Centchroman and tamoxifen in mastalgia: A randomized controlled trial

Mastalgia can be incapacitating for some individuals, necessitating medical intervention. Only a limited number of drugs have demonstrated effectiveness in managing the symptoms. An emerging option is oral centchroman, purported to be effective in this condition. Clinical trials are necessary to determine its role in the treatment of mastalgia.

An evaluator-blinded randomized controlled trial was conducted at a tertiary care teaching hospital to compare the efficacy of tamoxifen 10 mg and centchroman 30 mg daily. The study aimed to investigate the effect of treatment on the Visual Analog Scale (VAS) score of pain and the number of painful days per menstrual cycle or month. Following appropriate exclusion and randomization procedures, 51 patients completed the treatment and follow-up.

Centchroman was more effective in controlling pain in the first month (p =0.04). No significant difference in the VAS score of pain was observed at the third or sixth month. Both drugs were effective in reducing the number of painful days, with no statistically significant difference between them. The recurrence rate at the sixth month was also not different (P = 0.41). Overall, 32% of patients on centchroman and 38.4% of patients on tamoxifen either failed to achieve satisfactory pain relief or experienced recurrences.

Centchroman is a safe and effective substitute for tamoxifen, demonstrating superior early symptom control, albeit with a slightly increased occurrence of adverse effects. In the event that no symptomatic relief is observed within a one-month trial of either medication, discontinuation is recommended, as prolonged use is unlikely to yield additional relief. CTRI registration no.- CTRI/2021/01/030206.