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Randomized Controlled Trial
. 2008 Mar 26:8:5.
doi: 10.1186/1472-6874-8-5.

Symptom reporting and quality of life in the Estonian Postmenopausal Hormone Therapy Trial

Affiliations
Randomized Controlled Trial

Symptom reporting and quality of life in the Estonian Postmenopausal Hormone Therapy Trial

Piret Veerus et al. BMC Womens Health. .

Abstract

Background: The aim of the study was to determine the effect of postmenopausal hormone therapy on women's symptom reporting and quality of life in a randomized trial.

Methods: 1823 women participated in the Estonian Postmenopausal Hormone Therapy (EPHT) Trial between 1999 and 2004. Women were randomized to open-label continuous combined hormone therapy or no treatment, or to blind hormone therapy or placebo. The average follow-up period was 3.6 years. Prevalence of symptoms and quality of life according to EQ-5D were assessed by annually mailed questionnaires.

Results: In the hormone therapy arms, less women reported hot flushes (OR 0.20; 95% CI: 0.14-0.28), sweating (OR 0.56; 95% CI: 0.44-0.72), and sleeping problems (OR 0.66; 95% CI: 0.52-0.84), but more women reported episodes of vaginal bleeding (OR 19.65; 95% CI: 12.15-31.79). There was no difference between the trial arms in the prevalence of other symptoms over time. Quality of life did not depend on hormone therapy use.

Conclusion: Postmenopausal hormone therapy decreased vasomotor symptoms and sleeping problems, but increased episodes of vaginal bleeding, and had no effect on quality of life.

Trial registration number: ISRCTN35338757.

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Figures

Figure 1
Figure 1
Flow chart of the EPHT Trial.
Figure 2
Figure 2
Prevalence of hot flushes in different trial arms in the EPHT Trial over time.
Figure 3
Figure 3
Prevalence of sweating in different trial arms in the EPHT Trial over time.
Figure 4
Figure 4
Prevalence of sleeping problems in different trial arms in the EPHT Trial over time.

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