| Methods |
Concealment: unclear
Blinding: double‐blind (double‐dummy technique)
Drop‐outs/withdrawals: 19 of 72 (no details for single groups reported)
Jadad score: 1‐1‐0
IV score: 1‐0‐0‐0.5‐0.5‐0 |
| Participants |
Number of patients included/analyzed: 72/66
Demographics: 83% female, mean age 40 years
Diagnosis: mild to moderate major depression (DSM‐IV criteria)
Setting: Institute of Psychiatry, University Sao Paulo, Brasil
Baseline: extrapolated from figure HAMD score hypericum group 15, placebo 17, fluoxetine, 15 |
| Interventions |
Treatment: Hypericum extract Iperisan 3x1 (900 mg) daily for 8 weeks
Control 1: Placebo
Control 2: Fluoxetine 20 mg/day for 8 weeks (1 capsule fluoxetine and 2 capsules placebo per day) |
| Outcomes |
Observation period: 1‐week prerandomzationw ash‐out, 8 weeks post randomization
Physician‐rated: Hamilton Depression Scale (HAMD, 21 items, response = at least 50% redution, remission < 8 on the 17 item scale), Montgomery‐Asberg Depression rating Scale (MADRS), Clinical Global Impression Index (CGI)
Patient‐rated: none |
| Notes |
Publication misses important details. Authors inquired for additional information but no response received |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment? |
Unclear risk |
B ‐ Unclear |
