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Saw Palmetto Multigenics intensive care (with mixed carotenoids) Zinc AG Phyto-complete EPA-DHA Ultra-prostagen Andriol For Patients only: PSA, DHT and estrogen monitoring Testosterone Benign Prostatic Hypertrophy Efficacy of Pygeum africanum extract in the treatment of micturitional disorders due to benign prostatic hyperplasia. Evaluation of objective and subjective parameters. A multicenter, randomized, double-blind trial The efficacy of an extract of Pygeum africanum in the treatment of micturitional disorders due to benign prostatic hyperplasia was tested in a multicenter 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 centers in Germany, France and Austria. Evaluation was mainly based on quantitative parameters such as residual urine, uroflowmetry and the precise monitoring of polyuria and nocturia. Treatment with the Pygeum africanum extract led to a marked clinical improvement, [and] 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<0.001. During therapy with Pygeum africanum extract, gastrointestinal side effects occurred in 5 patients. Treatment was discontinued in three of those cases. Barlet, A, et al. Wien Klin Wochenschr 22:667-673; 1990. Standardized Pygeum africanum extract in the treatment of benign prostatic hypertrophy: A controlled clinical study vs. placebo The authors present the results of a double-blind study vs. placebo in 40 patients with non-advanced benign prostatic hypertrophy [BPH]. The patients were treated with a standardized Pygeum africanum extract (at a dosage of 100 mg per day, administered orally, for 60 days). The clinical pre-treatment and post-treatment evaluation was based on the symptomatology, on the results of a rectal examination, and on an analysis of the results of urine flow measurements. Preliminary results reveal a statistically significant improvement in polyuria, urgency, dysuria, and urine flow in the patients who were treated with the active substance. Bassi P., et al.Min Urol e Nefrol 39:45-50; 1987. Urological and sexual evaluation of the treatment of benign prostate pathology with high doses of Pygeum africanum 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, contemporarily, from sexual disturbances. No side effects have been observed during the treatment. The urinary disturbances have been evaluated by anamnesys and prostatic transrectal-echography; sexual disorders have been evaluated by anamnesys and nocturnal penile tumescence and rigidity (NPTR) monitoring. Furthermore, dosage of serum levels of the hormones LH, FSH, prolactin, 17 b 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 periurethral edema. Also an improvement of sexual behavior has been obtained; but we have not found significant differences between serum hormonal levels before and after therapy, as well as for NPTR. Carani C, et al. Arch It Urol. 63:341-345; 1991 Controlled study of the effects of Pygeum africanum extract on the functional symptoms of prostatic adenoma 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 percent 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. Dufour B, et al. Ann Urol 3:193-195; 1984. An urodynamic study of patients with benign prostatic hypertrophy treated conservatively with phytotherapy or testosterone Conservative therapy of benign prostatic hypertrophy comprises the administration of oestrogens, gestagens, androgens and anti-androgens. Phytodrugs, which contain an extract of Sabal serrulatum or Pygeum Africana as active substance are without side effects and are, therefore, being used increasingly. 74 patients with irritable or obstructive bladder symptoms due to benign prostatic hypertrophy were treated with a phytodrug (Sabal serrulatum) or with testosterone throughout a period of three months. In group one (20 patients given phytodrugs and 10 patients given testosterone) clinical symptoms and measurements of residual urine, residual urine quotient, bladder capacity, micturition pressure and maximum urethral closure pressure were recorded at the beginning and at the end of therapy. In group two 28 patients were treated with the phytodrug in the first and third months with an intervening placebo trial lasting four weeks and 16 patients were given testosterone. Clinical symptoms and uroflow and residual urine only were charted in this group. None of the patients in either group showed an improvement in the urodynamic parameters of obstruction, but all patients felt a subjective alleviation of their symptoms. Flamm J, Kiesswetter H, English M. Wien Klin Wochenschr 91:622-627; 1979 Treatment of the obstructive symptomatology of prostatic adenoma using an extract of Serenoa repens: A double-blind clinical study vs. placebo Treatment of obstruction in prostatic adenoma using an extract of Serenoa repens. Double-blind clinical test v. placebo. After a brief pharmacological description of a hexane extract of Serenoa Repens, a product with a hormone-like action, a report is presented of its use in the treatment of 27 patients with Stage I and II prostatic adenomas aged 49-81.The drug was used in a double-blind test against a placebo on a homogeneous group of patients and effectively improved urinary symptoms and urine flowmeter graphs. In two cases the drug reduced the volume of the adenoma. Distinctly positive results were obtained in 42.9% of the cases treated with the active drug and in 15.4% of those given the placebo. Systemic tolerance as revealed by blood pressure, pulse rate, clinical examination and chemical tests were excellent. In one case only treatment was suspended when the patient complained of gastric problems. Tasca, A, et al. Min Urol e Nefrol 37:87-91; 1985 Medical treatment of the prostatic adenoma: A controlled test of PA 109 [Permixon: Serenoa repens extract] vs. placebo in 110 patients 110 patients presenting with a prostatic adenoma sufficiently symptomatic to be treated medically, but not requiring surgical management, were included in a controlled test whose effectiveness was assessed after one month on the basis of objective criteria (nocturia, urinary output, post micturitional residue) and subjective criteria (dysuria, patients' opinions). PA 109 appeared significantly more effective than a placebo, especially in the objective criteria (p< 10). Perfectly tolerated, clinically and biologically, this efficacy was again found in a supplementary study of forty seven patients, with a mean follow-up of 14.5 months, and over 2-1/2 years in some cases. Under the study conditions, and on the basis of the study criteria, PA 109 seems a good treatment for micturitional disorders associated with non-surgical adenomas of the prostate. G. Champault, A.M. Bonnard, J. Cauquil, J.C. Patel. Ann Urol 6:407-410; 1984. The effect of Permixon on androgen receptors Permixon, the liposterolic extract of the plant Serenoa Repens is a recently introduced drug for the treatment of benign prostatic hyperplasia. The effect of Permixon on dihydrotestosterone and testosterone binding by eleven different tissue specimens was tested. The drug reduced the mean uptake of both hormones by 40.9°h and 41.9% respectively in all tissue specimens. Since hirsutism and virilism are among other gynecological problems caused either by excessive androgen stimulation or excess end organ response, we suggest that Permixon could be a useful treatment in such conditions and recommend further investigations of the possible therapeutic values of the drug in gynecological practice. Magdy M, et al. Acta Obstet Gynecol Scand 67: 397-399; 1988. Evidence that Serenoa repens extract displays an antiestrogenic activity in prostatic tissue of benign prostatic hypertrophy patients A double-blind placebo controlled study was performed in 35 benign prostatic hypertrophy (BPH) patients never treated before. The patients were randomize into two groups, the 1st (18 cases) receiving Serenoa repens extract (160 mg. t.d.) for 3 months up to the day before the operation of transvesical adenomectomy and the 2nd (17 cases) receiving placebo. Steroid receptors were evaluated in the nuclear (n) and cytosolic (c) fraction using the saturation analysis technique (Scatchard analysis or single saturating dose assay) for androgen (AR) and estrogen (ER) receptors and the enzyme immunoassay (EIA) for ER and progesterone receptors (PgR). Scatchard analysis of ERc and ERn revealed the presence of two classes of binding sites, one with high-affinity low-capacity binding and the other with low-affinity high-capacity binding. In the untreated BPH group, ER were higher in the n than in the c fraction. Ern were positive in 14 cases and ERc in 12 of 17 cases. In the BPH group treated with S. repens extract on the contrary, ERn were negative for both binding classes in 17 cases and ERc in 6 of 18 cases. Using EIA, Ern and ERc were detected in all 15 samples examined, but in the treated group, ERn were significantly (p < 0.01) lower than in the untreated group, whilst ERc remained almost unchanged. Similar results were obtained measuring PgR; the n fraction of the treated group prostatic samples was significantly (p < 0.01) lower than that of the untreated group. Finally, the determination of AR showed that ARn were positive in 6 of 10 untreated cases and in only 1 of 10 treated cases, whilst ARc were almost the same in the two groups. In conclusion, these findings show that S. repens extract is able to inhibit the nuclear estrogen receptors in prostatic tissue samples of BPH patients. The results obtained with the Scatchard analysis or the single saturating-dose assay are confirmed by ER-EIA and by PgR-EIA representing a marker of the estrogenic activity. A possible explanation for these findings is that S. repens extract contains at least two fractions, one with antiandrogenic, the other with antiestrogenic effect, able to block the translocation of ERc to the nuclei by competition. It cannot be excluded, however, that the primary effect is antiestrogenic and that the inactivation of AR and PgR is secondary to ER blockade. DiSilverio F, et al. Eur Urol 21:309-314; 1992. Lack of effects of a liposterolic extract of Serenoa repens on plasma levels of testosterone, follicle-stimulating hormone, and luteinizing hormone Twenty men, aged 50 to 75 years (mean, 67 years), suffering from benign prostatic hypertrophy received 160 mg of a liposterolic extract of Serenoa repens, twice daily for 30 days. Before and at the end of treatment, plasma levels of testosterone, follicle-stimulating hormone, and luteinizing hormone were determined. No changes in plasma hormone levels occurred as a result of treatment. It is concluded that Serenoa extract, which is useful in the treatment of benign prostatic hypertrophy, does not act via systemic changes of hormone levels. Casarosa C, Cosci di Coscio M, Fratta M. Clin Ther 10:585-588; 1988. These statements have not been evaluated by the Food and Drug Administration. These products are not intended to diagnose, treat, cure or prevent any disease. |