Rickels 2000.
Methods |
Study design: Randomised controlled trial Study grouping: Parallel group Blinding: Double Duration: 11 to 13 weeks Single‐centre |
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Participants |
Baseline characteristics No significant differences between the groups; only data for the combined participant group reported:
Inclusion criteria: Participants were required to have a diagnosis of generalised anxiety disorder according to DSM‐III‐R, to be at least 21 years old, and to have been taking diazepam, lorazepam, or alprazolam in therapeutic doses continuously for the past 12 months. Exclusion criteria: Panic disorder diagnosis Pretreatment: No significant group differences |
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Interventions |
Intervention characteristics Benzodiazepine taper schedule: 4‐week stabilisation phase, 4‐ to 6‐week taper phase: 25% reduction per week, 5‐week benzodiazepine‐free phase, the experimental drug continued for the first 3 weeks of the benzodiazepine‐free phase
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Outcomes |
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Identification |
Sponsorship source: Supported by NIMH grant MH‐08957. Dr Greenblatt was supported by NIMH grant MH‐34223 and grant DA‐05258 from the National Institute on Drug Abuse. The medications used were provided by Bristol‐Myers Squibb CNS Group, Wallingford, CT. Country: USA Setting: Outpatients Declarations of interest: Not mentioned Authors name: Karl Rickels Institution: Mood and Anxiety Disorders Section, Department of Psychiatry, University of Pennsylvania, Philadelphia Email: krickels@mail.med.upenn.edu Address: University Science Center, 3600 Market St., Suite 803, Philadelphia, PA 19104 |
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Notes | Adverse events not reported appropriately for a meta‐analysis. We selected only the imipramine versus placebo comparison for this meta‐analysis because we did not consider it relevant to combine the experimental intervention groups into a single group (cf. Cochrane Handbook 16.5.4 on how to include multiple groups from 1 study). |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Comment: Not described |
Allocation concealment (selection bias) | Unclear risk | Comment: Not described |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Quote: "Medication was prepared double blind in identical capsules containing either 5 mg buspirone, 25 mg imipramine, or placebo" Comment: Sufficiently done |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Comment: Not described |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Comment: Not clearly described |
Selective reporting (reporting bias) | Low risk | Comment: Probably not, relevant outcome measures |
Other bias | Low risk | Comment: No other sources of bias evident. |