| Methods |
Concealment: numbered pharmacy
Blinding: double‐blind (double‐dummy)
Drop‐outs/withdrawals: 1 of 126 (hypericum), 1 of 113 (fluoxetine)
Jadad score: 1‐2‐1
IV score: 1‐0‐1‐0.5‐0.5‐1 |
| Participants |
Patients included/analyzed: 230/228
Demographics: 157 female, mean age 46 years
Diagnosis: mild to moderate depression (ICD‐10 F32.0/32.1)
Setting: 7 practices (internal medicine) in Germany
Baseline: HAMD values 19.6 +/‐ 3.1 (hypericum), 19.5 +/‐ 2.4 (fluoxetine) |
| Interventions |
Treatment: Hypericum extract Ze 117 2x1 coated tablet (500 mg) for 6 weeks
Control: Fluoxetine 1x1 capsule (20 mg) for 6 weeks |
| Outcomes |
Observation period: 6 weeks
Physician‐rated: Hamilton Depression Scale (HAMD, 21 items; response = at least 50% reduction or score < 10), Clinical Global Impression (CGI)
Physician‐rated: visual analogue scale |
| Notes |
Additional information (particulary responder rates and 17‐item HAMD scores) provided by author and sponsor (Zeller AG, Romanshorn, Switzerland) |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment? |
Low risk |
A ‐ Adequate |
