| Methods |
Concealment: numbered pharmacy
Blinding: double‐blind
Drop‐out/withdrawals: 12 of 123 (hypericum 600 mg), 19 of 127 (hypericum 1200 mg), 8 of 82 (placebo)
Jadad score: 2‐2‐1
IV score: 1‐1‐0.5‐1‐1‐1 |
| Participants |
Patientns included/analyzed: 332/324
Demographics: 63% female, mean age 46 years
Diagnosis: mild or moderate, single or recurrent, major depressive episode (DSM IV 296.21/22, 296.31/32)
Setting: 11 psychiatric and 5 GP practices in Germany
Baseline: HAMD score hypericum 600 mg group 22.8 +/‐ 3.3, hypericum 1200 mg group 22.6 +/‐3.8, placebo group 23.6 +/‐ 4.2 |
| Interventions |
Treatment 1: 1 tablet hypericum extract (600 mg) daily + 1 placebo tablet for 6 weeks
Treatment 2: 2x1 tablet hypericum extract (total daily extract dosage 1200 mg) daily for 6 weeks
Control: 2x1 tablet placebo daily for 6 weeks |
| Outcomes |
Observation period: 6 weeks
Physician‐rated: Hamilton depression Scale (HAMD, 17 items; response = atleast 50% score reduction), Clinical Global Impression Index (CGI), Montgomery‐Asberg Depression Scale (MADRS)
Patient‐rated: Beck Depression Inventory (BDI), qualtiy of life (SF‐36) |
| Notes |
Randomization in 3:3:2 ratio
Additional information provided by sponsor |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment? |
Low risk |
A ‐ Adequate |
