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Luteal Phase Sertraline Curbs Premenstrual Dysphoric Disorder
A DGReview of :"Efficacy of intermittent, luteal phase sertraline treatment of premenstrual dysphoric disorder1."
Obstetrics & Gynecology
12/23/2002
By Anne MacLennan
Intermittently administered sertraline is significantly more effective than is placebo for premenstrual dysphoric disorder during the luteal phase of the menstrual cycle.
It is also well tolerated, suggest Dr U Halbreich and colleagues from the State University of New York at Buffalo School of Medicine, Buffalo, New York, United States.
Their goal was to evaluate the efficacy and tolerability of sertraline in premenstrual dysphoric disorder when treatment was limited to the luteal phase.
Study participants were 281 women with this menstrually-related condition that intermittently causes disabling emotional, behavioural and physical symptoms. (All met Diagnostic and Statistical Manual of Mental Disorders [4th edition] criteria).
The subjects completed two prospective screening cycles and one single-blind placebo cycle and were then randomised to three cycles of double blind, luteal phase treatment with either a placebo or sertraline in a flexible daily dose of 50 mg to 100 mg.
Outcome measures included the Daily Record of Severity of Problems and the Clinical Global Impression Severity and Improvement scales.
The significant superiority of luteal phase treatment with sertraline versus placebo was demonstrated by end-point analysis of Clinical Global Impression Improvement scale scores (sertraline, 2.3 ± 1.1, versus placebo, 2.7 ± 1.1; P <.001), and cycle three Daily Record of Severity of Problems change scores (sertraline, 27.6 ± 26.8, versus placebo, 17.6 ± 23.3; P <.002).
There was also a significant difference in responder rates in favour of sertraline (50 percent) versus placebo (26 percent, P <.001) by cycle one. (Responder was defined as a Clinical Global Impression Improvement scale score of one or two.)
In addition, quality of life and functioning outcomes were significantly improved by the drug.
About eight percent of patients on sertraline, and less than one percent on placebo, discontinued treatment because of adverse events.
Obstet Gynecol 2002 Dec;100(6):1219-29.
"Efficacy of intermittent, luteal phase sertraline treatment of premenstrual dysphoric disorder1."
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