Centchroman vs tamoxifen for regression of mastalgia: a randomized controlled trial.

INTRODUCTION: Several agents have been tried in the management of mastalgia. Centchroman (Ormeloxifene), a novel non-steroidal selective estrogen receptor modulator (SERM), has also been recently used in the management of mastalgia.

METHODS: Eligible patients, who had mastalgia for more than 3 months, were randomized into two groups - Group A received centchroman 30 mg daily and Group B received tamoxifen 10 mg daily. Treatment was continued for a total of 12 weeks; thereafter, patients were followed for another 12 weeks without medication to assess the continuum of relief. Pain severity was measured with VAS score. Patients were considered to have complete pain relief if their VAS score decreased to 3 or less.

RESULTS: Patients, in both the groups, showed gradual improvement in mastalgia with passage of time up to 12 weeks. Following cessation of treatment at 12 weeks, partial relapse of pain was observed at 24 weeks. There was no significant difference between Group A and Group B in terms of mean VAS Score and proportion of women reporting pain relief at 4, 8, 12, and 24 weeks. Fifteen patients in Group A had side effects namely dizziness, menstrual irregularities and development of ovarian cysts. There was no side effect noted in group B.

CONCLUSION: Centchroman and tamoxifen were found to be of similar effectiveness in providing pain relief in mastalgia. High frequency of side effects, particularly development of ovarian cyst, in patients receiving centchroman is a matter of concern.