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. (October 2022)

• Record Type: Journal Article
• Authors: Weyns, Anne-Sophie; Verlaet, Annelies A.J.; Breynaert, Annelies; Naessens, Tania; Fransen, Erik; Verhelst, Helene; Van West, Dirk; Van Ingelghem, Ingrid; Jonckheere, An I.; Beysen, Diane; Kenis, Sandra; Moens, Els; van Roest, Aalt P.J.; Savelkoul, Huub F.J.; De Bruyne, Tess; Pieters, Luc; Ceulemans, Berten; Hermans, Nina
• Is Part Of: Journal of functional foods. Volume 97(2022)
• Publication Date: 2022-10
• Subjects: ADHD -- Behaviour -- French Maritime Pine Bark Extract -- Methylphenidate -- Antioxidant -- Polyphenols; ADHD Attention-Deficit Hyperactivity Disorder -- ANOVA Analysis of Variance -- CNS central nervous system -- FFQ Food Frequency Questionnaire -- GI gastrointestinal -- HI hyperactivity/impulsivity -- HPLC High Pressure Liquid Chromatography -- IA inattention -- IQ Intelligence coefficient -- LMM Linear Mixed Model -- MPH Methylphenidate -- PBE French Maritime Pine Bark Extract -- PCQ Physical Complaints Questionnaire -- RS Rating-Scale -- SEQ Social-Emotional Questionnaire -- USP United States Pharmacopeia -- UZA University Hospital Antwerp -- UZ Ghent University Hospital Ghent -- ZNA Hospital Network Antwerp; Functional foods -- Analysis -- Periodicals; Food -- Biotechnology -- Periodicals; Nutrition -- Periodicals; 613.2
• DOI: 10.1016/j.jff.2022.105246
• Languages: English
• ISSNs: 1756-4646

Abstract

Graphical abstract: Graphical abstract with the main results of the clinical trial Highlights: 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. Abstract: Objectives: 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. Results: 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. Conclusions: 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.