A randomized control trial to assess efficacy of Mifepristone in medical management of uterine fibroid

Arora, Devendra; Chawla, Jaya; Kochar, Swati; Sharma, JB

doi:10.1016/j.mjafi.2017.02.013

Cited by 15 publications

(18 citation statements)

References 14 publications

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“…Recently, different administration schedules were evaluated in two Indian trials, using weekly or biweekly doses of 50 mg claiming good results 126,127. Using the vaginal route for the administration of 10 mg daily of MFP, treatment significantly reduced the volume of fibroids 128…”

Section: Selective Progesterone Receptor Modulators (Sprms)mentioning

confidence: 99%

<p>Uterine fibroids: an update on current and emerging medical treatment options</p>

Farris

Bastianelli

Rosato

et al. 2019

TCRM

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Uterine fibroids are the most common gynecological disorder, classically requiring surgery when symptomatic. Although attempts at finding a nonsurgical cure date back to centuries, it is only around the middle of the last century that serious attempts at a medical treatment were carried out. Initially, both progestins and estrogen–progestin combinations have been utilized, although proof of their usefulness is lacking. A major step forward was achieved when peptide analogs of the GnRH were introduced, first those with superagonist properties and subsequently those acting as antagonists. Initially, the latter produced side effects preventing their routine utilization; eventually, this problem was overcome following the synthesis of cetrorelix. Because both types of analogs produce hypoestrogenism, their use is limited to a maximum of 6 months and, for this reason, today they are utilized as an adjuvant treatment before surgery with overall good results. Over the last decade, new, nonpeptidic, orally active GnRH-receptor blockers have also been synthesized. One of them, Elagolix, is in the early stages of testing in women with fibroids. Another fundamental development has been the utilization of the so-called selective progesterone receptor modulators, sometimes referred to as “antiprogestins”. The first such compound to be applied to the long-term treatment of fibroids was Mifepristone; today, this compound is mostly used outside of Western Countries, where the substance of choice is Ulipristal acetate. Large clinical trials have proven the effectiveness of Ulipristal in the long-term medical therapy of fibroids, although some caution must be exercised because of the rare occurrence of liver complications. All selective progesterone receptor modulators produce unique endometrial changes that are today considered benign, reversible, and without negative consequences. In conclusion, long-term medical treatment of fibroids seems possible today, especially in premenopausal women.

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Section: Selective Progesterone Receptor Modulators (Sprms)mentioning

confidence: 99%

<p>Uterine fibroids: an update on current and emerging medical treatment options</p>

Farris

Bastianelli

Rosato

et al. 2019

TCRM

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“…9 One more study conducted by Arora et al it was found that all patients became amenorrhic at the end of treatment, resulting in a PBAC score of "zero". 10 This concluded that mifepristone is an effective choice of treatment for fibroid and related symptoms in perimenopausal age group and in patients who want to avoid surgical treatment.…”

Section: Discussionmentioning

confidence: 95%

Study the effect of mifepristone on clinical symptoms and its side effects in patients with fibroid uterus

Seher¹,

Chauhan²,

Mangla³

2018

Int J Reprod Contracept Obstet Gynecol

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Background: Fibroid can lead to a variety of clinical symptoms including pain, menorrhagia, and lump in abdomen. The availability of a safe and efficient medical management options for symptomatic fibroid is of considerable clinical and public health importance. The present study is designed to see the safety and efficacy of mifepristone in the medical management of uterine fibroids. Methods: The study was conducted in the Department of Obstetrics and Gynaecology, Himalayan Institute of Medical Sciences, Swami Ram Nagar, Dehradun over a period of 12 months. A total of 40 patients were included in the study. Results: Amount of bleeding was assessed by PBAC score, which significantly reduced by 83.9% at the end of treatment. And 62% patients developed amenorrhoea due to mifepristone. Similarly, pain abdomen/dysmenorrhoea was assessed by Numeric Pain Rating Scale, which also showed a significant reduction in 55% patients with no pain at the end of 3 months. Conclusions:The study clearly shows that Mifepristone is a safe and effective option to manage fibroid uterus and its associated symptoms.

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“…A study conducted by Arora CD et al, it was seen that with mifepristone all patients without exception had amenorrhea bringing the PBAC score to 'zero'. 17 In one more study conducted by Shradha et al, patients out of 50 became amenorrhea, and there is no patient with menorrhagia at the end of treatment. 18 Therefore, Mifepristone is a reasonable choice of treatment in perimenopausal age group and patients who want to avoid surgery.…”

Section: Discussionmentioning

confidence: 97%

Role of selective progesterone receptor modulators in the treatment of symptomatic uterine fibroids

Naresh

Mani

Yadav

et al. 2020

Int J Reprod Contracept Obstet Gynecol

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Background: Uterine leiomyomas are benign tumours of smooth muscle cells and fibrous tissue that develop within the wall of the uterus. Objective of this study was to compare efficacy and safety of Mifepristone and Ulipristal acetate in the treatment of symptomatic uterine fibroids.Methods: The present randomized comparative prospective study was conducted among 120 non-pregnant and non-lactating females of age 25-50 years with symptomatic fibroids reported in the department of obstetrics and gynecology, Chhatrapati Shivaji Subharti Hospital, Meerut, Uttar Pradesh for a duration of 2 years from September 2017 to July 2019.The selected subjects were divided into two treatment arms i.e. Group 1: ulipristal acetate: 5 mg OD for 3 months and Group 2: mifepristone: 25 mg OD for 3 months. Detailed history of the patient, general physical examination and systemic examination was done followed by per abdomen examination, per speculum and per vaginal examination. A blood examination, USG (pelvis), Pap smear and endometrial biopsy was done. Subjects visited the hospital at visit 1, visit 2, visit 3, visit 4, visit 5 and visit 6 for 6 months.Results: In both the groups, maximum subjects were in the age group of 36-40 years, followed by 41-50 years. When mean PBAC score at first, second, third, fourth and fifth visit was compared statistically among ulipristal acetate and mifepristone group, it was found to be statistically significant. Uterine pain was reduced more in mifepristone group as compared to ulipristal acetate group at all the different intervals. Size was reduced more in mifepristone group as compared to ulipristal acetate group at all the different intervals.Conclusions: Authors conclude from this study that mifepristone should be preferred over ulipristal acetate for treatment of symptomatic fibroids.

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A randomized control trial to assess efficacy of Mifepristone in medical management of uterine fibroid

Abstract: Mifepristone when given in bi-weekly doses was found to be safe, efficacious, and cost effective as compared to treatment with tranexemic acid and mefenemic acid for management of fibroid uterus.

Cited by 15 publications

References 14 publications

<p>Uterine fibroids: an update on current and emerging medical treatment options</p>

<p>Uterine fibroids: an update on current and emerging medical treatment options</p>

Study the effect of mifepristone on clinical symptoms and its side effects in patients with fibroid uterus

Role of selective progesterone receptor modulators in the treatment of symptomatic uterine fibroids

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