Effect of Fluoxetine Therapy on Breath-Holding Spells in Children: A Clinical Trial Study

Background: Breath-holding spells (BHS) is a sudden and reflexive phenomenon that is common in infancy and early childhood. Despite the harmless nature of BHS, being subjected to this phenomenon is very stressful for parents and sometimes requires treatment. In this study, we evaluated the efficacy of fluoxetine therapy (as an anxiolytic medication) on ​​pediatric BHS. Materials and Methods: The present clinical trial study was carried out on 30 patients with BHS referring to Neurology Clinic of Ghaem Hospital, Mashhad, Iran, in 2018. The subjects were randomly divided into control (n = 15), and intervention (n= 15) groups. The control group was then treated with iron and the intervention group with iron and fluoxetine for 3 months. The frequency and duration of BHS before and after treatment were compared in both groups. The results were later analyzed using SPSS version 16.0. Results: The present study was carried out on 30 children. The mean of infants’ age in the control and intervention groups was 20.26 ± 5.8 and 22.46 ± 5.2 months, respectively (P>0.05). The mean frequency and the duration of BHS decreased from 8.2 ± 4.3 to 1.6 ± 2.4 times per week (p = 0.000), and from 50.66 ± 26.26 to 5.4 ± 6 seconds (p = 0.000) in the control group; and from 7.2 ± 3 to 2.06 ± 2.7 times per week (p = 0.001), and 50.66 ± 38 to 8.8 ± 7.9 seconds (p = 0.002) in the intervention group, which was indicative of a statistically significant difference. However, the difference in the mean frequency and duration of BHS in the intervention group, which represents the effect of fluoxetine, was not statistically significant (p = 0.411 and p = 0.792, respectively). Conclusion: The results of the present research confirm the effect of iron therapy on decreasing the mean frequency and duration of BHS, but also indicate the ineffectiveness of synergistic administration of fluoxetine and iron on decreasing mean frequency and duration of BHS.