions identical to Group 1. Cointerventions: all participants had received prior treatment that consisted of antibiotics, anti‐inflammatories, plant extracts, alpha1‐blocker, 5‐alpha‐reductase inhibitors, antimuscarinics, anxiolytics and neuromodulation agents. 2 weeks prior to study, participants halted all medications used to control their specific prostatic symptoms. Throughout study, participants received no drugs that could influence the results, such as antibiotics, anti‐inflammatories, antidepressants or pain relievers.
Outcomes	Prostatitis score How measured: NIH‐CPSI score. Time points measured: 1 week before treatment (baseline), 1 week after initial treatment (mid‐point), 2 weeks after initial treatment (end point), 4 weeks after end point (4 weeks' follow‐up) and 12 weeks after end point (12 weeks' follow‐up). Time points reported: 0 and 2 weeks (the other time points were only available graphically). Adverse events How measured: narratively.
Funding sources	Not reported.
Declarations of interest	'None.'
Notes	None.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Reported that their sample was randomly recruited. No information for this domain. We wrote to study authors for clarification.
Allocation concealment (selection bias)	Low risk	Indicated that allocating participants to the 2 groups was random using the closed envelop technique.
Blinding of participants and personnel (performance bias) Subjective outcomes	High risk	Quote: 'Single blind.' Subjective outcome.
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Authors used the same device turned off as sham procedure; however, no information on how effective this method of masking was, considering the noticeably different procedures. We wrote to study authors for clarification.
Incomplete outcome data (attrition bias) All outcomes	Low risk	All outcomes: 2/40 participants in Group 1 and 3/40 participants in Group 2 had missing outcome data.
Selective reporting (reporting bias)	High risk	No protocol available. Data presented graphically for NIH‐CPSI score. Post hoc analysis of responders was presented numerically. We wrote to study authors for data.
Other bias	Low risk	No other sources of bias identified.