Table 6 Pezella et al., 2001
Domain | Description | Review author’s judgement |
|---|---|---|
Sequence generation | Randomized study, method not described. | “Unclear” |
Allocation concealment | Double dummy technique was used. Assignment envelopes are not described. | “Unclear” |
Blinding of participants, personnel, and outcome | Double blind study. More frequent anticholinegic AEs in the amitriptyline group, which could break blinding. | “Unclear” |
Incomplete outcome data | Main outcome was the MADRS score. 16 withdrawals in the paroxetine group and 19 in the amitriptyline group. 9 dropouts in the paroxetine group and 10 in the amitriptyline group due to AEs. Other reasons for withdrawals are not reported. Analysis according to ITT principle. Missing data imputation method: LOCF. | “No” |
Selective outcome reporting | Protocol is not available. All pre-specified outcomes of interest are reported in the pre-specified way. | “Yes” |
Other sources of bias | The study appears to be free of other sources of bias. | “Yes” |