Koshino 1983.
Methods | Allocation: "randomly allocated", Details not reported. Blindness: "double‐blind," Details not reported Duration: 6 weeks Design: Parallel Setting: Inpatients in a psychiatric hospital in Japan |
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Participants | Diagnosis: antipsychotic‐induced TD, Schizophrenia N = 28 Sex: Male 16, Female 12 Age: 59.3 (SD: 8.29) History: Duration of TD not reported. |
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Interventions | 1. Dihydrogenated Ergot Alkaloids (6 mg/day, 6 week). N = 14
2. Placebo. N = 14 Concomitant medication not reported. |
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Outcomes | Tardive dyskinesia: Not clinically improved Tardive dyskinesia: Not any improved Tardive dyskinesia: Simpson scale Tardive dyskinesia: Deterioration Mental state: Not any change in general mental state Adverse effects general Leaving the study general Leaving the study Due to side effect |
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Notes | Sponsorship source: Dihydrogenated Ergot Alkaloids and placebo tablets supplied by Sandoz Assessed and data extracted by Yusuke Ogawa. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | "randomly allocated", Details not reported. |
Allocation concealment (selection bias) | Low risk | Randomization was conducted by the third person (outside of the research group). Allocation codes were stored until the end of the study |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | "double‐blind," Details not reported. |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | "double‐blind," Details not reported. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Twenty‐eight patients were admitted to the study, and all of them completed the 4‐week trial. |
Selective reporting (reporting bias) | Unclear risk | Unclear if all pre‐defined outcomes were reported. A protocol is not available. |
Other bias | Unclear risk | Insufficient information to make a judgement. |