Comment: The quality of evidence is downgraded by study quality (unclear allocation concealment, blinding and selective reporting).
A Cochrane review [Abstract] 1 included 31 studies. SSRIs were found to be highly effective in treating the premenstrual symptoms (SMD - 0.65, 95% CI -0.46 to -0.84; I²=58%, 9 trials, n=1276). Secondary analysis showed that they were effective in treating physical , functional and behavioural symptoms . Luteal phase only and continuous administration were both effective. All SSRIs (fluoxetine, paroxetine, sertraline, escitalopram, and citalopram) were effective. Withdrawals due to side effects were twice as likely to occur in the treatment group (OR moderate dose: OR 2.55, 95% CI 1.84 to 3.53; 15 studies, n=2447 women; no heterogeneity).The most common side effects associated with a moderate dose of SSRIs were nausea (NNH = 7), asthenia or decreased energy (NNH = 9), somnolence (NNH = 13), fatigue (NNH = 14), decreased libido (NNH = 14) and sweating (NNH = 14).
A systemativ review 4 included 49 trials focusing on pharmacological/chemical agents on premenstrual dysphoric disorder (PMDD). Based on a qualitative synthesis, the best therapeutic option in patients free of other mental disorders were SSRIs (especially paroxetine and fluoxetine) and low doses of oral estroprogestins.
A double-blind, placebo-controlled, multisite, parallel-group randomized clinical trial 3 included 252 women with PMDD. Treatment (placebo or sertraline hydrochloride, 50 to 100 mg/d) was started at symptom onset and continued until the first few days of menses for 6 menstrual cycles. 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 < .01) and were more likely to respond to treatment (77 of 115 patients [67.0%] for sertraline and 65 of 124 [52.4%] for placebo; χ;21 = 5.23; P = .02).
A systematic review 2 including 5 RCTs with a total of 1 063 subjects was abstracted in DARE. The overall standardised mean difference was -1.066 (95% CI -1.381 to -0.750) and an OR of 6.91 (95% CI 3.90 to 12.29) in favour of SSRIs. Withdrawal due to side effects was 2.5 times more likely in the active-treatment group than in the placebo group (OR 2.42, 95% CI 1.59 to 3.67). SSRIs were not statistically more effective than other antidepressants (3 trials), SMD 0.287, 95% CI -0.586 to 0.011).
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