Kazamatsuri 1973.
Methods | Allocation: "randomly"
Blindness: rater blind
Duration: 24 weeks (4‐week antipsychotic and antiparkinsonism drug cessation and placebo administration, 18‐week intervention and then 2 weeks placebo)
Design: parallel Setting: inpatients, USA |
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Participants | Diagnosis: chronic psychotic patients: chronic schizophrenia (10), mentally deficient (2), chronic brain syndrome (1); all manifesting typical buccolinguomasticatory oral dyskinesia associated with long‐term antipsychotic medication
N = 13
Sex: 5 women and 8 men
Age: mean 55.8 years, range 41‐63 years History: duration of TD not reported |
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Interventions | 4 week washout from antiparkinsonism and antipsychotic medication (all replaced by placebo), then:. 1. haloperidol: dose 4 mg twice/d. From week 15 dose was doubled to 16 mg/d. N = 7 2. tetrabenazine: dose 50 mg twice/d. From week 15 onwards, dose was doubled to 200 mg/d. N = 6 Concomitant medications: "Other medications, such as antidiabetic or anticonvulsant drugs, were continued unchanged." |
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Outcomes | TD symptoms: not clinically improved TD symptoms: no improvement TD symptoms: deterioration Leaving the study early Unable to use ‐ TD scale scores and adverse effects: EPS Ward behaviour (NOSIE) (means, SDs not reported) |
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Notes | Sponsorship source: supported in part by Public Health Service grant from the National institute of Mental Health. Tetrabenazine and placebo tablets were provided by Hoffman‐La Roche. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | "The 13 patients were divided randomly into two groups." further details not reported |
Allocation concealment (selection bias) | Unclear risk | Allocation concealment not reported |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Blinding of participants and personnel not reported |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | "A frequency count of mouth movements (18), done by a psychiatrist blind to the study design was used to assess oral dyskinesia." |
Incomplete outcome data (attrition bias) All outcomes | High risk | 2/7 (29%) participants dropped out from the haloperidol group; no further details are provided for addressing the outcomes of these participants. No participants dropped out from the tetrabenazine group. |
Selective reporting (reporting bias) | High risk | TD scale scores and extrapyramidal symptoms scale scores not fully reported |
Other bias | Unclear risk | Insufficient information to make a judgement |