Comment:The quality of evidence is downgraded by indirectness (short follow-up time) and imprecise results (few studies).
A Cochrane review [Abstract] 1 included 3 studies with a total of 401 subjects younger than 18 years of age. They all had autistic disorder. Two RCTs (n=316) evaluated use of aripiprazole for a duration of 8 weeks. Meta-analysis of study results revealed a mean improvement of -6.17 points on the Aberrant Behavior Checklist (ABC) - Irritability subscale (95% CIs -9.07 to -3.26; 2 studies, n=308), -7.93 points on the ABC - Hyperactivity subscale (95% CI -10.98 to -4.88; 2 studies, n=308) and -2.66 points on the ABC - Stereotypy subscale (95% CI -3.55 to -1.77, 2 studies, n=308) when taking aripiprazole vs. placebo. In terms of side effects, aripiprazole yielded a greater increase in weight, with a mean increase of 1.13 kg relative to placebo (95% CI 0.71 to 1.54, 2 studies, n=308), and had a higher RR for sedation (RR 4.28, 95% CI 1.58 to 11.60; 2 studies, n=313) and tremor (RR 10.26, 95% CI 1.37 to 76.63; 2 studies, n=313). A discontinuation study, where treatment was continued until relapse or up to 16 weeks, found that 35% of those who continued intervention with aripiprazole relapsed with respect to their symptoms of irritability, compared with 52% of those randomised to placebo, for a HR of 0.57 (95% CI 0.28 to 1.12, n=85).
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