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Sleep problems after short-term hormone therapy suspension: secondary analysis of a randomized trial.

ABSTRACT: Because hormone therapy use benefits sleep, sleep problems may occur after suspension. We tested the effects of short-term hormone therapy suspension on sleep problems.A total of 1,704 women aged 45 to 80 years at Group Health were randomized to suspend hormone therapy for 1 or 2 months or to continue using hormone therapy. This study included 1,405 women willing to suspend hormone therapy use who returned both baseline and follow-up questionnaires, administered within approximately 3 months of randomization. We used generalized linear models to examine the relationships between hormone therapy suspension and nine individual items from a modified General Sleep Disturbance Scale (number of days experienced in the past week) and an overall sleep quality index at follow-up. We tested whether age, hormone therapy type, or duration of use modified these relationships.Suspension of hormone therapy for 1 or 2 months was associated with greater frequency of sleep problems for the overall sleep quality index and most individual sleep items. For example, the incident rate ratios for waking too early (95% CI) were 1.23 (1.10-1.38) for the women in the 1-month suspension group and 1.30 (1.17-1.45) for the 2-month suspension group, compared with women who continued the use of hormone therapy. Age and type of and duration of hormone therapy use did not modify these relationships.Short-term hormone therapy suspension was related to moderately greater frequency of sleep problems. Alternative forms of sleep management may benefit women who choose to discontinue hormone therapy use.

SUBMITTER: Tom SE

PROVIDER: S-EPMC3203993 | biostudies-literature | 2011 Nov

REPOSITORIES: biostudies-literature

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Sleep problems after short-term hormone therapy suspension: secondary analysis of a randomized trial.

Tom Sarah E SE Anderson Melissa L ML Landis Carol A CA Bowles Erin J Aiello EJ Woods Nancy F NF Reed Susan D SD Newton Katherine M KM Buist Diana S M DS

Menopause (New York, N.Y.) 20111101 11

<h4>Objective</h4>Because hormone therapy use benefits sleep, sleep problems may occur after suspension. We tested the effects of short-term hormone therapy suspension on sleep problems.<h4>Methods</h4>A total of 1,704 women aged 45 to 80 years at Group Health were randomized to suspend hormone therapy for 1 or 2 months or to continue using hormone therapy. This study included 1,405 women willing to suspend hormone therapy use who returned both baseline and follow-up questionnaires, administered ...[more]

PMID: 21785373

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Project description:BackgroundWithout population-based evidence, some clinicians recommend short-term suspension of hormone therapy to improve the performance of mammography. Hormone therapy increases breast density, and abnormal screening mammograms are more common among women with denser breasts and among women using hormone therapy.ObjectiveTo test whether 1 to 2 months of hormone therapy suspension before screening mammography decreases additional mammographic imaging (recall) in women age 45 to 80 years.Design3-group randomized, controlled trial.SettingIntegrated health plan in western Washington from 2004 to 2007.Patients1704 women age 45 to 80 years who used hormone therapy at their most recent screening (index) mammography, were due for screening (study) mammography, and were still using hormone therapy.InterventionBlock random assignment (by breast density and hormone therapy type) to no hormone therapy suspension (n = 567) or suspension for 1 month (n = 570) or 2 months (n = 567) before study mammography. One blinded expert radiologist interpreted all mammograms.MeasurementsRecall was the primary outcome, and change in mammographic breast density (percentage and dense area) between the index and study mammograms was the secondary outcome.ResultsMammography recall rates were 11.3% (61 of 542 women in the no-suspension group), 12.3% (50 of 478 women in the 1-month suspension group), and 9.8% (44 of 451 women in the 2-month suspension group). No subgroups were identified in which brief suspension of hormone therapy resulted in decreased mammography recall. With suspension, decreases in percentage of breast density were orderly and statistically significant: 0.1% (no-suspension group), -0.9% (1-month suspension group), and -1.5% (2-month suspension group). Similar ordered decreases were observed for dense area. Women in the suspension groups experienced increased menopause symptoms.LimitationsResults can only be generalized to women age 45 to 80 years who have used hormone therapy for at least 1 year and will consider short-term suspension; most eligible women (61%) declined participation. Mammography recall was determined by 1 expert radiologist.ConclusionBrief hormone therapy suspension was associated with small changes in breast density and did not affect recall rates. No evidence supports short-term hormone therapy suspension before mammography.

Project description:IntroductionBorderline personality disorder (BPD) is a severe and prevalent psychiatric disorder. Mentalization-based therapy (MBT) is an evidence-based intervention for BPD, and several countries offer treatment programs for BPD lasting for years, which is resource demanding. No previous trial has compared short-term with long-term MBT.ObjectiveThe aim of the study was to assess the efficacy and safety of short-term versus long-term MBT for outpatients with BPD.MethodsAdult outpatients (≥18 years) with subthreshold or diagnosed BPD were randomly assigned (1:1) to short-term MBT (5 months) or long-term MBT (14 months). The primary outcome was BPD symptoms assessed with the Zanarini Rating Scale for Borderline Personality Disorder. Secondary outcomes were functional impairment, quality of life, global functioning, and severe self-harm. All outcomes were primarily assessed at 16 months after randomization. This trial was prospectively registered at <ext-link ext-link-type="uri" xlink:href="http://ClinicalTrials.gov" xmlns:xlink="http://www.w3.org/1999/xlink">ClinicalTrials.gov</ext-link>, NCT03677037.ResultsBetween October 4, 2018, and December 3, 2020, we randomly assigned 166 participants to short-term MBT (n = 84) or long-term MBT (n = 82). Regression analyses showed no evidence of a difference when assessing BPD symptoms (MD 0.99; 95% CI: -1.06 to 3.03; p = 0.341), level of functioning (MD 1.44; 95% CI: -1.43 to 4.32; p = 0.321), quality of life (MD -0.91; 95% CI: -4.62 to 2.79; p = 0.626), global functioning (MD -2.25; 95% CI: -6.70 to 2.20; p = 0.318), or severe self-harm (RR 1.37; 95% CI: 0.70-2.84; p = 0.335). More participants in the long-term MBT group had a serious adverse event compared with short-term MBT (RR 1.63; 95% CI: 0.94-3.07; p = 0.088), primarily driven by a difference in psychiatric hospitalizations (RR 2.03; 95% CI: 0.99-5.09; p = 0.056).ConclusionLong-term MBT did not lead to lower levels of BPD symptoms, nor did it influence any of the secondary outcomes compared with short-term MBT.

Project description:BackgroundInfant behavioral sleep problems are common, with potential negative consequences. We conducted a randomized controlled trial to assess effects of a sleep intervention comprising a two-hour group teaching session and four support calls over 2 weeks. Our primary outcomes were reduced numbers of nightly wakes or parent report of sleep problem severity. Secondary outcomes included improvement in parental depression, fatigue, sleep, and parent cognitions about infant sleep.MethodsTwo hundred thirty five families of six-to-eight month-old infants were randomly allocated to intervention (n = 117) or to control teaching sessions (n = 118) where parents received instruction on infant safety. Outcome measures were observed at baseline and at 6 weeks post intervention. Nightly observation was based on actigraphy and sleep diaries over six days. Secondary outcomes were derived from the Multidimensional Assessment of Fatigue Scale, Center for Epidemiologic Studies Depression Measure, Pittsburgh Sleep Quality Index, and Maternal (parental) Cognitions about Infant Sleep Questionnaire.ResultsOne hundred eight intervention and 107 control families provided six-week follow-up information with complete actigraphy data for 96 in each group: 96.9% of intervention and 97.9% of control infants had an average of 2 or more nightly wakes, a risk difference of -0.2% (95% CI: -1.32, 0.91). 4% of intervention and 14% of control infants had parent-assessed severe sleep problems: relative risk 0.3, a risk difference of -10% (CI: 0.11, 0.84-16.8 to -2.2). Relative to controls, intervention parents reported improved baseline-adjusted parental depression (CI: -3.7 to -0.4), fatigue (CI: -5.74 to -1.68), sleep quality (CI: -1.5 to -0.2), and sleep cognitions: doubts (CI: -2.0 to -0.6), feeding (CI: - 2.1 to - 0.7), anger (CI: - 1.8 to - 0.4) and setting limits (CI: -3.5 to -1.5).ConclusionsThe intervention improved caregivers' assessments of infant sleep problem severity and parental depression, fatigue, sleep, and sleep cognitions compared with controls.Trial registrationISRCTN42169337 , NCT00877162.

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Sleep problems after short-term hormone therapy suspension: secondary analysis of a randomized trial.

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Sleep problems after short-term hormone therapy suspension: secondary analysis of a randomized trial.

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