Methods |
Six‐week double‐blind, randomised multicentre study |
Participants |
Patients with ICD‐10 depression, with a score between 16 and 24 points on Hamilton Rating Scale for Depression (HDRS‐17).
Age range: 18‐73 years
Exclusion criteria: participation in a clinical study less than 4 weeks, pregnancy and lactation, insufficient contraception, suicide risk, dementia, or other severe intellectual impairment, chronic alcohol or drug abuse or dependence, severe cardiac, liver, kidney or respiratory insufficiency, neoplasia, Parkinson's or Alzheimer's disease, hypersensitivity to an ingredient of the Hypericum perforatum, febrile illness, anaemia, thyroid or parathyroid disease, pituitary insufficiency. |
Interventions |
Fluoxetine: 35 participants
Hypericum: 35 participants
Fluoxetine dose: 40 mg/day
Hypericum dose: 300 mg/day |
Outcomes |
HDRS‐17, von Zerssen Depression Scale (VZD), Clinical Global Impression (CGI) Scale |
Notes |
Funding: by industry |
Risk of bias |
Bias |
Authors' judgement |
Support for judgement |
Random sequence generation (selection bias) |
Unclear risk |
Randomised, no other information |
Allocation concealment (selection bias) |
Unclear risk |
No information provided |
Blinding (performance bias and detection bias)
All outcomes |
Unclear risk |
Double blind, no further information |
Blinding of participants and personnel (performance bias)
All outcomes |
Unclear risk |
Double blind, no further information |
Blinding of outcome assessment (detection bias)
All outcomes |
Unclear risk |
Double blind, no further information |
Incomplete outcome data (attrition bias)
All outcomes |
High risk |
Number of dropouts reported, but reasons not specified. Endpoint scores reported without denominator |
Selective reporting (reporting bias) |
Unclear risk |
Side effects not reported. Mean endpoint scores and standard deviation reported |
Other bias |
High risk |
Last author's affiliation was PhytoPharm Consulting, Istitute for Phytopharmaceuticals, Berlin; probably this company produces Hypericum perforatum
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