Trial reportThe Indian journal of medical research2013
Low dose mifepristone in medical management of uterine leiomyoma - an experience from a tertiary care hospital from north India.
Trial report in The Indian journal of medical research, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03210324 (Mifepristone Tablets in the Treatment of Symptomatic Uterine Fibroids With Safety and Efficacy in Open, Multicenter Phase IV Clinical Studies), which is not on this map. Cited by 13 papers, 1 of them a synthesis that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Mifepristone Tablets in the Treatment of Symptomatic Uterine Fibroids With Safety and Efficacy in Open, Multicenter Phase IV Clinical Studies
Who cites it
13 citing papers in PubMed, 1 synthesis or guideline pooled it, 33 citations in OpenAlex.
- Selective progesterone receptor modulators (SPRMs) for uterine fibroids.The Cochrane database of systematic reviews · 2017Pooled it
- Effect of paracetamol, dexketoprofen trometamol, lidocaine spray, pethidine & diclofenac sodium application for pain relief during fractional curettage: A randomized controlled trial.The Indian journal of medical research · 2015Trial
- Endometrial Changes Associated with Mifepristone: A Review.International journal of general medicine · 2025Review
- Review
- Evidence-Based Management of Uterine Fibroids With Botanical Drugs-A Review.Frontiers in pharmacology · 2022Review
- A prospective interventional study to evaluate the effects of medical therapy (Mifepristone 25 mg) on the management of uterine fibroids.Journal of family medicine and primary care · 2020Article
- Uterine fibroids: an update on current and emerging medical treatment options.Therapeutics and clinical risk management · 2019Review
- Current medical treatment of uterine fibroids.Obstetrics & gynecology science · 2018Review
- A randomized control trial to assess efficacy of Mifepristone in medical management of uterine fibroid.Medical journal, Armed Forces India · 2017Article
- Efficacy of Use of Long-Term, Low-Dose Mifepristone for the Treatment of Fibroids.Journal of obstetrics and gynaecology of India · 2016Article
- Mifepristone Therapy in Symptomatic Leiomyomata Using a Variable Dose Pattern with a Favourable Outcome.Journal of mid-life healthArticle
- Epidemiological and genetic clues for molecular mechanisms involved in uterine leiomyoma development and growth.Human reproduction updateReview
- Mifepristone in Fibroids: Comparative Study of Safety and Efficacy of Biweekly Dosage Vs Daily Dosage Schedule.Journal of mid-life healthArticle
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
7 authors at 2 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
BACKGROUND &
objectivesUterine myoma is a common indication for hysterectomy in India. An effective medical treatment option may reduce hysterectomy associated morbidity. This study was undertaken to evaluate efficacy and safety of low dose mifepristone in medical management of myoma and to compare two doses - 10 vs. 25 mg/day.
methodsIn this randomized clinical trial, women with symptomatic myoma or myoma>5 cm were included. Uterine size >20 wk, fibroids >15 cm were excluded. Pictorial blood loss assessment chart (PBAC) score was used to assess menstrual-blood-loss and visual analog scale (VAS) for other symptoms. Haemogram, liver function test, ultrasound with doppler and endometrial histology was performed. Patients were randomized and were given oral mifepristone as 25 mg/day in group 1 and 10 mg/day in group 2 for 3 months. Patients were followed at 1, 3 and 6 months.
resultsSeventy patients in group 1 and 73 in group 2 completed treatment. Mean PBAC score reduced from 253 to 19.8 and from 289.2 to 10.4 at 1 and 3 months in groups 1 and 2, respectively. At 3 months, 67 of 70 (95.7%) patients of group 1 and 66 of 73 (90.4%) of group 2 developed amenorrhoea which reverted after median 34 (range 4-85) days. Mean myoma volume decreased by 35.7 per cent (from 176.8 to 113.7 cm 3 ) and 22.5 per cent (from 147.6 to 114.4 cm 3 ) at 3 months in groups 1 and 2, respectively. Side effects seen were leg cramps in 7 of 70 (10%) and 5 of 73 (6.8%) and hot-flushes in 5 of 70 (7.1%) and 5 of 73 (6.8%) in groups 1 and 2, respectively. Repeat endometrial-histopathology did not reveal any complex hyperplasia or atypia in either group. INTERPRETATION &
conclusionsMifepristone (10 and 25 mg) caused symptomatic relief with more than 90 per cent reduction in menstrual blood. Greater myoma size reduction occured with 25 mg dose. Amenorrhoea was developed in 90-95 per cent patients which was reversible. It can be a reasonable choice for management of uterine leiomyoma as it is administered orally, cost-effective and has mild side effects.
Indexed as
Identifiers
23852296PMC3734720W1888084970What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.