Cropper 1987.
| Methods | Randomised controlled trial, 4 weeks | |
| Participants | 100 patients in general practice with mixed symptoms of anxiety and depression. Minimum score of at least 9 in both components of the Hospital Anxiety and Depression Scale (HADS) Aged 18 to 69 years |
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| Interventions | Alprazolam versus dothiepin (50/50 patients) Maximum dose: alprazolam 3 mg, dothiepin 150 mg Mean maximum daily dose: alprazolam 2.33 mg, dothiepin 115 mg |
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| Outcomes | Primary outcomes: not described Secondary outcomes: All‐cause withdrawals after 4 weeks: alprazolam 8 (4.0%), dothiepin 8 (4.0%) Withdrawals due to side effects: alprazolam 2 (4.1%), dothiepin 5 (10.6%) Number drug‐related adverse effects: alprazolam 5 (10.2%), dothiepin 9 (19.2%) Physician's global assessment of severity of illness after 4 weeks: alprazolam 0.95 (initial score of 2.47, SD 0.58), dothiepin 0.76 (initial score of 2.38, SD 0.66) HADS, self report, depression scale score after 4 weeks: alprazolam: 6.6 (SD 3.76) and dothiepin 5.9 (SD 3.11) |
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| Notes | Patients must have complied with the protocol for 2 weeks to be included in the analysis of the treatment. Side effect data are available for those who attended the first week follow‐up assessment | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | "Patients were randomly and blindly allocated to treatment groups..." No other information is provided |
| Allocation concealment (selection bias) | Unclear risk | No information provided |
| Blinding (performance bias and detection bias) Patients | Low risk | "The study medications were presented in identical capsules, each containing..." |
| Blinding (performance bias and detection bias) Physicians | Unclear risk | "...and a new bottle was dispensed for the next study period." No other information is provided |
| Blinding (performance bias and detection bias) Investigators | Unclear risk | No information provided |
| Incomplete outcome data (attrition bias) HDRS | Unclear risk | 16 patients were not included for analysis due to protocol violations (alprazolam 6, dothiepin 3) and adverse effects (alprazolam 2, dothiepin 5). Different reasons for dropout were not equally distributed between the treatment groups; there was no intention‐to‐treat analysis. |
| Incomplete outcome data (attrition bias) Withdrawals/side effects | Low risk | All data for patients who attended the week 1 follow‐up assessment were analysed |
| Selective reporting (reporting bias) | Unclear risk | No information provided |
| Other bias | High risk | Patients included with mixed anxiety and depression Maximum dose of alprazolam is adequate therapeutic maximum dose in contrast to the maximum dose of dothiepin, which is lower than the recommended maximum therapeutic range (100 to 200 mg) Support from alprazolam manufacturer |
| Placebo washout | Unclear risk | No information provided |