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. 2018 Apr 17;2018(4):CD000203. doi: 10.1002/14651858.CD000203.pub4

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.
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.
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.
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.
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.