| Methods |
Concealment: unclear
Blinding: double‐blind
Drop‐outs/withdrawals: 18/45 in the hypericum group, 23 of 47 in the fluoxetine group and 22 of 43 in the placebo group
Jadad score: 1‐1‐0
IV score: 1‐0‐1‐0.5‐0.5‐0 |
| Participants |
Number of patients included/analyzed: 135/135
Demographics: 57% female, mean age 37 years
Diagnosis: mild to moderate major depression
Setting: 2 psychiatric outpatient departments in the US
Baseline: HAMD score (17 items) 19.6 +/‐ 3.5 in the hypericum group, 19.9 +/‐ 2.9 in the fluoxetine and 19.6 +/‐ 3.1 in the placebo group |
| Interventions |
Treatment: Hypericum extract LI 160 3x1 tablets (900 mg) for 12 weeks (+ 1 capsule placebo)
Control 1: Fluoxetine 1x20 mg (capsule) for 12 weeks (+ 3x1 placebo tablets)
Control 2: Placebo (1x1 capsule, 3x1 tablets) |
| Outcomes |
Observation period: 12 weeks (+ 1 week placebo run‐in)
Physician‐rated: Hamilton Depression Scale (HAMD, 17 items; response = at least 50% reduction), Clinical Global Impression Index (CGI)
Patient‐rated: Beck Depression Inventory (BDI) |
| Notes |
High drop‐out rate (intent to treat analysis); recruitment stopped before planned sample size was reached due to decision of the sponsor (lichtwer Pharma, Berlin). Only remission rates reported (and use instead of responder data for analyses) |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment? |
Unclear risk |
B ‐ Unclear |
