Effectiveness of Low Dose Mifepristone in Medical Management of Fibroids
Kanika Kumari, Himanshi Goel, Ayushi Hada
Keywords :
Fibroids, Fibroid volume, Heavy menstrual bleeding, Leiomyoma, Medical management of fibroids, Mifepristone, Selective progesterone receptor modulators
Citation Information :
Kumari K, Goel H, Hada A. Effectiveness of Low Dose Mifepristone in Medical Management of Fibroids. J South Asian Feder Obs Gynae 2024; 16 (2):98-102.
Introduction: Uterine fibroids can adversely affect the quality of life of women of reproductive age. Symptomatic fibroids are managed medically or surgically. Medical treatment of fibroids includes selective progesterone receptor modulators (SPRM) like ulipristal and mifepristone and GnRH analogs, which reduce bleeding and inhibit the growth of Leiomyoma. At present, ulipristal and GnRH analogs are available in India for medical management which are expensive and associated with side effects which precludes their long use. Mifepristone is used as an off-label indication in medical management of fibroid. This study was conducted using 5 mg dose to see efficacy in reducing blood loss in symptomatic fibroids and associated side effects.
Materials and methods: A single arm interventional clinical trial was conducted at a tertiary Government Hospital in New Delhi enrolling 70 women aged 14–49 years, having fibroids causing heavy menstrual bleeding (AUB-L). Uterine size >14 weeks, suspected or confirmed uterine malignancy and those with severe medical disease were excluded. Study participants were given 5 mg oral mifepristone daily for 3 months. The primary outcome studied was reduction in uterine bleeding measured by pictorial blood loss assessment chart (PBAC) at 1, 3, and 6 months. Reduction in fibroid size, uterine volume, and endometrial thickness was measured by ultrasonography at 3 months. Side effects were noted and at 6 months of enrollment PBAC was further assessed for any residual effect.
Results: A total of 49 (70%) and 55 (78.5%) women were found to be amenorrheic after 1 and 3 months of starting mifepristone, respectively. After 3 months, there was a statistically significant improvement of 21.6% in hemoglobin (p < 0.0001). There was statistically significant reduction in fibroid and uterus volume (p = 0.005 and 0.046, respectively). No significant change in endometrial thickness was noted. The side effects reported were minor.
Conclusion: Low-dose mifepristone can be considered as an effective, safe, and cheap alternative for medical management of myoma-related abnormal uterine bleeding as well as for preoperative correction of anemia.
Stewart EA, Cookson CL, Gandolfo RA, et al. Epidemiology of uterine fibroids: A systematic review. Int J Obstet Gynaecol 2017;124(10): 1501–1512. DOI: 10.1111/1471-0528.14640.
Rezk A, Kahn J, Singh M. Fertility Sparing Management in Uterine Fibroids. [Updated 2023 Apr 14]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2023. Available from: https://www.ncbi.nlm.nih.gov/books/NBK574504/.
Wagenfeld A, Saunders PT, Whitaker L, et al. Selective progesterone receptor modulators (SPRMs): Progesterone receptor action, mode of action on the endometrium and treatment options in gynaecological therapies. Expert Opin Ther Targets 2016;20(9):1045–1054. DOI: 10.1080/14728222.2016.1180368.
Kulshreshtha V, Kriplani A, Agarwal N, et al. Low dose mifepristone in medical management of uterine leiomyoma – An experience from a tertiary care hospital from North India. Indian J Med Res 2013;137(6):1154–1162. PMID: 23852296.
Lamba S, Singh A, Roy P, et al. Mifepristone in fibroids: An alternative! J South Asian Feder Obst Gynae 2018;10(1):29–32. DOI: 10.5005/jp-journals-10006-1553.
Jayashree V, Mallika A, Roopa K. Mifepristone for medical management of leiomyomata uteri: A prospective study. Int J Clin Obstet Gynaecol 2020;4(6):72–76. DOI: https://doi.org/10.33545/gynae.2020.v4.i6b.734.
Zhang D, Sun P, Zhao T. Effect of mifepristone in the treatment of uterine leiomyoma. Int J Front Med 2021;3(2):5–8. DOI: 10.25236/IJFM.2021.030202.
Reddy AS, Saranya G. Efficacy of low dose mifepristone in the treatment of symptomatic uterine fibroids. J Med Sci Clin Res 2020;8(7):480–483. DOI: https://dx.doi.org/10.18535/jmscr/v8i7.76.
Shen Q, Zou S, Sheng B, et al. Mifepristone inhibits IGF-1 signalling pathway in the treatment of uterine leiomyomas. Drug Des Devel Ther 2019;13:3161–3170. DOI: 10.2147/DDDT.S212157.
Singh M, Chourasia A, Singh S, et al. Comparison of ormeloxifen and mifepristone in management of leiomyoma uterus. Indian J Obstet Gynecol Res 2019;6(2):202–207. DOI: https://doi.org/10.18231/j.ijogr.2019.046.
Saxena R, Goyal R, Jain R. Effects of low dose oral mifepristone on uterine fibroids. Indian Obstetr Gynaecol 2019;9(4):38–42. Available from: https://iog.org.in/index.php/iog/article/view/495.
LiverTox: Clinical and Research Information on Drug-Induced Liver Injury [Internet]. Bethesda (MD): National Institute of Diabetes and Digestive and Kidney Diseases; 2012. Gonadotropin Releasing Hormone (GnRH) Analogues. [Updated 2018 Mar 20]. PMID: 31643176.9817071107.
Donnez J, Arriagada P, Marciniak M, et al. Liver safety parameters of ulipristal acetate for the treatment of uterine fibroids: A comprehensive review of the clinical development program. Expert Opin Drug Saf 2018;17(12):1225–1232. DOI: 10.1080/14740338.2018.1550070.
Sohn GS, Cho S, Kim YM, et al. Working Group of Society of Uterine Leiomyoma. Current medical treatment of uterine fibroids. Obstet Gynecol Sci 2018;61(2):192–201. DOI: 10.5468/ogs.2018.61.2.192.
Ali M, Sara AR, Al Hendy A. Elagolix in the treatment of heavy menstrual bleeding associated with uterine fibroids in premenopausal women. Expert Rev Clin Pharmacol 2021;14(4):427–437. DOI: 10.1080/17512433.2021.1900726.
Uimari O, Subramaniam KS, Vollenhoven B, et al. Uterine fibroids (Leiomyomata) and heavy menstrual bleeding. Front Reprod Health 2022;4:818243. DOI: 10.3389/frph.2022.818243.
Hartmann KE, Fonnesbeck C, Surawicz T, et al. Management of uterine fibroids [Internet]. Rockville (MD): Agency for Healthcare Research and Quality (US); 2017 Dec. Report No.: 17(18)-EHC028-EF. PMID: 30789683.