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: CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov www.clinicaltrials.gov NCT00133705 LEVEL OF EVIDENCE: I.
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Authors | Kevin Fiscella, Steven H Eisinger, Sean Meldrum, Changyong Feng, Susan G Fisher, David S Guzick |
Journal | Obstetrics and gynecology
(Obstet Gynecol)
Vol. 108
Issue 6
Pg. 1381-7
(Dec 2006)
ISSN: 0029-7844 [Print] United States |
PMID | 17138770
(Publication Type: Journal Article, Randomized Controlled Trial, Research Support, N.I.H., Extramural)
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Chemical References |
- Hormone Antagonists
- Mifepristone
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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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