Chouinard 1999.
| Methods | Twelve‐week double‐blind, randomised, multicentre study | |
| Participants | Patients fulfilling DSM‐III criteria for major depressive disorder, with a score of at least 20 on Hamilton Rating Scale for Depression (HDRS‐21). Age: not stated Exclusion criteria: significant concurrent illness including renal, hepatic, cardiovascular or neurological disease, non‐stabilised diabetes, other current Axis I psychiatric diagnosis; organic brain syndrome, past or present abuse of alcohol or drugs; pregnancy or lactating; ECT; continuous lithium therapy in preceding 2 months, use of important psychotropic drug, current therapy with an anticoagulant or type 1 antiarrhythmic. |
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| Interventions | Fluoxetine: 101 participants Paroxetine: 102 participants Fluoxetine dose range: 20‐80 mg/day Paroxetine dose range: 20‐50 mg/day Chloral hydrate was allowed just during the first two weeks of the study | |
| Outcomes | Primary outcomes: HDRS‐21, Clinical Global Impression Secondary outcomes: HDRS‐21 anxiety and somatization scores | |
| Notes | Response: decrease of at least 50% in the HDRS‐21 total score and/or a total score less than 10 Two participants dropped out (1 in the fluoxetine and 1 in the paroxetine group) due to attempted suicide Funding: by industry | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Randomised, no further information |
| Allocation concealment (selection bias) | Unclear risk | No information provided |
| Blinding (performance bias and detection bias) All outcomes | Unclear risk | Double blind, no other information |
| Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Double blind, no other information |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Double blind, no other information |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Quote: "the efficacy analysis included all randomised patients who underwent at least one on‐therapy efficacy evaluation". Number of patients responding to treatment reported with denominator. Reason for withdrawal reported |
| Selective reporting (reporting bias) | Low risk | Effect side reported only with an incidence over 10% |
| Other bias | High risk | Funding by SmithKline, and this company produces paroxetine |