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

AbstractOBJECTIVE:
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.
AuthorsKevin Fiscella, Steven H Eisinger, Sean Meldrum, Changyong Feng, Susan G Fisher, David S Guzick
JournalObstetrics and gynecology (Obstet Gynecol) Vol. 108 Issue 6 Pg. 1381-7 (Dec 2006) ISSN: 0029-7844 [Print] United States
PMID17138770 (Publication Type: Journal Article, Randomized Controlled Trial, Research Support, N.I.H., Extramural)
Chemical References
  • Hormone Antagonists
  • Mifepristone
Topics
  • Adult
  • Female
  • Hormone Antagonists (administration & dosage, therapeutic use)
  • Humans
  • Leiomyomatosis (diagnostic imaging, drug therapy, physiopathology)
  • Middle Aged
  • Mifepristone (administration & dosage, therapeutic use)
  • Organ Size
  • Pain
  • Quality of Life
  • Treatment Outcome
  • Ultrasonography
  • Uterine Neoplasms (diagnostic imaging, drug therapy, physiopathology)
  • Uterus (diagnostic imaging, pathology)

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