Summary of findings for the main comparison. ARIPIPRAZOLE (IM) compared to PLACEBO/NIL for psychosis‐induced aggression or agitation (rapid tranquillisation).
| ARIPIPRAZOLE compared to PLACEBO/NIL for psychosis‐induced aggression or agitation (rapid tranquillisation) | ||||||
| Patient or population: psychosis‐induced aggression or agitation (rapid tranquillisation) Setting: hospital Intervention: ARIPIPRAZOLE (intramuscular) Comparison: PLACEBO/NIL | ||||||
| Outcomes | Anticipated absolute effects* (95% CI) | Relative effect (95% CI) | № of participants (studies) | Quality of the evidence (GRADE) | Comments | |
| Risk with PLACEBO/NIL | Risk with ARIPIPRAZOLE | |||||
| Tranquillisation or asleep | Not reported | |||||
| Repeated need for tranquillisation ‐ needing additional injections during 24 hours | Low | RR 0.69 (0.56 to 0.85) | 382 (2 RCTs) | ⊕⊝⊝⊝ VERY LOW 1, 2 | ||
| 250 per 1.000 | 173 per 1.000 (140 to 213) | |||||
| Moderate | ||||||
| 600 per 1.000 | 414 per 1.000 (336 to 510) | |||||
| High | ||||||
| 750 per 1.000 | 518 per 1.000 (420 to 638) | |||||
| Specific behaviour: Agitation ‐ clinically important change (PANSS ‐EC reduction ≥ 40% from baseline) ‐ up to 2 hours | Low | RR 1.50 (1.17 to 1.92) | 382 (2 RCTs) | ⊕⊝⊝⊝ VERY LOW 1, 2 | ||
| 100 per 1.000 | 150 per 1.000 (117 to 192) | |||||
| Moderate | ||||||
| 350 per 1.000 | 525 per 1.000 (410 to 672) | |||||
| High | ||||||
| 700 per 1.000 | 1000 per 1.000 (819 to 1.000) | |||||
| Global state: non‐responders to the first injection | Low | RR 0.49 (0.34 to 0.71) | 263 (1 RCT) | ⊕⊕⊝⊝ LOW 2 | ||
| 200 per 1.000 | 98 per 1.000 (68 to 142) | |||||
| Moderate | ||||||
| 450 per 1.000 | 221 per 1.000 (153 to 320) | |||||
| High | ||||||
| 700 per 1.000 | 343 per 1.000 (238 to 497) | |||||
| Adverse effects: one or more adverse events during 24 hours (only reported if occurred in ≥ 5% of people) | Study population | RR 1.51 (0.93 to 2.46) | 117 (1 RCT) | ⊕⊝⊝⊝ VERY LOW 1, 2 | ||
| 295 per 1.000 | 446 per 1.000 (274 to 726) | |||||
| Economic outcomes | Not reported | |||||
| *The risk in the intervention group (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 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 the 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 | ||||||
1 Risk of bias: rated 'serious' (downgraded by 1) ‐ randomisation procedure is not reported for both the included studies, and allocation concealment procedure is not consistently reported in Bristol‐Myers 2005. While for the 'randomisation' bias, studies are at least reported as 'randomised', as for the latter that allocation concealment was correctly handled could not be implied.
2 Indirectness: rated 'very serious' (downgraded by 2) ‐ participants included in the studies had levels of agitation not so pronounced by inclusion criteria, potentially under‐estimating or more likely over‐estimating true effectiveness.