Sleep, vigilance and cognition in postmenopausal women: placebo-controlled studies with 2 mg estradiol valerate, with and without 3 mg dienogest.

OBJECTIVE: To determine the effects in postmenopausal women with insomnia of hormone replacement therapy (HRT) with 2 mg estradiol valerate (E2V) alone, or in combination with 3 mg dienogest (DNG), in the context of the introduction of the novel preparation Climodien (2 mg E2V/2 mg DNG) (Schering AG, Berlin, Germany).
METHODS: Parallel groups of women with insomnia related to the postmenopausal syndrome were randomized to 2 months' treatment with 2 mg E2V, 2 mg E2V/3 mg DNG or placebo (respectively, n = 17, 16, 16). Patients were then studied with techniques for assessing sleep quality, vigilance and cognition. Sleep quality was determined subjectively by means of the questionnaire-based sleep and awakening quality scale (SSA), and objectively with polysomnography. Sleep-related breathing disorders were evaluated by means of the apnea/hypopnea index. Vigilance was measured using quantitative electroencephalography with statistical probability mapping. Cognition (speed of information processing, cognition processing capacity and perceptual processing resources) was studied using the techniques of auditory event-related potentials (P300 latency and amplitude). RESULTS AND
CONCLUSIONS: Treatment with 2 mg E2V and 2 mg E2V/3 mg DNG significantly improved subjective sleep quality and showed trends towards improvements in objective sleep quality. The combination of 2 mg E2V/3 mg DNG also improved the apnea/hypopnea index. Vigilance was slightly improved by treatment with 2 mg E2V and markedly with 2 mg E2V/3 mg DNG. Speed of information processing was improved with 2 mg EV2 and 2 mg E2V/3 mg DNG, whilst the latter also improved cognitive processing capacity and perceptual processing resources. The study provides evidence that HRT can improve sleep quality and mental functioning in postmenopausal women and that E2V/DNG combinations, such as 2 mg E2V/2 mg DNG, should be considered for this indication and also for the treatment of sleep-related breathing disorders in the menopause. The addition of dienogest to estradiol valerate did not antagonize the benefits of estradiol valerate in terms of sleep quality but rather potentiated estradiol valerate-related improvements in vigilance and some aspects of cognition.

RCT Entities:   Population Interventions Outcomes