Centchroman as First-line Treatment for Mastalgia: Results of an Open-label, Single-arm Trial

Abstract

Mastalgia is a distressing symptom and may be severe enough to interfere with usual daily activities. Breast pain is either cyclical or noncyclical. Currently; multiple options are available for the treatment of mastalgia including hormonal and nonhormonal agents. This study was conducted to evaluate the role of centchroman as a nonhormonal first-line treatment for moderate to severe mastalgia. To accomplish this; a prospective open-label, single-arm study was done using the Pretest-Posttest Design. A total of 100 women suffering from mastalgia were grouped according to the characteristic pattern of breast pain (cyclic and noncyclic) and received centchroman 30 mg/day for 12 weeks followed by observation for 12 weeks. The efficacy analysis of centchroman was done by comparing median Visual Analog Scale score, median pain duration and side effects over time among the two groups. Centchroman significantly alleviates mastalgia with minimal side effects. The median pain score was significantly reduced over successive visits (1, 4, 12, and 24 weeks). The median pain duration decreased remarkably over time in comparison to the baseline (p = 0.001). Overall the response rate was 88% at the end of 12 weeks and 85% at the end of 24 weeks. The drug was found more effective with a quicker response in cyclic pattern of matalgia. Complete response was observed in 66% of cyclic mastalgia and 40% of noncyclic mastalgia patients at 1 week of therapy. The response was improved over time in both groups and at completion of treatment (12 weeks) 92% patients in cyclic group and 80% patients in noncyclic group were pain free. The effect of the drug persisted till the completion (24 weeks) of the study (p = 0.001). These results imply that centchroman is very effective in treating breast pain and can be prescribed as drug of first choice for mastalgia.

Keywords: breast pain; centchroman; mastalgia.