Summary of findings 3. CLOZAPINE + RISPERIDONE versus CLOZAPINE + SULPIRIDE (Kong 2001).
Clozapine + risperidone versus clozapine + sulpiride for treatment‐resistant schizophrenia | ||||||
Patient or population: people with treatment‐resistant schizophrenia Setting: inpatients Intervention: risperidone (+ CLO) Comparison: sulpiride (+ CLO) | ||||||
Outcomes | Anticipated absolute effects* (95% CI) | Relative effect (95% CI) | No of participants (studies) | Quality of the evidence (GRADE) | Comments | |
Risk with Sulpiride (+ CLO) | Risk with Risperidone (+ CLO) | |||||
Clinical response: no clinically significant response in mental state: 20% to 50% reduction in PANSS total score | Study population | RR 0.82 (0.40 to 1.68) | 60 (1 RCT) | ⊕⊝⊝⊝ Very low 1,2,3,4 | ‐ | |
367 per 1000 | 301 per 1000 (147 to 616) | |||||
Moderate | ||||||
367 per 1000 | 301 per 1000 (147 to 616) | |||||
Adverse effects: weight gain | Study population | RR 0.40 (0.08 to 1.90) | 60 (1 RCT) | ⊕⊝⊝⊝ Very low 1,2,4,5 | ‐ | |
167 per 1000 | 67 per 1000 (13 to 317) | |||||
Moderate | ||||||
167 per 1000 | 67 per 1000 (13 to 317) | |||||
Clinical response: mean score/change in global state | See comment | See comment | ‐ | (1 RCT) | ‐ | No data reported. |
Clinical response: mean score/change in mental state: mean PANSS total score (high = poor) | The mean score/change in mental state (PANSS total) was 0 | The mean score/change in mental state (PANSS total) in the intervention group was 2.28 undefined fewer (7.41 fewer to 2.85 more) | ‐ | 60 (1 RCT) | ⊕⊝⊝⊝ Very low 1,2,6,7 | ‐ |
Leaving the study early: acceptability of treatment ‐ as measured by completion of trial | Study population | Not estimable | 60 (1 RCT) | ⊕⊝⊝⊝ Very low 1,2,8,9 | ‐ | |
0 per 1000 | 0 per 1000 (0 to 0) | |||||
Service utilisation outcomes: hospital admission or days in hospital | See comment | See comment | Not estimable | ‐ | ‐ | No data reported. |
Quality of life/satisfaction with care for either recipients of care or carers: significant change in quality of life/satisfaction | See comment | See comment | Not estimable | ‐ | ‐ | No data reported. |
*The risk in the intervention group (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; CLO: clozapine; PANSS: Positive and Negative Syndrome Scale; RCT: randomised controlled trial; RR: risk ratio. | ||||||
GRADE Working Group grades of evidence High quality: We are very confident that the true effect lies close to that of the estimate of the effect. Moderate quality: We are moderately confident in the effect estimate: The true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different. Low quality: Our confidence in the effect estimate is limited: The true effect may be substantially different from the estimate of the effect. Very low quality: We have very little confidence in the effect estimate: The true effect is likely to be substantially different from the estimate of effect. |
1 Risk of bias: downgraded by 2 levels because unclear (so potentially high) risk of biases (selection, performance, detection, reporting).
2 Inconsistency and publication bias: not applicable (no meta‐analysis).
3 Indirectness: downgraded by 1 level because unclear population applicability (inclusion criteria not clearly specified). Not downgraded by 2 levels because rating scale measures participant‐important outcome (mental state).
4 Imprecision: downgraded by 2 levels because underpowered to detect difference and CI around relative effect includes appreciable benefit and harm.
5 Indirectness: downgraded by 1 level because unclear population applicability (inclusion criteria not clearly specified). Not downgraded by 2 levels because weight gain a direct measure of a participant‐important outcome.
6 Indirectness: downgraded by 1 level because unclear population applicability (inclusion criteria not clearly specified). Not downgraded by 2 levels because rating scale measures participant‐important outcome (mental state).
7 Imprecision: downgraded by 1 level because underpowered to detect difference. Not downgraded by 2 levels because CI around mean difference did not include appreciable benefit and appreciable harm (total score on PANSS = 120).
8 Indirectness: downgraded by 2 levels because unclear population applicability (inclusion criteria not clearly specified) and leaving the study early a surrogate measure of acceptability of treatment.
9 Imprecision: downgraded by 1 level because underpowered to detect difference. Not downgraded by 2 levels because no CI.