Effect of mifepristone for symptomatic leiomyomata on quality of life and uterine size: a randomized controlled trial.

Abstract:

OBJECTIVE:To assess the effect of low-dose mifepristone on quality of life, pain, bleeding, and uterine size among women with symptomatic leiomyomata. METHODS:Forty-two women with symptomatic uterine leiomyomata and uterine volume of 160 mL or more were randomized to mifepristone, 5 mg daily, or placebo for 26 weeks. Quality of life (Uterine Fibroid Symptoms Quality of Life Questionnaire and Medical Outcomes Study 36-Item Short Form survey) and uterine and leiomyoma size (ultrasonography) were assessed at baseline, and at 1 month, 3 months, and 6 months of treatment. Bleeding (daily logs and pictorial charts) and pain (McGill Pain Questionnaire) were assessed monthly. Endometrial pathology was assessed at baseline and 6 months. RESULTS:Forty-two women were randomized; 37 women completed all 6 months. Women randomized to mifepristone showed an improvement in leiomyoma-specific quality of life. Forty-one percent became amenorrheic, rates of anemia improved, and adjusted uterine size was reduced by 47%. Compared with the placebo group, improvements in these outcomes in the treatment group were significantly greater (P<.05 to .001). There were no significant differences in adverse effects between the groups. No endometrial hyperplasia was noted in any participant. CONCLUSION:Low-dose mifepristone improves leiomyoma-specific quality of life and reduces leiomyoma size among women with symptomatic leiomyomata. CLINICAL TRIAL REGISTRATION:ClinicalTrials.gov www.clinicaltrials.gov NCT00133705 LEVEL OF EVIDENCE:I.

journal_name

Obstet Gynecol

authors

Fiscella K,Eisinger SH,Meldrum S,Feng C,Fisher SG,Guzick DS

doi

10.1097/01.AOG.0000243776.23391.7b

subject

Has Abstract

pub_date

2006-12-01 00:00:00

pages

1381-7

issue

6

eissn

0029-7844

issn

1873-233X

pii

108/6/1381

journal_volume

108

pub_type

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