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

Abstract

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.