| Methods |
Concealment: central telephone randomization
Blinding: double‐blind (double‐dummy)
Drop‐outs/withdrawals: 31 of 113 in hypericum group, 32 of 116 in placebo group, and 32 of 111 in sertraline group
Jadad score: 2‐2‐1
IV score: 1‐1‐1‐0.5‐0.5‐0.5 |
| Participants |
Number of patients included/analyzed: 340/340
Demographics: 66% female, mean age 43 years
Diagnosis: major depression (DSM‐IV)
Setting: 12 academic and community psychiatric research clinics in the US
Baseline: HAMD scores 23.1 +/‐ 2.7 (hypericum), 22.7 +/‐ 2.7 (placebo), 22.5 +/‐ 2.5 (sertraline) |
| Interventions |
Treatment: Hypericum LI 160 extract 900 to 1500 mg for 8 weeks
Control 1: Placebo for 8 weeks
Control 2: Sertraline 50 to 100 mg for 8 weeks |
| Outcomes |
Observation period: 1 weeks run‐in, 8 weeks treatment, 18 weeks follow‐up for responders
Physician‐rated: Hamilton Depression Scale (HAMD, response = at least 50% reduction or score < 10), Clinical Global Impression Index (CGI), Global Assessment of Functioning (GAF)
Patient‐rated: Beck Depression Inventory (BDI), Sheehan Disability Scale (SDS) |
| Notes |
Trial funded by public institution (NIH). Large proportion of patients with chronic depression. Some unblinding detected (sole trial which reported a check of blinding). Authors provided additional data |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment? |
Low risk |
A ‐ Adequate |
