€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€ *****ANNALES D UROLOGIE***** Dufour B Choquenet C Revol M Faure G Jorest R [Controlled study of the effects of Pygeum africanum extract on the functional symptoms of prostatic adenoma] Etude controlee des effets de l'extrait de Pygeum africanum sur les symptomes fonctionnels de l'adenome prostatique. In: Ann Urol (Paris) (1984 May) 18(3):193-5 ISSN: 0003-4401 (Published in French) Two random groups of sixty patients each were given an extract of pygeum africanum in one group, and a placebo in the other. The results highlight the placebo effect (50 per cent of cases), and that the extract provided an overall improvement in the functional symptoms. The differences between the two treatments were statistically significant for nocturnal frequency, difficulty in starting micturition, and incomplete emptying of the bladder. Registry Numbers: 661-19-8 (tadenan) €€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€ Clavert A Cranz C Riffaud JP Marquer C Lacolle JY Bollack C [Effects of an extract of the bark of Pygeum africanum (V.1326) on prostatic secretions in the rat and in man] Effets d'un extrait d'ecorce de Pygeum africanum (V.1326) sur les secretions prostatiques du rat et de l'homme. In: Ann Urol (Paris) (1986) 20(5):341-3 ISSN: 0003-4401 (Published in French) Treatment with V.1326 in the rat induces an increase in prostatic secretion. In men with insufficient prostatic secretion, this treatment also induces an increased secretion. Registry Numbers: 661-19-8 (tadenan) €€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€ *****ARCHIVIO ITALIANO DI UROLOGIA, NEFROLOGIA, ANDROLOGIA***** Carani C Salvioli V Scuteri A Borelli A Baldini A Granata AR Marrama P [Urological and sexual evaluation of treatment of benign prostatic disease using Pygeum africanum at high doses] Valutazione urologica e sessuologica del trattamento della patologia prostatica benigna mediante Pygeum africanum ad alte dosi. In: Arch Ital Urol Nefrol Androl (1991 Sep) 63(3):341-5 ISSN: 1120-8538 (Published in Italian) This clinical study has been designed to evaluate the efficacy of an extract of Pygeum Africanum (Tadenan) (Roussel-Pharma) in patients suffering from prostatic hypertrophy or chronic prostatitis. The drug has been administrated to 18 patients, for 60 days, as double of standard dosage (200 mg/die per os, instead of 100 mg/die). Because of the high frequency of association of sexual disorders with those two pathologies, we have extended the study also to sexual disorders selecting patients suffering from prostatic hypertrophy or chronic prostatitis and, simultaneously, from sexual disturbances. No side effects have been observed during the treatment. The urinary disturbances have been evaluated by anamnesis and prostatic transrectal echography; sexual disorders have been evaluated by anamnesis and nocturnal penile tumescence and rigidity (NPTR) monitoring. Furthermore, dosage of serum levels of the hormones LH, FSH, Prolactin, 17 beta-Estradiol and Testosterone has been performed before and after therapy. Pygeum Africanum extract administration improved all the urinary parameters we investigated; prostatic echography relieved reduction of peri-urethral edema. Also an improvement of sexual behaviour has been obtained; but we have not found significant differences between serum hormonal levels before and after therapy, as well as for NPTR. Registry Numbers: 50-28-2 (Estradiol) 57-85-2 (Testosterone) 661-19-8 (tadenan) €€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€ *****CLINICAL THERAPEUTICS***** Krzeski T Kazon M Borkowski A Witeska A Kuczera J Combined extracts of Urtica dioica and Pygeum africanum in the treatment of benign prostatic hyperplasia: double-blind comparison of two doses. In: Clin Ther (1993 Nov-Dec) 15(6):1011-20 ISSN: 0149-2918 The 134 patients (aged 53 to 84 years) with symptoms of benign prostatic hyperplasia were drawn from two medical centers in Warsaw. The patients were randomly assigned to receive two capsules of the standard dose of an urtica/pygeum preparation (300 mg of Urtica dioica root extract combined with 25 mg of Pygeum africanum bark extract) or two capsules containing half the standard dose twice daily for 8 weeks. After 28 days' treatment, urine flow, residual urine, and nycturia were significantly reduced in both treatment groups. After 56 days' treatment, further significant decreases were found in residual urine (half-dose group) and in nycturia (both groups). There were no between-group differences in these measures of efficacy. Five patients reported adverse effects of treatment; treatment was not discontinued in any patient because of side effects. It is concluded that half doses of the urtica/pygeum extract are as safe and effective as the recommended full doses. €€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€ *****JOURNAL OF ETHNOPHARMACOLOGY***** Bonati A How and why should we standardize phytopharmaceutical drugs for clinical validation? In: J Ethnopharmacol (1991 Apr) 32(1-3):195-7 ISSN: 0378-8741 Standardized extracts are needed to carry out reliable clinical trials. The standardization of an extract does not include only a whole of analytical controls: it requires also a thorough description of the starting drug and of the whole extraction process, both basic items for the constancy of the quality of an extract. Another not minor aspect in the standardization of an extract is its nomenclature which must include all the necessary data for a clear definition (drug, physical state, solvent of extraction, composition) of the extract itself. Two examples of standardization are described, one concerning an extract whose therapeutical active constituents are known (anthocyanoside complex of Vaccinium myrtillus) and the other concerning an extract whose constituents must be regarded as chemical markers (Pygeum africamum extract). €€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€ *****JOURNAL OF LIPID MEDIATORS AND CELL SIGNALLING***** Paubert-Braquet M Cave A Hocquemiller R Delacroix D Dupont C Hedef N Borgeat P Effect of Pygeum africanum extract on A23187-stimulated production of lipoxygenase metabolites from human polymorphonuclear cells. In: J Lipid Mediat Cell Signal (1994 May) 9(3):285-90 ISSN: 0929-7855 Pygeum africanum extract has been used for more than 20 years in France in patients suffering from benign prostatic hypertrophy (BPH). The extract displays anti-inflammatory activity and inhibits bladder hyperreactivity during the above conditions. However, the mechanism of action of P. africanum extract has never been clearly resolved. It has been recently demonstrated that infiltration by inflammatory cells may be involved in the development of BPH. Certain of these cell types, such as macrophages, are known to produce chemotactic mediators including leukotrienes, and thus may contribute to the development of the disease. In order to investigate the potential effect of P. africanum extract on arachidonate metabolism, we examined its effect in vitro on leukotriene (LT) synthesis in human polymorphonuclear cells stimulated with the calcium ionophore A23187. Two formulations of the extract were tested, one dissolved in DMSO and one aqueous solution obtained after alkalinization (0.1 N; NaOH/acidification (0.1 N; HCl). Neither formulation had any effect on cell viability which was above 95% in both cases. P. africanum extract dissolved in DMSO significantly inhibited the production of 5- lipoxygenase metabolites (5-HETE, 20-COOH LTB4, LTB4 and 20-OH LTB4) at concentrations as low as 3 micrograms/ml (p < 0.01), while the same extract dissolved in NaOH/HCl only exhibited an inhibitory effect at 10 micrograms/ml (p < 0.01). This difference apparently reflects the greater solubility of the active components in the extract in DMSO. The ability of P. africanum to antagonize 5- lipoxygenase metabolite production may contribute, at least in part, to its therapeutic activity in inflammatory component of BPH. Registry Numbers: EC 1.13.11.34 (Arachidonate 5-Lipoxygenase) 1310-73-2 (Sodium Hydroxide) 52665-69-7 (Calcimycin) 661-19-8 (tadenan) 7647-01-0 (Hydrochloric Acid) €€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€ *****REVUE DU PRATICIEN***** Dagues F Costa P [Medical treatment of disorders of the bladder sphincter] Traitements medicamenteux des troubles vesico-sphincteriens. In: Rev Prat (1995 Feb 1) 45(3):337-41 ISSN: 0035-2640 (Published in French) A lot of drugs can increase or decrease bladder activity or urethral sphincter activity. Some of them are used for treatment of incontinence or chronic retention. In case of severe pollakiuria or urge incontinence secondary to bladder instability, numerous medications can be used: anticholinergic agents, musculotropic relaxants, calcium antagonists, prostaglandin inhibitors, beta- adrenergic agonists, tricyclic antidepressants. Anticholinergic agents are regularly used on first choice. When stress incontinence is present, alpha agonists administered with estrogen and perineal reeducation represent the first stage before surgery. For medical treatment of retention, if there is not outlet obstruction, one can increase detrusor activity with betanechol chloride. In case of outlet obstruction, alpha-blockers or 5 alpha-reductase inhibitors can be used, if there is benign prostatic hyperplasia. Pygeum africanum can be used, but to date there is no clinical study proving its efficacy. €€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€ *****WIENER KLINISCHE WOCHENSCHRIFT***** Barlet A Albrecht J Aubert A Fischer M Grof F Grothuesmann HG Masson JC Mazeman E Mermon R Reichelt H et al [Efficacy of Pygeum africanum extract in the medical therapy of urination disorders due to benign prostatic hyperplasia: evaluation of objective and subjective parameters. A placebo-controlled double- blind multicenter study] Wirksamkeit eines Extraktes aus Pygeum africanum in der medikamentosen Therapie von Miktionsstorungen infolge einer benignen Prostatahyperplasie: Bewertung objektiver und subjektiver Parameter. Eine placebokontrollierte doppelblinde Multizenterstudie. In: Wien Klin Wochenschr (1990 Nov 23) 102(22):667-73 ISSN: 0043-5325 (Published in German) The efficacy of an extract of Pygeum africanum in the treatment of micturitional disorders due to benign prostatic hyperplasia was tested in a multicentre double-blind trial versus placebo. Capsules containing 50 mg of Pygeum africanum extract or placebo were administered at a dosage of 1 capsule in the morning and 1 capsule in the evening over a period of 60 days. 263 patients were included in this study, which was carried out in 8 centres in Germany, France, and Austria. Evaluation was mainly based on quantitative parameters such as residual urine, uroflowmetry and the precise monitoring of diurnal and nocturnal pollakiuria. Treatment with the Pygeum africanum extract led to a marked clinical improvement: a comparison of the quantitative parameters showed a significant difference between the Pygeum africanum group and the placebo group with respect to therapeutic response. The characteristic subjective symptoms of micturitional disorders, which were evaluated by the patients in a qualitative manner, were also significantly improved by administration of Pygeum africanum extract. Overall assessment at the end of therapy, showed that micturition improved in 66% of the patients treated with Pygeum africanum extract, as compared with an improvement of 31% in the placebo group. The difference was significant at the statistical level of p less than 0.001. During therapy with Pygeum africanum extract, gastrointestinal side effects occurred in 5 patients. Treatment was discontinued in three of those cases. Registry Numbers: 661-19-8 (tadenan) €€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€