RESUMO
OBJECTIVE: To compare the effect of a Serenoa repens extract with placebo for symptoms of benign prostatic hyperplasia (BPH). PATIENTS AND METHODS: In a double-blind placebo-controlled randomized trial between January 1999 and March 2000, 100 men with symptoms of BPH, aged < 80 years, with a maximum urinary flow rate of 5-15 mL/s for a voiding volume of 150 mL, were randomly and equally allocated to 320 mg S. repens extract or placebo (paraffin oil). The main outcome measures were the International Prostate Symptom Score (IPSS), peak urinary flow rate, and the Rosen International Index of Erectile Function (IIEF) questionnaire. RESULTS: There was no significant difference between the treatments over the 12 weeks of the study in the IPSS, peak urinary flow rate or for the IIEF questionnaire. CONCLUSIONS: During the trial all participants had some improvement in their symptoms of BPH but there was no significant beneficial effect of this S. repens extract over placebo in this 12-week trial.
Assuntos
Antagonistas de Androgênios/uso terapêutico , Fitoterapia/métodos , Extratos Vegetais/uso terapêutico , Hiperplasia Prostática/tratamento farmacológico , Retenção Urinária/tratamento farmacológico , Método Duplo-Cego , Disfunção Erétil/induzido quimicamente , Humanos , Masculino , Pessoa de Meia-Idade , Hiperplasia Prostática/fisiopatologia , Serenoa , Resultado do Tratamento , Micção/fisiologiaRESUMO
OBJECTIVES: Bacillus Calmette-Guérin (BCG) and interferon alpha-2b (IFN alpha 2b) have been used individually for the treatment of bladder cancer. We used a low dose of BCG combined with IFN alpha 2b to determine the safety and to assess the efficacy of this combination therapy. METHODS: A study of 12 patients with superficial bladder cancer evaluated the safety and efficacy of a combination of low-dose BCG and IFN alpha 2b, given weekly for 6 weeks. Three patients were assigned to each of four groups in which 60 mg of BCG was combined with 10, 30, 60, or 100 x 10(6) IU of IFN alpha 2b. RESULTS: The combination BCG/IFN alpha 2b therapy was well tolerated, with adverse effects being mild to moderate and resolved at the end of treatment. At 12 months post-treatment there has been no tumor progression. Two patients with previous multifocal transitional cell carcinoma have had solitary recurrences. One patient has had recurrent carcinoma in situ. CONCLUSIONS: This preliminary study found combination BCG/IFN alpha 2b induction therapy to be safe and well tolerated. These early results show a high response rate, but efficacy can only be determined with Phase II and III studies.
