Summary of findings 2. RISPERIDONE DEPOT compared with GENERAL ORAL ANTIPSYCHOTICS for schizophrenia.
| RISPERIDONE DEPOT compared with GENERAL ORAL ANTIPSYCHOTICS for schizophrenia | ||||||
| Patient or population: patients with schizophrenia Settings: Intervention: RISPERIDONE DEPOT Comparison: GENERAL ORAL ANTIPSYCHOTICS | ||||||
| Outcomes | Illustrative comparative risks* (95% CI) | Relative effect (95% CI) | No of Participants (studies) | Quality of the evidence (GRADE) | Comments | |
| Assumed risk | Corresponding risk | |||||
| GENERAL ORAL ANTIPSYCHOTICS | RISPERIDONE DEPOT | |||||
| Global state: Relapse (any reason) ‐ long term Number of participants relapsing in each treatment arm. | Moderate | RR 2.13 (0.84 to 5.43) | 63 (1 study) | ⊕⊝⊝⊝ very low2,3 | Criteria for relapse were derived from Csernansky 2002.<BR/> | |
| 161 per 10001 | 343 per 1000 (135 to 874) | |||||
| Mental state: clinically significant improvement in mental state ‐ long term | See comment | See comment | Not estimable | 0 (0) | See comment | Outcomes relating to mental state were unusable due to high study attrition. |
| Leaving the study early: Any reason ‐ long term | Study population | RR 1.24 (0.98 to 1.57) | 467 (2 studies) | ⊕⊕⊕⊝ moderate | ||
| 322 per 10004 | 399 per 1000 (315 to 505) | |||||
| Moderate | ||||||
| 387 per 10004 | 480 per 1000 (379 to 608) | |||||
| Adverse events: General: Severe adverse event ‐ any dose risperidone depot ‐ short term | See comment | See comment | Not estimable | 0 (0) | See comment | "Severe adverse events" were not explicitly reported. |
| Adverse events: Specific ‐ prolactin‐related ‐ long term It is unclear how adverse events were reported | Low | RR 10.27 (0.59 to 180.05) | 85 (1 study) | ⊕⊝⊝⊝ very low2,6 | ||
| 10 per 10005 | 103 per 1000 (6 to 1000) | |||||
| Moderate | ||||||
| 100 per 10005 | 1000 per 1000 (59 to 1000) | |||||
| High | ||||||
| 200 per 10005 | 1000 per 1000 (118 to 1000) | |||||
| Adverse events: Specific ‐ weight increase ‐ long term It is unclear how adverse events were reported | Study population | RR 1.33 (0.56 to 3.17) | 85 (1 study) | ⊕⊝⊝⊝ very low2,6 | ||
| 171 per 10004 | 227 per 1000 (96 to 541) | |||||
| Moderate | ||||||
| 171 per 10004 | 227 per 1000 (96 to 542) | |||||
| Adverse events: Nervous system disorders (inc. EPS) ‐ long term It is unclear how adverse events were reported | Study population | RR 1.34 (1.13 to 1.58) | 369 (1 study) | ⊕⊝⊝⊝ very low2,6 | ||
| 171 per 10004 | 227 per 1000 (96 to 541) | |||||
| Moderate | ||||||
| 171 per 10004 | 227 per 1000 (96 to 542) | |||||
| *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 Assumed risk: mean baseline presented for one individual study. 2 Risk of bias: 'very serious' ‐ a high level of attrition (> 50%), the open‐label nature of this study and the fact that it was supported by the manufacturers of depot risperidone result in a very serious risk of bias. 3 Imprecision: 'serious' ‐ the sample size for this outcome was small (n = 63). 4 Assumed risk: median control group risk from the studies. 5 Assumed risk: control risk relates to 'low' (0%). 6 Serious risk of imprecision due to the small sample size of this study.