Methods |
Study design: parallel group randomised trial. Study dates: not available. Setting: outpatient. Country: Italy. |
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Participants |
Inclusion criteria: aged 30‐50 years diagnosed with chronic abacterial prostatitis with history of 1 year of symptoms. Exclusion criteria: hypersensitivity to the drug, liver or kidney failure, neoplastic pathology of prostate or positive cultures of urine or prostate secretions. Sample size: 20. Age (years): overall 42.5 (SD 6.8). Baseline NIH‐CPSI score: not available. Sex: men. |
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Interventions |
Group 1 (n = 10): Seaprose S (Flaminase, Formenti) 30 mg 3 times daily in combination with local hyperthermia, total of 7 sessions on alternate days of 60 min in duration, reaching local temperature of 42.5‐43.5 °C. Group 2 (n = 10): 7 sessions of local hyperthermia alone. Cointerventions: no anti‐inflammatory treatment permitted. |
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Outcomes | None of the outcomes of the review were reported. | |
Funding sources | Not available. | |
Declarations of interest | Not available. | |
Notes | Seaprose S is a semi‐alkaline crystallised protein derived from the purified culture of Aspergillus melleus. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Randomisation performed using random numbers table (Fisher and Yates). |
Allocation concealment (selection bias) | Unclear risk | No description of allocation concealment. |
Blinding of participants and personnel (performance bias) Subjective outcomes | High risk | Open label study. |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Open label study. |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | No information available. |
Selective reporting (reporting bias) | Unclear risk | No protocol available (none of the review outcomes were reported). |
Other bias | Low risk | No other sources of bias identified. |