PYGEUM-AFRICANUM EXTRACT FOR THE TREATMENT OF PATIENTS WITH BENIGN PROSTATIC HYPERPLASIA - A REVIEW OF 25 YEARS OF PUBLISHED EXPERIENCE

Pygeum africanum bark extract has been used to treat mild and moderate symptomatic benign prostatic hyperplasia (BPH) in France since 1969. The extract has several potentially relevant pharmacologic properties: modulation of age-related hypercontractility of the bladder detrusor muscle; anti-inflammatory activity, including inhibition of chemotactic activity of leukotrienes; inhibition of fibroblast proliferation; and improvement of prostatic histology and secretion, The constituents of the extract have a safe toxicologic profile, and some of them have anticarcinogenic and antimutagenic properties. Published clinical experience includes 2262 patients, of whom 452 received the active product in comparative studies. Global outcome scores are rated as good or better in at least half the patients in most studies. Objective parameters were measured in some open-label and all comparative studies and included maximum flow rate, voided volume, residual volume, nocturia, daytime frequency, and other symptoms. The placebo effect on these parameters was often large. Nonetheless, the majority of placebo-controlled studies, which compared changes from baseline in patients who received placebo versus patients who received P africanum extract, showed a statistically significant advantage for most objective parameters with the active compound. This finding was particularly true of more recent and larger studies. Clinical tolerability of the extract was excellent, with most studies reporting the complete absence of any adverse effects. Thus published clinical data from 2262 patients during the last 25 years show that P africanum bark extract is an effective and exceptionally well-tolerated treatment for mild and moderate symptomatic BPH. P africanum extract has a pharmacologic profile distinct from other classes of drugs now being proposed for BPH treatment (alpha-adrenoceptor antagonists and 5-alpha-reductase inhibitors). The recent resurgence of interest in nonsurgical treatments for this condition should prompt a reappraisal of P africanum extract, perhaps in comparative trials with these other drug classes.