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OBJECTIVE: To compare the change in severity of depressive symptoms and occurrence of side effects in primary care patients treated with St John's wort (SJW) and sertraline. DESIGN: Double-blind, randomized 12-week trial. SETTING: Community-based offices of 12 family physicians practising in greater Montreal, Que. PARTICIPANTS: Eighty-seven men and women with major depression and an initial score of > or = 16 on the Hamilton Rating Scale for Depression (Ham-D). INTERVENTIONS: Patients were randomized to treatment with either sertraline (50 to 100 mg/d) or SJW (900 to 1800 mg/d) in a double-blind fashion. Assessment of depression was done at entry and at 2, 4, 8, and 12 weeks using the Ham-D, the Beck Depression Inventory (BDI), and a questionnaire asking about compliance and side effects. MAIN OUTCOME MEASURES: Changes from baseline in Ham-D and BDI scores and self-reported side effects. RESULTS: There were no important differences in changes in mean Ham-D and BDI scores (using intention-to-treat analysis), with and without adjustment for baseline demographic characteristics, between the two groups at 12 weeks. Significantly more side effects were reported in the sertraline group than in the SJW group at 2 and 4 weeks' follow up. CONCLUSION: The more benign side effects of SJW make it a good first choice for this patient population.