Simpson 1988.
Methods | Allocation: "randomly assigned".
Blindness: double, identical‐appearing tablets.
Duration: 20 weeks (6 weeks observation, 4 weeks dose finding, 6 weeks' treatment, 4 weeks follow‐up).
Design: parallel. Setting: Inpatients from 2 chronic care institutions, USA. Raters: not reported. |
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Participants | Diagnosis: tardive dyskinesia in subjects treated with antipsychotics.
N = 17.
Sex: 8 M, 9 F.
Age: mean 46 years, range 32 to 70 years. Duration of TD: no information. |
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Interventions | 1. Carbidopa/levodopa: full dose: 50/350 mg/d (6 weeks of treatment, and 4 weeks of follow‐up after drug withdrawal). N = 9. 2. Placebo (6 weeks of treatment, and 4 weeks of follow‐up after drug withdrawal). N = 8. "When the appropriate dose was established in the dose finding period, patients received that dose for the next 6 weeks". Concomitant medication: no information. |
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Outcomes | TD symptoms: improvement and deterioration (AIMS and Simpson Abbreviated Dyskiesia Scale). Leaving the study early. Unable to use ‐ Treatment‐related side‐effects. Mental state: BPRS, SANS (F and P values only). |
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Notes | Sponsorship source: not reported. Medication and placebo supplied by Merck Sharp and Dohme, Rahway, NJ. (Unclear if medications were supplied free of charge). | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | "Patients were randomly assigned"; further details not reported. |
Allocation concealment (selection bias) | Unclear risk | Allocation concealment not reported. |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | "active (Sinemet) or placebo tablets (supplied by Merck Sharp and Dohme, Rahway, NJ). Both groups of patients received the same number of identical‐appearing tablets." |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | "double‐blind". Details not reported. |
Incomplete outcome data (attrition bias) All outcomes | High risk | "Fifteen of the 17 patients completed the trial; there were two dropouts. A female patient experienced "seizures" and the blind was, therefore, broken; a male patient eloped from the hospital. Both patients were found to be in the placebo group." 25% dropped out from the placebo group versus 0% in the active medication group. According to the degrees of freedom in the F‐test, only completers must have been analysed. |
Selective reporting (reporting bias) | High risk | "Because the AIMS and Simpson scale were very highly correlated, only data from the Simpson scale are presented." Also, mental state data (BPRS and SANS) unusable: reported as F and P values. Adverse Events (Treatment Emergent Side Effects Scale) outcome data not reported. |
Other bias | Unclear risk | Insufficient information reported to make a judgement. |