Banerji 1989.
Methods | Randomised controlled trial, 4 weeks | |
Participants | 104 patients in general practice suffering from neurotic or reactive depression (for at least 2 weeks) entered the study, 3 were lost to follow‐up, 104 patients were included. An RDS score of at least 6 with a CAS score of no more than the RDS was required to be eligible for entry Patients who were withdrawn from the study before week 2 were not included in the analysis of data for therapeutic efficacy, but were evaluated for side effects. 21 patients failed to complete 2 weeks treatment ‐> 80 participants (40 each group) were evaluated for treatment Aged 18 to 70 years |
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Interventions | Alprazolam versus amitriptyline Maximum dose: alprazolam 3 mg and amitriptyline 150 mg Average daily dose alprazolam 1.8 mg and for amitriptyline 63.8 mg | |
Outcomes | Primary outcome: Mean HDRS after 4 weeks: alprazolam 9.2 (initial 21.9) and amitriptyline 5.9 (initial 21.1) 50% reduction of baseline HDRS score: alprazolam 26/40 (72%), 32/40 amitriptyline (84%) Secondary outcome: All‐cause withdrawals: alprazolam 10/51 (20%), amitriptyline 13/53 (25%) Withdrawals due to side effects: alprazolam 6/51 (12%), amitriptyline 11/53 (21)% Physicians' evaluation of no side effects: alprazolam 36%, amitriptyline 54% Side effects: insomnia alprazolam 22%, amitriptyline 6%, headache alprazolam 20%, amitriptyline 4%, dry mouth 30%, amitriptyline 65% |
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Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | "Randomised design". No information provided |
Allocation concealment (selection bias) | Unclear risk | No information provided |
Blinding (performance bias and detection bias) Patients | Low risk | "The drugs were presented in identical capsules." The drugs looked the same, but there appears to have been a difference in side effect profile. |
Blinding (performance bias and detection bias) Physicians | Unclear risk | "The drugs were presented in identical capsules." No further information provided; unclear how physicians administered the drugs, while the tablets looked the same. |
Blinding (performance bias and detection bias) Investigators | Unclear risk | "The drugs were presented in identical capsules" |
Incomplete outcome data (attrition bias) HDRS | High risk | 20% of the included patients were withdrawn from the study and were not evaluated for treatment |
Incomplete outcome data (attrition bias) Withdrawals/side effects | Unclear risk | “...21 patients failed to complete two weeks treatment with the investigational drug (seven protocol violations and 14 withdrawals)” From table: 7 protocol violations: 5 alprazolam and 2 amitriptyline, 13 withdrawals due to side effects: 4 alprazolam and 9 amitriptyline and 1 withdrawal due to feeling improved: alprazolam |
Selective reporting (reporting bias) | Unclear risk | No information provided |
Other bias | Unclear risk | Low therapeutic dosage of amitriptyline in comparison to that of alprazolam |
Placebo washout | Low risk | No information provided |