Effect of Topical Lettuce (Lactuca sativa L.) Seed Oil on Childhood Sleep Disorders: a Randomized Double-Blind Controlled Trial

Abstract

Background and objectives: Sleep disorders are among the most common complaints in childhood. Considering the pitfalls regarding safety and efficacy of conventional treatments for sleep disorders in children and based on the Persian medicine literature and results of recent animal and clinical investigations, this study was conducted to evaluate the effect of topical lettuce seed oil in these patients. Methods: The study was a double-blind randomized controlled trial in 3-6 years old children with sleep disorders. They were randomly assigned to receive either topical placebo oil and clonidine capsule or lettuce seed oil and placebo capsule for three weeks. Lettuce seed oil was prepared using cold press method. Persian version of "BEARS" pediatric sleep questionnaire was used before and after the intervention. Data analysis was performed using SPSS software (version 20) and p<0.05 was considered as statistically significant. Results: At the end of study, 67 patients out of 72 completed the study. Similar to control group, children in intervention group significantly improved regarding bedtime issues (p<0.001), excessive daytime sleepiness (p=0.003), night awakenings (p=0.008), and problems in regularity and duration of sleep (p<0.001); however, no significant change was observed regarding the snoring in both groups. Conclusions: Topical use of lettuce seed oil on forehead and temporal areas of children could be considered as a safe and effective treatment for sleep disorders. However, further studies with larger sample size, longer duration of follow-up, and with the use of objective outcome measures are warranted.