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. 2018 Jan 8;2018(1):CD008074. doi: 10.1002/14651858.CD008074.pub2

Comparison 2. ARIPIPRAZOLE (intramuscular) vs OTHER ANTIPSYCHOTIC: a. HALOPERIDOL (intramuscular).

Outcome or subgroup title No. of studies No. of participants Statistical method Effect size
1 Repeated need for tranquillisation 2   Risk Ratio (M‐H, Fixed, 95% CI) Subtotals only
1.1 needing additional injections during 24 hours 2 477 Risk Ratio (M‐H, Fixed, 95% CI) 1.28 [1.00, 1.63]
1.2 needing 1 additional injection during 24 hours 1 117 Risk Ratio (M‐H, Fixed, 95% CI) 1.34 [0.66, 2.70]
1.3 needing 2 additional injections during 24 hours 1 117 Risk Ratio (M‐H, Fixed, 95% CI) 2.37 [0.77, 7.26]
2 Specific behaviour: 1a. Agitation ‐ clinically important change (PANSS‐ EC reduction ≥ 40% from baseline) 2   Risk Ratio (M‐H, Fixed, 95% CI) Subtotals only
2.1 up to 2 hours 2 477 Risk Ratio (M‐H, Fixed, 95% CI) 0.94 [0.80, 1.11]
3 Specific behaviour: 1b. Agitation ‐ average scores ‐ i. up to 2 hours 2   Mean Difference (IV, Fixed, 95% CI) Subtotals only
3.1 change score (ABS, high=worse) 2 473 Mean Difference (IV, Fixed, 95% CI) 0.55 [‐1.00, 2.10]
3.2 change score (ACES, low=agitated, high=sedated) 2 473 Mean Difference (IV, Fixed, 95% CI) 0.12 [‐0.30, 0.55]
3.3 change score (PANSS‐EC, high=worse) 1 357 Mean Difference (IV, Fixed, 95% CI) 0.48 [‐1.16, 2.12]
3.4 change score (PANSS‐EC, high=worse, schizophrenia subgroup) 2 336 Mean Difference (IV, Fixed, 95% CI) 0.07 [‐0.99, 1.13]
3.5 change score (PANSS‐EC, high=worse, non‐sedated patients subgroup based on ACES) 2 422 Mean Difference (IV, Fixed, 95% CI) 0.12 [‐0.82, 1.06]
3.6 change score (PANSS‐EC, high=worse, non‐sedated patients subgroup based on AEs) 2 448 Mean Difference (IV, Fixed, 95% CI) 0.26 [‐0.68, 1.19]
4 Global state: 1. Various 2   Risk Ratio (M‐H, Fixed, 95% CI) Subtotals only
4.1 non‐responders to the first injection 1 360 Risk Ratio (M‐H, Fixed, 95% CI) 1.18 [0.78, 1.79]
4.2 need for benzodiazepine up to 24 hours 2 477 Risk Ratio (M‐H, Fixed, 95% CI) 0.79 [0.46, 1.35]
5 Global outcome: 2. Average scores ‐ i. up to 2 hours 2   Mean Difference (IV, Fixed, 95% CI) Subtotals only
5.1 endpoint score (CGI‐I, high=worse) 2 473 Mean Difference (IV, Fixed, 95% CI) 0.02 [‐0.19, 0.23]
5.2 endpoint score (CGI‐I, high=worse, schizophrenia subgroup 1 79 Mean Difference (IV, Fixed, 95% CI) 0.02 [‐0.44, 0.48]
5.3 change score (CGI‐S, high=worse) 2 473 Mean Difference (IV, Fixed, 95% CI) ‐0.07 [‐0.36, 0.22]
6 Mental state: 1. Average scores ‐ i. up to 2 hours 1   Mean Difference (IV, Fixed, 95% CI) Subtotals only
6.1 change score up to 2 hours (BPRS total, high=worse) 1 102 Mean Difference (IV, Fixed, 95% CI) 2.03 [‐1.70, 5.76]
6.2 change score up to 2 hours (BPRS positive subscale, high=worse) 1 103 Mean Difference (IV, Fixed, 95% CI) 0.23 [‐0.82, 1.28]
7 Adverse effects: 1a. General 2   Risk Ratio (M‐H, Fixed, 95% CI) Subtotals only
7.1 one or more drug related adverse events during 24 hours 1 113 Risk Ratio (M‐H, Fixed, 95% CI) 0.91 [0.61, 1.35]
7.2 onset or increased severity of adverse effects after 2nd injection 1 358 Risk Ratio (M‐H, Fixed, 95% CI) 0.74 [0.57, 0.96]
8 Adverse effects: 1b. General ‐ serious 2   Risk Ratio (M‐H, Fixed, 95% CI) Subtotals only
8.1 death 1 358 Risk Ratio (M‐H, Fixed, 95% CI) 0.0 [0.0, 0.0]
8.2 rated as serious 2 471 Risk Ratio (M‐H, Fixed, 95% CI) 1.73 [0.54, 5.52]
8.3 tonic clonic seizure 1 113 Risk Ratio (M‐H, Fixed, 95% CI) 3.05 [0.13, 73.38]
9 Adverse effects: 2a. Specific ‐ arousal 2   Risk Ratio (M‐H, Fixed, 95% CI) Subtotals only
9.1 insomnia during 24 hours 1 358 Risk Ratio (M‐H, Fixed, 95% CI) 0.48 [0.23, 0.97]
9.2 "over" sedated during 24 hours 1 358 Risk Ratio (M‐H, Fixed, 95% CI) 0.60 [0.34, 1.07]
9.3 somnolence during 24 hours 2 471 Risk Ratio (M‐H, Fixed, 95% CI) 0.81 [0.41, 1.58]
10 Adverse effects: 2b. Specific ‐ cardiovascular 2   Risk Ratio (M‐H, Fixed, 95% CI) Subtotals only
10.1 dizziness during 24 hours 2 471 Risk Ratio (M‐H, Fixed, 95% CI) 1.41 [0.66, 3.01]
10.2 sinus tachycardia during 24 hours 1 113 Risk Ratio (M‐H, Fixed, 95% CI) 0.15 [0.01, 2.75]
10.3 tachycardia during 24 hours 1 113 Risk Ratio (M‐H, Fixed, 95% CI) 4.07 [0.47, 35.31]
11 Adverse effects: 2c. Specific ‐ movement disorders 2   Risk Ratio (M‐H, Fixed, 95% CI) Subtotals only
11.1 akathisia during 24 hours 1 113 Risk Ratio (M‐H, Fixed, 95% CI) 0.51 [0.13, 1.94]
11.2 dystonia during 24 hours 1 113 Risk Ratio (M‐H, Fixed, 95% CI) 0.25 [0.03, 2.21]
11.3 EPS during 24 hours 2 471 Risk Ratio (M‐H, Fixed, 95% CI) 0.29 [0.12, 0.70]
12 Adverse effects: 2d. Specific ‐ miscellaneous 2   Risk Ratio (M‐H, Fixed, 95% CI) Subtotals only
12.1 agitation during 24 hours 2 471 Risk Ratio (M‐H, Fixed, 95% CI) 1.04 [0.42, 2.58]
12.2 headache during 24 hours 2 471 Risk Ratio (M‐H, Fixed, 95% CI) 1.16 [0.62, 2.18]
12.3 pain at injection site 2 471 Risk Ratio (M‐H, Fixed, 95% CI) 3.12 [0.75, 12.91]
12.4 nausea during 24 hours 2 471 Risk Ratio (M‐H, Fixed, 95% CI) 5.52 [1.63, 18.70]
12.5 vomiting during 24 hours 1 113 Risk Ratio (M‐H, Fixed, 95% CI) 2.04 [0.19, 21.82]
13 Leaving the study early 2   Risk Ratio (M‐H, Fixed, 95% CI) Subtotals only
13.1 any reason 2 477 Risk Ratio (M‐H, Fixed, 95% CI) 0.49 [0.20, 1.18]
13.2 lack of efficacy 2 477 Risk Ratio (M‐H, Fixed, 95% CI) 1.05 [0.15, 7.43]
13.3 withdrew consent 2 477 Risk Ratio (M‐H, Fixed, 95% CI) 0.35 [0.10, 1.28]
13.4 adverse effects 2 477 Risk Ratio (M‐H, Fixed, 95% CI) 1.06 [0.18, 6.04]
13.5 other 2 477 Risk Ratio (M‐H, Fixed, 95% CI) 0.75 [0.15, 3.78]