1 Leaving the study early ‐ any reason |
16 |
1305 |
Risk Ratio (M‐H, Fixed, 95% CI) |
1.11 [0.89, 1.38] |
1.1 short term ‐ up to 6 weeks |
7 |
380 |
Risk Ratio (M‐H, Fixed, 95% CI) |
1.06 [0.84, 1.34] |
1.2 medium term ‐ 7 ‐ 26 weeks |
9 |
925 |
Risk Ratio (M‐H, Fixed, 95% CI) |
1.22 [0.76, 1.97] |
2 Removed from analysis |
11 |
793 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.99 [0.54, 1.79] |
3 Global effect: 1. Not improved (CGI) |
13 |
580 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.86 [0.68, 1.09] |
3.1 short term ‐ up to 6 weeks |
6 |
294 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.84 [0.58, 1.21] |
3.2 medium term ‐ 7 ‐ 26 weeks |
7 |
286 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.88 [0.65, 1.19] |
4 Global effect: 2. Not ready for discharge ‐ up to 4 weeks |
2 |
73 |
Risk Ratio (M‐H, Fixed, 95% CI) |
1.18 [0.87, 1.60] |
5 Global effect: 3. Needing additional antipsychotic/sedative drugs ‐ up to 6 weeks |
2 |
87 |
Risk Ratio (M‐H, Fixed, 95% CI) |
1.14 [0.62, 2.12] |
6 Global effect: 4. Participant rating of illness |
2 |
|
Risk Ratio (M‐H, Fixed, 95% CI) |
Subtotals only |
6.1 did not feel better ‐ 4 weeks |
2 |
104 |
Risk Ratio (M‐H, Fixed, 95% CI) |
1.23 [0.69, 2.21] |
6.2 much, or very much better ‐ 4 weeks |
1 |
50 |
Risk Ratio (M‐H, Fixed, 95% CI) |
1.0 [0.73, 1.37] |
6.3 worse ‐ 4 weeks |
2 |
104 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.33 [0.04, 3.01] |
6.4 would not prefer to stay on medication ‐ 4 weeks |
2 |
104 |
Risk Ratio (M‐H, Fixed, 95% CI) |
1.19 [0.78, 1.81] |
6.5 prefer another medication ‐ 4 weeks |
2 |
104 |
Risk Ratio (M‐H, Fixed, 95% CI) |
1.19 [0.78, 1.81] |
7 Mental state: 1a. General ‐ not improved, by 8 weeks (BPRS/PANSS) |
6 |
915 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.89 [0.76, 1.05] |
8 Mental state: 1b. General ‐ average endpoint score, by 8 weeks (BPRS, high score=worse) |
3 |
465 |
Mean Difference (IV, Fixed, 95% CI) |
‐1.80 [‐2.92, ‐0.67] |
9 Mental state: 1c. General ‐ average endpoint score, by 8 weeks (PANSS, high score=worse) |
1 |
80 |
Mean Difference (IV, Fixed, 95% CI) |
‐1.75 [‐8.60, 5.10] |
10 Mental state: 1d. General ‐ average change score (BPRS, high score=worse) |
3 |
465 |
Mean Difference (IV, Fixed, 95% CI) |
‐1.38 [‐2.60, ‐0.16] |
11 Mental state: 2. Specific |
5 |
|
Risk Ratio (M‐H, Fixed, 95% CI) |
Subtotals only |
11.1 anxiety ‐ 6 weeks |
1 |
54 |
Risk Ratio (M‐H, Fixed, 95% CI) |
1.44 [0.35, 5.81] |
11.2 anxiety ‐ 7 ‐ 26 weeks |
1 |
30 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.33 [0.01, 7.58] |
11.3 behaviour changes (not specified), by 12 weeks |
2 |
122 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.94 [0.59, 1.50] |
11.4 depression ‐ 4 weeks |
1 |
54 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.5 [0.05, 5.19] |
11.5 excitement ‐ 4 weeks |
1 |
54 |
Risk Ratio (M‐H, Fixed, 95% CI) |
2.0 [0.19, 20.77] |
11.6 restlessness ‐ 4 weeks |
1 |
54 |
Risk Ratio (M‐H, Fixed, 95% CI) |
1.25 [0.38, 4.16] |
11.7 restlessness ‐ 7 ‐ 26 weeks |
1 |
30 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.33 [0.01, 7.58] |
11.8 violence or aggression ‐ 4 weeks |
1 |
54 |
Risk Ratio (M‐H, Fixed, 95% CI) |
2.0 [0.19, 20.77] |
12 Adverse effects: 1. Average change score, by 8 weeks (TESS, high score=worse) |
3 |
340 |
Mean Difference (IV, Fixed, 95% CI) |
‐0.07 [‐0.11, ‐0.03] |
13 Adverse effects: 2. Any adverse event |
14 |
627 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.97 [0.88, 1.06] |
13.1 up to 6 weeks |
7 |
318 |
Risk Ratio (M‐H, Fixed, 95% CI) |
1.02 [0.91, 1.13] |
13.2 7 ‐ 26 weeks |
7 |
309 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.89 [0.76, 1.05] |
14 Adverse effects: 3. Anticholinergic effects ‐ specific symptoms |
9 |
|
Risk Ratio (M‐H, Fixed, 95% CI) |
Subtotals only |
14.1 blurred vision ‐ up to 6 weeks |
4 |
187 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.93 [0.63, 1.39] |
14.2 blurred vision ‐ 12 weeks |
1 |
57 |
Risk Ratio (M‐H, Fixed, 95% CI) |
1.58 [0.52, 4.79] |
14.3 constipation ‐ 4 weeks |
1 |
54 |
Risk Ratio (M‐H, Fixed, 95% CI) |
1.14 [0.92, 1.40] |
14.4 constipation ‐ 7 ‐ 26 weeks |
3 |
124 |
Risk Ratio (M‐H, Fixed, 95% CI) |
1.20 [0.48, 2.96] |
14.5 dry mouth ‐ up to 6 weeks |
3 |
151 |
Risk Ratio (M‐H, Fixed, 95% CI) |
1.35 [0.76, 2.39] |
14.6 dry mouth ‐ 7 ‐ 26 weeks |
3 |
147 |
Risk Ratio (M‐H, Fixed, 95% CI) |
1.16 [0.60, 2.26] |
14.7 nasal congestion ‐ 12 weeks |
1 |
57 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.6 [0.11, 3.32] |
15 Adverse effects: 4. Cardiovascular problems |
12 |
|
Risk Ratio (M‐H, Fixed, 95% CI) |
Subtotals only |
15.1 hypertension ‐ 12 weeks |
1 |
37 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.53 [0.05, 5.33] |
15.2 ECG abnormalites ‐ up to 4 weeks |
2 |
76 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.83 [0.37, 1.90] |
15.3 ECG abnormalities ‐ up to 12 weeks |
4 |
456 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.40 [0.11, 1.47] |
15.4 hypotension ‐ 7 ‐ 26 weeks |
5 |
280 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.84 [0.46, 1.52] |
15.5 syncope ‐ 8 weeks |
1 |
57 |
Risk Ratio (M‐H, Fixed, 95% CI) |
2.7 [0.30, 24.43] |
15.6 tachycardia ‐ 7 to 26 weeks |
6 |
365 |
Risk Ratio (M‐H, Fixed, 95% CI) |
1.08 [0.78, 1.47] |
15.7 unspecified ‐ 12 weeks |
2 |
122 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.83 [0.45, 1.54] |
16 Adverse effects: 5. Gastrointestinal problems |
5 |
|
Risk Ratio (M‐H, Fixed, 95% CI) |
Subtotals only |
16.1 abdominal pain ‐ 6 weeks |
1 |
54 |
Risk Ratio (M‐H, Fixed, 95% CI) |
1.44 [0.35, 5.81] |
16.2 appetite loss ‐ 4 weeks |
1 |
54 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.92 [0.49, 1.70] |
16.3 constipation ‐ 8 weeks |
1 |
60 |
Risk Ratio (M‐H, Fixed, 95% CI) |
5.0 [0.25, 99.95] |
16.4 diarrhoea ‐ 4 weeks |
1 |
54 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.5 [0.05, 5.19] |
16.5 diarrhoea ‐ 12 weeks |
1 |
57 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.18 [0.01, 3.60] |
16.6 nausea or vomiting ‐ 4 weeks |
2 |
95 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.73 [0.15, 3.60] |
16.7 nausea or vomiting ‐ 12 weeks |
1 |
57 |
Risk Ratio (M‐H, Fixed, 95% CI) |
1.8 [0.17, 18.75] |
16.8 stomach trouble ‐ 4 weeks |
1 |
54 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.67 [0.12, 3.68] |
17 Adverse effects: 6. Movement disorders |
19 |
|
Risk Ratio (M‐H, Fixed, 95% CI) |
Subtotals only |
17.1 agitation ‐ 8 weeks |
1 |
132 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.18 [0.01, 3.18] |
17.2 akathisia ‐ up to 6 weeks |
3 |
162 |
Risk Ratio (M‐H, Fixed, 95% CI) |
1.07 [0.52, 2.19] |
17.3 akathisia ‐ up to 12 weeks |
3 |
157 |
Risk Ratio (M‐H, Fixed, 95% CI) |
1.22 [0.80, 1.88] |
17.4 akinesia ‐ 4 weeks |
1 |
50 |
Risk Ratio (M‐H, Fixed, 95% CI) |
9.0 [0.51, 158.85] |
17.5 dyskinesia ‐ 4 weeks |
1 |
29 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.93 [0.29, 3.03] |
17.6 dystonia ‐ up to 6 weeks |
4 |
205 |
Risk Ratio (M‐H, Fixed, 95% CI) |
1.80 [0.91, 3.54] |
17.7 dystonia ‐ up to 12 weeks |
2 |
117 |
Risk Ratio (M‐H, Fixed, 95% CI) |
1.20 [0.59, 2.42] |
17.8 extrapyramidial ‐ up to 4 weeks |
4 |
169 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.97 [0.77, 1.23] |
17.9 extrapyramidal ‐ up to 12 weeks |
4 |
314 |
Risk Ratio (M‐H, Fixed, 95% CI) |
1.08 [0.85, 1.38] |
17.10 excess salivation ‐ 4 weeks |
1 |
50 |
Risk Ratio (M‐H, Fixed, 95% CI) |
1.42 [0.87, 2.31] |
17.11 excess salivation ‐ 7 ‐ 26 weeks |
3 |
124 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.93 [0.39, 2.19] |
17.12 fixed stare ‐ 6 weeks |
1 |
54 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.81 [0.20, 3.27] |
17.13 heavy muscles ‐ up to 6 weeks |
2 |
108 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.70 [0.21, 2.32] |
17.14 muscle cramp ‐ 6 weeks |
1 |
54 |
Risk Ratio (M‐H, Fixed, 95% CI) |
1.44 [0.35, 5.81] |
17.15 muscle spasm ‐ 6 weeks |
1 |
54 |
Risk Ratio (M‐H, Fixed, 95% CI) |
1.08 [0.30, 3.87] |
17.16 muscle spasm ‐ 26 weeks |
1 |
30 |
Risk Ratio (M‐H, Fixed, 95% CI) |
2.0 [0.20, 19.78] |
17.17 needing additional anticholinergic medication ‐ up to 6 weeks |
7 |
302 |
Risk Ratio (M‐H, Fixed, 95% CI) |
1.04 [0.81, 1.33] |
17.18 needing additional anticholinergic medication ‐ up to 12 weeks |
3 |
120 |
Risk Ratio (M‐H, Fixed, 95% CI) |
1.10 [0.71, 1.72] |
17.19 oculogyric crisis ‐ 6 weeks |
1 |
54 |
Risk Ratio (M‐H, Fixed, 95% CI) |
1.35 [0.40, 4.48] |
17.20 rigidity ‐ up to 6 weeks |
4 |
212 |
Risk Ratio (M‐H, Fixed, 95% CI) |
1.20 [0.96, 1.50] |
17.21 rigidity ‐ 7 ‐ 26 weeks |
3 |
124 |
Risk Ratio (M‐H, Fixed, 95% CI) |
1.03 [0.51, 2.06] |
17.22 thick speech ‐ up to 6 weeks |
2 |
108 |
Risk Ratio (M‐H, Fixed, 95% CI) |
1.23 [0.44, 3.39] |
17.23 tremor ‐ up to 6 weeks |
4 |
212 |
Risk Ratio (M‐H, Fixed, 95% CI) |
1.11 [0.81, 1.51] |
17.24 tremor ‐ 7 to 26 weeks |
4 |
184 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.84 [0.54, 1.32] |
17.25 twisting movement ‐ 8 weeks |
1 |
60 |
Risk Ratio (M‐H, Fixed, 95% CI) |
2.0 [0.19, 20.90] |
18 Adverse effects: 7. Neurological problems |
9 |
|
Risk Ratio (M‐H, Fixed, 95% CI) |
Subtotals only |
18.1 ataxia ‐ 4 weeks |
1 |
41 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.26 [0.03, 2.15] |
18.2 clumsiness ‐ 26 weeks |
1 |
30 |
Risk Ratio (M‐H, Fixed, 95% CI) |
3.0 [0.13, 68.26] |
18.3 confusion/cloudiness ‐ 6 weeks |
1 |
54 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.81 [0.20, 3.27] |
18.4 confusion/cloudiness ‐ 7 to 26 weeks |
2 |
87 |
Risk Ratio (M‐H, Fixed, 95% CI) |
2.85 [0.61, 13.24] |
18.5 dizziness, fainting, weakness ‐ up to 6 weeks |
2 |
95 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.93 [0.37, 2.36] |
18.6 dizziness/fainting, weakness ‐ 7 ‐ 26 weeks |
3 |
137 |
Risk Ratio (M‐H, Fixed, 95% CI) |
1.59 [0.67, 3.75] |
18.7 giddiness ‐ 4 weeks |
1 |
54 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.4 [0.08, 1.89] |
18.8 seizures ‐ up to 12 weeks |
3 |
302 |
Risk Ratio (M‐H, Fixed, 95% CI) |
3.94 [0.45, 34.72] |
18.9 unsteadiness ‐ 26 weeks |
1 |
30 |
Risk Ratio (M‐H, Fixed, 95% CI) |
3.0 [0.35, 25.68] |
19 Adverse effects: 8. Sleep problems |
12 |
|
Risk Ratio (M‐H, Fixed, 95% CI) |
Subtotals only |
19.1 drowsiness / sedation ‐ up to 6 weeks |
6 |
279 |
Risk Ratio (M‐H, Fixed, 95% CI) |
1.14 [0.79, 1.65] |
19.2 drowsiness/ sedation ‐ up to 12 weeks |
6 |
408 |
Risk Ratio (M‐H, Fixed, 95% CI) |
1.38 [1.02, 1.86] |
19.3 fatigue ‐ 6 weeks |
1 |
54 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.65 [0.17, 2.44] |
19.4 insomnia ‐ up to 6 weeks |
3 |
137 |
Risk Ratio (M‐H, Fixed, 95% CI) |
1.00 [0.56, 1.81] |
19.5 insomnia ‐ up to 12 weeks |
2 |
189 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.30 [0.13, 0.69] |
19.6 lethargy ‐ up to 6 weeks |
2 |
108 |
Risk Ratio (M‐H, Fixed, 95% CI) |
1.69 [0.77, 3.75] |
20 Adverse effects: 9. Weight changes |
4 |
|
Risk Ratio (M‐H, Fixed, 95% CI) |
Subtotals only |
20.1 weight increase ‐ 6 weeks |
1 |
29 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.47 [0.10, 2.16] |
20.2 weight increase 12 weeks |
2 |
169 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.57 [0.30, 1.10] |
20.3 weight loss ‐ 6 weeks |
1 |
29 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.62 [0.12, 3.19] |
20.4 weight loss ‐ 12 weeks |
2 |
87 |
Risk Ratio (M‐H, Fixed, 95% CI) |
1.38 [0.58, 3.31] |
21 Adverse effects: 10. Others |
16 |
|
Risk Ratio (M‐H, Fixed, 95% CI) |
Subtotals only |
21.1 abnormal blood results ‐ up to 6 weeks |
5 |
235 |
Risk Ratio (M‐H, Fixed, 95% CI) |
1.15 [0.60, 2.22] |
21.2 abnormal blood results ‐ up to 12 weeks |
5 |
506 |
Risk Ratio (M‐H, Fixed, 95% CI) |
1.06 [0.76, 1.47] |
21.3 anxiety ‐ 8 weeks |
1 |
132 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.29 [0.07, 1.20] |
21.4 difficulty swallowing ‐ 6 weeks |
1 |
54 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.81 [0.20, 3.27] |
21.5 headache ‐ 6 weeks |
1 |
54 |
Risk Ratio (M‐H, Fixed, 95% CI) |
1.44 [0.35, 5.81] |
21.6 headache ‐ 12 weeks |
1 |
57 |
Risk Ratio (M‐H, Fixed, 95% CI) |
1.35 [0.24, 7.48] |
21.7 libido ‐ decrease ‐ 4 weeks |
1 |
41 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.21 [0.01, 4.11] |
21.9 opthalmic changes ‐ 12 weeks |
2 |
86 |
Risk Ratio (M‐H, Fixed, 95% CI) |
1.01 [0.15, 6.81] |
21.10 ringing in ears ‐ 6 weeks |
1 |
54 |
Risk Ratio (M‐H, Fixed, 95% CI) |
1.44 [0.35, 5.81] |
21.11 skin problems ‐ rash ‐ 4 weeks |
2 |
95 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.34 [0.09, 1.33] |
21.12 skin problems ‐ rash ‐ 7 ‐ 26 weeks |
4 |
184 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.20 [0.05, 0.77] |
21.13 swelling of hands/face ‐ 4 weeks |
1 |
54 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.67 [0.28, 1.61] |
21.14 swelling of hands/face ‐ 26 weeks |
1 |
30 |
Risk Ratio (M‐H, Fixed, 95% CI) |
5.0 [0.26, 96.13] |
21.15 tingling sensation ‐ 6 weeks |
1 |
54 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.65 [0.17, 2.44] |
21.16 lactation ‐ 12 weeks |
1 |
37 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.35 [0.02, 8.09] |
21.17 sweating ‐ 72 hours |
1 |
47 |
Risk Ratio (M‐H, Fixed, 95% CI) |
2.09 [0.20, 21.48] |
21.18 sweating ‐ 12 weeks |
1 |
57 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.30 [0.01, 7.09] |
21.19 excitement ‐ 12 weeks |
1 |
57 |
Risk Ratio (M‐H, Fixed, 95% CI) |
4.05 [0.96, 17.12] |
21.20 depression ‐ 12 weeks |
1 |
57 |
Risk Ratio (M‐H, Fixed, 95% CI) |
1.2 [0.48, 3.02] |
21.21 lacrimation ‐12 weeks |
1 |
57 |
Risk Ratio (M‐H, Fixed, 95% CI) |
2.71 [0.12, 63.84] |
21.22 breathlessness ‐ 12 weeks |
1 |
57 |
Risk Ratio (M‐H, Fixed, 95% CI) |
2.71 [0.12, 63.84] |
21.23 bulimia ‐ 12 weeks |
1 |
57 |
Risk Ratio (M‐H, Fixed, 95% CI) |
2.71 [0.12, 63.84] |
21.24 hypersalivation ‐ 8 weeks |
1 |
60 |
Risk Ratio (M‐H, Fixed, 95% CI) |
2.0 [0.55, 7.27] |