Domain | Description | Review author’s judgement |
---|---|---|
Sequence generation | Randomization method is not described. | “Unclear” |
Allocation concealment | The exact method is not described. | “Unclear” |
Blinding of participants, personnel, and outcome | Double blind trial. The authors do not address this issue. | “Unclear” |
Incomplete outcome data | The main outcome was the number of patients with success criteria (HADS score≤8) and with response criteria (≥50% improvement in HADS score). There were 15 dropouts in the fluoxetine group (FG) and 7 dropouts in the placebo group (PG). The reasons for dropouts in the FG were: 7 due to AEs, 3 decided to interrupt their participation for unknown reasons, 1 due to alcohol abuse, and 4 for other reasons: | “Unclear” |
(Non-compliance, investigator’s decision, lost to follow-up). The reasons for dropouts in the PG were: 2 due to concomitant events, 4 for unknown reasons, 1 for psychiatric reasons. The authors used an ITT basis for the success and response rates. The exact missing data imputation method is not being reported. | ||
Selective outcome reporting | No study protocol available. All pre-specified outcomes are reported in the pre-specified way. | “Yes” |
Other sources of bias | The study seems to be free of other sources of bias. | “Yes” |