BACKGROUND: Although traditionally dosed combined oral contraceptives (COCs) (21 days of active pills, 7 days of inactive pills) have not been demonstrated as superior to placebo for the treatment of premenstrual dysphoria (PMD), some randomized controlled trials (RCTs) indicate that oral contraceptives administered with a shortened or eliminated hormone-free interval are superior to placebo. However, results of such trials are mixed, and no existing studies have directly compared continuous and intermittent dosing schedules of the same oral contraceptive. The present study compared placebo, intermittent dosing of oral contraceptives, and continuous dosing of contraceptives for the treatment of PMD. METHODS:Fifty-five women with prospectively confirmed PMD completed a three-arm, RCT in which they were randomized to 3 months of placebo (n = 22), intermittent drospirenone/ethinyl estradiol dosed on a 21-7 schedule (n = 17), or continuous drospirenone/estradiol (n = 16) following a baseline assessment month. RESULTS: All three groups demonstrated similar, robust reductions in premenstrual symptoms over time. A marked placebo response was observed. CONCLUSIONS: The study fails to replicate a uniquely beneficial effect of continuous COC on PMD. Additional work is needed to understand the psychosocial context bolstering the placebo response in women with PMD.
RCT Entities:
BACKGROUND: Although traditionally dosed combined oral contraceptives (COCs) (21 days of active pills, 7 days of inactive pills) have not been demonstrated as superior to placebo for the treatment of premenstrual dysphoria (PMD), some randomized controlled trials (RCTs) indicate that oral contraceptives administered with a shortened or eliminated hormone-free interval are superior to placebo. However, results of such trials are mixed, and no existing studies have directly compared continuous and intermittent dosing schedules of the same oral contraceptive. The present study compared placebo, intermittent dosing of oral contraceptives, and continuous dosing of contraceptives for the treatment of PMD. METHODS: Fifty-five women with prospectively confirmed PMD completed a three-arm, RCT in which they were randomized to 3 months of placebo (n = 22), intermittent drospirenone/ethinyl estradiol dosed on a 21-7 schedule (n = 17), or continuous drospirenone/estradiol (n = 16) following a baseline assessment month. RESULTS: All three groups demonstrated similar, robust reductions in premenstrual symptoms over time. A marked placebo response was observed. CONCLUSIONS: The study fails to replicate a uniquely beneficial effect of continuous COC on PMD. Additional work is needed to understand the psychosocial context bolstering the placebo response in women with PMD.
Authors: Mark Sinyor; Anthony J Levitt; Amy H Cheung; Ayal Schaffer; Alex Kiss; Yekta Dowlati; Krista L Lanctôt Journal: J Clin Psychiatry Date: 2010-01-26 Impact factor: 4.384
Authors: Sarah C Lidstone; Michael Schulzer; Katherine Dinelle; Edwin Mak; Vesna Sossi; Thomas J Ruth; Raul de la Fuente-Fernández; Anthony G Phillips; A Jon Stoessl Journal: Arch Gen Psychiatry Date: 2010-08
Authors: Tory A Eisenlohr-Moul; Susan S Girdler; Katja M Schmalenberger; Danyelle N Dawson; Pallavi Surana; Jacqueline L Johnson; David R Rubinow Journal: Am J Psychiatry Date: 2016-08-13 Impact factor: 18.112