Antiandrogenic treatment of benign prostatic hyperplasia: a placebo controlled trial

Abstract

In a randomized triple-blind multicentre study, injections with the anti-androgenic agent oxendolone were compared with placebo in the treatment of benign prostatic hyperplasia. Thirty patients were treated with weekly injections of oxendolone 200 mg during a 3 months' period, and 30 patients were allocated to placebo treatment. During oxendolone treatment the maximum urinary flow rate increased statistically significantly (from 6.8 ml/s to 8.2 ml/s). However compared to placebo, the oxendolone effect was statistically insignificant. A slight but statistically significant improvement of the symptoms "sensation of retention", "urgency" and "frequency", was observed following oxendolone treatment, but an almost identical effect was seen in the placebo group. Following either treatment no change was observed in the residual urine volumes, in prostatic volume as measured by transrectal ultrasonotomography, or in any other therapeutic parameters. Conservative treatment of benign prostatic hyperplasia with the antiandrogen oxendolone in a dose of 200 mg a week cannot be recommended for clinical use.

Flavoxate Treatment of Micturition Disorders Accompanying Benign Prostatic Hypertrophy: A Double-Blind Placebo-Controlled Multicenter Investigation

“…Our investigation confirms the well-known placebo effects [1,10] by demonstrating statistically significant time-related changes in both groups for several efficacy variables including the total symptom score and by 48% of patients judging placebo to have some effect, and this expresses the necessity of controlled investigations.…”

Evidence‐based meta‐analysis of pharmacotherapy for benign prostatic hypertrophy

“…An RCT in which 30 patients were each treated with oxendolone or placebo reported that the drug was not clinically recommended because it did not improve subjective and objective symptoms 46 …”