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To Evaluate the Efficacy and Safety of Mifepristone in Reducing the Size & Symptoms of Uterine Leiomyoma/Fibroids

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Abstract

Background and Study Objective

Uterine leiomyomas, or fibroids, are prevalent benign gynecological tumors affecting many women during their reproductive years. While surgical excision has long been the gold standard for fibroid treatment, the pharmacological management, including progesterone receptor modulators like mifepristone (RU 486), has garnered attention due to the reduced surgical approaches. However, there is a notable paucity of research on the effectiveness of mifepristone, on the same. This study seeks to evaluate the safety and efficacy of mifepristone in reducing uterine leiomyoma size and alleviating associated symptoms.

Methodology

Conducted prospectively, the study enrolled 20 pre-menopausal women, aged 18 years or older, from Nanavati Max Super Speciality Hospital Mumbai, Maharashtra, India. Participants were selected based on specific inclusion criteria, including the presence of at least one uterine myoma with a minimum diameter of 2.5 cm as confirmed by ultrasound. Participants had an average age of 39.75 years and an average BMI of 27.58 kg/m2.

Results

The study found that mifepristone significantly reduced uterine volume by 75%, with hemoglobin levels substantially improving from 9 gm/dL initially to 12.51 gm/dL after six months. Pain intensity, assessed using the Visual Analog Scale (VAS) score, gradually decreased from baseline to three-month, with all 20 patients reporting the complete absence of pelvic pain by six months.

Conclusion

This prospective study highlights mifepristone’s promise as a non-surgical approach to effectively reduce uterine fibroid volume, improve hemoglobin levels, and mitigate uterine blood loss in patients.

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Abbreviations

VAS:

Visual Analog Scale

BMI:

Body Mass Index

FDA:

Food and Drug Administration

GnRH:

Gonadotropin-Releasing Hormone

SPGRMs:

Selective Progesterone Receptor Modulators

References

  1. Adamson GD. Treatment of uterine fibroids current findings with gonadotrophin releasing hormone agonists. Am J Obstet Gynecol. 1992;166:746–51.

    Article  CAS  PubMed  Google Scholar 

  2. Prusty RK, Choithani C, Gupta SD. Predictors of hysterectomy among married women 15–49 years in India. Reprod Health. 2018;15(1):3.

    Article  PubMed  PubMed Central  Google Scholar 

  3. Carlson KJ, Nichols DH, Schiff I. Indications of hysterectomy. N Engl J Med. 1993;328:856–60.

    Article  CAS  PubMed  Google Scholar 

  4. Cardozo ER, Segars JH, Banks BJ, Henne MB, Stregman BJ. The estimated annual cost of uterine myoma in United Sates. Am J Obstet Gynecol. 2012;206(211):e1-9.

    Google Scholar 

  5. Delco V, la Marca A, Margante G. Short term treatment of uterine fibromyomas with danazol gynecol. Obstet Invest. 1999;47:258–62.

    Article  Google Scholar 

  6. Stovall TG, Summit RL Jr, Washburn SA, Ling FW. Gonadotropin releasing hormone agonist use before hysterectomy. Am J Obstet Gynecol. 1994;170:1744–51.

    Article  CAS  PubMed  Google Scholar 

  7. Salle B, Sergeant P, Awada A, Bied-Damon V, Gaucherand P, Boisson C, et al. Transvaginal ultrasound vascular and morphological changes in uteri exposed to diethylstilbestrol in utero. Hum Reprod. 1996;11:2531–6.

    Article  CAS  PubMed  Google Scholar 

  8. Eisinger SH, Bonfiglio T, Fiscella K, Meldrum S, Guzick DS. Twelve-month safety and efficacy of low dose mifepristone for uterine myomas. J Minim Invasive Gynecol. 2005;12:227–33.

    Article  PubMed  Google Scholar 

  9. Eisinger SH, Fiscella J, Bonfiglio T, Meldrum S, Fiscella K. Open-label study of ultra-low-dose mifepristone for the treatment of uterine leiomyomata. Eur J Obstet Gynecol Reprod Biol. 2009;146:215–8.

    Article  CAS  PubMed  Google Scholar 

  10. Bagaria M, Suneja A, Vaid NB, Gulaeria K, Mishra K. Low dose mifepristone in treatment of uterine myoma: a randomized double-blind placebo controlled clinical trial. Aust N Z J Obstet Gynaecol. 2009;49:77–83.

    Article  PubMed  Google Scholar 

  11. Murphy AA, Kettel LM, Morales AJ, Roberts VJ, Yen SSC. Regression of uterine leiomyomata in response to antiprogesterone RU 486. J Clin Endocrinol Metab. 1993;76:513–7.

    CAS  PubMed  Google Scholar 

  12. Kettel LM, Murphy AA, Morales AJ, Yen SS. Clinical efficacy of the antiprogesterone RU486 in the treatment of endometriosis and uterine fibroids. Hum Reprod. 1994;9:116–20.

    Article  PubMed  Google Scholar 

  13. Engman M, Granberg S, Williams AR, Meng CX, Lalitkumar PG, Gemzell DK. Mifepristone for treatment of uterine leiomyoma-A prospective randomized placebo cotrolled trial. Hum Reprod. 2009;24:1870–9.

    Article  CAS  PubMed  Google Scholar 

  14. Newfield RS, Spitz IM, Isacson C, New MI. Long-term mifepristone (RU486) therapy resulting in massive benign endometrial hyperplasia. Clin Endocrinol (Oxf). 2001;54:399–404.

    Article  CAS  PubMed  Google Scholar 

  15. Steinauer J, Pritts EA, Jackson R, Jacoby AF. Systematic review of mifepristone for the treatment of uterine leiomyomata. Obstet Gynecol. 2004;103:1331–6.

    Article  CAS  PubMed  Google Scholar 

  16. Carbonell Esteve JL, Riveron AM, Cano M, Ortiz AI, Valle A, Texido CS. Mifepristone 2.5 mg versus 5 mg daily in treatment of leiomyoma before surgery. Int J Women’s Health. 2012;4:75–84.

    Article  Google Scholar 

  17. Yang Y, Zhang S, Li K. Treatment of uterine leiomyoma by two different doses of mifepristone. Zhonghua Fu Chan Ke Za Zhi. 1996;31:624–6.

    CAS  PubMed  Google Scholar 

  18. Reinsch RC, Murphy AA, Morales AJ, Yen SSC. The effects of RU 486 and leuprolide acetate on uterine artery blood flow in the fibroid uterus. A prospective randomized study. Am J Obstet Gynecol. 1994;170:1623–8.

    Article  CAS  PubMed  Google Scholar 

  19. Eisinger SH, Meldrum S, Fiscella K, le Roux HD, Guzick DS. Low-dose mifepristone for uterine leiomyomata. Obstet Gynecol. 2003;101:243–50.

    CAS  PubMed  Google Scholar 

  20. Donnez J, Tatarchuk TF, Bouchard P, Puscasiu L, Zakharenko NF, Ivanova T, et al. PEARL I study group. Ulipristal acetate versus placebo for fibroid treatment before surgery. N Engl J Med. 2012;366:409–20.

    Article  CAS  PubMed  Google Scholar 

  21. Fiscella K, Eisinger SH, Meldrum S, Feng C, Fisher SG, Guzick DS. Effect of mifepristone for symptomatic leiomyomata on quality of life and uterine size: a randomized controlled trial. Obstet Gynecol. 2006;108:1381–7.

    Article  CAS  PubMed  Google Scholar 

  22. Heikinheimo O, Ranta S, Grunberg S, Lähteenmäki P, Spitz IM. Alterations in the pituitary-thyroid and pituitary-adrenal axes–consequences of long-term mifepristone treatment. Metabolism. 1997;46:292–6.

    Article  CAS  PubMed  Google Scholar 

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Authors and Affiliations

  1. Department of Gynaecology & Obstetrics, Nanavati Max Super Speciality Hospital, Mumbai, Maharashtra, India

    Suruchi Desai, Shreya Oswal & Chirag Patel

  2. Department of Radiology, Nanavati Max Super Speciality Hospital, Mumbai, Maharashtra, India

    Rashmi Parikh

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  1. Suruchi Desai
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  2. Shreya Oswal
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Correspondence to Suruchi Desai.

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Ethical Approval

This is an observational study. The study conduct was approved by an Institutional Ethics Committee.

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Dr Suruchi Desai is a Senior Consultant; Dr Shreya Oswal is a Junior Consultant; Dr Chirag Patel is a Junior Resident; Dr Rashmi Parikh is a Senior Consultant Radiologist.

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Desai, S., Oswal, S., Patel, C. et al. To Evaluate the Efficacy and Safety of Mifepristone in Reducing the Size & Symptoms of Uterine Leiomyoma/Fibroids. J Obstet Gynecol India 74, 250–255 (2024). https://doi.org/10.1007/s13224-023-01903-3

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  • DOI: https://doi.org/10.1007/s13224-023-01903-3

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