Efficacy and safety of the extract ofSerenoa repens in the treatment of benign prostatic hyperplasia: therapeutic equivalence between twice and once daily dosage forms

Autor: K. Vanderkerckhove, J. Braeckman, J. Géczy, J. Bruhwyler
Rok vydání: 1997
Předmět:
Zdroj: Phytotherapy Research. 11:558-563
ISSN: 1099-1573
0951-418X
DOI: 10.1002/(sici)1099-1573(199712)11:8<558::aid-ptr158>3.0.co;2-u
Popis: The efficacy and safety of two dosage forms (160 mg b.i.d. and 320 mg o.d.) of the extract of Serenoa repens were compared during a 1-year treatment in 132 patients suffering from benign prostatic hyperplasia (BPH). Both dosage forms induced a significant improvement in the efficacy variables: international prostate symptom score (60% after 1 year), quality of life score (85% of patients were satisfied after 1 year of treatment), prostatic volume (12% after 1 year), maximum flow rate (22% after 1 year), mean flow rate (17% after 1 year) and residual urinary volume (16% after 1 year). No significant differences were found between the two dosage forms. The percentage of patients or investigators evaluating that the treatment had a medium or bad tolerance was never superior to 4%. Nineteen side effects were observed in 16 patients (12.1%), 8 patients in each group. The majority of these side effects (at least 75%) were related to the natural evolution of the disease itself rather than to the medication. We conclude that the extract of Serenoa repens in its two dosage forms is a safe and effective treatment for the mictional problems associated with BPH. Consequently, it appears to offer a potential pharmacologic alternative capable of improving BPH symptoms in patients with mild-to-moderate disease. © 1997 John Wiley & Sons, Ltd.
Databáze: OpenAIRE
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