Uhlenhuth 1989.
| Methods | Study design: Randomised controlled trial | |
| Participants |
Diagnosis: DSM ‐ III panic disorder or agoraphobia with panic attacks Method of diagnosis: SCID‐UP Age: M = 31.54, SD = 7.12 Sex: 58% female Location: USA; setting: outpatients Co‐morbidities: patients with another primary psychiatric disorder or a physical disorder judged likely to interfere with the study were excluded Rescue medication: not stated |
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| Interventions |
Participants were randomly assigned to either: (1) alprazolam 2 mg arm (n = 20) Duration: 8 weeks Treatment Protocol: fixed dosage 2 mg (2) alprazolam 6 mg arm (n = 21) Duration: 8 weeks Treatment Protocol: fixed dosage 6 mg (3) imipramine arm (n = 20) Duration: 8 weeks Treatment Protocol: fixed dosage 225 mg (4) placebo arm (n = 20) Duration: 8 weeks |
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| Outcomes |
Time points for assessment: weeks 1, 2, 3, 4, 6, 8 Outcomes: 1. number of panic attacks (major, spontaneous, minor, situational) 2. Marks & Matthews Phobia Scale 3. disability 4. Hamilton Rating Scale for Anxiety (HAMA) 5. Hamilton Rating Scale for Depression (HRSD) 6. SAFTEE‐UP for adverse effects |
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| Notes |
Date of study: not stated Funding source: sponsored by Upjohn Company Declarations of interest among the primary researchers: not stated. |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Quote: "random". |
| Allocation concealment (selection bias) | Unclear risk | No information provided. |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk | Quote: "All patients received two identical appearing capsules four times daily". |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote: "All patients received two identical appearing capsules four times daily". |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Quote: "two sets of outcome analysis were employed; one included all 81 patients who entered treatment, and the other included only the 63 patients who completed at least 4 weeks of treatment. Both sets of analysis presented here were based on the final (last available) clinical score for each patient (endpoint analysis). Patterns of dropout by treatment were analysed by survival analysis using the actuarial life table method." |
| Selective reporting (reporting bias) | Low risk | All outcomes were reported. |
| Other bias | High risk | Sponsored by Upjohn Company; the role of the funder in planning, conducting and writing the study is not discussed. |