Effects of transdermal estradiol gel and oral tibolone on health-related quality of life after surgical menopause

Objective: To study the effects of 6 months of treatment with transdermal estradiol gel versus oral tibolone on health-related quality of life (HRQOL) after surgical menopause. Methods: In a randomized single-blind trial, Indian women received either oral tibolone tablets (2.5 mg) or transdermal estradiol gel (0.06%) daily. Each woman scored herself on the Menopause Rating Scale (MRS) II at the beginning of the study and after 6 months. Independent t tests were used to determine the significance of changes in HRQOL. Results: In total, 31 (81.6%) women who received estradiol gel and 38 (100.0%) women who received tibolone completed treatment. Intent-to-treat analysis showed that, after 6 months of treatment, the total MRS score was significantly reduced in the tibolone group compared with the transdermal estradiol gel group (-9.5 +/- 5.1 versus -4.9 +/- 5.7: 95% confidence interval, 2.0-7.0: P<0.01). Significant improvements were also noted in the tibolone group in terms of somatovegetative (P=0.04) and psychologic (P<0.01) domains. Conclusion: Oral tibolone treatment was more effective than transdermal estradiol gel at improving HRQOL in Indian women with surgical menopause. (C) 2010 International Federation of Gynecology and Obstetrics. Published by Elsevier Ireland Ltd. All rights reserved.