Clinical Investigation of French Maritime Pine Bark Extract on Attention-Deficit Hyperactivity Disorder as compared to Methylphenidate and Placebo: Part 1: Efficacy in a Randomised Trial

Abstract

Graphical abstract with the main results of the clinical trial • Assessing the value of French Maritime Pine Bark Extract (PBE) in ADHD therapy as compared to methylphenidate (MPH) and placebo in a 10-week randomised trial; • Teachers reported significant improvement of total and hyperactivity/impulsivity ADHD-RS scores (primary outcome) by PBE and MPH after 10 weeks compared to placebo; • Adverse effects reported five times more frequently for MPH than for PBE; • PBE is a valuable treatment option in paediatric ADHD especially for those not willing to take standard medication or experiencing side effects. Determine the effect of French Maritime Pine Bark Extract (PBE; Pycnogenol®) on Attention-Deficit Hyperactivity Disorder (ADHD) behaviour and co-morbid physical/psychiatric symptoms, compared to placebo and the medicine MPH, and to assess its tolerability. Behaviour (measured by the ADHD-Rating Scale (ADHD-RS) and Social-Emotional Questionnaire (SEQ)) and physical complaints were evaluated in weeks 5 and 10. Eighty-eight paediatric ADHD patients (70 % male, mean age 10.1 years) were randomised to placebo (n = 30), PBE (n = 32) or MPH (n = 26). Teachers reported significant improvement of total and hyperactivity/impulsivity ADHD-RS scores by PBE and MPH after 10 weeks compared to placebo. MPH also improved inattention. SEQ ratings support ADHD-RS results. Adverse effects were reported five times more frequently for MPH than for PBE. PBE appears a good alternative for MPH in paediatric ADHD and especially in the primary school environment, a fortiori when considering its almost complete lack of adverse effects.