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] |