Gerlach 1978.
Methods | Allocation: randomised ‐ no further information.
Blindness: double, not described.
Design: two period cross‐over (no washout).
Duration: 3 weeks in each period. Setting: inpatients, Denmark. |
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Participants | Diagnosis: schizophrenia, manic‐depressive illness, dementia and chronic alcoholism (no criteria) and antipsychotic induced TD. Duration of TD: not reported. N = 20. Sex: 15 males and 3 females, 2 not specified. Age: median 66 years, range 47‐ 79 years. |
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Interventions | 1. Baclofen: dose increasing over 2 weeks to 120 mg/day max; range 20 mg to 120 mg/day. N = 10. 2. Placebo. N = 8. Stable but unspecified dose of antipsychotic medication. Anticholinergics and benzodiazepines allowed. |
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Outcomes | TD symptoms: GRS. Adverse effects. Leaving study early. Behaviour: NOSIE. | |
Notes | Source of support: Baclofen and placebo tablets were supplied by Ciba‐Geigy Ltd. 2 people left study early (refusal to continue medication); unclear about the treatment status of these people. Not possible to separate people with manic‐depressive, dementia or chronic alcoholism from the analysis. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | "Random allocation", no further details. |
Allocation concealment (selection bias) | Unclear risk | No further details. |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | "Double" "Baclofen, 10 mg, and placebo were administered in tablets of identical appearance" |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | "The patients were evaluated by means of live and video‐taped interviews, first before the study, then weekly during the two treatment phases" |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Two people left study early (refusal to continue medication); unclear about the treatment status of these people. Not possible to separate people with manic‐depressive, dementia or chronic alcoholism from the analysis. |
Selective reporting (reporting bias) | Unclear risk | Unclear if all outcomes have been reported. |
Other bias | Unclear risk | The groups seem to have been similar in their baseline characteristics (except for diagnosis). Very small sample size; cross‐over design. |