Mohanty 1999.
| Methods | Site not described Randomization not described Blinding: double blinded |
|
| Participants | Geographic region: NR Study setting: clinic N = 75 Baseline modified Boyarsky: NR Baseline prostate volume: SR 28.78 mL; placebo 29.89 mL Mean age (range): NR (40 to 90) years Race: NR Diagnostic criteria: BPH grades I or II; symptomatic; without surgical indication; took no BPH drug treatment for last 30 days. | |
| Interventions | Control: matching placebo, 1 capsule twice daily Treatment: SR, 1 capsule twice daily Study duration: 2 months Lost to follow‐up: SR n = 2; placebo n = 0 | |
| Outcomes | Modified Boyarsky (range 0 to 27, with a higher score indicating worse symptoms) Frequency Nocturia Peak urine flow Residual volume Prostate size (ultrasound) Adverse events |
|
| Notes | Exclusions: men with prostate conditions other than BPH (carcinoma of the prostate, infective prostatitis); serious renal, hepatic and cardiac conditions. | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | not described |
| Allocation concealment (selection bias) | Unclear risk | not described |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk | adequate |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | not mentioned |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | adequate |
| Selective reporting (reporting bias) | Low risk | none |
| Other bias | Unclear risk | no description of baseline comparability of the two arms other than for age |