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. 2018 Apr 17;2018(4):CD000203. doi: 10.1002/14651858.CD000203.pub4

Comparison 1. GABA AGONIST DRUGS versus PLACEBO.

Outcome or subgroup title No. of studies No. of participants Statistical method Effect size
1 Tardive dyskinesia: 1. Not improved to a clinically important extent ‐ medium term 6 258 Risk Ratio (M‐H, Fixed, 95% CI) 0.83 [0.74, 0.92]
1.1 baclofen 2 64 Risk Ratio (M‐H, Fixed, 95% CI) 0.89 [0.70, 1.13]
1.2 progabide 1 13 Risk Ratio (M‐H, Fixed, 95% CI) 0.68 [0.36, 1.25]
1.3 sodium valproate 2 141 Risk Ratio (M‐H, Fixed, 95% CI) 0.86 [0.76, 0.96]
1.4 gamma‐aminobutyric acid 1 40 Risk Ratio (M‐H, Fixed, 95% CI) 0.67 [0.45, 0.98]
2 Tardive dyskinesia: 2. Not any improvement 8 271 Risk Ratio (M‐H, Fixed, 95% CI) 0.72 [0.60, 0.86]
2.1 baclofen ‐ short term 1 10 Risk Ratio (M‐H, Fixed, 95% CI) 1.0 [0.22, 4.56]
2.2 baclofen ‐ medium term 1 33 Risk Ratio (M‐H, Fixed, 95% CI) 1.02 [0.27, 3.84]
2.3 progabide ‐ medium term 1 13 Risk Ratio (M‐H, Fixed, 95% CI) 1.09 [0.05, 21.67]
2.4 sodium valproate ‐ short term 1 32 Risk Ratio (M‐H, Fixed, 95% CI) 0.52 [0.32, 0.83]
2.5 sodium valproate ‐ medium term 2 141 Risk Ratio (M‐H, Fixed, 95% CI) 0.85 [0.71, 1.01]
2.6 THIP ‐ short term 1 2 Risk Ratio (M‐H, Fixed, 95% CI) 0.33 [0.03, 4.19]
2.7 gamma‐aminobutyric acid ‐ medium term 1 40 Risk Ratio (M‐H, Fixed, 95% CI) 0.36 [0.16, 0.80]
3 Tardive dyskinesia: 3. Average endpoint scores (different scales, high score = poor, data skewed)     Other data No numeric data
4 Tardive dyskinesia: 4. Average change scores (different scales, high score = poor, data skewed)     Other data No numeric data
5 Tardive dyskinesia: 5. Deterioration of symptoms 5 136 Risk Ratio (M‐H, Fixed, 95% CI) 1.90 [0.70, 5.16]
5.1 baclofen ‐ short term 2 28 Risk Ratio (M‐H, Fixed, 95% CI) 2.45 [0.11, 53.25]
5.2 baclofen ‐ medium term 2 61 Risk Ratio (M‐H, Fixed, 95% CI) 0.76 [0.13, 4.30]
5.3 sodium valproate ‐ medium term 1 47 Risk Ratio (M‐H, Fixed, 95% CI) 3.41 [0.77, 15.19]
6 Adverse effects 10   Risk Ratio (M‐H, Fixed, 95% CI) Subtotals only
6.1 ataxia (baclofen, sodium valproate) 2 95 Risk Ratio (M‐H, Fixed, 95% CI) 3.25 [0.36, 29.73]
6.2 dizzy/confused (baclofen, progabide) 3 62 Risk Ratio (M‐H, Fixed, 95% CI) 4.54 [1.14, 18.11]
6.3 loss of muscle tone (baclofen) 1 10 Risk Ratio (M‐H, Fixed, 95% CI) 3.0 [0.15, 59.89]
6.4 nausea/vomiting (baclofen) 2 64 Risk Ratio (M‐H, Fixed, 95% CI) 2.61 [0.79, 8.67]
6.5 restlessness/akathisia (baclofen, sodium valproate) 2 80 Risk Ratio (M‐H, Fixed, 95% CI) 1.05 [0.32, 3.49]
6.6 sedation/drowsiness (baclofen, sodium valporate) 4 144 Risk Ratio (M‐H, Fixed, 95% CI) 2.29 [1.08, 4.86]
6.7 seizures (THIP) 1 2 Risk Ratio (M‐H, Fixed, 95% CI) 3.0 [0.24, 37.67]
6.8 Hypothension (Gamma‐ Aminobutyric acid, Sodium Valproate) 2 119 Risk Ratio (M‐H, Fixed, 95% CI) 3.04 [0.33, 28.31]
6.9 Diarrhoea (Gamma‐ Aminobutyric acid) 1 40 Risk Ratio (M‐H, Fixed, 95% CI) 3.0 [0.13, 69.52]
6.10 Leucocyte decrease (sodium valporate) 1 79 Risk Ratio (M‐H, Fixed, 95% CI) 3.08 [0.13, 73.27]
6.11 Low platelet (sodium valporate) 1 79 Risk Ratio (M‐H, Fixed, 95% CI) 17.43 [1.04, 291.96]
6.12 any ‐ baclofen 1 10 Risk Ratio (M‐H, Fixed, 95% CI) 0.0 [0.0, 0.0]
7 Mental state: 1. Deterioration 6 121 Risk Ratio (M‐H, Fixed, 95% CI) 2.65 [0.71, 9.86]
7.1 baclofen ‐ short term 2 28 Risk Ratio (M‐H, Fixed, 95% CI) 4.09 [0.22, 74.78]
7.2 baclofen ‐ medium term 1 31 Risk Ratio (M‐H, Fixed, 95% CI) 0.0 [0.0, 0.0]
7.3 progabide ‐ medium term 1 13 Risk Ratio (M‐H, Fixed, 95% CI) 1.82 [0.11, 30.27]
7.4 sodium valproate ‐ medium term 1 47 Risk Ratio (M‐H, Fixed, 95% CI) 2.27 [0.22, 23.38]
7.5 THIP ‐ short term 1 2 Risk Ratio (M‐H, Fixed, 95% CI) 3.0 [0.24, 37.67]
8 Mental state: 2. Average endpoint score (BPRS, high score = poor) 1   Mean Difference (IV, Fixed, 95% CI) Subtotals only
8.1 Gamma‐Aminobutyric acid ‐ medium term 1 40 Mean Difference (IV, Fixed, 95% CI) 0.03 [‐3.29, 3.35]
9 Leaving the study early 6 218 Risk Ratio (M‐H, Fixed, 95% CI) 1.47 [0.69, 3.15]
9.1 baclofen 3 63 Risk Ratio (M‐H, Fixed, 95% CI) 0.39 [0.07, 2.24]
9.2 progabide 1 13 Risk Ratio (M‐H, Fixed, 95% CI) 1.09 [0.05, 21.67]
9.3 sodium valproate 2 142 Risk Ratio (M‐H, Fixed, 95% CI) 2.48 [0.93, 6.61]