Table 9 Costa et al., 1985
Domain | Description | Review author’s judgement |
|---|---|---|
Sequence generation | The randomization method is not described. | “Unclear” |
Allocation concealment | Exact method is not described. | “Unclear” |
Blinding of participants, personnel, and outcome | Double blind trial. The issue is not adequately addressed. | “Unclear” |
Incomplete outcome data | The main outcome was the HDRS score. 7 dropout in the mianserin group (MG) and 15 in the placebo group (PG). Reasons for withdrawal: 1 in each group due to AEs, 2 in PG due to lack of efficacy, the treatment by one patient in the PG was interrupted by the investigator, 2 in MG and 4 MG ended the anticancer treatment, 2 in MG due to cancer complications, 1 in MG and 2 in PG due to temporary withdrawal from the anticancer treatment, 2 in PG refused anticancer therapy and were dismissed, 3 in PG had problems at home and 1 in MG died. The authors used an ITT analysis. Missing data imputation method: LOCF approach. Proportionally about one third (30%) of the patients were dropouts, which can induce bias in intervention effect estimate. | “No” |
Selective outcome reporting | No study protocol available. All pre-specified outcomes are reported in the pre-specified way. The response criteria are not pre-specified. | “No” |
Other sources of bias | The study seems to be free of other sources of bias. | “Yes” |