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. 2016 Dec 15;2016(12):CD006918. doi: 10.1002/14651858.CD006918.pub3

Comparison 1. RISPERIDONE vs PLACEBO.

Outcome or subgroup title No. of studies No. of participants Statistical method Effect size
1 Mental state: no clinically significant response in psychotic symptoms (defined by various scale total score change) ‐ short term (up to 12 weeks) 7   Risk Ratio (M‐H, Random, 95% CI) Subtotals only
1.1 defined by PANSS<30% decline 3 707 Risk Ratio (M‐H, Random, 95% CI) 0.74 [0.67, 0.83]
1.2 defined by PANSS/BPRS <20% decline 6 864 Risk Ratio (M‐H, Random, 95% CI) 0.64 [0.52, 0.78]
2 Leaving the study early ‐ short term (up to 12 weeks) 12   Risk Ratio (M‐H, Random, 95% CI) Subtotals only
2.1 any reason 12 2261 Risk Ratio (M‐H, Random, 95% CI) 0.69 [0.62, 0.78]
2.2 due to adverse events 10 2081 Risk Ratio (M‐H, Random, 95% CI) 0.78 [0.59, 1.03]
2.3 due to lack of efficacy 11 2211 Risk Ratio (M‐H, Random, 95% CI) 0.39 [0.29, 0.51]
2.4 due to noncompliance 4 534 Risk Ratio (M‐H, Random, 95% CI) 1.15 [0.33, 4.05]
2.5 lost to follow‐up 6 1545 Risk Ratio (M‐H, Random, 95% CI) 0.79 [0.25, 2.56]
2.6 protocol violation 4 1257 Risk Ratio (M‐H, Random, 95% CI) 0.79 [0.39, 1.62]
2.7 reported death 10 1532 Risk Ratio (M‐H, Random, 95% CI) 3.07 [0.13, 74.28]
2.8 withdrawal of consent 7 1589 Risk Ratio (M‐H, Random, 95% CI) 1.12 [0.80, 1.56]
2.9 other 3 615 Risk Ratio (M‐H, Random, 95% CI) 1.03 [0.68, 1.57]
3 Global state: 1. average endpoint scores of CGI severity scale (high=poor) ‐ short term (up to 12 weeks) 3 457 Mean Difference (IV, Random, 95% CI) ‐0.81 [‐0.89, ‐0.73]
4 Global state: 2. no significant clinical improvement CGI ‐ short term (up to 12 weeks) 4 594 Risk Ratio (M‐H, Random, 95% CI) 0.69 [0.57, 0.83]
5 Global state: 3. needing additional medication ‐ short term (up to 12 weeks) 6   Risk Ratio (M‐H, Random, 95% CI) Subtotals only
5.1 benzodiazepine 1 42 Risk Ratio (M‐H, Random, 95% CI) 0.96 [0.77, 1.20]
5.2 benzodiazepine derivatives ‐ Lorazepam 2 228 Risk Ratio (M‐H, Random, 95% CI) 0.93 [0.68, 1.27]
5.3 benzodiazepine derivatives ‐ Nitrazepam 1 184 Risk Ratio (M‐H, Random, 95% CI) 0.51 [0.10, 2.72]
5.4 benzodiazepine related drugs ‐ Zolpidem 1 184 Risk Ratio (M‐H, Random, 95% CI) 0.81 [0.53, 1.23]
5.5 sedative/hypnotic 2 230 Risk Ratio (M‐H, Random, 95% CI) 0.86 [0.69, 1.06]
5.6 antiparkinsonian 2 172 Risk Ratio (M‐H, Random, 95% CI) 1.21 [0.79, 1.86]
5.7 psychotropics 1 186 Risk Ratio (M‐H, Random, 95% CI) 0.62 [0.45, 0.85]
6 Mental state: 1. average endpoint scores on various scales on psychotic symptoms (high=poor) ‐ short term (up to 12 weeks) 3   Mean Difference (IV, Random, 95% CI) Subtotals only
6.1 BPRS total 2 171 Mean Difference (IV, Random, 95% CI) ‐12.69 [‐17.06, ‐8.32]
6.2 PANSS total 3 457 Mean Difference (IV, Random, 95% CI) ‐17.81 [‐18.17, ‐17.45]
6.3 PANSS general pathology 1 44 Mean Difference (IV, Random, 95% CI) ‐13.20 [‐20.15, ‐6.25]
6.4 PANSS negative symptom 3 457 Mean Difference (IV, Random, 95% CI) ‐3.10 [‐3.19, ‐3.01]
6.5 PANSS positive symptom 3 457 Mean Difference (IV, Random, 95% CI) ‐5.49 [‐6.18, ‐4.80]
7 Mental state: 2. skewed data ‐ short term (up to 12 weeks)     Other data No numeric data
7.1 average endpoint score BPRS total (high=poor)     Other data No numeric data
7.2 average change score of CGI‐C (larger decline=good)     Other data No numeric data
7.3 average change score of CGI‐SI (larger decline=good)     Other data No numeric data
7.4 average change score of HAM‐D‐17 (larger decline=good)     Other data No numeric data
7.5 average change score of PANSS total (larger decline=good)     Other data No numeric data
7.6 average change score of PANSS negative symptom (larger decline=good)     Other data No numeric data
7.7 average change score of PANSS positive symptom (larger decline=good)     Other data No numeric data
8 Adverse effects: 1a. extrapyramidal ‐ various effects ‐ short term (up to 12 weeks) 11   Risk Ratio (M‐H, Random, 95% CI) Subtotals only
8.1 general ‐ any significant EPS 7 1511 Risk Ratio (M‐H, Random, 95% CI) 1.56 [1.13, 2.15]
8.2 general ‐ no improvement on AIMS score 1 42 Risk Ratio (M‐H, Random, 95% CI) 0.30 [0.15, 0.61]
8.3 general ‐ no improvement on BAS score 1 226 Risk Ratio (M‐H, Random, 95% CI) 1.14 [1.01, 1.28]
8.4 general ‐ needing medication for EPS 2 94 Risk Ratio (M‐H, Random, 95% CI) 1.14 [0.78, 1.67]
8.5 specific ‐ akathisia 5 1204 Risk Ratio (M‐H, Random, 95% CI) 2.58 [1.41, 4.72]
8.6 specific ‐ bradykinesia 2 485 Risk Ratio (M‐H, Random, 95% CI) 0.87 [0.60, 1.24]
8.7 specific ‐ dyskinesia 1 303 Risk Ratio (M‐H, Random, 95% CI) 0.32 [0.01, 7.86]
8.8 specific ‐ dystonia 3 687 Risk Ratio (M‐H, Random, 95% CI) 3.40 [0.26, 44.46]
8.9 specific ‐ hypertonia 3 505 Risk Ratio (M‐H, Random, 95% CI) 2.98 [1.35, 6.59]
8.10 specific ‐ parkinsonism 2 485 Risk Ratio (M‐H, Random, 95% CI) 7.64 [1.40, 41.59]
8.11 specific ‐ tardive dyskinesia 1 303 Risk Ratio (M‐H, Random, 95% CI) 6.77 [0.35, 130.03]
8.12 specific ‐ tremor 5 1204 Risk Ratio (M‐H, Random, 95% CI) 1.60 [0.89, 2.88]
9 Adverse effects: 1b. extrapyramidal ‐ AIMS average endpoint score ‐ short term (up to 12 weeks) 1   Mean Difference (IV, Random, 95% CI) Subtotals only
10 Adverse effects: 1c. extrapyramidal ‐ skewed data (various scales) ‐ short term (up to 12 weeks)     Other data No numeric data
10.1 average change score of AIMS     Other data No numeric data
10.2 average change score of CGI severity dyskinesia     Other data No numeric data
10.3 average change score of CGI severity parkinsonism     Other data No numeric data
10.4 average change score of ESRS     Other data No numeric data
10.5 average change score of ESRS ‐ akathisia     Other data No numeric data
10.6 average change score of ESRS ‐ dystonia     Other data No numeric data
10.7 average change score of ESRS ‐ dyskinesia     Other data No numeric data
10.8 average change score of ESRS ‐ parkinsonism     Other data No numeric data
11 Adverse effects: 2. any adverse event ‐ short term (up to 12 weeks) 9   Risk Ratio (M‐H, Random, 95% CI) Subtotals only
11.1 any adverse event 7 1610 Risk Ratio (M‐H, Random, 95% CI) 1.05 [0.96, 1.15]
11.2 asthenia 2 639 Risk Ratio (M‐H, Random, 95% CI) 1.93 [0.62, 6.02]
11.3 back pain 1 202 Risk Ratio (M‐H, Random, 95% CI) 1.04 [0.38, 2.86]
11.4 blurred vision 1 202 Risk Ratio (M‐H, Random, 95% CI) 4.16 [0.47, 36.59]
11.5 cogwheel rigidity 1 226 Risk Ratio (M‐H, Random, 95% CI) 5.25 [0.69, 39.88]
11.6 death 1 182 Risk Ratio (M‐H, Random, 95% CI) 3.13 [0.13, 75.92]
11.7 dental disorder 1 202 Risk Ratio (M‐H, Random, 95% CI) 3.64 [0.78, 17.11]
11.8 dysmenorrhoea 2 495 Risk Ratio (M‐H, Random, 95% CI) 1.10 [0.04, 30.00]
11.9 fatigue 2 558 Risk Ratio (M‐H, Random, 95% CI) 2.23 [0.69, 7.22]
11.10 fever 1 130 Risk Ratio (M‐H, Random, 95% CI) 9.28 [0.51, 168.90]
11.11 infection 1 202 Risk Ratio (M‐H, Random, 95% CI) 0.52 [0.10, 2.78]
11.12 salivation ‐ increased 1 202 Risk Ratio (M‐H, Random, 95% CI) 7.28 [0.38, 139.15]
11.13 pyrexia 1 182 Risk Ratio (M‐H, Random, 95% CI) 1.19 [0.45, 3.16]
11.14 pain 1 121 Risk Ratio (M‐H, Random, 95% CI) 1.58 [0.47, 5.31]
11.15 rash (skin) 1 202 Risk Ratio (M‐H, Random, 95% CI) 1.19 [0.45, 3.16]
11.16 vaginitis 1 58 Risk Ratio (M‐H, Random, 95% CI) 1.07 [0.07, 16.32]
11.17 hyperhidrosis 1 437 Risk Ratio (M‐H, Random, 95% CI) 10.35 [0.50, 214.17]
12 Adverse effects: 3. cardiovascular ‐ short term (up to 12 weeks) 4   Risk Ratio (M‐H, Random, 95% CI) Subtotals only
12.1 dizziness ‐ orthostatic 1 44 Risk Ratio (M‐H, Random, 95% CI) 3.0 [0.13, 69.87]
12.2 ECG abnormal 1 182 Risk Ratio (M‐H, Random, 95% CI) 9.40 [0.51, 172.11]
12.3 heart rate decreased 1 182 Risk Ratio (M‐H, Random, 95% CI) 0.52 [0.05, 5.66]
12.4 heart rate increased 1 182 Risk Ratio (M‐H, Random, 95% CI) 0.85 [0.37, 1.96]
12.5 hypotension ‐ postural 1 44 Risk Ratio (M‐H, Random, 95% CI) 3.0 [0.13, 69.87]
12.6 QTc > 450 milliseconds or > 10% increase from baseline 2 380 Risk Ratio (M‐H, Random, 95% CI) 8.46 [1.07, 67.07]
12.7 tachycardia 2 332 Risk Ratio (M‐H, Random, 95% CI) 12.22 [2.33, 64.10]
13 Adverse effects: 4. central nervous system ‐ short term (up to 12 weeks) 10   Risk Ratio (M‐H, Random, 95% CI) Subtotals only
13.1 agitation 8 1388 Risk Ratio (M‐H, Random, 95% CI) 0.93 [0.75, 1.17]
13.2 anxiety 6 1225 Risk Ratio (M‐H, Random, 95% CI) 1.04 [0.73, 1.48]
13.3 dizziness 5 970 Risk Ratio (M‐H, Random, 95% CI) 1.41 [0.65, 3.05]
13.4 headache 10 1905 Risk Ratio (M‐H, Random, 95% CI) 0.99 [0.81, 1.21]
13.5 insomnia 10 1905 Risk Ratio (M‐H, Random, 95% CI) 1.16 [0.97, 1.39]
13.6 sedation 2 517 Risk Ratio (M‐H, Random, 95% CI) 1.84 [0.52, 6.50]
13.7 somnolence 6 951 Risk Ratio (M‐H, Random, 95% CI) 1.61 [1.06, 2.45]
13.8 restlessness 2 619 Risk Ratio (M‐H, Random, 95% CI) 1.16 [0.49, 2.74]
14 Adverse effects: 5. endocrine ‐ serum prolactin increase above reference range (23 ng/ml) ‐ short term (up to 12 weeks) 2 323 Risk Ratio (M‐H, Random, 95% CI) 12.14 [4.38, 33.68]
15 Adverse effects: 6. gastrointestinal system ‐ short term (up to 12 weeks) 10   Risk Ratio (M‐H, Random, 95% CI) Subtotals only
15.1 constipation 8 1695 Risk Ratio (M‐H, Random, 95% CI) 1.88 [1.19, 2.96]
15.2 diarrhoea 1 202 Risk Ratio (M‐H, Random, 95% CI) 0.92 [0.37, 2.30]
15.3 dry mouth 1 202 Risk Ratio (M‐H, Random, 95% CI) 2.43 [0.65, 9.12]
15.4 dyspepsia 5 1058 Risk Ratio (M‐H, Random, 95% CI) 1.24 [0.64, 2.40]
15.5 nausea 6 1225 Risk Ratio (M‐H, Random, 95% CI) 1.18 [0.75, 1.86]
15.6 vomiting 5 1181 Risk Ratio (M‐H, Random, 95% CI) 1.16 [0.65, 2.07]
16 Adverse effects: 7a. metabolic ‐ weight gain ‐ short term (up to 12 weeks) 6   Risk Ratio (M‐H, Random, 95% CI) Subtotals only
16.1 any gain 3 910 Risk Ratio (M‐H, Random, 95% CI) 3.77 [1.34, 10.63]
16.2 >7% increase from baseline 3 606 Risk Ratio (M‐H, Random, 95% CI) 3.47 [1.64, 7.33]
17 Adverse effects: 7b. metabolic ‐ skewed data ‐ average change value on lipid profile ‐ short term (up to 12 weeks)     Other data No numeric data
17.1 cholesterol ‐ total     Other data No numeric data
17.2 HDL     Other data No numeric data
17.3 LDL     Other data No numeric data
17.4 triglycerides     Other data No numeric data
17.5 VLDL     Other data No numeric data
18 Adverse effects: 8. musculoskeletal system ‐ short term (up to 12 weeks) 1   Risk Ratio (M‐H, Random, 95% CI) Subtotals only
18.1 myalgia 1 202 Risk Ratio (M‐H, Random, 95% CI) 0.69 [0.12, 4.06]
18.2 Joint disorder 1 202 Risk Ratio (M‐H, Random, 95% CI) 2.60 [0.52, 13.10]
19 Adverse effects: 9. physiology ‐ short term (up to 12 weeks) 2   Risk Ratio (M‐H, Random, 95% CI) Subtotals only
19.1 ALT increased 1 182 Risk Ratio (M‐H, Random, 95% CI) 1.04 [0.07, 16.45]
19.2 AST increased 1 182 Risk Ratio (M‐H, Random, 95% CI) 0.0 [0.0, 0.0]
19.3 blood CPK increased 2 619 Risk Ratio (M‐H, Random, 95% CI) 0.67 [0.23, 1.95]
19.4 blood pressure increased 1 182 Risk Ratio (M‐H, Random, 95% CI) 1.04 [0.15, 7.26]
20 Adverse effects: 10. respiratory system ‐ short term (up to 12 weeks) 4   Risk Ratio (M‐H, Random, 95% CI) Subtotals only
20.1 upper respiratory infection 2 323 Risk Ratio (M‐H, Random, 95% CI) 2.83 [1.03, 7.74]
20.2 pharyngitis 1 202 Risk Ratio (M‐H, Random, 95% CI) 0.42 [0.08, 2.10]
20.3 rhinitis 2 306 Risk Ratio (M‐H, Random, 95% CI) 10.81 [2.58, 45.29]
20.4 sinusitis 1 437 Risk Ratio (M‐H, Random, 95% CI) 1.04 [0.09, 11.36]