Effect of escitalopram on insomnia symptoms and subjective sleep quality in healthy perimenopausal and postmenopausal women with hot flashes: A randomized controlled trial

Article (PDF Available)inMenopause (New York, N.Y.) 19(8):848-55 · March 2012with27 Reads
DOI: 10.1097/gme.0b013e3182476099 · Source: PubMed
The aim of this study was to determine the effect of escitalopram on insomnia symptoms and subjective sleep quality in healthy perimenopausal and postmenopausal women with hot flashes. A randomized, blinded, multicenter, placebo-controlled parallel-group 8-week trial with 205 women (95 African American, 102 white, 8 other) was conducted between July 2009 and June 2010. The participants received escitalopram (10-20 mg/d) or placebo. Insomnia symptoms (Insomnia Severity Index [ISI]) and subjective sleep quality (Pittsburgh Sleep Quality Index [PSQI]) at weeks 4 and 8 were the prespecified secondary outcomes. A total of 199 women (97%) provided ISI data, and 194 (95%) women provided PSQI data at follow-up. At baseline, mean hot flash frequency was 9.78 per day (SD, 5.60), mean ISI was 11.4 (SD, 6.3), and mean PSQI was 8.0 (SD, 3.7). Treatment with escitalopram reduced ISI at week 8 (mean difference, -2.00; 95% CI, -3.43 to -0.57; P < 0.001 overall treatment effect), with mean differences of -4.73 (95% CI, -5.72 to -3.75) in the escitalopram group and -2.73 (95% CI, -3.78 to -1.69) in the placebo group. The reduction in PSQI was greater in the escitalopram than in the placebo group at week 8 (mean difference, -1.31; 95% CI, -2.14 to -0.49; P < 0.001 overall treatment effect). Clinical improvement in insomnia symptoms and subjective sleep quality (≥50% decreases in ISI and PSQI from baseline) was observed more frequently in the escitalopram group than in the placebo group (ISI, 50.0% vs 35.4%, P = 0.04; PSQI, 29.6% vs 19.2%, P = 0.09). Among healthy perimenopausal and postmenopausal women with hot flashes, escitalopram at 10 to 20 mg/day compared with placebo reduced insomnia symptoms and improved subjective sleep quality at 8 weeks of follow-up.

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Available from: Nancy F Woods, Dec 01, 2014
    • "Therefore, this present work aimed to assess the risk-benefit ratio of various non-hormonal treatment options. Among them, four non-hormonal treatments appear to have significant evidence for a beneficial effect in treating vasomotor climacteric or androgen-ablation symptoms, although some studied the effects over a period shorter than 12 weeks: gabapentin/pregabalin (Loprinzi et al. 2002a; Guttuso et al. 2003; Reddy et al. 2006; Loprinzi et al. 2007; Butt et al. 2008; Saadati et al. 2013; Agarwal et al. 2014; Pinkerton et al. 2014; Loprinzi et al. 2010; Pandya et al. 2004; Pandya et al. 2005; Bordeleau et al. 2010; Loprinzi et al. 2009; Moraska et al. 2010), SSRIs (Stearns et al. 2003; Stearns et al. 2005; Simon et al. 2013; Huang et al. 2013; Stearns et al. 2000; Gordon et al. 2006; Grady et al. 2007; Kerwin et al. 2007; Aedo et al. 2011; Kimmick et al. 2006; Wu et al. 2009; Suvanto-Luukkonen et al. 2005; Oktem et al. 2007; Loprinzi et al. 2002b; Barton et al. 2010; Barton et al. 2003; Defronzo Dobkin et al. 2009; Freedman et al. 2011; Freeman et al. 2011; Carpenter et al. 2012; Ensrud et al. 2012), venlafaxine/ desvenlafaxine (Evans et al. 2005; Loprinzi et al. 2006; Loprinzi et al. 1998; Carpenter et al. 2007; Quella et al. 1999; Loprinzi et al. 2000; Loibl et al. 2007; Buijs et al. 2009; Boekhout et al. 2011; Bordeleau et al. 2010; Vitolins et al. 2013; Speroff et al. 2008; Archer et al. 2009a; Archer et al. 2009b; Cheng et al. 2013; Bouchard et al. 2012; Pinkerton et al. 2013), and CREs (Drewe et al. 2013; Lopatka et al. 2007; Vermes et al. 2005; Liske et al. 2002; Frei-Kleiner et al. 2005; Schellenberg et al. 2012; Osmers et al. 2005; Ross 2012; Newton et al. 2006; Geller et al. 2009; Stoll 1987; Wuttke et al. 2003; Nappi et al. 2005; Bai et al. 2007; Uebelhack et al. 2006; Briese et al. 2007; Oktem et al. 2007; Huang et al. 2013; Pockaj et al. 2004; Jacobson et al. 2001; Pockaj et al. 2006; Hernández Munoz & Pluchino 2003; Rostock et al. 2011). Randomised, controlled trials that have shown a pharmacological effect and are at least 12 weeks duration , as required by FDA and EMA (FDA. "
    [Show abstract] [Hide abstract] ABSTRACT: The cardinal climacteric symptoms of hot flushes and night sweats affect 24-93% of all women during the physiological transition from reproductive to post-reproductive life. Though efficacious, hormonal therapy and partial oestrogenic compounds are linked to a significant increase in breast cancer. Non-hormonal treatments are thus greatly appreciated. This systematic review of published hormonal and non-hormonal treatments for climacteric, and breast and prostate cancer-associated hot flushes, examines clinical efficacy and therapy-related cancer risk modulation. A PubMed search included literature up to June 19, 2014 without limits for initial dates or language, with the search terms, (hot flush* OR hot flash*) AND (clinical trial* OR clinical stud*) AND (randomi* OR observational) NOT review). Retrieved references identified further papers. The focus was on hot flushes; other symptoms (night sweats, irritability, etc.) were not specifically screened. Included were some 610 clinical studies where a measured effect of the intervention, intensity and severity were documented, and where patients received treatment of pharmaceutical quality. Only 147 of these references described studies with alternative non-hormonal treatments in post-menopausal women and in breast and prostate cancer survivors; these results are presented in Additional file 1. The most effective hot flush treatment is oestrogenic hormones, or a combination of oestrogen and progestins, though benefits are partially outweighed by a significantly increased risk for breast cancer development. This review illustrates that certain non-hormonal treatments, including selective serotonin reuptake inhibitors, gabapentin/pregabalin, and Cimicifuga racemosa extracts, show a positive risk-benefit ratio.
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  • Article · Aug 2012
  • [Show abstract] [Hide abstract] ABSTRACT: OBJECTIVE: To evaluate the effects of escitalopram 10-20mg/day on menopause-related quality of life and pain in healthy menopausal women with hot flashes. STUDY DESIGN: A double-blind, placebo-controlled randomized trial of escitalopram 10-20mg/day vs. identical placebo was conducted among 205 women ages 40-62 years with an average of ≥4 daily hot flashes recruited at 4 clinical sites from July 2009 to June 2010. MAIN OUTCOME MEASURES: The primary trial outcomes, reported previously, were the frequency and severity of vasomotor symptoms at 8 weeks. Here, we report on the pre-specified secondary endpoints of total and domain scores from the Menopause-Specific Quality of Life Questionnaire (MENQOL) and the pain intensity and interference scale (PEG). RESULTS: Outcome data were collected on 97% of randomized women and 87% of women took at least 70% of their study medication. Treatment with escitalopram resulted in significantly greater improvement in total MENQOL scores (mean difference at 8 weeks of -0.41; 95% confidence interval (CI) -0.71 to -0.11; p<0.001), as well as Vasomotor, Psychosocial, and Physical domain scores with the largest difference seen in the Vasomotor domain (mean difference -0.75; 95% CI -1.28 to -0.22; p=0.02). There was no significant treatment group difference for the Sexual Function domain. Escitalopram treatment resulted in statistically significant improvements in PEG scores compared to placebo (mean treatment group difference at 8 weeks of -0.33; 95% CI -0.81 to 0.15; p=0.045). CONCLUSIONS: Treatment with escitalopram 10-20mg/day in healthy women with vasomotor symptoms significantly improved menopause-related quality of life and pain.
    Full-text · Article · Sep 2012
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