Abstract
Objectives: Centchroman (also known as Ormeloxifene) is one of the selective estrogen receptor modulators, or SERMs, a class of medication which acts selectively on the estrogen receptor. Because of its selective antiestrogen action, centchroman has been used for treatment of mastalgia and fibroadenoma.
Materials And Methods: Benign breast disease patients up to 35 years of age attending surgery outpatient department from August 2012 to September 2014 and fulfilling inclusion criterion were included in the study. The patients were started on centchroman 30 mg on daily for a period of 12 weeks and were followed at weeks 4, 8, 12, and 24 to assess response to therapy. The Results were recorded as per clinical examination, ultrasonography for breast lump size and visual analog scale (VAS) for pain.
Results: A total of 130 patients were included in the study, 88 (67.70%) of whom had mastalgia with or without nodularity, and 42 (32.30%) had fibroadenoma. Noncyclical pain was in 71 patients (80.70%), and cyclical pain was recorded in only 17 (19.30%) patients. A VAS score of 10 was recorded by 62 (70.50%) patients (severe pain), and the remaining 26 patients (29.50%) had VAS score from 7 to 10. Fibroadenoma size ranged from 1.5 to 5 cm, single or multiple in one or both breast. There was a good response in the mastalgia group, with a decrease in the VAS scoring from 10 to 3 in 69 (78.40%) of the patients in the first week. Almost all of the patients were painless at the end of first month, with complete disappearance of the nodularity. In the fibroadenoma group there was a mixed response, with complete disappearance in 21 (35%), partial regression (decrease in volume of fibroadenoma) in 29 (48.30%) and no response at all in the remaining 10 (16.70%) a period of 6 months. There were few side effects with scanty menses or amenorrhea as the only side effect.
Conclusions: Centchroman is a safe drug for the treatment of mastalgia and fibroadenoma. It has shown good results in mastalgia and fibroadenoma, is an effective, safe and inexpensive.
Key Words: Fibroadenoma, Centchroman, Saheli.
References
1. Preece PE, Mansel RE, Bolton PM, Hughes LE, Baum M, Gravelle IH. Clinical syndromes of mastalgia.Lancet. 1976;2:670–3. doi: 10.1016/S0140-6736(76)92477-6.
2. Potten CS, Watson RJ, Williams GT, et al. The effect of age and menstrual cycle upon proliferative activity of the normal human breast. Br J Cancer. 1988;58:163–70. doi: 10.1038/bjc.1988.185.
3. Hughes LE, Mansel RE, Webster DJT. Problems of concept and nomenclature of benign breast disease. Benign disorders and diseases of the breast. 2. London: Saunders; 2000. p.15.
4. Barros AC, Mottola J, Ruiz CA. Reassurance in the treatment of mastalgia. Breast J. 1999;5:162. doi: 10.1046/j.1524-4741.1999.98089.x.
5. Minton JP, Foeking MK, Webster DJT, et al. Response of fibrocystic disease to caffeine withdrawal and correlation with cystic nucleotides with breast disease. Am J Obstet Gynecol. 1979;135:157.
6. Hadi MS. Sports Brassiere; Is it a solution for mastalgia? Breast J. 2000;6:407. doi: 10.1046/j.1524-4741.2000.20018.x.
7. Goyal A, Mansel RE. A randomized multicenter study of gamolenic acid with and without, antioxidants, vitamins and minerals in the management of mastalgia. Breast J. 2005;11:41–47. doi: 10.1111/j.1075-122X.2005.21492.x.
8. Srivastava A, Mansel RE, Arvind N, Prasad K, Dhar A, Chabra A. Evidence based management of Mastalgia: a meta-analysis of randomized trials. Breast. 2007;16:503–12. doi: 10.1016/j.breast.2007.03.003.
9. Hughes LE, Mansel RE, Webster DJT. Problems of concept and nomenclature of benign breast disease. Benign Disorders and Diseases of the Breast. 2. London: Saunders; 2000. p. 108.
10. Mansel RE, Preece PE, Huges LE. A double blind trial of prolactin inhibitor bromocriptine in painful benign breast disease. Br J Surg. 1978;65:724–727. doi: 10.1002/bjs.1800651015.
11. Messinis LE, Lolis D. Treatment of Premenstrual Mastalgia with Tamoxifen. Acta Obstet Gynecol Scand. 1988;67:307–309.
12. Fentiman IS, Caleffi M, Brame K, Chaudary MA, Hayward JL. Double-blind controlled trial of tamoxifen therapy for mastalgia. Lancet. 1986;1(8476):287–8. doi: 10.1016/S0140-6736(86)90825-1.
13. Kontostolis E, Stefanidis K, Navrozoglou I, Lolis D. Comparison of Tamoxifen with Danazol for treatment of cyclical mastalgia. Gynecol Endocrinol. 1997;11:393–397. doi: 10.3109/09513599709152566.
14. Singh MM, Centchroman A selective estrogen receptor modulator, as a contraceptive and for the management of hormone-related clinical disorder. Med Res Rev. 2001;21(4):302–347. doi: 10.1002/med.1011.
15. Kamboj VP, Setty BS, Chandra H, Roy SK, Kar AB. Biological profile of Centchroman—a new post-coital contraceptive. Indian J Exp Biol. 1977;15:1144–1150.
16. Vaidya R, Joshi U, Meherji P, Rege N, Betrabet S, Joshi L, Sheth A, Devi PK. Centchroman in healthy female volunteers. Indian J Exp Biol. 1977;15:1173–1176.
17. Multicentric trial with biweekly cum weekly dose. Lucknow: Central Drug Research Institute; 1991.
18. Lal J. Clinical pharmacokinetics and interaction of Centchroman- a mini review. Contraception. 2010.
19. Gumm R, Cunnick GH, Mokbel K. Evidence for the management of mastalgia. Curr Med Res Opin 20(5):681-684, Review, 2004.
DOI: http://dx.doi.org/10.18535/jmscr/v4i7.25
