| 4.1 Irritability |
3 |
267 |
Std. Mean Difference (IV, Random, 95% CI) |
‐0.06 [‐0.30, 0.18] |
| 4.1.1 SSRIs |
2 |
255 |
Std. Mean Difference (IV, Random, 95% CI) |
‐0.05 [‐0.29, 0.20] |
| 4.1.2 Dibenzoxazepine |
1 |
12 |
Std. Mean Difference (IV, Random, 95% CI) |
‐0.23 [‐1.37, 0.91] |
| 4.2 Adverse effects: cardiovascular |
2 |
|
Risk Ratio (IV, Random, 95% CI) |
Subtotals only |
| 4.2.1 Flushing |
1 |
12 |
Risk Ratio (IV, Random, 95% CI) |
2.00 [0.24, 16.61] |
| 4.2.2 Tachycardia |
2 |
35 |
Risk Ratio (IV, Random, 95% CI) |
2.67 [0.31, 23.25] |
| 4.3 Adverse effects: gastrointestinal |
10 |
|
Risk Ratio (IV, Random, 95% CI) |
Subtotals only |
| 4.3.1 Constipation |
2 |
70 |
Risk Ratio (IV, Random, 95% CI) |
0.95 [0.09, 10.03] |
| 4.3.2 Diarrhoea |
4 |
409 |
Risk Ratio (IV, Random, 95% CI) |
0.94 [0.33, 2.64] |
| 4.3.3 Dry mouth |
1 |
12 |
Risk Ratio (IV, Random, 95% CI) |
2.00 [0.24, 16.61] |
| 4.3.4 Gastrointestinal disturbance |
3 |
341 |
Risk Ratio (IV, Random, 95% CI) |
1.41 [0.97, 2.05] |
| 4.3.5 Nausea/abdominal pain |
5 |
251 |
Risk Ratio (IV, Random, 95% CI) |
1.67 [0.85, 3.27] |
| 4.3.6 Vomiting |
5 |
400 |
Risk Ratio (IV, Random, 95% CI) |
1.49 [0.76, 2.92] |
| 4.4 Adverse effect: immune system |
3 |
|
Risk Ratio (IV, Random, 95% CI) |
Subtotals only |
| 4.4.1 Allergies |
1 |
149 |
Risk Ratio (IV, Random, 95% CI) |
1.42 [0.70, 2.88] |
| 4.4.2 Cold, flu or other systemic infection |
1 |
149 |
Risk Ratio (IV, Random, 95% CI) |
1.24 [0.82, 1.87] |
| 4.4.3 Infections |
3 |
472 |
Risk Ratio (IV, Random, 95% CI) |
1.15 [0.85, 1.56] |
| 4.5 Adverse effects: metabolic |
7 |
|
Risk Ratio (IV, Random, 95% CI) |
Subtotals only |
| 4.5.1 Appetite disturbance |
1 |
165 |
Risk Ratio (IV, Random, 95% CI) |
0.55 [0.14, 2.23] |
| 4.5.2 Decreased appetite |
4 |
242 |
Risk Ratio (IV, Random, 95% CI) |
1.35 [0.68, 2.69] |
| 4.5.3 Decreased energy |
1 |
149 |
Risk Ratio (IV, Random, 95% CI) |
1.94 [1.13, 3.33] |
| 4.5.4 Increased appetite |
1 |
149 |
Risk Ratio (IV, Random, 95% CI) |
0.91 [0.35, 2.38] |
| 4.5.5 Weight gain |
2 |
93 |
Risk Ratio (IV, Random, 95% CI) |
1.47 [0.08, 27.39] |
| 4.6 Adverse effect: musculoskeletal |
2 |
|
Risk Ratio (IV, Random, 95% CI) |
Subtotals only |
| 4.6.1 Motor disturbance |
1 |
165 |
Risk Ratio (IV, Random, 95% CI) |
0.31 [0.03, 2.88] |
| 4.6.2 Neck pain |
1 |
37 |
Risk Ratio (IV, Random, 95% CI) |
2.09 [0.09, 48.04] |
| 4.7 Adverse effects: neurological |
10 |
|
Risk Ratio (IV, Random, 95% CI) |
Subtotals only |
| 4.7.1 Activation syndrome |
1 |
158 |
Risk Ratio (IV, Random, 95% CI) |
0.80 [0.31, 2.04] |
| 4.7.2 Agitation |
2 |
197 |
Risk Ratio (IV, Random, 95% CI) |
1.01 [0.59, 1.75] |
| 4.7.3 Aggression or hostility |
3 |
225 |
Risk Ratio (IV, Random, 95% CI) |
1.07 [0.59, 1.95] |
| 4.7.4 Anger/irritability |
2 |
167 |
Risk Ratio (IV, Random, 95% CI) |
1.31 [0.75, 2.29] |
| 4.7.5 Autonomic disturbance |
1 |
165 |
Risk Ratio (IV, Random, 95% CI) |
1.15 [0.32, 4.12] |
| 4.7.6 CNS disturbance |
1 |
165 |
Risk Ratio (IV, Random, 95% CI) |
0.75 [0.33, 1.72] |
| 4.7.7 Decreased attention |
2 |
207 |
Risk Ratio (IV, Random, 95% CI) |
4.16 [1.07, 16.11] |
| 4.7.8 Diaphoresis (sweating) |
1 |
36 |
Risk Ratio (IV, Random, 95% CI) |
3.00 [0.13, 69.09] |
| 4.7.9 Drowsiness/fatigue |
4 |
282 |
Risk Ratio (IV, Random, 95% CI) |
1.25 [0.65, 2.41] |
| 4.7.10 Headache |
3 |
244 |
Risk Ratio (IV, Random, 95% CI) |
1.53 [0.77, 3.07] |
| 4.7.11 Hyperactivity |
2 |
207 |
Risk Ratio (IV, Random, 95% CI) |
1.93 [0.47, 7.82] |
| 4.7.12 Increased speech |
1 |
149 |
Risk Ratio (IV, Random, 95% CI) |
2.08 [0.66, 6.62] |
| 4.7.13 Insomnia |
7 |
449 |
Risk Ratio (IV, Random, 95% CI) |
1.19 [0.87, 1.63] |
| 4.7.14 Mood disturbance |
1 |
165 |
Risk Ratio (IV, Random, 95% CI) |
1.32 [0.75, 2.31] |
| 4.7.15 Mood lability |
2 |
167 |
Risk Ratio (IV, Random, 95% CI) |
0.69 [0.27, 1.74] |
| 4.7.16 Numbness |
1 |
37 |
Risk Ratio (IV, Random, 95% CI) |
2.09 [0.09, 48.04] |
| 4.7.17 Restlessness |
1 |
149 |
Risk Ratio (IV, Random, 95% CI) |
1.93 [0.82, 4.57] |
| 4.7.18 Sedation |
3 |
117 |
Risk Ratio (IV, Random, 95% CI) |
1.91 [0.77, 4.72] |
| 4.7.19 Sleep disturbance |
2 |
223 |
Risk Ratio (IV, Random, 95% CI) |
1.24 [0.31, 4.92] |
| 4.7.20 Tremor |
3 |
85 |
Risk Ratio (IV, Random, 95% CI) |
2.56 [0.57, 11.60] |
| 4.7.21 Twitching |
1 |
12 |
Risk Ratio (IV, Random, 95% CI) |
7.00 [0.44, 111.91] |
| 4.7.22 Vertigo |
1 |
37 |
Risk Ratio (IV, Random, 95% CI) |
2.09 [0.09, 48.04] |
| 4.8 Adverse effects: psychological |
4 |
|
Risk Ratio (IV, Random, 95% CI) |
Subtotals only |
| 4.8.1 Anorexia |
1 |
39 |
Risk Ratio (IV, Random, 95% CI) |
1.58 [0.53, 4.74] |
| 4.8.2 Anxiety/nervousness |
2 |
188 |
Risk Ratio (IV, Random, 95% CI) |
0.66 [0.37, 1.18] |
| 4.8.3 Depression |
1 |
37 |
Risk Ratio (IV, Random, 95% CI) |
1.36 [0.14, 13.72] |
| 4.8.4 Impulsive/intrusive behaviour |
1 |
149 |
Risk Ratio (IV, Random, 95% CI) |
2.92 [1.11, 7.68] |
| 4.8.5 Self‐injury |
1 |
18 |
Risk Ratio (IV, Random, 95% CI) |
1.25 [0.09, 17.02] |
| 4.8.6 Silliness |
1 |
149 |
Risk Ratio (IV, Random, 95% CI) |
0.94 [0.40, 2.17] |
| 4.8.7 Stereotypy |
1 |
149 |
Risk Ratio (IV, Random, 95% CI) |
8.33 [1.07, 64.95] |
| 4.8.8 Suicidal ideation |
1 |
37 |
Risk Ratio (IV, Random, 95% CI) |
2.09 [0.09, 48.04] |
| 4.8.9 Unstable mood |
1 |
149 |
Risk Ratio (IV, Random, 95% CI) |
0.81 [0.32, 2.06] |
| 4.8.10 Verbal aggression |
1 |
37 |
Risk Ratio (IV, Random, 95% CI) |
0.23 [0.01, 5.34] |
| 4.8.11 Vivid or bad dreams |
1 |
37 |
Risk Ratio (IV, Random, 95% CI) |
4.87 [0.27, 87.94] |
| 4.9 Adverse effects: respiratory |
5 |
|
Risk Ratio (IV, Random, 95% CI) |
Subtotals only |
| 4.9.1 Cough |
1 |
18 |
Risk Ratio (IV, Random, 95% CI) |
1.67 [0.52, 5.39] |
| 4.9.2 Respiratory |
2 |
314 |
Risk Ratio (IV, Random, 95% CI) |
2.19 [0.86, 5.55] |
| 4.9.3 Upper respiratory infection (URI) |
2 |
216 |
Risk Ratio (IV, Random, 95% CI) |
0.98 [0.73, 1.31] |
| 4.10 Adverse effects: skin |
3 |
|
Risk Ratio (IV, Random, 95% CI) |
Subtotals only |
| 4.10.1 Rash or skin irritation |
3 |
332 |
Risk Ratio (IV, Random, 95% CI) |
1.00 [0.36, 2.78] |
| 4.11 Adverse effects: urinary |
3 |
|
Risk Ratio (IV, Random, 95% CI) |
Subtotals only |
| 4.11.1 Enuresis |
1 |
18 |
Risk Ratio (IV, Random, 95% CI) |
3.12 [0.81, 12.06] |
| 4.11.2 Polyuria |
1 |
37 |
Risk Ratio (IV, Random, 95% CI) |
2.09 [0.09, 48.04] |
| 4.11.3 Urinary tract infection (UTI) |
1 |
39 |
Risk Ratio (IV, Random, 95% CI) |
0.60 [0.21, 1.73] |
| 4.12 Adverse effects: other |
1 |
|
Risk Ratio (IV, Random, 95% CI) |
Subtotals only |
| 4.12.1 Salty taste |
1 |
37 |
Risk Ratio (IV, Random, 95% CI) |
2.09 [0.09, 48.04] |
| 4.12.2 Trembling (mild) |
1 |
37 |
Risk Ratio (IV, Random, 95% CI) |
2.09 [0.09, 48.04] |
| 4.13 Tolerability/acceptability: loss to follow‐up |
7 |
564 |
Risk Ratio (IV, Random, 95% CI) |
1.22 [0.93, 1.59] |
| 4.14 Subgroup analyses: gender ‐ irritability |
3 |
|
Mean Difference (IV, Random, 95% CI) |
Subtotals only |
| 4.14.1 Male and female participants |
2 |
255 |
Mean Difference (IV, Random, 95% CI) |
‐0.44 [‐2.79, 1.90] |
| 4.14.2 Male participants only |
1 |
12 |
Mean Difference (IV, Random, 95% CI) |
‐1.50 [‐8.37, 5.37] |
| 4.15 Serious adverse events |
2 |
76 |
Risk Ratio (IV, Random, 95% CI) |
0.98 [0.11, 8.85] |
| 4.15.1 Hospitalisation for dehydration |
1 |
58 |
Risk Ratio (IV, Random, 95% CI) |
2.45 [0.10, 57.85] |
| 4.15.2 Severe diarrhoea |
1 |
18 |
Risk Ratio (IV, Random, 95% CI) |
0.41 [0.02, 8.84] |
