학술논문
Symptomatic improvement of premenstrual dysphoric disorder with sertraline treatment: a randomized controlled trial
Document Type
Academic Journal
Author
Source
JAMA, The Journal of the American Medical Association. Sept 24, 1997, Vol. v278 Issue n12, p983, 6 p.
Subject
Language
ISSN
0098-7484
Abstract
Sertraline appears to be effective in the treatment of the psychological component of premenstrual syndrome (PMS). Many women with PMS become depressed, anxious and experience mood swings. Researchers randomly assigned 200 women with PMS to take the antidepressant drug sertraline or a placebo. Treatment began on the first day of menstruation and lasted for three menstrual cycles. The women were required to complete a form rating their symptoms every day. Sixty-two percent of the women taking sertraline reported a significant improvement compared to 34% of the placebo group.
Context. -- Premenstrual dysphoric disorder is an important cause of symptoms and functional impairment in menstruating women. Objective. -- To evaluate the officacy of sertraline hydrochloride for treatment of premenstrual dysphoria by measuring changes in symptom expression and functional impairment. Design. -- Two screening cycles followed by 1 single-blind placebo cycle and 3 cycles of randomized, double-blind, placebo treatment. Setting. -- Twelve university-affiliated outpatient psychiatry and gynecology clinics. Patients. -- Of the 447 women who requested participation, 243 met criteria for premenstrual dysphoric disorder and were randomized; 200 women completed the study. Intervention. -- A flexible (50-150 mg) daily dose of sertraline hydrochloride. Main Outcome Measures. -- The Daily Record of Severity of Problems, Hamilton Rating Scale for Depression, Clinical Global Impression Scale, and Social Adjustment Scale. Results. -- Mean ([+ or -]SD) total daily symptom scores decreased significantly (P[less than].001) in the sertraline-treated (64[+ or -]22 to 44[+ or -]19) compared with the placebo-treated (62[+ or -]22 to 54[+ or -]24) groups. Significant improvement (P[less than].05) was found for all clinically derived symptom clusters (depressive, physical, and anger/irritability symptoms). Hamilton Rating Scale for Depression scores decreased by 44% and 29% in the sertraline and placebo groups, respectively (P[less than].002). End-point global ratings showed much or very much improvement in 62% of the active treatment group and 34% of the placebo treatment group (P[less than].001). Reported functional impairment was substantial at baseline. improvement in psychosocial functioning with treatment was similar to what is found in studies of major depression. Conclusions. -- Sertraline was significantly better than placebo for treatment of premenstrual dysphoria as reflected by symptomatic improvement and change in reported functional impairment. Serotonin reuptake inhibitors such as sertraline are useful therapeutic options for women with premenstrual dysphoria.
Context. -- Premenstrual dysphoric disorder is an important cause of symptoms and functional impairment in menstruating women. Objective. -- To evaluate the officacy of sertraline hydrochloride for treatment of premenstrual dysphoria by measuring changes in symptom expression and functional impairment. Design. -- Two screening cycles followed by 1 single-blind placebo cycle and 3 cycles of randomized, double-blind, placebo treatment. Setting. -- Twelve university-affiliated outpatient psychiatry and gynecology clinics. Patients. -- Of the 447 women who requested participation, 243 met criteria for premenstrual dysphoric disorder and were randomized; 200 women completed the study. Intervention. -- A flexible (50-150 mg) daily dose of sertraline hydrochloride. Main Outcome Measures. -- The Daily Record of Severity of Problems, Hamilton Rating Scale for Depression, Clinical Global Impression Scale, and Social Adjustment Scale. Results. -- Mean ([+ or -]SD) total daily symptom scores decreased significantly (P[less than].001) in the sertraline-treated (64[+ or -]22 to 44[+ or -]19) compared with the placebo-treated (62[+ or -]22 to 54[+ or -]24) groups. Significant improvement (P[less than].05) was found for all clinically derived symptom clusters (depressive, physical, and anger/irritability symptoms). Hamilton Rating Scale for Depression scores decreased by 44% and 29% in the sertraline and placebo groups, respectively (P[less than].002). End-point global ratings showed much or very much improvement in 62% of the active treatment group and 34% of the placebo treatment group (P[less than].001). Reported functional impairment was substantial at baseline. improvement in psychosocial functioning with treatment was similar to what is found in studies of major depression. Conclusions. -- Sertraline was significantly better than placebo for treatment of premenstrual dysphoria as reflected by symptomatic improvement and change in reported functional impairment. Serotonin reuptake inhibitors such as sertraline are useful therapeutic options for women with premenstrual dysphoria.