Centchroman regresses mastalgia: a randomized comparison with danazol

Indian J Surg. 2011 Jun;73(3):199-205. doi: 10.1007/s12262-010-0216-z. Epub 2010 Nov 30.

Abstract

We conducted a randomized trial to evaluate effectiveness of Centchroman in control of mastalgia and compared it with Danazol. Research Question- Is proportion of pain relief achieved by Centchroman similar to or inferior to that achieved by Danazol? In a randomized controlled trial of Centchroman vs. Danazol in mastalgia, 81 patients with mastalgia were studied. Thirty-nine patients were randomized to Danazol arm and 42 in Centchroman arm. The treatment was given for 12 weeks, followed by observation for 12 weeks. The pain was measured by visual analogue scale (VAS) of 0-10. At 12 weeks 89.7% women achieved reduction in pain score to ≤3 in Centchroman group (pvalue 0.001). In Danazol group 69.44% women achieved reduction in pain score to ≤ 3 (p = 0.001). Three months after stopping therapy, Centchroman was more effective in pain score reduction at 24 weeks as compared to Danazol (p = 0.019). Centchroman is an effective, safe and inexpensive alternative to Danazol for treatment of mastalgia.

Electronic supplementary material: The online version of this article (doi:10.1007/s12262-010-0216-z) contains supplementary material, which is available to authorized users.

Keywords: Antiestrogen; Breast pain; Centchroman; Danazol; Mastalgia; Non-inferiority trial; Randomized trial.