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Effect of Pycnogenol® on attention-deficit hyperactivity disorder (ADHD) : study protocol for a randomised controlled trial

(2017) TRIALS. 18.
Author
Organization
Abstract
Background: Methylphenidate (MPH), the first choice medication for attention-deficit hyperactivity disorder (ADHD), is associated with serious adverse effects like arrhythmia. Evidence on the association of ADHD with immune and oxidant-antioxidant imbalances offers potential for antioxidant and/or immunomodulatory nutritional supplements as ADHD therapy. One small randomised trial in ADHD suggests, despite various limitations, therapeutic benefit from Pycnogenol (R), a herbal, polyphenol-rich extract. Methods: This phase III trial is a 10-week, randomised, double-blind, placebo and active treatment controlled multicentre trial with three parallel treatment arms to compare the effect of Pycnogenol r to MPH and placebo on the behaviour of 144 paediatric ADHD and attention-deficit disorder (ADD) patients. Evaluations of behaviour (measured by the ADHDRating Scale (primary endpoint) and the Social-emotional Questionnaire (SEQ)), immunity (plasma cytokine and antibody levels, white blood cell counts and faecal microbial composition), oxidative stress (erythrocyte glutathione, plasma lipid-soluble vitamins and malondialdehyde and urinary 8-OHdG levels, as well as antioxidant enzyme activity and gene expression), serum zinc and neuropeptide Y level, urinary catecholamines and physical complaints (Physical Complaints Questionnaire) will be performed in week 10 and compared to baseline. Acceptability evaluations will be based on adherence, dropouts and reports of adverse events. Dietary habits will be taken into account. Discussion: This trial takes into account comorbid behavioural and physical symptoms, as well as a broad range of innovative immune and oxidative biomarkers, expected to provide fundamental knowledge on ADHD aetiology and therapy. Research on microbiota in ADHD is novel. Moreover, the active control arm is rather unseen in research on nutritional supplements, but of great importance, as patients and parents are often concerned with the side effects of MPH.
Keywords
PINE BARK EXTRACT, DEFICIT/HYPERACTIVITY DISORDER, OXIDATIVE STRESS, POLYPHENOLIC EXTRACT, CLINICAL-TRIALS, HUMAN HEALTH, CHILDREN, DISEASE, GLUTATHIONE, MICROBIOTA, ADHD, ADD, Behaviour, Pycnogenol (R), Antioxidant, Polyphenols, Oxidative stress, Immunity, Catecholamines

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Citation

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Chicago
Verlaet, Annelies AJ, Berten Ceulemans, HELENE VERHELST, Dirk Van West, Tess De Bruyne, Luc Pieters, Huub FJ Savelkoul, and Nina Hermans. 2017. “Effect of Pycnogenol® on Attention-deficit Hyperactivity Disorder (ADHD) : Study Protocol for a Randomised Controlled Trial.” Trials 18.
APA
Verlaet, A. A., Ceulemans, B., VERHELST, H., Van West, D., De Bruyne, T., Pieters, L., Savelkoul, H. F., et al. (2017). Effect of Pycnogenol® on attention-deficit hyperactivity disorder (ADHD) : study protocol for a randomised controlled trial. TRIALS, 18.
Vancouver
1.
Verlaet AA, Ceulemans B, VERHELST H, Van West D, De Bruyne T, Pieters L, et al. Effect of Pycnogenol® on attention-deficit hyperactivity disorder (ADHD) : study protocol for a randomised controlled trial. TRIALS. 2017;18.
MLA
Verlaet, Annelies AJ, Berten Ceulemans, HELENE VERHELST, et al. “Effect of Pycnogenol® on Attention-deficit Hyperactivity Disorder (ADHD) : Study Protocol for a Randomised Controlled Trial.” TRIALS 18 (2017): n. pag. Print.
@article{8525493,
  abstract     = {Background: Methylphenidate (MPH), the first choice medication for attention-deficit hyperactivity disorder (ADHD), is associated with serious adverse effects like arrhythmia. Evidence on the association of ADHD with immune and oxidant-antioxidant imbalances offers potential for antioxidant and/or immunomodulatory nutritional supplements as ADHD therapy. One small randomised trial in ADHD suggests, despite various limitations, therapeutic benefit from Pycnogenol (R), a herbal, polyphenol-rich extract. 
Methods: This phase III trial is a 10-week, randomised, double-blind, placebo and active treatment controlled multicentre trial with three parallel treatment arms to compare the effect of Pycnogenol r to MPH and placebo on the behaviour of 144 paediatric ADHD and attention-deficit disorder (ADD) patients. Evaluations of behaviour (measured by the ADHDRating Scale (primary endpoint) and the Social-emotional Questionnaire (SEQ)), immunity (plasma cytokine and antibody levels, white blood cell counts and faecal microbial composition), oxidative stress (erythrocyte glutathione, plasma lipid-soluble vitamins and malondialdehyde and urinary 8-OHdG levels, as well as antioxidant enzyme activity and gene expression), serum zinc and neuropeptide Y level, urinary catecholamines and physical complaints (Physical Complaints Questionnaire) will be performed in week 10 and compared to baseline. Acceptability evaluations will be based on adherence, dropouts and reports of adverse events. Dietary habits will be taken into account. 
Discussion: This trial takes into account comorbid behavioural and physical symptoms, as well as a broad range of innovative immune and oxidative biomarkers, expected to provide fundamental knowledge on ADHD aetiology and therapy. Research on microbiota in ADHD is novel. Moreover, the active control arm is rather unseen in research on nutritional supplements, but of great importance, as patients and parents are often concerned with the side effects of MPH.},
  articleno    = {145},
  author       = {Verlaet, Annelies AJ and Ceulemans, Berten and VERHELST, HELENE and Van West, Dirk and De Bruyne, Tess and Pieters, Luc and Savelkoul, Huub FJ and Hermans, Nina},
  issn         = {1745-6215},
  journal      = {TRIALS},
  keyword      = {PINE BARK EXTRACT,DEFICIT/HYPERACTIVITY DISORDER,OXIDATIVE STRESS,POLYPHENOLIC EXTRACT,CLINICAL-TRIALS,HUMAN HEALTH,CHILDREN,DISEASE,GLUTATHIONE,MICROBIOTA,ADHD,ADD,Behaviour,Pycnogenol (R),Antioxidant,Polyphenols,Oxidative stress,Immunity,Catecholamines},
  language     = {eng},
  pages        = {9},
  title        = {Effect of Pycnogenol{\textregistered} on attention-deficit hyperactivity disorder (ADHD) : study protocol for a randomised controlled trial},
  url          = {http://dx.doi.org/10.1186/s13063-017-1879-6},
  volume       = {18},
  year         = {2017},
}

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