Summary of findings 3. DOPAMINERGIC DRUGS compared to PLACEBO for antipsychotic‐induced tardive dyskinesia.
DOPAMINERGIC DRUGS compared to PLACEBO for antipsychotic‐induced tardive dyskinesia | ||||||
Patient or population: patients with antipsychotic‐induced tardive dyskinesia Settings: inpatients in the UK and the USA Intervention: DOPAMINERGIC DRUGS (carbidopa/levodopa, oxypertine, reserpine) 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 | DOPAMINERGIC DRUGS | |||||
Tardive dyskinesia: No clinically important improvement follow‐up: 2 weeks |
1000 per 1000 | 520 per 1000 (290 to 960) | RR 0.52 (0.29 to 0.96) | 20 (1 study) | ⊕⊕⊝⊝ low1,2 | The included study evaluated reserpine. |
Tardive dyskinesia: Deterioration follow‐up: 2‐6 weeks |
167 per 1000 | 197 per 1000 (58 to 665) | RR 1.18 (0.35 to 3.99) | 37 (2 studies) | ⊕⊝⊝⊝ very low1,3 | The included studies evaluated reserpine and carbidopa/levodopa. |
Adverse events ‐ not reported | See comment | See comment | Not estimable | 0 (0) | See comment | We found no studies rating this outcome. |
General mental state: Deterioration follow‐up: 24 weeks |
45 per 1000 | 100 per 1000 (10 to 1000) | RR 2.2 (0.22 to 22.45) | 42 (1 study) | ⊕⊝⊝⊝ very low3,4 | The included study evaluated oxypertine. |
Acceptability of treatment: Leaving the study early follow‐up: 2‐24 weeks |
111 per 1000 | 143 per 1000 (72 to 282) | RR 1.29 (0.65 to 2.54) | 163 (6 studies) | ⊕⊝⊝⊝ very low3,5,6,7 | Only two studies (59 participants) evaluating carbidopa/levodopa and oxypertine reported any events for this outcome. 4 studies evaluating amantadine, bromocriptine, and tiapride reported no events and consequently no estimates could be made for these 3 compounds. |
Social confidence, social inclusion, social networks, or personalised quality of life ‐ not reported | See comment | See comment | Not estimable | 0 (0) | See comment | This outcome was designated to be of importance, especially to patients. We found no studies rating this outcome. |
*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 step for risk of bias: unclear whether randomisation procedure and allocation concealment were carried out adequately, attrition was high (45%). 5 Downgraded one step for risk of bias: unclear whether randomisation procedure and allocation concealment were carried out adequately, attrition was high (45%) or unbalanced between groups (25% vs. 0%). 6 Downgraded one step for inconsistency: statistical heterogeneity was high (I² = 58%). 7 Downgraded one step for indirectness: leaving the study early can give an indication, but is not a direct measurement, of treatment acceptability.