Indian Journal of Surgery

, Volume 81, Issue 3, pp 271–276 | Cite as

Effective Regression of Mastalgia with Centchroman and Tamoxifen: a Randomised Comparison

  • Sarada Khadka
  • Shailesh Adhikary
  • Saroj Rajbanshi
  • Sudeep Khaniya
  • Chandra Shekhar Agrawal
  • Surya Niraula
  • Anurag SrivastavaEmail author
Original Article


Mastalgia is defined as pain in the breast for more than 1 week of menstrual cycle. A number of drugs have been recommended for its treatment. However, there is some debate among the experts about the most beneficial agent. In this study, we compared the effectiveness and cost-effectiveness of centchroman and tamoxifen in the treatment of mastalgia. We recruited 106 ladies with mastalgia in a two-arm parallel design open-labelled randomised controlled trial with a non-inferiority hypothesis comparing 3-month therapy with either centchroman or tamoxifen. The response of therapy was assessed by visual analogue scale (VAS) of 0–10, on 1-, 2-, 3-, and 6-month follow-up. Direct and indirect costs were computed for each patient. Baseline mean VAS score was 6.25 in tamoxifen and 6.49 in centchroman group. Women in both groups enjoyed significant pain relief (pain score became < 3). The number of patients who achieved VAS less than 3 were 51 (96.2%) in centchroman and 49 (92.5%) in tamoxifen group at the end of 3 months of treatment. Centchroman was found to be more effective than tamoxifen (p < 0.001). Cost per unit successful relief of mastalgia in the centchroman group was 393 Nepalese Rupees and that in the tamoxifen group was 311.5 Nepalese Rupees. Centchroman is not inferior to Tamoxifen in relieving mastalgia. Tamoxifen proved more cost-effective than centchroman because of lower cost of tamoxifen in Nepal.


Centchroman Tamoxifen Mastalgia Breast pain Randomised controlled trial Non-inferiority trial Cost-effectiveness 



Authors express gratitude to Dr. Narendra Pandit and Dr. Dhan Keshar Khadka for their help in conducting the study and preparing the manuscript.

Funding Support

B. P. Koirala Institute of Health Sciences, Nepal.

Compliance with Ethical Standards

The study was approved by Institute Ethics Committee.

Conflict of Interest

The authors declare that they have no conflict of interest.

Presented in Meeting



  1. 1.
    Dhar A, Srivastava A (2007) Role of centchroman in regression of mastalgia and fibroadenoma. World J Surg 31:1178–1184CrossRefGoogle Scholar
  2. 2.
    Hughes LE, Mansel RE, Webster DJ (1987) Aberrations of normal development and involution (ANDI): a new perspective on pathogenesis and nomenclature of benign breast disorders. Lancet 2:1316–1319CrossRefGoogle Scholar
  3. 3.
    Kataria K, Dhar A, Srivastava A, Kumar S, Goyal A (2014) A systematic review of current understanding and management of mastalgia. Indian J Surg 76(3):217–222. CrossRefGoogle Scholar
  4. 4.
    Parveen S, Sarwar G, Ali M et al (2007) Danazol versus oil of evening primrose in the treatment of mastalgia. Pak J Surg 23(1):10–13Google Scholar
  5. 5.
    Breast pain-cyclical. NICE CKS (internet). First line of treatment. September 2012 [cited 6 June 2014]. Available from: Http://!scenario recommendation
  6. 6.
    Bernardes JRM, Seixas MT, Lima GR (2003) The effect of tamoxifen on PCNA expression in fibroadenomas. Breast J 9:302–306CrossRefGoogle Scholar
  7. 7.
    GEMB Group (Grupo de Estudio de Mastopatias Benignas), Argentine (1997) Tamoxifen therapy for cyclical mastalgia: dose randomized trial. Breast 107(5):212–213Google Scholar
  8. 8.
    Fentiman IS, Caleffi M, Brame K, Chaudary MA, Hayward JL (1986) Double-blind controlled trial of tamoxifen therapy for mastalgia. Lancet 1(8476):287–288CrossRefGoogle Scholar
  9. 9.
    Sharma P, Sharma R, Yadav J, Yadav VK (2011) Centchroman a better alternative for hormonal oral contraceptives pills. Int J Pharm Bio Sci 2(1):587–598Google Scholar
  10. 10.
    Kumar S, Rai R, Agarwal GG, Dwivedi V, Kumar S, Das V (2013) A randomized, double-blind, placebo-controlled trial of ormeloxifene in breast pain and nodularity. Natl Med J India 26(2):69–74Google Scholar
  11. 11.
    Tejwani PL, Srivastava A, Nerkar H, Dhar A, Hari S, Thulkar S, Chumber S, Kumar S (2011) Centchroman regresses mastalgia: a randomized comparison with danazol. Indian J Surg 73(3):199–205CrossRefGoogle Scholar
  12. 12.
    Jain BK, Bansal A, Choudhary D, Garg PK, Mohanty D (2015) Centchroman vs tamoxifen for regression of mastalgia: a randomized controlled trial. Int J Surg 15:11–16CrossRefGoogle Scholar
  13. 13.
    Dhar D, Anand S, Sarkar D, Mukherjee SK, Paira SK, Mukherjee R (2018) A comparative study of centchroman vs tamoxifen in the management of mastalgia and fibroadenoma. Int J Sci Res 7(3):33–36Google Scholar
  14. 14.
    Rosolowich V, Saettler E, Szuck B, Lea RH, Weisberg F, Graham J, McLeod L, Rosolowich V (2006) SOGC Clinical Practice guidelines: mastalgia. J Obstet Gynaecol Can 28(1):49–60CrossRefGoogle Scholar

Copyright information

© Association of Surgeons of India 2018

Authors and Affiliations

  1. 1.Department of SurgeryB. P. Koirala Institute of Health SciencesDharanNepal
  2. 2.Department of Community Medicine and Public HealthB. P. Koirala Institute of Health SciencesDharanNepal
  3. 3.Department of Surgical DisciplinesAll India Institute of Medical SciencesNew DelhiIndia

Personalised recommendations