Summary of findings 1. Benzodiazepines compared to placebo for psychosis‐induced aggression or agitation.
| Benzodiazepines compared to placebo for psychosis‐induced aggression or agitation | ||||||
| Patient or population: people with psychosis‐induced aggression or agitation Settings: hospitals (Romania and US) Intervention: benzodiazepines 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 | Benzodiazepines | |||||
| Tranquillisation or asleep: sedation ‐ medium term Number of participants sedated Follow‐up: 24 hours | 59 per 10001 | 98 per 1000 (25 to 389) | RR 1.67 (0.42 to 6.61) | 102 (1 study) | ⊕⊝⊝⊝ Very low2,3,4 | ‐ |
| Global state: no improvement ‐ medium term As defined in each study Follow‐up: 24 hours | 569 per 10001 | 353 per 1000 (227 to 552) | RR 0.62 (0.40 to 0.97) | 102 (1 study) | ⊕⊝⊝⊝ Very low2,3,4 | ‐ |
| Global state: need for additional medication ‐ medium term Number of participants requiring additional medication Follow‐up: 24 hours | 529 per 10001 | 529 per 1000 (365 to 762) | RR 1.00 (0.69 to 1.44) | 102 (1 study) | ⊕⊝⊝⊝ Very low2,3,4 | ‐ |
| Adverse effects/events: extrapyramidal symptoms ‐ medium term Number of instances of extrapyramidal symptoms Follow‐up: 24 hours | 59 per 10001 | 19 per 1000 (2 to 182) | RR 0.33 (0.04 to 3.1) | 102 (1 study) | ⊕⊝⊝⊝ Very low2,3,4 | ‐ |
| Satisfaction with treatment: from the perspective of consumer, family and informal carers or professionals/carers at any point during the acute management stage | See comment | See comment | Not estimable | 0 (0) | See comment | No study reported this outcome. |
| Economic outcomes: cost‐effectiveness ‐ clinically important | See comment | See comment | Not estimable | 0 (0) | See comment | No study reported 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: we are very confident that the true effect lies close to that of the estimate of the effect. Moderate quality: we are moderately confident in the effect estimate; the true effect is likely to be close to the estimate of effect, but there is a possibility that it is substantially different. Low quality: our confidence in the effect estimate is limited; the true effect may be substantially different from the estimate of the effect. Very low quality: we have very little confidence in the effect estimate; the true effect is likely to be substantially different from the estimate of effect. | ||||||
1Assumed risk: mean baseline risk presented for single study. Equates with that of control group. 2Risk of bias: 'very serious' ‐ 90% of trial authors and coauthors were employed by trial sponsors at the time of the study ‐ downgraded by 1. 3Risk of bias: 'serious' ‐ randomisation poorly described ‐ downgraded by 1. 4Imprecision: 'serious' ‐ small sample size ‐ downgraded by 1.