Evaluation of Effects of Letrozole Compare to Danazole in Patients Confirmed Endometriosis: A Randomized Clinical Trial

In: مجله دانشکده پزشکی اصفهان, Vol 28, Iss 109 (2010) · 2010 · W2231789319
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Letrozole demonstrated greater effectiveness than danazole and placebo in alleviating chronic pelvic pain, dysmenorrhea, and dyspareunia in endometriosis patients over a six-month period.

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This randomized clinical trial enrolled 105 patients with endometriosis confirmed by laparoscopy and compared letrozole (2.5 mg/day) plus calcium and vitamin D versus danazole (600 mg/day) plus the same supplements, with a calcium/vitamin D placebo group. Over six months, pelvic pain, dysmenorrhea, and dyspareunia were assessed at baseline and monthly, and results were analyzed using SPSS with Friedman and Wilcoxon tests. Letrozole showed lower mean scores for chronic pelvic pain, dysmenorrhea, and dyspareunia than both danazole and placebo, with a significant improvement in dysmenorrhea by month 5 versus month 1 in the letrozole group. A key limitation explicitly reflected in the design is the relatively short six-month follow-up. This paper is centrally about endometriosis — it directly tests letrozole versus danazole for symptom relief in laparoscopically confirmed endometriosis.

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Abstract

Background: Letrozole is an aromatase inhibitor which can decrease estrogen production in peripheral tissues and endometriosis. Danazole, as an androgen, inhibits estrogen production in ovaries and recently has been introduced as an aromatase inhibitor; this study was designed to compare the effects of danazole with letrozole to relieve symptoms of endometriosis. Methods: In this randomized clinical trial study, 105 patients confirmed endometriosis by laparoscopy. These patients were randomly assigned to three groups: group 1 received letrozole tablet (2.5 mg/day), calcium (1000 mg/day) and vitamin D (800 IU/day), group 2 received danazole tablet (600 mg/day), calcium (1000 mg/day) and vitamin D (800 IU/day) and group 3 (placebo group) received calcium (1000 mg/day) and vitamin D (800 IU/day). Pelvic pain, dysmenorrhea and dyspareunia were assessed in participants before study and monthly during the study for six months. Data were analyzed via SPSS15 software with Freidman and Wilcoxon tests. Findings: Mean age was not statistically different in three groups. Totally, 105 participants were enrolled in this study; 38 patients in letrozole group, 37 patients in danazole group and 31 patients in placebo group. In letrozol group, the mean of chronic pelvic pain, dysmenorrhea and dyspareunia score were less than danazole and placebo groups. The Wilcoxon test showed significant difference between mean of dysmenorrhea score at the 5th month after treatment compare to the 1st month in letrozol group (P = 0.025). Conclusion: This study showed that letrozole is more effective than danazole in relief chronic pelvic pain, dyspareunia and dysmenorrhea. Keywords: Letrozole, Danazole, Endometriosis, Laparoscopy.
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مجله دانشکده پزشکی اصفهان (Nov 2010) Evaluation of Effects of Letrozole Compare to Danazole in Patients Confirmed Endometriosis: A Randomized Clinical Trial Abstract Background: Letrozole is an aromatase inhibitor which can decrease estrogen production in peripheral tissues and endometriosis. Danazole, as an androgen, inhibits estrogen production in ovaries and recently has been introduced as an aromatase inhibitor; this study was designed to compare the effects of danazole with letrozole to relieve symptoms of endometriosis. Methods: In this randomized clinical trial study, 105 patients confirmed endometriosis by laparoscopy. These patients were randomly assigned to three groups: group 1 received letrozole tablet (2.5 mg/day), calcium (1000 mg/day) and vitamin D (800 IU/day), group 2 received danazole tablet (600 mg/day), calcium (1000 mg/day) and vitamin D (800 IU/day) and group 3 (placebo group) received calcium (1000 mg/day) and vitamin D (800 IU/day). Pelvic pain, dysmenorrhea and dyspareunia were assessed in participants before study and monthly during the study for six months. Data were analyzed via SPSS15 software with Freidman and Wilcoxon tests. Findings: Mean age was not statistically different in three groups. Totally, 105 participants were enrolled in this study; 38 patients in letrozole group, 37 patients in danazole group and 31 patients in placebo group. In letrozol group, the mean of chronic pelvic pain, dysmenorrhea and dyspareunia score were less than danazole and placebo groups. The Wilcoxon test showed significant difference between mean of dysmenorrhea score at the 5th month after treatment compare to the 1st month in letrozol group (P = 0.025). Conclusion: This study showed that letrozole is more effective than danazole in relief chronic pelvic pain, dyspareunia and dysmenorrhea. Keywords: Letrozole, Danazole, Endometriosis, Laparoscopy.

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endometriosischronic_pelvic_paindysmenorrheadyspareunia

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