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Symptom-Onset Dosing of Sertraline for the Treatment of Premenstrual Dysphoric Disorder: A Randomized Clinical Trial.

ABSTRACT: Serotonin reuptake inhibitors (SRIs) are efficacious treatments for premenstrual dysphoric disorder (PMDD) when given daily or for half of the menstrual cycle during the luteal phase. Preliminary studies suggest that SRI treatment can be shortened to the interval from symptom onset through the beginning of menses.To determine the efficacy of symptom-onset dosing with the SRI sertraline hydrochloride for treatment of PMDD.A double-blind, placebo-controlled, multisite, parallel-group randomized clinical trial conducted September 1, 2007, to February 29, 2012, at 3 university medical centers. In all, 252 women with PMDD started treatment at symptom onset and continued until the first few days of menses for 6 menstrual cycles. Intent-to-treat analyses were performed February 28, 2014, through April 21, 2015.Placebo or sertraline hydrochloride, 50 to 100 mg/d, during the symptomatic interval.Premenstrual Tension Scale (PMTS) score was the primary outcome measure (score range, 0-36; 36 indicates most severe score). Secondary outcome measures included the Inventory of Depressive Symptomatology-Clinician-Rated (IDS-C) (score range, 0-84; 84 indicates most severe score), Daily Record of Severity of Problems (DRSP) (total and subscale scores; higher scores indicate most severe problems), Clinical Global Impression (CGI) scales (score range, 1-7; 7 indicates most severe symptoms and least improvement), and Michelson SSRI (Selective SRI) Withdrawal Symptoms Scale scores (range, 0-51; higher scores indicate more severe withdrawal symptoms).Among the participants, 125 with PMDD were randomized to sertraline, and 127 to placebo. At baseline the mean (SD) PMTS scores for sertaline and placebo were 22.3 (4.8) and 21.4 (4.5), respectively, which declined to 11.7 (6.8) and 12.0 (6.9), respectively; group mean difference, 1.88 (95% CI, 0.01-3.75; P?=?.06). The mean (SD) estimated difference in IDS-C scores between baseline (35.4 [10.7] for sertraline; 32.8 [10.4] for placebo) and the end point (15.3 [10.7] for sertraline; 17.8 [11.0] for placebo) favored the sertraline group by 5.14 (95% CI, 1.97-8.31) points (P?=?.02). Compared with the placebo group, those assigned to sertraline showed greater improvement on the total DRSP score (estimated mean difference, 1.09 [95% CI, 0.96-1.25] points; P?=?.02) and Anger/Irritability DRSP subscale score (1.22 [95% CI,?1.05-1.41] points; P?

SUBMITTER: Yonkers KA

PROVIDER: S-EPMC4811029 | biostudies-literature | 2015 Oct

REPOSITORIES: biostudies-literature

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Symptom-Onset Dosing of Sertraline for the Treatment of Premenstrual Dysphoric Disorder: A Randomized Clinical Trial.

Yonkers Kimberly A KA Kornstein Susan G SG Gueorguieva Ralitza R Merry Brian B Van Steenburgh Kari K Altemus Margaret M

JAMA psychiatry 20151001 10

<h4>Importance</h4>Serotonin reuptake inhibitors (SRIs) are efficacious treatments for premenstrual dysphoric disorder (PMDD) when given daily or for half of the menstrual cycle during the luteal phase. Preliminary studies suggest that SRI treatment can be shortened to the interval from symptom onset through the beginning of menses.<h4>Objective</h4>To determine the efficacy of symptom-onset dosing with the SRI sertraline hydrochloride for treatment of PMDD.<h4>Design, setting, and participants< ...[more]

PMID: 26351969

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Project description:BACKGROUND:During their reproductive years about 10% of women experience some kind of symptoms before menstruation (PMS) in a degree that affects their quality of life (QOL). Acupuncture and herbal medicine has been a recent favorable therapeutic approach. Thus we aimed to review the effects of acupuncture and herbal medicine in the past decade as a preceding research in order to further investigate the most effective Korean Medicine treatment for PMS/PMDD. METHODS:A systematic literature search was conducted using electronic databases on studies published between 2002 and 2012. Our review included randomized controlled clinical trials (RCTs) of acupuncture and herbal medicine for PMS/PMDD. Interventions include acupuncture or herbal medicine. Clinical information including statistical tests was extracted from the articles and summarized in tabular form or in the text. Study outcomes were presented as the rate of improvement (%) and/or end-of-treatment scores. RESULTS:The search yielded 19 studies. In screening the RCTs, 8 studies in acupuncture and 11 studies in herbal medicine that matched the criteria were identified. Different acupuncture techniques including traditional acupuncture, hand acupuncture and moxibustion, and traditional acupuncture technique with auricular points, have been selected for analysis. In herbal medicine, studies on Vitex Agnus castus, Hypericum perforatum, Xiao yao san, Elsholtzia splendens, Cirsium japonicum, and Gingko biloba L. were identified. Experimental groups with Acupuncture and herbal medicine treatment (all herbal medicine except Cirsium japonicum) had significantly improved results regarding PMS/PMDD. CONCLUSIONS:Limited evidence supports the efficacy of alternative medicinal interventions such as acupuncture and herbal medicine in controlling premenstrual syndrome and premenstrual dysphoric disorder. Acupuncture and herbal medicine treatments for premenstrual syndrome and premenstrual dysphoric disorder showed a 50% or better reduction of symptoms compared to the initial state. In both acupuncture and herbal medical interventions, there have been no serious adverse events reported, proving the safety of the interventions while most of the interventions provided over 50% relief of symptoms associated with PMS/PMDD. Stricter diagnostic criteria may have excluded many participants from some studies. Also, depending on the severity of symptoms, the rate of improvement in the outcomes of the studies may have greatly differed.

Project description:Bipolar disorder (BD) and premenstrual dysphoric disorder (PMDD) are two cyclic mood illnesses, sometimes presenting together. Their comorbidity appears to be linked to common biological mechanisms and usually results in more severity of mood symptoms and a poorer long-term outcome. Nevertheless, the management of comorbid PMDD/BD has been scarcely studied. Therefore, the aim of the present paper was to review the published literature on the treatment of comorbid PMDD/BD and to provide point-by-point hypotheses to address these complex clinical cases. We searched PubMed to identify the studies focused on the treatment and management of comorbid PMDD/BD using the following search words, alone and in combination: premenstrual dysphoric disorder, bipolar disorder, comorbid, treatment, management, pharmacotherapy, psychotherapy. The search was conducted on the 1st of June 2019 and yielded 55 records. Four papers met our inclusion/exclusion criteria and were therefore included in our qualitative synthesis. Integrating the few data pertaining to the treatment of comorbid PMDD/BD with the large amount of published data on the two conditions separately, we can suggest that the management of comorbid PMDD/BD needs as a first step to stabilize the bipolar symptoms by means of optimal dosages of mood stabilizers. Then, in euthymic BD patients, the PMDD symptoms could be treated with estroprogestins (first-line treatment). On the contrary, during acute phases of BD, antidepressants (for major depressive episodes) and atypical antipsychotics/hormonal modulators (for manic episodes) could be considered as promising add-on treatments to mood stabilizers. In case of resistant PMDD/BD symptoms, combined strategies should be taken into account, as well as alternative treatments, such as lifestyle changes. In conclusion, RCTs on comorbid PMDD/BD are still lacking. The management of this complex condition is therefore challenging and it requires a tailored treatment.

Project description:AimPremenstrual dysphoric disorder (PMDD) has predictable, cyclic, psychological, and somatic symptoms, such as sleep problems. They result in functional impairment, are aggravated in the late luteal phase of the menstrual cycle, and are resolved by menstruation. The present study evaluated the insomnia, inattention, and fatigue symptoms of PMDD and their fluctuations during the menstrual cycle.MethodsA total of 100 women were diagnosed as having PMDD based on psychiatric interviews and a prospective investigation of three menstrual cycles. A total of 96 individuals without PMDD were recruited as controls. Their symptoms, namely insomnia, inattention, and fatigue as well as functional impairment were assessed by using the premenstrual symptoms screening tool, the Pittsburgh insomnia rating scale, the attention and performance self-assessment scale, and the fatigue-assessment scale during both premenstrual and follicular phases.ResultsIn both the premenstrual and follicular phases, women with PMDD experienced more severe insomnia, inattentiveness, and fatigue than did women in the control group. A paired t-test demonstrated that women with PMDD had more severe severity insomnia, inattentiveness, and fatigue in the luteal phase than in the follicular phase. A repeated-measures analysis of variance demonstrated that the interaction period of PMDD and a menstrual cycle was significantly associated with insomnia, inattentiveness, and fatigue. A further correlation analysis demonstrated that all three symptoms were positively associated with self-reported functional impairment due to PMDD.ConclusionsOur results demonstrated that women with PMDD experienced an exacerbation of insomnia, memory problems, difficulty maintaining focus, and fatigue in the premenstrual phase. These symptoms are correlated with PMDD symptoms severity and functional impairment, and as such, they should be evaluated, and interventions should be employed in the late luteal phase of women with PMDD.

Dataset Information

Symptom-Onset Dosing of Sertraline for the Treatment of Premenstrual Dysphoric Disorder: A Randomized Clinical Trial.

Publications

Symptom-Onset Dosing of Sertraline for the Treatment of Premenstrual Dysphoric Disorder: A Randomized Clinical Trial.

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