Improved quality of life is partly explained by fewer symptoms after treatment of fibroids with mifepristone.
OBJECTIVE
To examine mediators of mifepristone treatment on improvements in health-related quality of life (HRQOL) among women with symptomatic fibroids.


METHODS
The study sample included women with symptomatic uterine fibroids who were treated with 5mg or 2.5mg of mifepristone or placebo. Assessments of uterine size (ultrasound), pain (McGill pain questionnaire), bleeding (diary), anemia (gm/dL), and HRQOL measured using the uterine fibroid symptom quality of life scale were done at baseline, 3 months, and 6 months. The improvements in HRQOL that could be explained by changes in these clinical factors were assessed.


RESULTS
The final sample included 62 women. Treatment with mifepristone was associated with significant improvement in HRQOL, which was explained in part by reduction in pain (28%, P<0.001) and bleeding (18%, P<0.001). Reduction in uterine volume was of marginal significance (P=0.05) and was associated with a decrease in HRQOL (7%). Much of the impact of treatment on HRQOL (61%) remained unexplained in this model.


CONCLUSIONS
Improvements in HRQOL after treatment with mifepristone are partly explained by improvements in pain and bleeding, but not uterine size. However, most of the improvement in HRQOL is not explained by improvements in these clinical parameters.
Department Biostatistics and Computational Biology, School of Medicine and Dentistry, University of Rochester, New York, USA.
Changyong
C
Feng
Sean
S
Meldrum
Kevin
K
Fiscella
D000328:Adult; D000740:Anemia / Q000188:drug therapy; D005260:Female; D006727:Hormone Antagonists / Q000008:administration & dosage / Q000627:therapeutic use*; D006801:Humans; D007889:Leiomyoma / Q000188:drug therapy*; D008875:Middle Aged; D015735:Mifepristone / Q000008:administration & dosage / Q000627:therapeutic use*; D009929:Organ Size / Q000187:drug effects; D010146:Pain / Q000188:drug therapy; D011788:Quality of Life; D016032:Randomized Controlled Trials as Topic; D014463:Ultrasonography; D014594:Uterine Neoplasms / Q000188:drug therapy*; D014599:Uterus / Q000000981:diagnostic imaging / Q000187:drug effects / Q000503:physiopathology
D006727:Hormone Antagonists; D015735:Mifepristone