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 chemotacti c activity of leukotrienes; inhibition of fibroblast proliferation; an d improvement of prostatic histology and secretion, The constituents o f the extract have a safe toxicologic profile, and some of them have a nticarcinogenic and antimutagenic properties. Published clinical exper ience includes 2262 patients, of whom 452 received the active product in comparative studies. Global outcome scores are rated as good or bet ter in at least half the patients in most studies. Objective parameter s were measured in some open-label and all comparative studies and inc luded maximum flow rate, voided volume, residual volume, nocturia, day time frequency, and other symptoms. The placebo effect on these parame ters 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 st atistically significant advantage for most objective parameters with t he 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 effe cts. Thus published clinical data from 2262 patients during the last 2 5 years show that P africanum bark extract is an effective and excepti onally well-tolerated treatment for mild and moderate symptomatic BPH. P africanum extract has a pharmacologic profile distinct from other c lasses of drugs now being proposed for BPH treatment (alpha-adrenocept or antagonists and 5-alpha-reductase inhibitors). The recent resurgenc e of interest in nonsurgical treatments for this condition should prom pt a reappraisal of P africanum extract, perhaps in comparative trials with these other drug classes.