Kornstein 2006.

Methods	Randomised double‐blind placebo‐controlled 3‐arm study with parallel groups
Participants	Country: USA Site: Conducted in 22 psychiatric and gynaecological outpatient clinics in the US Recruitment: Women recruited through advertisements in the media. 314 women randomised and allocated to sertraline 25 mg (n=98), sertraline 50.0 mg (n=97) or placebo (N=101) Inclusion: Aged between 24 and 45 years, having regular menstrual cycles (24 to 36 days), and meeting criteria for PMS based on Daily Symptom Report (DSR) for 2 cycles. A total score >80 for luteal phase, along with at least 3 DSR items showing at least moderate severity for 2 out of 6 premenstrual days, moderate distress for at least 2 out of 6 premenstrual days and minimal to no symptoms during the follicular phase (days 5‐10). Exclusion: Decrease of 30% or more in DSR total score for the 6 premenstrual days during the single blind placebo cycle, use of oral contraceptives or other hormonal preparations within six months prior to screening, pregnant, lactating or planning pregnancy, LH levels > 38 or FSH > 20 in patients aged >38 years, post‐hysterectomy or failure to demonstrate ovulation in the two screening cycles, failure to respond to an adequate trial of 2 or more antidepressants to treat premenstrual symptoms, symptomatic endometriosis (or treatment in the past 3 months), history of major depressive episode or other mental disorder or substance misuse in past year, history of eating disorder in previous 2 years, current or lifetime history of psychiatric disorders, current use of any psychotropic medication, positive urine drug screen, current suicide risk, any acute or unstable medical illness or clinically significant laboratory abnormality.
Interventions	Screening: Two cycles Placebo run in: None Intervention: Two cycles treatment with 25 mg or 50 mg sertraline luteal phase only versus placebo followed by one cycle of continuous dosing followed by one cycle of symptom‐onset dosing; compared to placebo Timing of administration: as above. No details of average drug received Summary measures: Data were summarised for luteal phase as a sum of the last seven days of the cycle and averaged over two cycles in the paper
Outcomes	Daily Symptom Report; Clinical Global Impression‐ Severity of Illness (CGI‐ S); Clinical Global Improvement (CGI‐I); Patient Global Evaluation (PGE); Quality of Life Enjoyment and Satisfaction Scale (Q‐LES‐Q); Social Adjustment Scale Self Report (SAS‐SR)
Notes	Study funded by Pfizer Data relating to luteal phase SSRI versus placebo comparison (2 cycles) included in this review
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	States randomised but method not reported
Allocation concealment (selection bias)	Unclear risk	Method not reported
Blinding (performance bias and detection bias) All outcomes	Unclear risk	Double blinded, no further details
Incomplete outcome data (attrition bias) All outcomes	High risk	269 women analysed out of 314 randomised (86%) 98 allocated to sertraline 25mg and 74 completed (76%) (adverse events = 7, protocol violation = 5, withdrew consent = 4, loss to follow up = 2, other/administrative = 6) 97 allocated to sertraline 50mg 77 completed (79%) (adverse events = 10, protocol violation= 1, withdrew consent = 1, loss to follow up = 5, other/administrative = 3) 101 allocated to placebo and 79 completed (78%) (adverse events = 8, protocol violation = 2, withdrew consent = 6, loss to follow up = 2, other administrative = 4)
Selective reporting (reporting bias)	Unclear risk	Adverse effects data collected retrospectively at follow‐up visits
Other bias	Unclear risk	Only included women who had responded to an adequate trial of 2 or more antidepressants to treat premenstrual symptoms