A Cochrane review [Abstract] 1 included 15 studies with a total of 2428 patients with schizophrenia. Most patients were aged between late 30s and early 40s. Eight studies took place in the inpatient setting. The follow-up time for all the studies was 12 weeks or less. Patients in the risperidone group were more likely to achieve a significant clinical improvement in mental state (RR 0.64, CI 0.52 to 0.78; 6 RCTs, n = 864). The effect withstood, even when 3 studies with >50% attrition rate were removed from the analysis (RR 0.77, CI 0.67 to 0.88; 3 RCTs, n = 589). Participants receiving placebo were less likely to have a clinically significant improvement on Clinical Global Impression scale (CGI) than those receiving risperidone (RR 0.69, CI 0.57 to 0.83; 4 RCTs, n = 594). Overall, the risperidone group was 31% less likely to leave early compared to placebo group (RR 0.69, 95% CI 0.62 to 0.78; 12 RCTs, n = 2261). Significant extrapyramidal side effect were more likely to occur in the risperidone group (RR 1.56, 95% CI 1.13 to 2.15; 7 RCTs, n = 1511).When risperidone and placebo were augmented with clozapine, there were no significant differences between groups for clinical response as defined by a less than 20% reduction in PANSS/BPRS scores (RR 1.15, 95% CI 0.93 to 1.42; 2 RCTs, n = 98) and attrition (leaving the study early for any reason) (RR 1.13, 95% CI 0.53 to 2.42; 3 RCTs, n = 167). One study (n=68) measured clinically significant responses using the CGI, no effect was evident (RR 1.12 95% CI 0.87 to 1.44). No data were available for extrapyramidal adverse effects.
Comment: The quality of evidence is downgraded by study quality (unclear allocation concealment, more than 20% loss to follow up) and indirectness (short follow-up time).
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