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. 2018 Jan 26;2018(1):CD012551. doi: 10.1002/14651858.CD012551.pub2
Methods Study design: parallel group randomised trial.
Study dates: not available.
Setting: outpatient.
Country: Italy.
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.
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.
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.