| 1 Global state: 1.No clinically significant response (as defined by original studies) |
12 |
991 |
Risk Ratio (M‐H, Random, 95% CI) |
0.92 [0.64, 1.32] |
| 2 Global state: 2a. Average endpoint total score (short term, up to 12 weeks, high=poor) |
11 |
991 |
Mean Difference (IV, Random, 95% CI) |
‐1.00 [‐2.58, 0.57] |
| 2.1 CGI |
1 |
80 |
Mean Difference (IV, Random, 95% CI) |
0.10 [‐0.49, 0.69] |
| 2.2 PANSS |
10 |
831 |
Mean Difference (IV, Random, 95% CI) |
‐0.88 [‐3.15, 1.40] |
| 2.3 BPRS |
1 |
80 |
Mean Difference (IV, Random, 95% CI) |
‐2.63 [‐4.55, ‐0.71] |
| 3 Global state: 2b. Average endpoint scale score (medium term, 12 to 24 weeks, high=poor) |
1 |
|
Mean Difference (IV, Random, 95% CI) |
Subtotals only |
| 3.1 PANSS |
1 |
100 |
Mean Difference (IV, Random, 95% CI) |
‐1.20 [‐5.67, 3.27] |
| 4 Global state: 3. Average endpoint SI score (CGI, high=poor) |
1 |
|
Mean Difference (IV, Random, 95% CI) |
Subtotals only |
| 4.1 up to 12 weeks ‐short term |
1 |
108 |
Mean Difference (IV, Random, 95% CI) |
0.10 [‐0.41, 0.61] |
| 5 Mental state: 2a. Specific ‐ binary outcomes |
8 |
|
Risk Ratio (M‐H, Random, 95% CI) |
Subtotals only |
| 5.1 agitation (short term, up to 12 weeks) |
5 |
423 |
Risk Ratio (M‐H, Random, 95% CI) |
1.29 [0.27, 6.27] |
| 5.2 anxiety (short term, up to 12 weeks) |
2 |
168 |
Risk Ratio (M‐H, Random, 95% CI) |
2.18 [0.51, 9.35] |
| 5.3 depression (short term, up to 12 weeks) |
1 |
108 |
Risk Ratio (M‐H, Random, 95% CI) |
0.33 [0.01, 8.01] |
| 5.4 agitation (medium term, 12 to 26 weeks) |
1 |
100 |
Risk Ratio (M‐H, Random, 95% CI) |
0.33 [0.01, 7.99] |
| 6 Mental state: 3. Specific ‐ average endpoint positive score (PANSS, high=poor) |
8 |
683 |
Mean Difference (IV, Random, 95% CI) |
‐0.83 [‐1.99, 0.32] |
| 6.1 by up to 12 weeks ‐ short term |
7 |
583 |
Mean Difference (IV, Random, 95% CI) |
‐0.97 [‐2.34, 0.41] |
| 6.2 from 12‐26 weeks ‐ medium term |
1 |
100 |
Mean Difference (IV, Random, 95% CI) |
‐0.10 [‐1.32, 1.12] |
| 7 Mental state: 4. Specific ‐ average endpoint negative score (PANSS, high=poor) |
7 |
543 |
Mean Difference (IV, Random, 95% CI) |
‐0.48 [‐1.17, 0.21] |
| 7.1 up to 12 weeks ‐ short term |
6 |
443 |
Mean Difference (IV, Random, 95% CI) |
‐0.68 [‐1.52, 0.17] |
| 7.2 from 12‐26 weeks ‐ medium term |
1 |
100 |
Mean Difference (IV, Random, 95% CI) |
0.0 [‐1.23, 1.23] |
| 8 Mental state: 5. Specific ‐ average endpoint general pathological score (PANSS, high=poor ) |
11 |
931 |
Mean Difference (IV, Random, 95% CI) |
‐1.69 [‐3.81, 0.43] |
| 8.1 up to 12 weeks ‐ short term |
10 |
831 |
Mean Difference (IV, Random, 95% CI) |
‐1.83 [‐4.19, 0.54] |
| 8.2 from 12‐26 weeks ‐ medium term |
1 |
100 |
Mean Difference (IV, Random, 95% CI) |
‐0.40 [‐2.52, 1.72] |
| 9 Mental state: 6. average scores of various scales (high=poor, skewed data) |
|
|
Other data |
No numeric data |
| 9.1 BPRS endpoint scale score |
|
|
Other data |
No numeric data |
| 9.2 PANSS general pathology subscale score |
|
|
Other data |
No numeric data |
| 9.3 PANSS negative subscale score |
|
|
Other data |
No numeric data |
| 9.4 PANSS positive subscale score |
|
|
Other data |
No numeric data |
| 9.5 PANSS total endpoint scale score |
|
|
Other data |
No numeric data |
| 10 Leaving the study early |
2 |
|
Risk Ratio (M‐H, Random, 95% CI) |
Subtotals only |
| 10.1 any reason |
2 |
168 |
Risk Ratio (M‐H, Random, 95% CI) |
0.80 [0.22, 2.87] |
| 10.2 no effect |
1 |
108 |
Risk Ratio (M‐H, Random, 95% CI) |
0.33 [0.01, 8.01] |
| 10.3 early discharge |
1 |
60 |
Risk Ratio (M‐H, Random, 95% CI) |
3.0 [0.13, 70.83] |
| 10.4 early treatment termination |
2 |
168 |
Risk Ratio (M‐H, Random, 95% CI) |
1.35 [0.09, 19.24] |
| 10.5 violation of test scheme |
1 |
108 |
Risk Ratio (M‐H, Random, 95% CI) |
5.0 [0.25, 101.77] |
| 10.6 withdrew informed consent |
1 |
108 |
Risk Ratio (M‐H, Random, 95% CI) |
0.33 [0.01, 8.01] |
| 11 Quality of life: Average score (medium term, 12 to 24 weeks, WHO‐QOL‐100, low=poor) |
1 |
|
Mean Difference (IV, Random, 95% CI) |
Subtotals only |
| 11.1 Total score |
1 |
100 |
Mean Difference (IV, Random, 95% CI) |
2.60 [1.31, 3.89] |
| 11.2 Physical health |
1 |
100 |
Mean Difference (IV, Random, 95% CI) |
6.0 [4.38, 7.62] |
| 11.3 Mental health |
1 |
100 |
Mean Difference (IV, Random, 95% CI) |
9.10 [5.92, 12.28] |
| 11.4 Social function |
1 |
100 |
Mean Difference (IV, Random, 95% CI) |
5.60 [3.33, 7.87] |
| 11.5 Spiritual pillar |
1 |
100 |
Mean Difference (IV, Random, 95% CI) |
0.10 [‐1.49, 1.69] |
| 11.6 Environmental area |
1 |
100 |
Mean Difference (IV, Random, 95% CI) |
11.5 [5.86, 17.14] |
| 11.7 Independence |
1 |
100 |
Mean Difference (IV, Random, 95% CI) |
6.20 [3.05, 9.35] |
| 12 Adverse effects:1. At least one adverse effect |
8 |
1362 |
Risk Ratio (M‐H, Random, 95% CI) |
0.89 [0.66, 1.20] |
| 12.1 non‐specific |
3 |
258 |
Risk Ratio (M‐H, Random, 95% CI) |
0.98 [0.70, 1.37] |
| 12.2 abnormal urinary test result |
1 |
108 |
Risk Ratio (M‐H, Random, 95% CI) |
0.33 [0.01, 8.01] |
| 12.3 liver function abnormal |
8 |
658 |
Risk Ratio (M‐H, Random, 95% CI) |
0.54 [0.26, 1.13] |
| 12.4 stuffy nose |
2 |
188 |
Risk Ratio (M‐H, Random, 95% CI) |
3.0 [0.32, 28.32] |
| 12.5 sweating |
1 |
70 |
Risk Ratio (M‐H, Random, 95% CI) |
1.0 [0.07, 15.36] |
| 12.6 urine routine abnormal |
1 |
80 |
Risk Ratio (M‐H, Random, 95% CI) |
0.33 [0.01, 7.95] |
| 13 Adverse effects: 2. Cardiac effects (short term, up to 12 weeks) |
9 |
|
Risk Ratio (M‐H, Random, 95% CI) |
Subtotals only |
| 13.1 abnormal ECG |
6 |
528 |
Risk Ratio (M‐H, Random, 95% CI) |
0.95 [0.40, 2.26] |
| 13.2 blood pressure‐ decrease |
4 |
348 |
Risk Ratio (M‐H, Random, 95% CI) |
0.52 [0.20, 1.32] |
| 13.3 QTc prolongation |
3 |
225 |
Risk Ratio (M‐H, Random, 95% CI) |
0.34 [0.08, 1.39] |
| 13.4 tachycardia |
8 |
643 |
Risk Ratio (M‐H, Random, 95% CI) |
0.35 [0.18, 0.69] |
| 14 Adverse effects: 3. Central / peripheral nervous system |
10 |
|
Risk Ratio (M‐H, Random, 95% CI) |
Subtotals only |
| 14.1 blurred vision (short term, up to 12 weeks) |
6 |
521 |
Risk Ratio (M‐H, Random, 95% CI) |
0.88 [0.31, 2.49] |
| 14.2 dizziness (short term, up to 12 weeks) |
8 |
671 |
Risk Ratio (M‐H, Random, 95% CI) |
0.64 [0.34, 1.22] |
| 14.3 headache (short term, up to 12 weeks) |
5 |
436 |
Risk Ratio (M‐H, Random, 95% CI) |
3.15 [0.52, 18.94] |
| 14.4 insomnia (short term, up to 12 weeks) |
7 |
591 |
Risk Ratio (M‐H, Random, 95% CI) |
2.12 [0.88, 5.10] |
| 14.5 somnolence (short term, up to 12 weeks) |
9 |
731 |
Risk Ratio (M‐H, Random, 95% CI) |
0.34 [0.15, 0.77] |
| 14.6 dizziness (medium term, 12 to 24 weeks) |
1 |
100 |
Risk Ratio (M‐H, Random, 95% CI) |
0.86 [0.31, 2.37] |
| 14.7 headache (medium term, 12 to 24 weeks) |
1 |
100 |
Risk Ratio (M‐H, Random, 95% CI) |
9.00 [1.18, 68.42] |
| 14.8 insomnia (medium term, 12 to 24 weeks) |
1 |
100 |
Risk Ratio (M‐H, Random, 95% CI) |
2.0 [0.19, 21.36] |
| 14.9 somnolence (medium term, 12 to 24 weeks) |
1 |
100 |
Risk Ratio (M‐H, Random, 95% CI) |
0.8 [0.34, 1.86] |
| 15 Adverse effects: 4. Extrapyramidal symptoms ‐ various (short term, up to 12 weeks) |
10 |
|
Risk Ratio (M‐H, Random, 95% CI) |
Subtotals only |
| 15.1 akathisia |
7 |
571 |
Risk Ratio (M‐H, Random, 95% CI) |
1.15 [0.49, 2.70] |
| 15.2 dystonia |
2 |
145 |
Risk Ratio (M‐H, Random, 95% CI) |
0.47 [0.06, 3.53] |
| 15.3 general extrapyramidal symptoms |
4 |
348 |
Risk Ratio (M‐H, Random, 95% CI) |
2.80 [0.64, 12.31] |
| 15.4 tremor |
4 |
343 |
Risk Ratio (M‐H, Random, 95% CI) |
0.44 [0.09, 2.07] |
| 16 Adverse effects: 5. Gastrointestinal |
8 |
|
Risk Ratio (M‐H, Random, 95% CI) |
Subtotals only |
| 16.1 constipation (short term, up to 12 weeks) |
7 |
591 |
Risk Ratio (M‐H, Random, 95% CI) |
0.38 [0.19, 0.75] |
| 16.2 dry mouth (short term, up to 12 weeks) |
7 |
611 |
Risk Ratio (M‐H, Random, 95% CI) |
0.23 [0.10, 0.53] |
| 16.3 nausea / vomiting (short term, up to 12 weeks) |
7 |
611 |
Risk Ratio (M‐H, Random, 95% CI) |
2.68 [1.36, 5.26] |
| 16.4 dry mouth (medium term, 12 to 24 weeks) |
1 |
100 |
Risk Ratio (M‐H, Random, 95% CI) |
0.11 [0.01, 0.84] |
| 16.5 nausea / vomiting (medium term, 12 to 24 weeks) |
1 |
100 |
Risk Ratio (M‐H, Random, 95% CI) |
7.00 [0.89, 54.83] |
| 17 Adverse effects: 6. Haematological |
3 |
|
Risk Ratio (M‐H, Random, 95% CI) |
Subtotals only |
| 17.1 blood routine abnormal (short term, up to 12 weeks) |
1 |
85 |
Risk Ratio (M‐H, Random, 95% CI) |
0.31 [0.01, 7.43] |
| 17.2 leucopenia (short term, up to 12 weeks) |
2 |
140 |
Risk Ratio (M‐H, Random, 95% CI) |
1.0 [0.07, 15.26] |
| 18 Adverse events: 7. Hormonal |
7 |
|
Risk Ratio (M‐H, Random, 95% CI) |
Subtotals only |
| 18.1 menstrual disorder (short term, up to 12 weeks) |
6 |
518 |
Risk Ratio (M‐H, Random, 95% CI) |
0.58 [0.20, 1.64] |
| 18.2 menstrual disorder (medium term, 12 to 24 weeks) |
1 |
100 |
Risk Ratio (M‐H, Random, 95% CI) |
0.5 [0.05, 5.34] |
| 19 Adverse effects: 8a. Metabolic ‐ binary measures |
11 |
|
Risk Ratio (M‐H, Random, 95% CI) |
Subtotals only |
| 19.1 decreased appetite (short term, up to 12 weeks) |
4 |
328 |
Risk Ratio (M‐H, Random, 95% CI) |
0.28 [0.06, 1.39] |
| 19.2 lactation (short term, up to 12 weeks) |
5 |
383 |
Risk Ratio (M‐H, Random, 95% CI) |
0.57 [0.17, 1.92] |
| 19.3 weight gain (short term, up to 12 weeks) |
10 |
823 |
Risk Ratio (M‐H, Random, 95% CI) |
0.45 [0.24, 0.85] |
| 19.4 decreased appetite (medium term, 12 to 24 weeks) |
1 |
100 |
Risk Ratio (M‐H, Random, 95% CI) |
0.13 [0.02, 0.96] |
| 19.5 lactation (medium term, 12 to 24 weeks) |
1 |
100 |
Risk Ratio (M‐H, Random, 95% CI) |
0.0 [0.0, 0.0] |
| 19.6 weight gain (medium term, 12 to 24 weeks) |
1 |
100 |
Risk Ratio (M‐H, Random, 95% CI) |
0.5 [0.05, 5.34] |
| 20 Adverse effects: 8b. Metabolic ‐ continuous measure |
1 |
|
Mean Difference (IV, Random, 95% CI) |
Subtotals only |
| 20.1 cholesterol ‐ TC average endpoint level (in mmol/L, high=poor) |
1 |
180 |
Mean Difference (IV, Random, 95% CI) |
‐0.19 [‐0.36, ‐0.02] |
| 20.2 cholesterol‐TG average endpoint level (in mmol/L, high=poor) |
1 |
180 |
Mean Difference (IV, Random, 95% CI) |
‐0.04 [‐0.21, 0.13] |
| 20.3 cholesterol ‐ LDL average endpoint level (in mmol/L, high=poor) |
1 |
180 |
Mean Difference (IV, Random, 95% CI) |
‐0.12 [‐0.26, 0.02] |
| 20.4 waistline‐ average endpoint level (in cm, high=poor) |
1 |
180 |
Mean Difference (IV, Random, 95% CI) |
‐1.80 [‐3.88, 0.28] |
| 20.5 weight‐ average endpoint level (in Kg, high=poor) |
1 |
180 |
Mean Difference (IV, Random, 95% CI) |
1.30 [‐1.30, 3.90] |
| 20.6 cholesterol ‐ HDL average endpoint (in mmol/L, low=poor)) |
1 |
180 |
Mean Difference (IV, Random, 95% CI) |
‐0.02 [‐0.11, 0.07] |
