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. 2017 Mar 23;2017(3):CD006324. doi: 10.1002/14651858.CD006324.pub3

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 evidenceHigh 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.