Clinical subtypes of premenstrual syndrome and responses to sertraline treatment

Abstract

Objective: To estimate response of diagnosis and symptom-based subtypes to sertraline treatment.

Methods: This was a secondary data analysis for women who were diagnosed with premenstrual syndrome (PMS) or premenstrual dysphoric disorder and treated in three National Institutes of Health-supported clinical trials (N=447). Three PMS subtypes were identified based on predominance of psychological, physical, or both symptom types. Scores for each symptom and a total premenstrual score at baseline and endpoint were calculated from daily symptom diaries. Change from baseline after three treated menstrual cycles (or endpoint if sooner) was estimated using linear regression models adjusted for baseline severity.

Results: The PMS and premenstrual dysphoric disorder diagnoses improved similarly with sertraline relative to placebo, whereas symptom-based subtypes had differential responses to treatment. The mixed symptom subtype had the strongest response to sertraline relative to placebo (Daily Symptom Rating difference 33.80; 95% confidence interval [CI] 17.16-50.44; P<.001), and the physical symptom subtype had the poorest response to sertraline (Daily Symptom Rating difference 9.50; 95% CI -16.29 to 35.28; P=.470). Results based on clinical improvement (50% decrease from baseline) indicated that 8.3 participants in the mixed symptom subtype, 3.9 in the psychological subtype, and 7.1 in the physical subtype are needed to observe one woman in the subtype who would achieve clinical improvement.

Conclusion: The PMS and premenstrual dysphoric disorder diagnoses have similar response to sertraline treatment, but symptom-based subtypes have significantly different responses to this treatment. Mixed and psychological symptom subtypes improved whereas the physical symptom subtype did not improve significantly. Identifying the patient's predominant symptoms and their severity is important for individualized treatment and a possible response to a selective serotonin reuptake inhibitor.

Level of evidence: II.

Figure 1

Mean Daily Symptom Rating change (gray bars) from baseline (total bars) by treatment and diagnosis. The number of women taking sertraline was 42 women with premenstrual dysphoric disorder, and 266 with premenstrual syndrome; the number of women taking the placebo was 15 (premenstrual dysphoric disorder) and 104 (premenstrual syndrome). All P values are from the linear regression model of change from baseline with treatment, diagnosis, baseline severity and interaction of treatment by diagnosis. P=.119 for interaction of treatment by diagnosis.

Figure 2

Symptom response to sertraline treatment. Sertraline n=328; placebo n=119. Significance level is P≤.003 with Bonferroni adjustment. *Raw score range: 0–24; higher scores are more severe. ^†General linear regression model adjusted for baseline severity.

Figure 3

Adjusted mean Daily Symptom Rating change (gray bars) from baseline (total bars) by treatment and subtype. The number of women in the Subtype 1 (mixed psychological and physical symptoms) group taking sertraline was 196, and the number taking the placebo was 78; for women in the Subtype 2 (predominant psychological symptoms)group, 51 women took sertraline, and nine took the placebo; for women in the Subtype 3 (predominant physical symptoms)group, 81 took sertraline, and 32 took the placebo. All P values are from the linear regression model of change from baseline with treatment, subtype, baseline severity and interaction of treatment by subtype.