Evidence map›Paper›PMID 32046747›Full record

ArticleTrials2020

Evaluation of the effects of pycnogenol (French maritime pine bark extract) supplementation on inflammatory biomarkers and nutritional and clinical status in traumatic brain injury patients in an intensive care unit: A randomized clinical trial protocol.

Mahsa Malekahmadi, Omid Moradi Moghaddam, Sheikh Mohammed Shariful Islam, Kiarash Tanha, Mohsen Nematy, Naseh Pahlavani, Safieh Firouzi, Mohammad Reza Zali, Abdolreza Norouzy

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in Trials, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03777683 (Evaluation the Effects of French Maritime Pine Bark Extract Supplementation on the Inflammatory Biomarkers, Nutritional and Clinical Status in Traumatic Brain Injury Patients, in Intensive Care Unit; A Randomized Clinical Trial), which is not on this map. Cited by 12 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
12citing papers in PubMed, 1 pooled it
5.7field-weighted citation impact, top 3% 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.

NCT03777683 phase1 / phase2completednot on this map

Evaluation the Effects of French Maritime Pine Bark Extract Supplementation on the Inflammatory Biomarkers, Nutritional and Clinical Status in Traumatic Brain Injury Patients, in Intensive Care Unit; A Randomized Clinical Trial

TypeinterventionalSponsorMashhad University of Medical SciencesRan2019 to 2020Enrolled67ConditionsTraumatic Brain InjuryArmsDietary Supplement (OLIGOPIN), Placebo
3 · Its place in the literature

Who cites it

12 citing papers in PubMed, 1 synthesis or guideline pooled it, 36 citations in OpenAlex.

  1. Pooled it
  2. Review
  3. Mitochondrial-targeted therapies in traumatic brain injury: From bench to bedside.Neurotherapeutics : the journal of the American Society for Experimental NeuroTherapeutics · 2025
    Review
  4. Article
  5. Article
  6. Review
  7. Article
  8. Review
  9. Article
  10. Antioxidant therapies in traumatic brain injury.Neurochemistry international · 2022
    Article
  11. Review
  12. 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

9 authors at 4 institutions in 2 countries.

Mahsa MalekahmadiStudent Research Committee, Mashhad University of Medical Sciences, Mashhad, Iran.
Omid Moradi MoghaddamTrauma and Injury Research Center, Critical Care Department, Rasoul-e-Akram Complex Hospital, Iran University of Medical Sciences, Tehran, Iran.
Sheikh Mohammed Shariful IslamInstitute for Physical Activity and Nutrition (IPAN), School of Exercise and Nutrition Sciences, Deakin University, Melbourne, Australia.
Kiarash TanhaDepartment of Biostatistics, School of Public Health, Iran University of Medical Sciences, Tehran, Iran.
Mohsen NematyNutrition Department, Faculty of Medicine, Mashhad University of Medical Sciences, Bahonar St, Mashhad, Iran.
Naseh PahlavaniStudent Research Committee, Mashhad University of Medical Sciences, Mashhad, Iran.
Safieh FirouziStudent Research Committee, Mashhad University of Medical Sciences, Mashhad, Iran.
Mohammad Reza ZaliBehbood Research Center for Gastroenterology and Liver Diseases, Tehran, Iran.
Abdolreza NorouzyNutrition Department, Faculty of Medicine, Mashhad University of Medical Sciences, Bahonar St, Mashhad, Iran. norouzya@mums.ac.ir.
Mashhad University of Medical Sciences · IRIran University of Medical Sciences · IRDeakin University · AUMiddle East Liver Disease Center · IR

Funding

Iran University of Medical Sciences 13572mashhad university of medical sciences 970612
6 · The paper itself

Abstract

backgroundTraumatic brain injury (TBI) is one of the major health and socioeconomic problems in the world. Immune-enhancing enteral formula has been proven to significantly reduce infection rate in TBI patients. One of the ingredients that can be used in immunonutrition formulas to reduce inflammation and oxidative stress is pycnogenol.

objectiveThe objective of this work is to survey the effect of pycnogenol on the clinical, nutritional, and inflammatory status of TBI patients.

methodsThis is a double-blind, randomized controlled trial. Block randomization will be used. An intervention group will receive pycnogenol supplementation of 150 mg for 10 days and a control group will receive a placebo for the same duration. Inflammatory status (IL-6, IL- 1β, C-reactive protein) and oxidative stress status (malondialdehyde, total antioxidant capacity), at the baseline, at the 5th day, and at the end of the study (10th day) will be measured. Clinical and nutritional status will be assessed three times during the intervention. The Sequential Organ Failure Assessment (SOFA) questionnaire for assessment of organ failure will be filled out every other day. The mortality rate will be calculated within 28 days of the start of the intervention. Weight, body mass index, and body composition will be measured. All analyses will be conducted by an initially assigned study arm in an intention-to-treat analysis. DISCUSSION: We expect that supplementation of 150 mg pycnogenol for 10 days will improve clinical and nutritional status and reduce the inflammation and oxidative stress of the TBI patients.

trial registrationThis trial is registered at clinicaltrials.gov (ref: NCT03777683) at 12/13/2018.

Indexed as

AdolescentAdultAgedAntioxidantsBiomarkersBrain Injuries, TraumaticClinical Trials, Phase I as TopicClinical Trials, Phase II as TopicDietary SupplementsDouble-Blind MethodFemaleFlavonoidsHumansIntensive Care UnitsMaleMiddle AgedAntioxidantsBiomarkersFlavonoidsPlant ExtractspycnogenolsCritical careFrench maritime pine bark extractInflammationNutrition supportPycnogenolTraumatic brain injury

Identifiers

PMID32046747
PMCPMC7014642
OpenAlexW3005637371

What OpenQuestion holds

Textmetadata
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.