A brief research report on the efficacy of Griffonia and Lactium supplementation in a clinical preschool sample with anxiety disorders and emotional dysregulation.

Anxiety in pre-schoolers predicts the persistence of anxiety during school age and mid-adolescence and may also interfere with later social and academic functioning. Currently, while no pharmacological treatments are specifically approved for anxiety disorders in the preschool population, novel nutraceutical compounds with potential anxiolytic effects have received increasing research attention. We conducted an exploratory single-center, longitudinal, interventional study aimed at evaluating the efficacy of a 3-month supplementation with a dietary supplement containing Griffonia and Lactium in 22 preschool children (3-6.11 years; mean age 4.6 ± 0.8 years) diagnosed with an anxiety disorder, either as a primary condition or comorbid with other internalizing and externalizing disorders, particularly emotional dysregulation. A small subpopulation of the sample continued supplementation for a total of 6 months, and efficacy outcomes were compared with those observed in participants who received the supplement for only 3 months. Additionally, maintenance of the effects was assessed at a follow-up evaluation conducted 3 months after discontinuation of the dietary supplement. Efficacy of the dietary supplementation at predefined time points was evaluated using both a parent-reported questionnaire (Preschool Anxiety Scale-Parent Report, PAS) and clinician-rated scales derived from available data, including clinical observation (Children's Global Assessment Scale, CGAS and Clinical Global Impression, CGI). The results of the present study suggest that 3 months of supplementation with a Griffonia- and Lactium-based dietary supplement, in addition to demonstrating a favorable safety profile, may be associated with improvements in anxiety symptoms and overall functioning. These effects appear to be maintained up to three months after treatment discontinuation. Moreover, a longer duration of dietary supplement administration, lasting six months, may appear to be associated with more sustained clinical improvement over time. Although this study provides a relevant contribution to an underexplored area of research in the preschool population, the findings should be considered exploratory and further validation through randomized controlled trials is required.