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. 2018 Jan 18;2018(1):CD000458. doi: 10.1002/14651858.CD000458.pub3

Summary of findings for the main comparison. NORADRENERGIC DRUGS compared to PLACEBO for antipsychotic‐induced tardive dyskinesia.

NORADRENERGIC DRUGS compared to PLACEBO for antipsychotic‐induced tardive dyskinesia
Patient or population: patients with antipsychotic‐induced tardive dyskinesia
 Settings: inpatients in Austria and the USA
 Intervention: NORADRENERGIC DRUGS (alpha‐methyldopa, celiprolol)
 Comparison: PLACEBO
Outcomes Illustrative comparative risks* (95% CI) Relative effect
 (95% CI) No of Participants
 (studies) Quality of the evidence
 (GRADE) Comments
Assumed risk Corresponding risk
PLACEBO NORADRENERGIC DRUGS
Tardive dyskinesia: No clinically important improvement
follow‐up: 2 weeks
1000 per 1000 330 per 1000
 (140 to 800) RR 0.33 
 (0.14 to 0.80) 20
 (1 study) ⊕⊕⊝⊝
 low1,2 The included study evaluated alpha‐methyldopa.
Tardive dyskinesia: deterioration
follow‐up: 2 weeks
100 per 1000 33 per 1000
 (2 to 732) RR 0.33 
 (0.02 to 7.32) 20
 (1 study) ⊕⊝⊝⊝
 very low1,3 The included study evaluated alpha‐methyldopa.
Adverse events ‐ not reported See comment See comment Not estimable 0
 (0) See comment We found no studies rating this outcome.
Mental state ‐ not reported See comment See comment Not estimable 0
 (0) See comment We found no studies rating this outcome.
Acceptability of treatment: Leaving the study early
follow‐up: 13 weeks
0 per 1000 0 per 1000
 (0 to 0) RR 5.28 
 (0.27 to 102.58) 35
 (1 study) ⊕⊝⊝⊝
 very low1,3 The included study evaluated celiprolol.
No improvement in quality of life
follow‐up: 13 weeks
944 per 1000 822 per 1000
 (642 to 1000) RR 0.87 
 (0.68 to 1.12) 35
 (1 study) ⊕⊝⊝⊝
 very low1,3 The included study evaluated celiprolol.
*The basis for the assumed risk (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).
 CI: Confidence interval; RR: Risk ratio;
GRADE Working Group grades of evidence
 High quality: Further research is very unlikely to change our confidence in the estimate of effect.
 Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate.
 Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate.
 Very low quality: We are very uncertain about the estimate.

1 Downgraded one step for risk of bias: unclear whether randomisation procedure and allocation concealment were carried out adequately, blinding of outcome assessors was not described.
 2 Downgraded one step for imprecision: few events and small sample size.
 3 Downgraded two steps for imprecision: few events, small sample size and wide CI that includes both no effect and appreciable benefit for intervention group.
 4 Downgraded one level for indirectness: leaving the study early can give an indication, but is not a direct measurement, of treatment acceptability.