A Randomized Control Study to Compare the Efficacy of Centchroman with Danazol in Control of Mastalgia in Fibrocystic Diseases of Breast

Abstract

Kelam Lavanya*, Sumit Shukla, Ankur Maheshwari, Avinash Goutam and Sarvagya Jain

Background: Mastalgia is the most common presenting symptom alongside lump and nodularity. There are several treatments in practice for treatment of mastalgia including the use of topical diclofenac ointment, oral linoleic acid (Mecgla), Vitamin E and topical evening primrose oil application. Danazol, an androgenic compound, has proved to be efficacious in the treatment of mastalgia, albeit with a range of side effects. Centchroman (or Ormiloxifene), sold under the trade name of Saheli, Chhaya and Sevista is a Selective Estrogen Receptor Modulator (SERM) has shown to be efficacious in treatment of mastalgia along with having fewer and milder side effects. This study aims at comparing the efficacy of Centchroman with that of Danazol in treatment of mastalgia due to fibrocystic diseases of breast and to assess the sustained response and recurrence of mastalgia in patients receiving Centchroman.

Materials and methods: All cases of fibrocystic breast diseases with mastalgia presenting to OPD at Department of Surgery, M.G.M Medical College and M.Y Hospital, Indore. This prospective randomized control study which was carried out on 60 patients, in which 30 patients were given Centchroman and rest 30 patients were given Danazol for mastalgia in Department of General Surgery M.Y. Hospital, Indore, M.P. Patient outcome was recorded using VAS Record analysis.

Discussion: In our study 60 patients complaining of Mastalgia were divided into two groups and one group was treated with Oral Centchroman while the other group was given Oral Danazol, the final results were as such-the tolerability of Centchroman was 100% whereas that of Danazol was only 90%. The reduction in mean VAS score for pain in patients of Centchroman group was significantly greater than reduction of mean VAS score in the Danazol group. The sustained response to therapy was better in the Danazol group. The difference in incidence of side effects is not significant between the two groups.

Conclusion: In our Randomized control study, we come to the conclusion that Centchroman is more efficacious than Danazol in treatment of mastalgia in fibrocystic diseases of breast, with better tolerability, fewer side effects and comparable long term sustained response and recurrence rates. Therefore it can be used as an alternative medication in treatment of mastalgia.