Evidence map›Paper›PMID 28351412›Full record

Trial reportTrials2017

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

Annelies A J Verlaet, Berten Ceulemans, Helene Verhelst, Dirk Van West, Tess De Bruyne, Luc Pieters, Huub F J Savelkoul, Nina Hermans

Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase IIIComparative StudyMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Trials, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02700685 (Effect of a Polyphenol-rich Plant Extract on Attention-Deficit Hyperactivity Disorder), which is not on this map. Cited by 19 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
19citing papers in PubMed, 4 pooled it
1.5field-weighted citation impact, top 19% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02700685 phase3completednot on this map

Effect of a Polyphenol-rich Plant Extract on Attention-Deficit Hyperactivity Disorder (ADHD): A Randomized, Double Blind, Placebo and Active Product Controlled Multicenter Trial.

TypeinterventionalSponsorNina HermansRan2017 to 2020Enrolled88ConditionsADHDArmsPycnogenol, Methylphenidate, Placebo
3 · Its place in the literature

Who cites it

19 citing papers in PubMed, 4 syntheses or guidelines pooled it, 24 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Pine bark (Pinus spp.) extract for treating chronic disorders.The Cochrane database of systematic reviews · 2020
    Pooled it
  5. Natural Molecules for Brain Health and Resilience.International journal of molecular sciences · 2026
    Review
  6. Review
  7. Review
  8. Article
  9. Review
  10. Dietary supplements in neurological diseases and brain aging.Journal of preventive medicine and hygiene · 2022
    Review
  11. Article
  12. Article
  13. Review
  14. Review
  15. Review
  16. Review
  17. Review
  18. Article
  19. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors at 5 institutions in 2 countries.

Annelies A J VerlaetDepartment of Pharmaceutical Sciences, Laboratory of Nutrition and Functional Food Science, University of Antwerp, Universiteitsplein 1, 2610, Wilrijk, Belgium. Annelies.verlaet@uantwerpen.be.
Berten CeulemansNeurology, University Hospital Antwerp, Wilrijkstraat 10, 2650, Edegem, Belgium.
Helene VerhelstPaediatric Neurology, University Hospital Ghent, De Pintelaan 185, 9000, Gent, Belgium.
Dirk Van WestHospital Networtk Antwerp, Universitary Child and Adolescent Psychiatry, Lindendreef 1, 2020, Antwerp, Belgium.
Tess De BruyneDepartment of Pharmaceutical Sciences, Laboratory of Nutrition and Functional Food Science, University of Antwerp, Universiteitsplein 1, 2610, Wilrijk, Belgium.
Luc PietersDepartment of Pharmaceutical Sciences, Laboratory of Nutrition and Functional Food Science, University of Antwerp, Universiteitsplein 1, 2610, Wilrijk, Belgium.
Huub F J SavelkoulCell Biology and Immunology Group, Wageningen University, De Elst 1, 6709 PG, Wageningen, The Netherlands.
Nina HermansDepartment of Pharmaceutical Sciences, Laboratory of Nutrition and Functional Food Science, University of Antwerp, Universiteitsplein 1, 2610, Wilrijk, Belgium.
University of Antwerp · BEAntwerp University Hospital · BEGhent University Hospital · BEWageningen University & Research · NLZiekenhuisnetwerk Antwerpen Stuivenberg · BE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundMethylphenidate (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®, a herbal, polyphenol-rich extract.

methodsThis 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® to MPH and placebo on the behaviour of 144 paediatric ADHD and attention-deficit disorder (ADD) patients. Evaluations of behaviour (measured by the ADHD-Rating 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.

trial registrationClinicaltrials.gov number: NCT02700685 . Registered on 18 January 2016. EudraCT 2016-000215-32 . Registered on 4 October 2016.

Indexed as

Adjuvants, ImmunologicAntioxidantsAttention Deficit Disorder with HyperactivityBelgiumBiomarkersCentral Nervous System StimulantsChildChild BehaviorClinical ProtocolsCytokinesDouble-Blind MethodFaceFeeding BehaviorFemaleFlavonoidsHumansAdjuvants, ImmunologicAntioxidantsBiomarkersCentral Nervous System StimulantsCytokinesFlavonoidsMethylphenidatePlant ExtractspycnogenolsADDADHDAntioxidantBehaviourCatecholaminesImmunityOxidative stressPolyphenolsPycnogenol®

Identifiers

PMID28351412
PMCPMC5370458
OpenAlexW2598160886

What OpenQuestion holds

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LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.