| Methods |
Concealment: unclear
Blinding: double‐blind
Drop‐outs/withdrawals: 6 of 35 in hypericum group, 3 of 35 in fluoxetine group
Jadad score: 1‐1‐1
IV score: 1‐0‐1‐0.5‐0.5‐0.5 |
| Participants |
Number of patients included/analyzed: 70/61
Demographics: 47 female, mean age 51 (treatment group) and 48 (control group)
Diagnosis: mild to modedrate depression (ICD 10 F32.0 and 32.1)
Setting: multicenter trial from Denmark
Baseline: HAMD score treatment group 20.0 +/‐ 3.2, control group 20.7 +/‐ 2.9 |
| Interventions |
Treatment: Hypericum extract (Calmigen) 2x1 coated tablet daily (300 mg extract) for 6 weeks
Control: Fluoxetine 2x20 mg 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, Clinical Global Impression Index (CGI), global assessment |
| Notes |
Contract research organization which performed the study contacted for additional information but no answer was received |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment? |
Unclear risk |
B ‐ Unclear |
