Methods |
Study design: parallel group randomised trial. Study dates: June 2002 to December 2005. Setting: outpatient setting. Country: China. |
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Participants |
Inclusion criteria: participants who meet the diagnostic criteria for chronic non‐bacterial prostatitis. Exclusion criteria: infection of urinary tract, EPS culture positive for bacteria, EPS routine test negative findings, benign prostatic hyperplasia, serious psychoneurosis, narrowing of urinary tract or prostate tumour. Participants with poor compliance and missing data were excluded. Sample size: 72. Age (years): overall 20˜46, mean 31. Baseline NIH‐CPSI score: not available. Sex: men. |
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Interventions |
Group 1 (n = 40): modified BiXieFenQing drink in morning and evening, 200 mL each + prostate massage once weekly. Group 2 (n = 32): modified BiXieFenQing drink in morning and evening, 200 mL each. Cointerventions: for participants with EPS mycoplasma culture positive, doxycycline given 0.1 g orally twice daily 2 weeks. Mycoplasma culture performed at weeks 1 and 2 after doxycycline treatment; if positive, another 2‐week doxycycline treatment was given (abnormal liver function was a contradiction for this treatment). |
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Outcomes |
Prostatitis symptoms How measured: NIH‐CPSI subscores and 'clinical cure.' Time points measured: before and after treatment. Time points reported: before and after treatment. |
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Funding sources | Not mentioned. | |
Declarations of interest | Not mentioned. | |
Notes | In the 72 participants included in this trial, 1 participant was complicated by epididymitis, 7 participants with mycoplasma culture positive. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Randomly assigned to Group 1 (40 participants) and Group 2 (32 participants) (in Chinese), but method for randomisation not mentioned. |
Allocation concealment (selection bias) | Unclear risk | Allocation concealment not described. |
Blinding of participants and personnel (performance bias) Subjective outcomes | High risk | Blinding of participants and personnel not described. Considering the visibly different interventions, blinding was unlikely. |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Blinding of outcome assessment not described. Self‐reported outcomes, see comment above. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | All outcomes: outcome data available for all participants. |
Selective reporting (reporting bias) | Unclear risk | Unclear whether there was selective outcome reporting (no protocol available). |
Other bias | Low risk | No other sources of bias identified. |