Effect of hormonal treatment on menopausal symptoms: experience from the
Estonian Postmenopausal Hormone Therapy Trial (EPHT)
[ISRCTN35338757]
Abstract
Objective First, to estimate the preventive and the curative effects of
postmenopausal hormone therapy (PHT) on menopausal symptoms, and
secondly to estimate the sensitivity of a woman to identify the exposure
to postmenopausal hormone therapy. Design Randomised and blinded trial
Setting Postmenopausal Hormone Therapy Trial in Estonia (EPHT),
1999-2002 Participants 593 women who responded to the relevant questions
both at the entry and one-year follow-up questionnaires in the blind
sub-trial Intervention HT or placebo at entry in women with or without
menopausal symptoms Results The participants were asked in the
questionnaires the presence of the menopausal symptoms of sweating, hot
flushes and sleeping disorders, and at one-year follow-up to identify
the exposure (HT or placebo). The net curative effect of HT (the
proportion of disappeared symptoms in symptomatic women in the HT arm
(46.4%) minus the same proportion in the placebo arm (25.8%) was
20.6%. The net preventive effect of HT (the proportion of incident
symptoms in asymptomatic women in the placebo arm, 44.4%, minus the
same proportion in the HT arm, 14.3%) was 30.1%. At one-year follow-up
34.6% of the women in the HT arm made a right guess on their arm. The
net sensitivity of guessing the HT (right guess on HT minus wrong guess
on placebo) was 15.8%. Conclusions The true HT effect on menopausal
symptoms was relatively small. The clinical practice may need to further
consider the benefit harm ratio of PHT [ISRCTN35338757].