Yin 2004.
Methods | Allocation: "randomly assigned".
Blinding: "double blind" "the sodium valproate and starch placebo were enclosed in capsule with same appearance, the interventions were coded by researchers as drug I and drug II".
Duration: 6 weeks. Location: inpatients, China. |
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Participants | Diagnosis: Antipsychotics‐induced TD (Schooler criteria). Duration of TD: not reported. N = 80. Sex: 80 male. Age:mean 44 (SD 8) years old. |
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Interventions | 1. Sodium valproate group: The initial dosage of sodium valproate was 0.2 g each time, three times per day; after 4 weeks if no adverse events, the dosage was titrated to 0.4 g each time, three times a day for 2 weeks, the treatment lasted for 6 weeks. N = 40. 2. Placebo group: starch capsule was the placebo treatment for 6 weeks. N = 40. All participants received stable doses of antipsychotics. Other concomitant medication was not reported. |
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Outcomes | TD clinical response. TD: AIMS. Mental state: BPRS. Adverse events: TESS, hypotension and disturbance of consciousness, leukocyte decrease, low platelet count. | |
Notes | Funding source: not reported. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | ....."randomly assigned…", no further details |
Allocation concealment (selection bias) | Unclear risk | The author did not state the method of allocation concealment. |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | ....."double blind" "the sodium valproate and starch placebo were enclosed in capsule with same appearance, the interventions were coded by researchers as drug I and drug II" : Blinding of participants and key study personnel ensured. |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Not stated. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | One participant in the treatment group left the study early. |
Selective reporting (reporting bias) | Unclear risk | Unclear if all outcomes have been reported. |
Other bias | Low risk | None obvious. |
TD ‐ tardive dyskinesia
TD scales AIMS ‐ Abnormal Involuntary Movement Scale. BRS ‐ Barnes & Kidger Rating Scale. GRS ‐ Gerlach Rating Scale. SEPS ‐ Smith Extrapyramidal Scale. SRS ‐ Simpson Rating Scale.
Global state scales CGI ‐ Clinical Global Improvement
Mental/behaviour state scales BPRS ‐ Brief Psychiatric Rating Scale NOSIE ‐ Nurses Observation Scale for Inpatient Evaluation
General scales TESS ‐ Treatment Emergent Symptom Scale
Medication abbreviations CPE ‐ chlorpromazine equivalent dosages GVG ‐ Gamma‐vynil GABA SV ‐ Sodium valproate THIP ‐ tetrahydroisoxazolopyridinol