Interpretation of results limited by high dropout rate, null findings of prespecified analyses
WEDNESDAY, Oct. 23, 2019 (HealthDay News) — Treatment with fluoxetine appears to result in significantly lower scores for obsessive compulsive behaviors at 16 weeks among children and adolescents with autism spectrum disorder (ASD), but interpretation of the data is limited, according to a study published in the Oct. 22/29 issue of the Journal of the American Medical Association.
Dinah S. Reddihough, M.D., from the Royal Children’s Hospital in Parkville, Australia, and colleagues conducted a multicenter trial involving participants aged 7.5 to 18 years with ASD and a total score of 6 or higher on the Children’s Yale-Brown Obsessive Compulsive Scale, modified for pervasive developmental disorder (CYBOCS-PDD). Participants were randomly assigned to receive either fluoxetine or placebo (75 and 71, respectively); 31 and 21 in the fluoxetine and placebo groups, respectively, did not complete treatment.
The researchers found that the mean CYBOCS-PDD score decreased from baseline to 16 weeks in the fluoxetine group (12.80 to 9.02 points; 3.72-point decrease; 95 percent confidence interval [CI], −4.85 to −2.60) and in the placebo group (from 13.13 to 10.89 points; 2.53-point decrease; 95 percent CI, −3.86 to −1.19). At 16 weeks, the between-group mean difference was −2.01 points (95 percent CI, −3.77 to −0.25; P = 0.03); with further adjustment, in the prespecified model, the between-group mean difference was −1.17 (95 percent CI, −3.01 to 0.67; P = 0.21).
“Interpretation is limited by the high dropout rate, null findings of prespecified analyses that accounted for potentially confounding factors and baseline imbalances, and CIs for the treatment effect that included the minimal clinically important difference,” the authors write.
One author disclosed financial ties to the pharmaceutical industry.
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