Effects of Letrozole Compared with Danazol on Patients with Confirmed Endometriosis: A Randomized Clinical Trial

Mohamad Ali Roghaei, Hatav Ghasemi Tehrani, Aliakbar Taherian, Navid Koleini
In: International Journal of Fertility and Sterility, Vol 4, Iss 2, Pp 67-72 (2010) · 2010 · doi:10.22074/ijfs.2010.45826 · W1550362770
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Letrozole significantly reduced endometriosis symptoms including pelvic pain, dysmenorrhea, and dyspareunia compared to danazol and placebo in a randomized clinical trial.

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This randomized clinical trial compared letrozole (2.5 mg/day) versus danazol (600 mg/day) versus placebo in 105 patients with confirmed endometriosis, assessing pelvic pain, dysmenorrhea, and dyspareunia at baseline and monthly for six months. Participants received calcium and vitamin D in all groups, and outcomes were analyzed with SPSS using Friedman and Wilcoxon tests. The letrozole group had lower mean scores for chronic pelvic pain, dysmenorrhea, and dyspareunia than both the danazol and placebo groups. The paper does not report explicit limitations such as blinding or adherence measures, which is a caveat for interpreting the findings. This paper is centrally about endometriosis—specifically a randomized comparison of letrozole versus danazol for symptom relief in confirmed (recurrent) endometriosis.

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Abstract

Background Letrozole is an aromatase inhibitor which can decrease estrogen production in peripheral tissues and endometriosis. Danazol, 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 Danazol with Letrozole on endometriosis symptom relief. Materials and methods This study was a randomized clinical trial in which 105 patients with confirmed endometriosis were randomly assigned to one of three groups. Group 1 received Letrozole tablets (2.5 mg/day), calcium (1000 mg/day) and vitamin D (800 IU/day). Group 2 received Danazol tablets (600 mg/day), calcium (1000 mg/day) and vitamin D (800 IU/day). Group 3 (placebo group) were assigned to take two calcium tablets daily (500 mg/tablet) and vitamin D (800 IU/day). Pelvic pain, dysmenorrhea and dyspareunia were assessed in participants at baseline and monthly during the study for a total of six months. Data were analyzed via SPSS version 15 software with Freidman and Wilcoxon tests. Results Mean age in three groups has no significant difference. Of the 105 participants who were enrolled in this study, 38 patients were assigned to group 1 (Letrozole group), 37 patients in group 2 (Danazol group) and 31 patients were placed in group 3 (placebo group). This study showed that the mean scores for chronic pelvic pain, dysmenorrhea and dyspareunia for the Letrozole group were less than the Danazol and placebo groups. Conclusion This study showed that Letrozole can be more effective than Danazol for reducing chronic pelvic pain, dyspareunia and dysmenorrhea in patients suffering from recurrent endometriosis (Registeration Number: IRCT138812043414N1).
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International Journal of Fertility and Sterility (Jul 2010) Effects of Letrozole Compared with Danazol on Patients with Confirmed Endometriosis: A Randomized Clinical Trial Abstract Background Letrozole is an aromatase inhibitor which can decrease estrogen production in peripheral tissues and endometriosis. Danazol, 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 Danazol with Letrozole on endometriosis symptom relief. Materials and methods This study was a randomized clinical trial in which 105 patients with confirmed endometriosis were randomly assigned to one of three groups. Group 1 received Letrozole tablets (2.5 mg/day), calcium (1000 mg/day) and vitamin D (800 IU/day). Group 2 received Danazol tablets (600 mg/day), calcium (1000 mg/day) and vitamin D (800 IU/day). Group 3 (placebo group) were assigned to take two calcium tablets daily (500 mg/tablet) and vitamin D (800 IU/day). Pelvic pain, dysmenorrhea and dyspareunia were assessed in participants at baseline and monthly during the study for a total of six months. Data were analyzed via SPSS version 15 software with Freidman and Wilcoxon tests. Results Mean age in three groups has no significant difference. Of the 105 participants who were enrolled in this study, 38 patients were assigned to group 1 (Letrozole group), 37 patients in group 2 (Danazol group) and 31 patients were placed in group 3 (placebo group). This study showed that the mean scores for chronic pelvic pain, dysmenorrhea and dyspareunia for the Letrozole group were less than the Danazol and placebo groups. Conclusion This study showed that Letrozole can be more effective than Danazol for reducing chronic pelvic pain, dyspareunia and dysmenorrhea in patients suffering from recurrent endometriosis (Registeration Number: IRCT138812043414N1). Keywords

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Condition tags

endometriosischronic_pelvic_paindysmenorrheadyspareunia

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