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

Piret Veerus,Krista Fischer,Elina Hemminki,Helle Karro,Mati Rahu,Sirpa-Liisa Hovi

doi:10.1186/1472-6874-8-5

Abstract

BackgroundThe 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.Methods1823 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.ResultsIn 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.ConclusionPostmenopausal hormone therapy decreased vasomotor symptoms and sleeping problems, but increased episodes of vaginal bleeding, and had no effect on quality of life.Trial registration numberISRCTN35338757

Highlights

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
There were no baseline differences in the prevalence of symptoms in different arms except for sweating, which was reported more often by women in the hormone therapy arm (50%) than in the non-treatment arm (44%) of the non-blind sub-trial (Table 2)
Longitudinal data analysis showed that throughout the trial, less women reported hot flushes, sweating and sleeping problems in hormone therapy arms than in non-therapy arms

Summary

Introduction

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. The effect of menopausal transition on women's lives is complex and includes changes in physical health, psychosomatic domains, and personal life [1]. Health-related quality of life may be severely compromised in women with vasomotor symptoms [2]. Up to 40% of women in Sweden experience vasomotor symptoms until the age of 64 years [3]. Hormone therapy may have side effects such as vaginal bleeding, breast tenderness, migraine headaches, mood alterations, and abdominal bloating that may affect quality of life [8].

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