Controlled randomized crossover of essential oils for quality of life in children with autism spectrum disorder (ASD): A pilot and feasibility study

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Introduction Essential oils have been touted to benefit children with autism spectrum disorder (ASD) in a multitude of ways. However, the lack of empirical evidence makes it difficult to accept this claim. We tested the feasibility of conducting a large randomized clinical crossover trial of an essential oils blend in children with ASD and evaluated its safety and efficacy for improving quality of life. Methods Children ages 3–9 with ASD were randomized to a crossover study of Reconnect™, an essential oils blend, versus a control. Outcomes were the Pediatric Quality of Life Inventory, Parent-Rated Anxiety Scale for ASD, Children’s Sleep Habits Questionnaire, and laboratory safety tests. Inflammatory cytokines and other labs were explored. Mixed-effects analyses were applied. Results Twenty-six participants evaluated as intent-to-treat population. Seventeen completed both conditions (61 %). Outcomes improved, but between-treatment differences in the crossover were nonsignificant ( p = .33–.16). At first treatment endpoint, anxiety decreased significantly more with active than control ( p = .015, d =1.01). Adverse events and hematological/hepatic/renal tests revealed no significant differences. C-reactive protein and interleukin-6 (IL-6) revealed no inflammation. Conclusion Recruitment was feasible, adherence was high, first-condition retention was high (92.7 %). Retention in second condition was low (65.4 %). A large crossover is not feasible. Anxiety results suggest further study in a randomized controlled trial with a parallel-groups design. Reconnect™ appears safe.

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