Low‐dose mifepristone in treatment of uterine leiomyoma: A randomised double‐blind placebo‐controlled clinical trial

Bagaria, Madhu; Suneja, Amita; Vaid, Neelam; Guleria, Kiran; Mishra, Kiran

doi:10.1111/j.1479-828x.2008.00931.x

Cited by 89 publications

(101 citation statements)

References 19 publications

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“…This ties in, moreover, with what happens to the surgical specimens in the study carried out by Bagaria et al [1], obtaining as it does an extremely high percentage of hyperplasias 12/19 (63.1%) at the end of treatment with 10 mg mifepristone which disappear completely when some time after termination of treatment these subjects undergo surgery and a histological sample is taken. In other words, the PAECs disappear in our study and in the Bagaria et al study the simple or without atypical complex hyperplasias when mifepristone treatment is discontinued [11].…”

Section: Discussionmentioning

confidence: 62%

Report on Repeated Mifepristone Treatment for Uterine Fibroids or Endometriosis

Estève¹

2013

J Clin Gynecol Obstet

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Section: Discussionmentioning

confidence: 62%

Report on Repeated Mifepristone Treatment for Uterine Fibroids or Endometriosis

Estève¹

2013

J Clin Gynecol Obstet

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“…Several clinical trials have been done since then with doses varying from 2.5 to 100 mg for 3-12 months [4]. Studies have found that a dose of 2.5 mg is not effective in reducing the myoma volume, but a dose as low as 5 mg per day and maximum as high as 50 mg per day was found effective [4,5]. In the present observational prospective ''before-after'' study, 50 mg mifepristone given once a week was used for 6 months.…”

Section: Discussionmentioning

confidence: 99%

Efficacy of Use of Long-Term, Low-Dose Mifepristone for the Treatment of Fibroids

Kapur

Angomchanu²,

Dey

2016

J Obstet Gynecol India

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Background Fibroid or myoma is the commonest reported tumor of uterus, and is one of the important reasons for hysterectomy in our setting. Different drugs are available for medical management of fibroid uterus including mifepristone, a progesterone antagonist. Varying dosage regimen for mifepristone was studied as medical management of fibroid uterus. The aim of the project was to study the effect of mifepristone on the symptoms and size of fibroids, especially using a low-dose regimen for 6 months. In addition, any symptomatic improvement of menorrhagia and dysmenorrhea was also studied. Methods The study was designed as an observational prospective ''before-after'' study. Women diagnosed with uterine fibroids attending OPD of a tertiary care hospital were selected according to the inclusion criteria. A total of 36 patients were enrolled in the study. Sample size was calculated to study changes in various parameters after 6 months treatment with mifepristone 50 mg once a week. Baseline investigations were performed and menstrual blood loss was assessed using pictorial blood assessment charts. Fifty milligrams of mifepristone weekly was used, and patient assessed at 1 and 6 month. They were also further followed up till 3 months after stopping the drug to 123 observe the changes in menstrual pattern, fibroid volume, hemoglobin and liver function tests. Baseline endometrial biopsy and another at 6 month on cessation of drug therapy were done for all patients.Results Majority of the study population comprised of perimenopausal women, i.e., 41-45 years (44 %). Fifty percent of the patients were Para 2 and belonged to the perimenopausal age-group (18 out of 36). The dominant presenting symptom was menorrhagia associated with dysmenorrhea and pelvic pain. After 6 months of treatment with mifepristone, the mean fibroid volume reduced from 204.33 to 113.16 cm 3 (n = 33); p B 0.001, and the percentage mean volume reduction of the fibroid in the study population was 44.57 % (range 1.10-100 %). Immediate reduction in bleeding PV was observed in 100 %, and 88.89 % (32/36) patients attained amenorrhea. The mean hemoglobin increased from 9.18 to 10.82 g/dl (p = 0.001).There was a transient rise in mean transaminases (AST/ ALT) levels at 6 months which reverted to normal at 9 months follow-up.Conclusion To conclude, 6 months therapy with 50 mg of mifepristone given weekly is efficacious and acceptable for the treatment of symptomatic leiomyoma, especially in a select group of patients. Although its use as a primary medical therapy is limited due to recurrence of fibroid after stopping treatment, it is useful for perimenopausal women whose myoma would regress after menopause, and younger infertile patients with small-size deep intramural myomas not easily accessible to either hysteroscopic or laparoscopic surgery. It is also beneficial as a preoperative adjunct, in patients with preoperative severe anemia and large fibroids where surgery is technically difficult. Mode of surgery can be changed to a lessinvasive vagina...

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“…Les données issues des autres études randomisées ayant comparé la mifépristone au placebo confirment ces constatations [79][80][81]. Bagaria et al rapportent eux aussi une augmentation du risque d'hyperplasie endométriale mais toujours sans atypie [80].…”

Section: Antagonistes Et Modulateurs Du Récepteur à La Progestéroneunclassified

Place des traitements médicaux : indication, durée, efficacité, chez la femme porteuse de fibromes utérins symptomatiques en période d’activité génitale

Koskas

Chabbert-Buffet

Douvier

et al. 2011

Journal de Gynécologie Obstétrique et Biologie de la Reproducti

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Low‐dose mifepristone in treatment of uterine leiomyoma: A randomised double‐blind placebo‐controlled clinical trial

Abstract: Ten milligrams mifepristone for three months is effective in reducing MBL, increasing haemoglobin and reducing uterine and leiomyoma volume with side-effect of endometrial hyperplasia.

Cited by 89 publications

References 19 publications

Report on Repeated Mifepristone Treatment for Uterine Fibroids or Endometriosis

Report on Repeated Mifepristone Treatment for Uterine Fibroids or Endometriosis

Efficacy of Use of Long-Term, Low-Dose Mifepristone for the Treatment of Fibroids

Place des traitements médicaux : indication, durée, efficacité, chez la femme porteuse de fibromes utérins symptomatiques en période d’activité génitale

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