Kaikai 2014

Methods	Study design: parallel group randomised trial. Study dates: September 2013 to March 2014. Setting: outpatient. Country: China.
Participants	Inclusion criteria: aged ≥ 18; years; participants had pain or discomfort of the lower abdomen, pelvis, lumbosacral region, penis, scrotum or perineum; participants had clinical manifestations such as frequent urination, urgent urination, urinary retention or sexual dysfunction; prostatic fluid: WBC and lecithin bodies count normal or abnormal, bacteria culture negative; EPS and urine culture negative; course of disease ≥ 3 months; NIH‐CPSI pain subscore and urination subscore ≥ 10; antibiotics treatment ineffective. Exclusion criteria: congenital urinary tract malformation, injury to urethra or history of transurethral surgery, history of infection of urinary system within 3 months, history of tumour or tuberculosis of urinary system or pelvis, neurological disorders, acute or chronic bacterial prostatitis, severe diseases of cardiovascular or endocrine system, history of taking alpha‐blockers or alpha‐adrenergic drugs. Sample size: 105. Age (years): overall: 18˜55, mean: 32.2. Baseline NIH‐CPSI score: Group 1: mean 25.9 (SD 2.43); Group 2: mean 26.17 (SD 2.38), Group 3: mean 26.85 (SD 2.15). Sex: men.
Interventions	Group A (n = 35): non‐intrusive ultrasound + integrated Chinese‐Western medications. Output frequency: 1.79 MHz. Output power: 3.15 W/cm2. Duration: 20 min. Administration of treatment every 3 days (total 7 times). Group B (n = 35): integrated Chinese‐Western medications only. QianLieShuTong capsule, orally, 3 times daily, 3 capsules each time. Tamsulosin hydrochloride delayed‐release capsule, 0.2 mg, orally, once daily. Taken for 1 month. Group C (n = 35): non‐intrusive ultrasound only.
Outcomes	Prostatitis symptoms How measured: NIH‐CPSI global and subscore. Time points measured: before and after treatment. Time points reported: before and after treatment. Subgroups: none. Adverse events How measured: narratively.
Funding sources	Not mentioned.
Declarations of interest	Not mentioned.
Notes	None.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Quote: '105 patients were randomly assigned to 3 groups, 35 patients each.' However, method for randomization not described.
Allocation concealment (selection bias)	Unclear risk	Allocation concealment not described.
Blinding of participants and personnel (performance bias) Subjective outcomes	High risk	Masking of participants and personnel not described. However, considerable visible difference between the 3 interventions. Therefore, masking unlikely.
Blinding of outcome assessment (detection bias) All outcomes	High risk	All outcomes (participant‐reported outcomes): blinding unlikely (see above).
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