Summary of findings 3. RISPERIDONE DEPOT compared with ORAL RISPERIDONE for schizophrenia.
| RISPERIDONE DEPOT compared with ORAL RISPERIDONE for schizophrenia | ||||||
| Patient or population: patients with schizophrenia Settings: Intervention: RISPERIDONE DEPOT Comparison: ORAL RISPERIDONE | ||||||
| Outcomes | Illustrative comparative risks* (95% CI) | Relative effect (95% CI) | No of Participants (studies) | Quality of the evidence (GRADE) | Comments | |
| Assumed risk | Corresponding risk | |||||
| ORAL RISPERIDONE | RISPERIDONE DEPOT | |||||
| Global state: Relapse ‐ long term | See comment | See comment | Not estimable | 0 (0) | See comment | Outcomes relating to relapse were not available for this comparison. |
| Mental state: average PANSS total score at endpoint (non‐ITT data) PANSS total scores (30 to 210) Higher scores are worse. | The mean mental state: average PANSS total score at endpoint (non‐ITT data) in the intervention groups was 1.05 higher (0.77 lower to 2.88 higher) | 591 (2 studies) | ⊕⊕⊕⊝ moderate1 | |||
| Leaving the study early: Any reason ‐ short term | Study population | RR 1.28 (0.92 to 1.79) | 690 (2 studies) | ⊕⊕⊕⊝ moderate1 | ||
| 145 per 10002 | 185 per 1000 (133 to 259) | |||||
| Moderate | ||||||
| 78 per 10002 | 100 per 1000 (72 to 140) | |||||
| 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 by these studies. |
| Adverse events: Movement disorder ‐ any extra pyramidal symptoms ‐ short term | Study population | RR 1.05 (0.59 to 1.88) | 640 (1 study) | ⊕⊕⊕⊝ moderate4 | ||
| 65 per 10003 | 69 per 1000 (39 to 123) | |||||
| Moderate | ||||||
| 65 per 10003 | 68 per 1000 (38 to 122) | |||||
| Adverse events: Specific: Mean (SD) weight increase in kg ‐ short term | The mean adverse events: specific: mean (SD) weight increase in kg ‐ short term in the control groups was 0.2 points | The mean adverse events: specific: mean (SD) weight increase in kg ‐ short term in the intervention groups was 0.2 higher (0.35 lower to 0.75 higher) | 640 (1 study) | ⊕⊕⊕⊝ moderate4 | ||
| Adverse events: Specific ‐ prolactin‐related | Moderate | RR 0.5 (0.15 to 1.65) | 640 (1 study) | ⊕⊕⊕⊝ moderate4 | ||
| 25 per 10003 | 12 per 1000 (4 to 41) | |||||
| *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: 'serious' ‐ both studies received funding support from the manufacturers of risperidone depot 2 Assumed risk: median control group risk from the studies. 3 Assumed risk: mean baseline presented for one individual study. 4 Risk of bias: 'serious' ‐ this research was supported by the manufacturers of risperidone depot.