Chen 1995.
Methods | Allocation: "cross over randomized trial".
Blinding: double‐blind with adequate description. Duration: 4 weeks. Design: cross‐over. Setting: inpatients, China. Raters: blinding of raters not reported. |
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Participants | Diagnosis: Antipsychotics‐induced tardive dyskinesia. N = 20*. Sex: 12 M, 8 F. Agemean 34.86 (SD 7.82) years old. Duration of TD: mean 3.52 (SD 2.38) years. |
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Interventions | 1. Bromocriptine Group: at first phase of the trial, the participants received bromocriptine, 1 capsule each time, twice per day for 4 weeks. The second phase was a 2‐week washout period. At the third phase of the trial, the participants received placebo for 4 weeks. N = 10.* 2. Placebo Group: at first phase of the trial, the participants received placebo for 4 weeks. The second phase was a 2‐week washout period. At the third phase of the trial, the participants received bromocriptine, 1 capsule each time, twice per day for 4 weeks. N = 10.* All participants received stable doses of antipsychotics before and during the study. Other concomitant medication was not reported. |
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Outcomes | Leaving the study early. Unable to use (data from first phase before cross‐over not reported separately) ‐ Abnormal Involuntary Movement Scale (AIMS). Clinical response of TD.** Adverse events: dizziness, nausea. Study authors were contacted but no more information was received. |
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Notes | *sequential test method was used; when the 10th participants completed the trial, a significant difference was detected, so they terminated enrolling participants. **clinical improvement defined as the decrease rate of AIMS score ≥ 20%. Data extracted by Sai Zhao from Chinese language report. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | "cross over randomized trial"; no further details reported. |
Allocation concealment (selection bias) | Low risk | "the interventions were coded as intervention A or B by the researcher in pharmacy". |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | "double blind study, the interventions were coded as intervention A or B by the researcher in pharmacy" "Participants and personnel did not know the allocation result". The 2 drugs were contained in capsules with same appearance. Blinding of participants and key study personnel ensured. |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Not reported. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | All participants completed the study. |
Selective reporting (reporting bias) | Unclear risk | Unclear if all predefined outcomes have been reported. A protocol is not available for verification. |
Other bias | Low risk | The study seems to be free of other sources of bias. |