Summary of findings for the main comparison. TRIFLUOPERAZINE versus PLACEBO for schizophrenia.
| TRIFLUOPERAZINE versus PLACEBO for schizophrenia | ||||||
| Patient or population: patients with schizophrenia Settings: inpatient and outpatient Intervention: TRIFLUOPERAZINE versus PLACEBO | ||||||
| Outcomes | Illustrative comparative risks* (95% CI) | Relative effect (95% CI) | No of Participants (studies) | Quality of the evidence (GRADE) | Comments | |
| Assumed risk | Corresponding risk | |||||
| Control | TRIFLUOPERAZINE versus PLACEBO | |||||
| Global state ‐ clinical improvement ‐ medium term As defined by each study Follow‐up: mean 19 weeks | Study population | RR 4.61 (1.54 to 13.84) | 417 (3 studies) | ⊕⊕⊝⊝ low4,5 | ||
| 20 per 10001,2 | 94 per 1000 (31 to 282)3 | |||||
| Moderate | ||||||
| 19 per 10001,2 | 88 per 1000 (29 to 263)3 | |||||
| Global state ‐ relapse or worsening ‐ medium term Numbers of participants experiencing relapse/worsening Follow‐up: mean 5 months | Study population | RR 0.34 (0.23 to 0.49) | 381 (2 studies) | ⊕⊕⊝⊝ low6,7 | ||
| 389 per 10001,2 | 132 per 1000 (90 to 191) | |||||
| Moderate | ||||||
| 250 per 10001,2 | 85 per 1000 (58 to 123) | |||||
| Mental state ‐ any clinically significant response in psychotic symptoms (as defined by each study) ‐ medium term Numbers of participants experiencing 'intensified symptoms' Follow‐up: mean 16 weeks | Study population | RR 1.05 (0.54 to 2.05) | 80 (2 studies) | ⊕⊝⊝⊝ very low6,8,9 | ||
| 225 per 10002 | 236 per 1000 (122 to 461) | |||||
| Moderate | ||||||
| 225 per 10002 | 236 per 1000 (122 to 461) | |||||
| Leaving the study early ‐ any reason ‐ medium term Number of participants leaving the studies early Follow‐up: mean 5 months | Study population | RR 0.67 (0.38 to 1.19) | 523 (5 studies) | ⊕⊝⊝⊝ very low6,8,11,12 | ||
| 336 per 100010 | 225 per 1000 (128 to 400) | |||||
| Moderate | ||||||
| 115 per 100010 | 77 per 1000 (44 to 137) | |||||
| Severe adverse effects ‐ short term Numbers of participants leaving the studies due to severe adverse effects Follow‐up: mean 2 months | Study population | RR 1.31 (0.22 to 7.8) | 67 (2 studies) | ⊕⊝⊝⊝ very low8,9,13 | ||
| 77 per 10001,2 | 101 per 1000 (17 to 600) | |||||
| Moderate | ||||||
| 71 per 10001,2 | 93 per 1000 (16 to 554) | |||||
| Behaviour ‐ any clinically significant agitation or distress ‐ medium term As defined by each study Follow‐up: 4 months | 38 per 1000 | 77 per 1000 (7 to 797) | RR 2 (0.19 to 20.72) | 52 (1 study) | ⊕⊝⊝⊝ very low6,8,9 | |
| Economic outcomes | See comment | See comment | Not estimable | 0 (0) | See comment | No studies reported this outcome. |
| *The basis for the assumed risk (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: Confidence interval; RR: Risk ratio; | ||||||
| GRADE Working Group grades of evidence High quality: Further research is very unlikely to change our confidence in the estimate of effect. Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate. Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate. Very low quality: We are very uncertain about the estimate. | ||||||
1 Moderate risk relates to the population percentage in the control group. 2 Median control group risk presented. 3 Data were presented as the positive outcome of 'clinical improvement' so the higher value indicates a favourable outcome. 4 Risk of bias: 'serious' ‐ 33% of the studies rated as a 'high' risk or bias over one or more of the domains; 100% of the included studies did not adequately describe randomisation methods. 5 Indirectness: 'serious' ‐ only 33% of the studies directly compared trifluoperazine to a placebo whereas 67% had other drug interventions in their respective trials. 6 Risk of bias: 'serious' ‐ 100% of the studies rated as a 'high' risk or bias over one or more of the domains; 100% of the included studies did not adequately describe randomisation methods. 7 Indirectness: 'serious' ‐ 50% of the studies directly compared trifluoperazine to a placebo whereas the remaining 50% had other drug interventions in their respective trials. 8 Imprecision: 'serious' ‐ 95% confidence intervals for best estimate of effect include both 'no effect' and appreciable benefit/harm. 9 Indirectness: 'serious' ‐ 100% had other drug interventions in their respective trials. 10 Note: moderate heterogeneity between studies. 11 Inconsistency: 'serious' ‐ moderate heterogeneity evident (I2 = 47%). 12 Indirectness: 'serious' ‐ 20% of the studies directly compared trifluoperazine to a placebo whereas the remaining 80% had other drug interventions in their respective trials. 13 Risk of bias: 'serious' ‐ 50% of the studies rated as a 'high' risk or bias over one or more of the domains; 50% of the included studies did not adequately describe randomisation methods.