PURPOSE: We evaluated the effects of oral tamoxifen and placebo in patients with Peyronie's disease. MATERIALS AND METHODS: We selected 25 patients with Peyronie's disease who did not have calcified plaque for treatment in the andrology outpatient clinic. A medical history was obtained, and physical examination, penile x-ray, penile ultrasound and pharmacologically induced erection with prostaglandin E1 were performed. Patients were randomly divided into group 1--those who received 20 mg. tamoxifen twice daily for 3 months and group 2--those who received placebo for the same period. The same evaluations were done 4 months later and results were compared. Qualitative (chi-square test) and quantitative (Student's t test) results were analyzed using the Yates correction factor with p <0.05 considered significant. RESULTS:Pain subsided in 66.6 and 75% of the patients treated with tamoxifen and placebo, respectively (p >0.05). In groups 1 and 2 a reduction in the penile deformity was noticed by 46.1 and 41.7% of the patients (p >0.05), and a decrease in plaque size was noticed by 30.7 and 25%, respectively. On the other hand, objective measurements did not reveal any difference in plaque area or curvature angle. CONCLUSIONS: This study did not show significant improvement in pain, curvature or plaque size in patients with Peyronie's disease who were treated withtamoxifen compared with those treated with placebo.
RCT Entities:
PURPOSE: We evaluated the effects of oral tamoxifen and placebo in patients with Peyronie's disease. MATERIALS AND METHODS: We selected 25 patients with Peyronie's disease who did not have calcified plaque for treatment in the andrology outpatient clinic. A medical history was obtained, and physical examination, penile x-ray, penile ultrasound and pharmacologically induced erection with prostaglandin E1 were performed. Patients were randomly divided into group 1--those who received 20 mg. tamoxifen twice daily for 3 months and group 2--those who received placebo for the same period. The same evaluations were done 4 months later and results were compared. Qualitative (chi-square test) and quantitative (Student's t test) results were analyzed using the Yates correction factor with p <0.05 considered significant. RESULTS:Pain subsided in 66.6 and 75% of the patients treated with tamoxifen and placebo, respectively (p >0.05). In groups 1 and 2 a reduction in the penile deformity was noticed by 46.1 and 41.7% of the patients (p >0.05), and a decrease in plaque size was noticed by 30.7 and 25%, respectively. On the other hand, objective measurements did not reveal any difference in plaque area or curvature angle. CONCLUSIONS: This study did not show significant improvement in pain, curvature or plaque size in patients with Peyronie's disease who were treated with tamoxifen compared with those treated with placebo.