Multicentre controlled trial of indoramin in the symptomatic relief of benign prostatic hypertrophy.
A group of 139 patients with symptoms of bladder outflow obstruction due to benign prostatic hypertrophy were entered into a double-blind, parallel group, multicentre study of 2 doses of indoramin versus placebo. There were 18 withdrawals or exclusions, leaving 121 patients for analysis. After 8 weeks, mean peak flow rates increased more in patients treated with indoramin 20 mg bd than in those with placebo. The difference between indoramin 20 mg nocte and placebo was not significant. The change in mean peak flow rate for the higher dose of indoramin represented an increase of 50%. Both patients and investigators reported that the patients' symptoms had improved significantly on both indoramin 20 mg bd and 20 mg nocte; 9 patients were withdrawn because of adverse events, 5 taking placebo and 2 in each of the treatment groups. It was concluded that indoramin 20 mg bd was both effective and well tolerated in the management of symptomatic benign prostatic hypertrophy.