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. 2016 Apr 14;2016(4):CD004161. doi: 10.1002/14651858.CD004161.pub2

Comparison 3. RISPERIDONE DEPOT vs ORAL RISPERIDONE.

Outcome or subgroup title No. of studies No. of participants Statistical method Effect size
1 Global state: 1. Moderate to severely ill at end of study period (CGI rating) 1   Risk Ratio (M‐H, Random, 95% CI) Subtotals only
1.1 short term 1 640 Risk Ratio (M‐H, Random, 95% CI) 1.06 [0.92, 1.22]
2 Global state: 2. Mean change from baseline (CGI‐S, high score = worse) 1   Mean Difference (IV, Random, 95% CI) Subtotals only
2.1 short term 1 50 Mean Difference (IV, Random, 95% CI) ‐0.04 [‐0.25, 0.17]
3 Global state: 3. Mean (SD) GAF score change to endpoint 1   Mean Difference (IV, Random, 95% CI) Subtotals only
3.1 short term 1 50 Mean Difference (IV, Random, 95% CI) ‐0.8 [‐5.66, 4.06]
4 Global state: 4. Needing use of benzodiazepine or sedative drugs 2 690 Risk Ratio (M‐H, Random, 95% CI) 0.87 [0.74, 1.02]
4.1 short term 2 690 Risk Ratio (M‐H, Random, 95% CI) 0.87 [0.74, 1.02]
5 Mental state: 1. Average change/endpoint scores (PANSS, high score = worse) 2   Mean Difference (IV, Random, 95% CI) Subtotals only
5.1 mean total (non ITT data) 1 541 Mean Difference (IV, Random, 95% CI) 0.0 [‐2.91, 2.91]
5.2 average change: 1. total (non ITT data) 2 591 Mean Difference (IV, Random, 95% CI) 1.05 [‐0.77, 2.88]
5.3 average change: 2. positive (non‐ITT data) 2 591 Mean Difference (IV, Random, 95% CI) 0.83 [‐0.69, 2.35]
5.4 average change: 3. negative (non ITT data) 2 591 Mean Difference (IV, Random, 95% CI) 0.03 [‐0.76, 0.82]
5.5 average change: 4. disorganised thoughts 1 541 Mean Difference (IV, Random, 95% CI) 0.10 [‐0.45, 0.65]
5.6 average change: 5. hostility/excitement 1 541 Mean Difference (IV, Random, 95% CI) 0.10 [‐0.18, 0.38]
5.7 average change: 6. anxiety/depression 1 541 Mean Difference (IV, Random, 95% CI) 0.10 [‐0.45, 0.65]
6 Leaving the study early: 1. Any reason 2 690 Risk Ratio (M‐H, Random, 95% CI) 1.28 [0.92, 1.79]
6.1 short term 2 690 Risk Ratio (M‐H, Random, 95% CI) 1.28 [0.92, 1.79]
7 Leaving the study early: 2. Specific 1   Risk Ratio (M‐H, Random, 95% CI) Subtotals only
7.1 adverse events ‐ short term 1 640 Risk Ratio (M‐H, Random, 95% CI) 1.21 [0.62, 2.35]
7.2 insufficient response ‐ short term 1 640 Risk Ratio (M‐H, Random, 95% CI) 1.51 [0.63, 3.64]
7.3 withdrawn consent ‐ short term 1 640 Risk Ratio (M‐H, Random, 95% CI) 1.32 [0.65, 2.66]
8 Quality of life: Mean (SD) SF‐36 score change/endpoint (high score = better) 1   Mean Difference (IV, Random, 95% CI) Subtotals only
8.1 Physical component summary 1 50 Mean Difference (IV, Random, 95% CI) 1.4 [‐2.64, 5.44]
8.2 Mental component summary 1 50 Mean Difference (IV, Random, 95% CI) ‐0.20 [‐5.06, 4.66]
8.3 Role physical 1 50 Mean Difference (IV, Random, 95% CI) 1.0 [‐20.71, 22.71]
8.4 Role emotional 1 50 Mean Difference (IV, Random, 95% CI) ‐10.60 [‐34.13, 12.93]
8.5 Vitality 1 50 Mean Difference (IV, Random, 95% CI) ‐1.6 [‐10.24, 7.04]
8.6 General health 1 50 Mean Difference (IV, Random, 95% CI) ‐2.60 [‐13.14, 7.94]
8.7 Mental health 1 50 Mean Difference (IV, Random, 95% CI) 5.8 [‐5.20, 16.80]
8.8 Bodily pain 1 50 Mean Difference (IV, Random, 95% CI) 3.70 [‐9.89, 17.29]
8.9 Physical function 1 50 Mean Difference (IV, Random, 95% CI) ‐4.6 [‐14.25, 5.05]
8.10 Social function 1 50 Mean Difference (IV, Random, 95% CI) 18.5 [3.98, 33.02]
9 Adverse events: 1. General 1   Risk Ratio (M‐H, Random, 95% CI) Subtotals only
9.1 any ‐ short term 1 640 Risk Ratio (M‐H, Random, 95% CI) 1.04 [0.91, 1.18]
9.2 death ‐ short term 1 640 Risk Ratio (M‐H, Random, 95% CI) 0.34 [0.01, 8.20]
10 Adverse events: 1. General: UKU average change score (high = worse) 1   Mean Difference (IV, Random, 95% CI) Subtotals only
10.1 short term 1 50 Mean Difference (IV, Random, 95% CI) ‐1.99 [‐3.59, ‐0.39]
11 Adverse events: 2. Specific 1   Risk Ratio (M‐H, Random, 95% CI) Subtotals only
11.1 anxiety 1 640 Risk Ratio (M‐H, Random, 95% CI) 1.40 [0.84, 2.34]
11.2 psychosis 1 640 Risk Ratio (M‐H, Random, 95% CI) 1.14 [0.58, 2.24]
11.3 prolactin related 1 640 Risk Ratio (M‐H, Random, 95% CI) 0.50 [0.15, 1.65]
11.4 impotence/ejaculation failure 1 640 Risk Ratio (M‐H, Random, 95% CI) 0.34 [0.01, 8.20]
11.5 dysmenorrhoea 1 640 Risk Ratio (M‐H, Random, 95% CI) 1.01 [0.06, 16.02]
11.6 hyperprolactinaemia 1 640 Risk Ratio (M‐H, Random, 95% CI) 0.20 [0.01, 4.18]
11.7 galactorrhoea 1 640 Risk Ratio (M‐H, Random, 95% CI) 1.01 [0.14, 7.10]
11.8 headache 1 640 Risk Ratio (M‐H, Random, 95% CI) 1.14 [0.66, 1.95]
11.9 insomnia 1 640 Risk Ratio (M‐H, Random, 95% CI) 1.08 [0.66, 1.74]
11.10 sexual dysfunction 1 640 Risk Ratio (M‐H, Random, 95% CI) 0.50 [0.05, 5.52]
12 Adverse events: 2. Specific: Mean (SD) weight increase in kg 1   Mean Difference (IV, Random, 95% CI) Subtotals only
12.1 short term 1 640 Mean Difference (IV, Random, 95% CI) 0.2 [‐0.35, 0.75]
13 Adverse events: 3. Movement disorder 2   Risk Ratio (M‐H, Random, 95% CI) Subtotals only
13.1 any extra pyramidal symptoms ‐ short term 1 640 Risk Ratio (M‐H, Random, 95% CI) 1.05 [0.59, 1.88]
13.2 participants requiring anti‐cholinergic drugs ‐ short term 2 690 Risk Ratio (M‐H, Random, 95% CI) 1.03 [0.66, 1.60]
13.3 tardive dyskinesia ‐ short term 1 640 Risk Ratio (M‐H, Random, 95% CI) 9.06 [0.49, 167.52]
14 Adverse events: Mean (SD) change in movement disorder rating scales 1   Mean Difference (IV, Random, 95% CI) Subtotals only
14.1 AIMS 1 50 Mean Difference (IV, Random, 95% CI) 1.16 [‐1.23, 3.55]
14.2 BARS 1 50 Mean Difference (IV, Random, 95% CI) 0.16 [‐0.65, 0.97]
14.3 SAS 1 50 Mean Difference (IV, Random, 95% CI) ‐0.55 [‐3.71, 2.61]