Evaluation The Effects of Pycnogenol (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

Background: Traumatic 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 patient. One of the ingredients that can be used in immunonutrition formulas to reduce inflammation and oxidative stress is pycnogenol.Objective: surveying the effect of pycnogenol on the clinical, nutritional and inflammatory status of TBI patients.Methods: This is double-blind, randomized controlled trial. Block randomization used. Intervention group received pycnogenol supplementation of 150 mg for 10 days. Control group received placebo for the same duration. Inflammatory status (IL-6, IL- 1β, C-reactive protein) and oxidative stress status (Malondialdehyde, total antioxidant capacity), at the base line, at the 5th day and at the end of the study (10th day) were measured. Clinical and nutritional status were assessed three times during the intervention. SOFA (sequential organ failure assessment) questionnaire for assessment of organ failure was filled out every other day. The mortality rate was calculated within 28 days of the start of the intervention. Weight, body mass index and body composition were measured.Results: These results were obtained by using the New way west test in Stata version 14. Supplementation with pycnogenol decreased IL-6 (27.29 pg / ml, P=0.01) in the intervention group. The CRP had a decrease of 4.11 pg / ml in the intervention group (P = 0.02). APACHE was reduced 31/3 unit (P = <0.001), SOFA was reduced 0.81 unit (P = 0.02) and Nutric was reduced 0.50 unit (P = 0.01). Anthropometric changes didn’t different over the time except dry lean mass in control group reduced significantly (P=0.04). Also, pycnogenol reduced the mortality by 15% in the intervention group compared to control group.Conclusion: Supplementation with pycnogenol in patients with traumatic brain injury can reduce inflammation and improve the clinical status and malnutrition score.Trial registration: This trial is registered at clinicaltrials.gov (ref: NCT03777683) at 12/13/2018.

کلیدواژه ها:

Traumatic brain injury ، critical care ، pycnogenol ، inflammation ، nutrition support ، French maritime pine bark extract