Methods |
Concealment: unclear
Blinding: double‐blind
Drop‐outs/withdrawals: 3 in group hypericum 1, 1 in group hypericum 2, 4 in placebo group
Jadad score: 2‐2‐1
IV score: 1‐0‐1‐1‐1‐1 |
Participants |
Patients included/analyzed: 147/147
Demographics: 117 female, mean age 49 years
Diagnosis: mild to moderate depression (DSM‐IV)
Setting: 11 practices in Germany
Baseline: HAMD score 20.9 +/‐ 3.1 (hypericum 1), 20.3 +/‐ 2.7 (hypericum 2), 21.2 +/‐ 3.3 (placebo) |
Interventions |
Treatment 1: Hypericum extract WS 5572 (5% hyperforin) 3x1 coated tablet (900 mg) for 6 weeks
Treatment 2: Hypericum extract WS 5573 (0.5% hyperforin) 3x1 coated tablet (900 mg) for 6 weeks
Control: Placebo for 6 weeks |
Outcomes |
Observation period: 6 weeks
Physician‐rated: Hamilton Depression Scale (HAMD, 17 items; response = at least 50% reduction), Clinical Global Impression Index (CGI)
Patient‐rated: von Zerssen Depression Scale (D‐S), global assessment |
Notes |
Includes a group receiving a second hypericum extract with very low hyperforin content (not included in meta‐analysis as this tests an extract which was not marketed) |
Risk of bias |
Bias |
Authors' judgement |
Support for judgement |
Allocation concealment? |
Low risk |
A ‐ Adequate |