Preliminary communicationThe measurement of premenstrual mood symptoms
Section snippets
Introduction:
Premenstrual syndrome (PMS) is characterized by a multitude of physical and mood symptoms that appear during the week prior to menstruation and resolve within a week after onset of menses. Most women in their reproductive years experience some premenstrual symptoms, however, 3 to 8% may experience extremely distressing premenstrual mood symptoms that interfere with their lifestyle, relationships, and occupational functioning (for review see Steiner, 1997). These women often meet research
Methods
Data collected during a multi-centre, double-blind, randomized, placebo controlled trial of fluoxetine in the treatment of premenstrual dysphoria were used for this analysis (Steiner et al., 1995). Eligible and consenting women who completed a two cycle placebo run-in phase were randomized to one of three treatment arms: fluoxetine 20 mg/daily, fluoxetine 60 mg/daily or placebo, and treated for six menstrual cycles. Prior to entering the trial, women were required to meet diagnostic criteria
Analysis
Data from the follicular and late luteal phases of the second baseline menstrual cycle (baseline) and the first treatment menstrual cycle (cycle 1) were analyzed. These observations were selected on the basis of our previous analysis which identified a significant improvement in luteal symptoms within the first treatment cycle for women who received fluoxetine compared to those who received placebo (Steiner et al., 1995). Only cases with complete VASs, PMTS-O/SR data for the same calendar day
Results
Three hundred and thirteen eligible women were randomized into the study. Matched and complete data were available for the majority of study participants at baseline (follicular 287/313; luteal 275/313) and for cycle 1 (follicular: 277/277; luteal: 236/277).
Chronbach's alpha was 0.89 or higher for the three scales (VAS-MOOD 0.94, PMTS-O 0.89, PMTS-SR 0.93) indicating a high level of internal consistency amongst individual scale items.
Mean menstrual cycle phase scores are listed in Table 1.
Discussion
To date, there is no consensus amongst investigators as to the best instruments for confirming prospectively the diagnosis of PMDD, nor is there consensus as to the instruments most appropriate to measure treatment effects in clinical trials. In this study we have demonstrated that single item VASs confirmed premenstrual worsening of specific mood symptoms and thus facilitated the identification of women considered most appropriate for this clinical trial. The item specific VASs also helped to
Acknowledgements
This study was supported by Eli Lilly Canada. We are indebted to the study subjects; to all the additonal members of the Canadian Fluoxetine/Premenstrual Dysphoria Collaborative study group and their teams; to Ms. Annette Wilkins for assistance in statistical analysis and data management; and to Mrs. Janice Rogers for assistance in the preparation of the manuscript.
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