Summary of findings for the main comparison. FLUPHENAZINE (ORAL) compared to AMISULPRIDE for schizophrenia.
| FLUPHENAZINE (ORAL) compared to AMISULPRIDE for schizophrenia | ||||||
| Patient or population: patients with schizophrenia Settings: Austria & EU Intervention: FLUPHENAZINE (ORAL) Comparison: AMISULPRIDE | ||||||
| Outcomes | Illustrative comparative risks* (95% CI) | Relative effect (95% CI) | No of Participants (studies) | Quality of the evidence (GRADE) | Comments | |
| Assumed risk | Corresponding risk | |||||
| AMISULPRIDE | FLUPHENAZINE (ORAL) | |||||
| Mental state: Average endpoint score BPRS total score ‐ short term (up to 12 weeks) (high = poor) Brief Psychiatric Rating Scale (BPRS). Scale from: 0 to 108. Follow‐up: 3 weeks | The mean mental state: average endpoint score BPRS total score ‐ short term (up to 12 weeks) (high = poor) in the control groups was 37.2 points | The mean mental state: average endpoint score BPRS total score ‐ short term (up to 12 weeks) (high = poor) in the intervention groups was 5.1 higher (‐2.35 to 12.55 higher) | 57 (1 study) | ⊕⊝⊝⊝ very low1,2 | ||
| Relapse (long term) ‐ not reported | See comment | See comment | Not estimable | ‐ | See comment | No study reported this outcome |
| Clinically important change in life skills (long term) ‐ not measured | See comment | See comment | Not estimable | ‐ | See comment | No study measured this outcome |
| Quality of life (long term) ‐ not measured | See comment | See comment | Not estimable | ‐ | See comment | No study measured this outcome |
| Adverse effects: Extrapyramidal effects ‐ concomitant anticholinergic medication ‐ short term (up to 12 weeks) Participants requiring concomitant anticholinergic medication Follow‐up: 3 weeks | 53 per 10003 | 412 per 1000 (56 to 1000) | RR 7.82 (1.07 to 57.26) | 36 (1 study) | ⊕⊝⊝⊝ very low2,4 | |
| Leaving the study early ‐ any reason ‐ short term (up to 12 weeks) Follow‐up: 3 weeks | Moderate | RR 1.19 (0.63 to 2.28) | 98 (2 studies) | ⊕⊝⊝⊝ very low2,4 | ||
| 10 per 10003 | 33 per 1000 (1 to 768) | |||||
| Cost‐effectiveness (long term) ‐ not measured | See comment | See comment | Not estimable | ‐ | See comment | No study measured 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 Risk of bias: rated 'serious' ‐ randomisation methods not clearly stated; not all outcomes reported, not all participants accounted for. Only one small study included (Boyer 1987, n = 62). 2 Imprecision: rated 'very serious' ‐ few participants, few events, leading to uncertainty in the precision of estimate of effect. 3 Control risk: mean baseline risk presented from single study. 4 Risk of bias: rated 'serious' ‐ randomisation methods not clearly stated; not all outcomes reported, sponsored by pharmaceutical company. Only one small study included (Saletu 1994, n = 40).