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. 2003 Apr 22;2003(2):CD000440. doi: 10.1002/14651858.CD000440

Comparison 1. RISPERIDONE vs TYPICAL NEUROLEPTIC MEDICATION.

Outcome or subgroup title No. of studies No. of participants Statistical method Effect size
1 Global state: 1. Not improved to a clinically important degree (using BPRS) 2   Risk Ratio (M‐H, Fixed, 95% CI) Subtotals only
1.1 short‐term (up to 12 weeks) 2 173 Risk Ratio (M‐H, Fixed, 95% CI) 0.80 [0.63, 1.02]
2 Global state: 2. Not improved to a clinically important degree (using CGI) 8 1126 Peto Odds Ratio (Peto, Fixed, 95% CI) 0.78 [0.61, 1.00]
2.1 short‐term (up to 12 weeks) 8 1126 Peto Odds Ratio (Peto, Fixed, 95% CI) 0.78 [0.61, 1.00]
3 Global state: 3. Not improved to a clinically important degree (no greater than 20% change in PANSS score) 11 3227 Risk Ratio (M‐H, Fixed, 95% CI) 0.80 [0.74, 0.87]
3.1 short‐term (up to 12 weeks) 9 2368 Risk Ratio (M‐H, Fixed, 95% CI) 0.85 [0.77, 0.93]
3.2 long‐term (over 26 weeks) 2 859 Risk Ratio (M‐H, Fixed, 95% CI) 0.73 [0.65, 0.83]
4 Global state: 4. Not improved to a clinically important degree (no greater than 40% change in PANSS score) 2   Risk Ratio (M‐H, Fixed, 95% CI) Subtotals only
4.1 short‐term (up to 12 weeks) 1 183 Risk Ratio (M‐H, Fixed, 95% CI) 0.85 [0.60, 1.21]
4.2 long‐term (over 26 weeks) 1 675 Risk Ratio (M‐H, Fixed, 95% CI) 0.75 [0.66, 0.84]
5 Global state: 5. Not improved to a clinically important degree (no greater than 60% chnage in PANSS score) 1   Risk Ratio (M‐H, Fixed, 95% CI) Subtotals only
5.3 long‐term (over 26 weeks) 1 675 Risk Ratio (M‐H, Fixed, 95% CI) 0.90 [0.84, 0.96]
6 Global state: 6. Not improved to a clinically important degree (as rated by participants) 1 67 Risk Ratio (M‐H, Fixed, 95% CI) 0.72 [0.47, 1.09]
6.1 short‐term (up to 12 weeks) 1 67 Risk Ratio (M‐H, Fixed, 95% CI) 0.72 [0.47, 1.09]
7 Global state: 7a. Relapse ‐ by 1 year 1 367 Risk Ratio (M‐H, Fixed, 95% CI) 0.64 [0.41, 0.99]
8 Global state: 7b. Relapse ‐ average number of days to relapse (skewed data)     Other data No numeric data
9 Global state: 6. Unable to be discharged from hospital by 8 weeks 1 62 Risk Ratio (M‐H, Fixed, 95% CI) 1.07 [0.65, 1.76]
10 Global state: 6. Change in CGI (continuous, high score = poor)* 4 503 Mean Difference (IV, Fixed, 95% CI) ‐0.11 [‐0.33, 0.11]
10.1 short‐term (up to 12 weeks) 4 503 Mean Difference (IV, Fixed, 95% CI) ‐0.11 [‐0.33, 0.11]
11 Mental state: 1. Change in PANSS by 12 weeks ‐ total (continuous, high score = poor)* 5 1815 Mean Difference (IV, Fixed, 95% CI) ‐1.52 [‐4.01, 0.97]
12 Mental state: 2. Change in PANSS by 12 weeks ‐ negative (continuous, high score = poor)* 4 1820 Mean Difference (IV, Fixed, 95% CI) ‐0.77 [‐1.62, 0.07]
13 Mental state: 3. Change in PANSS by 12 weeks ‐ positive (continuous, high score = poor)* 4 1820 Mean Difference (IV, Fixed, 95% CI) ‐0.24 [‐1.09, 0.60]
14 Mental state: 4. Change in BPRS by 12 weeks (continuous, high score = poor)* 4 1820 Mean Difference (IV, Fixed, 95% CI) ‐1.70 [‐3.22, ‐0.17]
15 Mental state: 5. PANSS endpoint score by 6 weeks (continuous, high score = poor) 1 20 Mean Difference (IV, Fixed, 95% CI) ‐2.75 [‐3.94, ‐1.56]
16 Mental state: 6. Anxiety/tension: short‐term (up to 12 weeks) 5 2087 Risk Ratio (M‐H, Fixed, 95% CI) 1.05 [0.79, 1.38]
17 Mental state: 7. Depression: short‐term (up to 12 weeks) 2 169 Risk Ratio (M‐H, Fixed, 95% CI) 0.72 [0.41, 1.25]
18 Behaviour: 1. Agitation: short‐term (up to 12 weeks) 4 724 Risk Ratio (M‐H, Fixed, 95% CI) 0.88 [0.64, 1.20]
19 Behaviour: 2. Use of medication for sedation: short‐term (up to 12 weeks) 3 198 Risk Ratio (M‐H, Fixed, 95% CI) 1.04 [0.79, 1.37]
20 Cognitive function: short‐term (up to 12 weeks) 4   Risk Ratio (M‐H, Fixed, 95% CI) Subtotals only
20.1 concentration difficulties 4 1548 Risk Ratio (M‐H, Fixed, 95% CI) 0.90 [0.75, 1.07]
20.2 memory difficulties 2 1469 Risk Ratio (M‐H, Fixed, 95% CI) 0.84 [0.69, 1.03]
21 Acceptability of treatment: 1a. Leaving study early ‐ adverse effect 11   Risk Ratio (M‐H, Fixed, 95% CI) Subtotals only
21.1 short‐term (up to 12 weeks) 11 2243 Risk Ratio (M‐H, Fixed, 95% CI) 0.82 [0.61, 1.09]
22 Acceptability of treatment: 1b. Leaving study early ‐ insufficient response 11 2498 Peto Odds Ratio (Peto, Fixed, 95% CI) 0.81 [0.60, 1.08]
22.1 short‐term (up to 12 weeks) 11 2498 Peto Odds Ratio (Peto, Fixed, 95% CI) 0.81 [0.60, 1.08]
23 Acceptability of treatment: 1c. Leaving the study early ‐ any reason 23 4364 Peto Odds Ratio (Peto, Fixed, 95% CI) 0.69 [0.59, 0.80]
23.1 short‐term (up to 12 weeks) 18 3066 Peto Odds Ratio (Peto, Fixed, 95% CI) 0.76 [0.63, 0.92]
23.2 medium term (12‐26 weeks) 1 28 Peto Odds Ratio (Peto, Fixed, 95% CI) 1.24 [0.17, 9.04]
23.3 long‐term (over 26 weeks) 4 1270 Peto Odds Ratio (Peto, Fixed, 95% CI) 0.55 [0.42, 0.73]
24 Acceptability of treatment: 2. Not acceptable ‐ as measured by direct questioning 1 60 Risk Ratio (M‐H, Fixed, 95% CI) 0.70 [0.40, 1.21]
24.1 short‐term (up to 12 weeks) 1 60 Risk Ratio (M‐H, Fixed, 95% CI) 0.70 [0.40, 1.21]
25 Adverse effects: 1. Experiencing at least one adverse effect 9 1276 Risk Ratio (M‐H, Fixed, 95% CI) 0.98 [0.93, 1.02]
26 Adverse effects: 2. Movement disorders ‐ general 14   Risk Ratio (M‐H, Fixed, 95% CI) Subtotals only
26.1 general movement disorders (extrapyramidal side effects) 10 2702 Risk Ratio (M‐H, Fixed, 95% CI) 0.63 [0.56, 0.71]
26.2 use of medication for movement disorders (antiparkinsonian drugs) 11 2524 Risk Ratio (M‐H, Fixed, 95% CI) 0.66 [0.58, 0.74]
26.3 number of people whose need for antiparkinson medication ceased during trial 1 88 Risk Ratio (M‐H, Fixed, 95% CI) 1.07 [0.39, 2.92]
27 Adverse effects: 3. Movement disorders ‐ specific 7   Risk Ratio (M‐H, Fixed, 95% CI) Subtotals only
27.1 abnormal involuntary movements (tardive dyskinesia) 1 62 Risk Ratio (M‐H, Fixed, 95% CI) 1.0 [0.07, 15.28]
27.2 distressing restlessness (akathesia) 4 731 Risk Ratio (M‐H, Fixed, 95% CI) 0.68 [0.52, 0.89]
27.3 postural disturbance (dystonia) 2 169 Risk Ratio (M‐H, Fixed, 95% CI) 0.72 [0.26, 1.99]
27.4 slow impovershed movement, stiffness (parkinsonism) 1 62 Risk Ratio (M‐H, Fixed, 95% CI) 0.89 [0.70, 1.12]
27.5 tremor 2 101 Risk Ratio (M‐H, Fixed, 95% CI) 0.97 [0.51, 1.83]
28 Adverse effects: 4. Movement disorders ‐ change in CGI (high score = poor) 4   Mean Difference (IV, Fixed, 95% CI) Subtotals only
28.1 severity of dyskinesia 3 1778 Mean Difference (IV, Fixed, 95% CI) ‐0.20 [‐0.34, ‐0.06]
28.2 severity of parkinsonism 3 468 Mean Difference (IV, Fixed, 95% CI) ‐0.78 [‐1.18, ‐0.39]
29 Adverse effects: 5. Movement disorders ‐ change in ESRS (high score = poor) 4   Mean Difference (IV, Fixed, 95% CI) Subtotals only
29.1 severity of parkinsonism 3 1507 Mean Difference (IV, Fixed, 95% CI) ‐2.07 [‐2.91, ‐1.23]
29.2 total 3 1708 Mean Difference (IV, Fixed, 95% CI) ‐0.68 [‐1.22, ‐0.15]
30 Adverse effects: 6. Movement disorders ‐ change in UKU (high score = poor) 1 1350 Mean Difference (IV, Fixed, 95% CI) ‐0.49 [‐0.51, ‐0.47]
31 Adverse effects: 7. SAS endpoint score by 6 weeks ( high score = poor) 1 20 Mean Difference (IV, Fixed, 95% CI) ‐0.35 [‐0.55, ‐0.15]
32 Adverse effects: 8. Anticholinergic effects (dry mouth, blurred vision, constipation, urinary difficulties) 9   Risk Ratio (M‐H, Fixed, 95% CI) Subtotals only
32.1 dry mouth 5 1616 Risk Ratio (M‐H, Fixed, 95% CI) 0.80 [0.59, 1.09]
32.2 blurred vision 5 1635 Risk Ratio (M‐H, Fixed, 95% CI) 0.83 [0.62, 1.10]
32.3 constipation 7 2165 Risk Ratio (M‐H, Fixed, 95% CI) 1.04 [0.80, 1.37]
32.4 difficulties passing urine 3 210 Risk Ratio (M‐H, Fixed, 95% CI) 0.24 [0.03, 2.12]
33 Adverse effects: 9. Sleep problems 14   Risk Ratio (M‐H, Fixed, 95% CI) Subtotals only
33.1 reduction ‐ insomnia 7 2699 Risk Ratio (M‐H, Fixed, 95% CI) 0.96 [0.82, 1.14]
33.2 reduction ‐ decreased duration or quality 3 1510 Risk Ratio (M‐H, Fixed, 95% CI) 0.89 [0.69, 1.14]
33.3 increase ‐ duration of sleep 2 1469 Risk Ratio (M‐H, Fixed, 95% CI) 0.95 [0.76, 1.18]
33.4 increase ‐ day time sleepiness (somnolence) 12 2711 Risk Ratio (M‐H, Fixed, 95% CI) 0.89 [0.79, 1.01]
34 Adverse effects: 10. Weight change 4   Risk Ratio (M‐H, Fixed, 95% CI) Subtotals only
34.1 loss 2 1469 Risk Ratio (M‐H, Fixed, 95% CI) 1.23 [0.98, 1.56]
34.2 gain 4 1708 Risk Ratio (M‐H, Fixed, 95% CI) 1.55 [1.25, 1.93]
35 Adverse effects: 11. Gastrointestinal problems 3   Risk Ratio (M‐H, Fixed, 95% CI) Subtotals only
35.1 dyspepsia 1 322 Risk Ratio (M‐H, Fixed, 95% CI) 1.55 [0.47, 5.09]
35.2 nausea 2 366 Risk Ratio (M‐H, Fixed, 95% CI) 1.18 [0.57, 2.44]
35.3 vomiting 2 689 Risk Ratio (M‐H, Fixed, 95% CI) 0.74 [0.43, 1.26]
36 Adverse effects: 12. Central nervous system 10   Risk Ratio (M‐H, Fixed, 95% CI) Subtotals only
36.1 dizziness 7 2426 Risk Ratio (M‐H, Fixed, 95% CI) 1.15 [0.92, 1.43]
36.2 headache 10 2891 Risk Ratio (M‐H, Fixed, 95% CI) 1.06 [0.88, 1.27]
37 Adverse effects: 13. Cardiovascular 6   Risk Ratio (M‐H, Fixed, 95% CI) Subtotals only
37.1 increased heart rate (tachycardia) 3 419 Risk Ratio (M‐H, Fixed, 95% CI) 0.85 [0.39, 1.82]
37.2 palpitations 2 85 Risk Ratio (M‐H, Fixed, 95% CI) 0.85 [0.32, 2.26]
37.3 low blood pressure (hypotension) 2 103 Risk Ratio (M‐H, Fixed, 95% CI) 0.96 [0.38, 2.43]
37.4 high blood pressure (hypertension) 1 367 Risk Ratio (M‐H, Fixed, 95% CI) 0.67 [0.35, 1.27]
38 Adverse effects: 14. Sexual problems 3   Risk Ratio (M‐H, Fixed, 95% CI) Subtotals only
38.1 erectile dysfunction 2 106 Risk Ratio (M‐H, Fixed, 95% CI) 1.55 [0.58, 4.20]
38.2 ejaculatory dysfunction 1 29 Risk Ratio (M‐H, Fixed, 95% CI) 4.12 [0.21, 78.89]
38.3 orgastic dysfunction 1 107 Risk Ratio (M‐H, Fixed, 95% CI) 1.89 [0.36, 9.89]
38.4 diminished sexual desire 2 1469 Risk Ratio (M‐H, Fixed, 95% CI) 0.96 [0.66, 1.41]
39 Adverse effects: 15. Menstrual problems 2   Risk Ratio (M‐H, Fixed, 95% CI) Subtotals only
39.1 amenorrhea 2 45 Risk Ratio (M‐H, Fixed, 95% CI) 1.86 [0.42, 8.17]
39.2 menorrhagia 1 30 Risk Ratio (M‐H, Fixed, 95% CI) 3.0 [0.13, 68.26]
40 Adverse effects: 16. Other 8   Risk Ratio (M‐H, Fixed, 95% CI) Subtotals only
40.1 nasal inflammation (rhinitis) 3 656 Risk Ratio (M‐H, Fixed, 95% CI) 1.99 [1.24, 3.19]
40.2 sweating 5 1606 Risk Ratio (M‐H, Fixed, 95% CI) 0.75 [0.55, 1.02]
40.3 too much saliva 1 183 Risk Ratio (M‐H, Fixed, 95% CI) 0.42 [0.08, 2.26]
40.4 psychosis 1 367 Risk Ratio (M‐H, Fixed, 95% CI) 0.70 [0.47, 1.04]
40.5 injury 1 367 Risk Ratio (M‐H, Fixed, 95% CI) 1.23 [0.68, 2.22]