Comparison of once and twice daily dosage forms of Pygeum africanum extract in patients with benign prostatic hyperplasia: A randomized, double-blind study, with long-term open label extension

Objectives. To compare the efficacy and safety of Pygeum africanum extract, 50 mg twice daily and 100 mg once daily. Methods. Patients with symptomatic benign prostatic hyperplasia (BPH) entered a 2-month randomized, parallel-group, double-blind, comparative phase (group A, 50 mg twice daily; group B, 100 mg once daily), followed by a IO-month, open phase (100 mg once daily). Main efficacy assessment parameters included International Prostate Symptom Score (IPSS), quality of life (QOL), and maximum urinary flow rate (Qmax). Results. Two hundred nine patients completed the comparative phase in compliance with the protocol; 174 were included in the open phase. Both treatments had similar efficacy. IPSS (baseline 17 in both groups) improved by 38% in group A and 35% in group B. QOL improved by 28% in both groups. Qmax increased by 1.63 mL/s (16%) in group A and 2.02 mL/s (19%) in group B. After 12 months, the IPSS fell from 16 (baseline) to 9 (-46%). Half of the patients had an IPSS below 8. Mean Qmax increased by 1.65 mL/s (15%). The safety profile was similar between groups and study phases. Conclusions. P. africanum extract at 50 mg twice daily and 100 mg once daily proved equally effective and safe at 2 months. Further improvements in efficacy with a satisfactory safety profile were documented after 12 months. (C) 1999, Elsevier Science Inc.