Effective Regression of Mastalgia with Centchroman and Tamoxifen: a Randomised Comparison
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Mastalgia is defined as pain in the breast for more than 1 week of menstrual cycle. A number of drugs have been recommended for its treatment. However, there is some debate among the experts about the most beneficial agent. In this study, we compared the effectiveness and cost-effectiveness of centchroman and tamoxifen in the treatment of mastalgia. We recruited 106 ladies with mastalgia in a two-arm parallel design open-labelled randomised controlled trial with a non-inferiority hypothesis comparing 3-month therapy with either centchroman or tamoxifen. The response of therapy was assessed by visual analogue scale (VAS) of 0–10, on 1-, 2-, 3-, and 6-month follow-up. Direct and indirect costs were computed for each patient. Baseline mean VAS score was 6.25 in tamoxifen and 6.49 in centchroman group. Women in both groups enjoyed significant pain relief (pain score became < 3). The number of patients who achieved VAS less than 3 were 51 (96.2%) in centchroman and 49 (92.5%) in tamoxifen group at the end of 3 months of treatment. Centchroman was found to be more effective than tamoxifen (p < 0.001). Cost per unit successful relief of mastalgia in the centchroman group was 393 Nepalese Rupees and that in the tamoxifen group was 311.5 Nepalese Rupees. Centchroman is not inferior to Tamoxifen in relieving mastalgia. Tamoxifen proved more cost-effective than centchroman because of lower cost of tamoxifen in Nepal.
KeywordsCentchroman Tamoxifen Mastalgia Breast pain Randomised controlled trial Non-inferiority trial Cost-effectiveness
Authors express gratitude to Dr. Narendra Pandit and Dr. Dhan Keshar Khadka for their help in conducting the study and preparing the manuscript.
B. P. Koirala Institute of Health Sciences, Nepal.
Compliance with Ethical Standards
The study was approved by Institute Ethics Committee.
Conflict of Interest
The authors declare that they have no conflict of interest.
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