Effect of raloxifene on quality of life: a prospective study using the Utian Quality of Life (UQOL) Scale.
OBJECTIVE
The Utian Quality of Life Scale (UQOL) is a new questionnaire used to quantify patient perception of quality of life in postmenopausal women. The current study is the first to use the UQOL in ascertaining treatment effects on quality of life in postmenopausal women.


METHODS
This was a randomized, double-blind, placebo-controlled study of healthy postmenopausal women. Participants were randomized to raloxifene 60 mg/day or placebo. Participants completed the UQOL at baseline, at 3 months, and at the 6-month study endpoint.


RESULTS
A total of 74 women (mean age, 55.6 years) were randomized. In the overall population, there were no significant changes from baseline to 6 months within or between treatment groups in any of the domains or total score, although raloxifene was associated with positive changes from baseline in the occupational (P = 0.093) and health (P = 0.055) domains. In women who completed the study, raloxifene was associated with a significant improvement from baseline in the occupational (P = 0.041) and health (P = 0.025) domains and in the total score (P = 0.044), whereas placebo had no effect. There were no statistically significant differences between raloxifene and placebo in any of the domains or total score.


CONCLUSIONS
Although there were no treatment group differences, raloxifene was associated with an improvement from baseline in the occupational and health domains and in the overall score of the UQOL. Larger studies are needed using the UQOL as a primary endpoint to determine whether the positive effects of raloxifene on quality of life observed in this trial are real or a chance finding.
Utian
Wulf H
WH
Rapid Medical Research Inc., Cleveland, OH, USA. utian@menopause.org
Janata
Jeffrey W
JW
Barbier
Suzanne
S
Rosen
Amy S
AS
Mayer
Mark H
MH
Taylor
Maida B
MB
D000328:Adult; D000368:Aged; D003863:Depression / Q000188:drug therapy* / Q000473:pathology; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008593:Menopause / Q000523:psychology*; D008875:Middle Aged; D011446:Prospective Studies; D011788:Quality of Life; D020849:Raloxifene Hydrochloride / Q000627:therapeutic use*; D020845:Selective Estrogen Receptor Modulators / Q000627:therapeutic use*; D011795:Surveys and Questionnaires / Q000592:standards*; D016896:Treatment Outcome; D014481:United States
D020845:Selective Estrogen Receptor Modulators; D020849:Raloxifene Hydrochloride