Champault Letter (Extract)

A double-blind trial of an extract of the plant Serenoa repens in benign prostatic hyperplasia

We report here the results of a double-blind clinical trial of the efficacy of PA109 (commercialised in France as Permixon®) in prostatic hyperplasia.

The double-blind, placebo-controlled study was performed with 110 outpatients (55 PA 109, 55 placebo). The symptoms of dysuria, nocturia and frequent and poor urinary flow, present in all subjects, were assessed. Investigations involved were flow rate and cystographic postmicturition residual volume. Exclusion criteria included: patients with an acute or unstable episode, adenomas requiring early surgery, carcinoma of the prostate or prostatic syndromes associated with other genito-urinary conditions. Patients were assigned to two comparable groups and received 320 mg per day (2 x 80 mg x 2) of PA109 or placebo. Before, and after 30 days' treatment the following were assessed; nocturia, intensity of dysuria, flow rate, post-micturition residue, self-rating by the patient and global rating by the physician.

PA109 (Permixon®) was used as tablets containing 80 mg of the liposterolic extract of Serenoa repens. Permixon is produced by P. F. Médicaments, 125 rue de la Faisanderie, 75116 Paris (French marketing authorisation number 324.808.3; 26 juin 1981). The usual dosage is 2 tablets twice daily.

Ninety-four patients were included in the analysis (44 placebo and 50 PA109). Eight patients were not available for terminal examination (six placebo and two PA109) and eight patients received antibiotic treatment during the study (five placebo and three PA109). Data were analysed using the paired t-test for quantitative values or the chi-squared test for qualitative results (Table 1).

As can be seen from Table 1 both objective and subjective signs were improved. This improvement was significantly superior to that achieved with placebo. Thus as predicted by pharmacological and biochemical studies PA109 would therefore appear to be a useful therapeutic tool in the treatment of benign prostatic hyperplasia.

PA109 was extremely well tolerated with less side-effects being reported during the study by patients receiving PA109 (five reports) than those receiving placebo (11 reports). All side-effects reported were minor (e.g. headache). In addition standard blood chemistry measurements showed no alterations.

G. CHAMPAULT¹, J. C. PATEL² & A. M. BONNARD³

¹Hôpital Jean Verdier, 93140 Bondy, France, ²Hôpital Ambroise Paré, 92100 Boulogne-Billancourt, France and ³Département de Recherche Clinique, P. F. Médicament, 125 rue de la Faisanderie, 75116 Paris, France

Received February 29, 1984, accepted May 4, 1984

Source: Letter to the Editors, Br. J. clin. Pharmac. (1984), 18, pp. 461-2.

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