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Enzogenol for cognitive functioning in traumatic brain injury: a pilot placebo‐controlled RCT
Author(s) -
Theadom A.,
Mahon S.,
BarkerCollo S.,
McPherson K.,
Rush E.,
Vandal A. C.,
Feigin V. L.
Publication year - 2013
Publication title -
european journal of neurology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.881
H-Index - 124
eISSN - 1468-1331
pISSN - 1351-5101
DOI - 10.1111/ene.12099
Subject(s) - medicine , placebo , randomized controlled trial , effects of sleep deprivation on cognitive performance , cognition , traumatic brain injury , mood , physical therapy , psychiatry , alternative medicine , pathology
Background and purpose E nzogenol, a flavonoid‐rich extract from P inus radiata bark with antioxidant and anti‐inflammatory properties has been shown to improve working memory in healthy adults. In traumatic brain injury ( TBI ), oxidation and inflammation have been linked to poorer cognitive outcomes. Hence, this phase II , randomized controlled trial investigated safety, compliance and efficacy of E nzogenol for improving cognitive functioning in people following mild TBI . Methods Sixty adults, who sustained a mild TBI , 3–12 months prior to recruitment, and who were experiencing persistent cognitive difficulties [Cognitive Failures Questionnaire ( CFQ ) score > 38], were randomized to receive E nzogenol (1000 mg/day) or matching placebo for 6 weeks. Subsequently, all participants received E nzogenol for a further 6 weeks, followed by placebo for 4 weeks. Compliance, side‐effects, cognitive failures, working and episodic memory, post‐concussive symptoms and mood were assessed at baseline, 6, 12 and 16 weeks. Simultaneous estimation of treatment effect and breakpoint was effected, with confidence intervals (CIs) obtained through a treatment–placebo balance‐preserving bootstrap procedure. Results Enzogenol was found to be safe and well tolerated. Trend and breakpoint analyses showed a significant reduction in cognitive failures after 6 weeks [mean CFQ score, 95% CI, E nzogenol versus placebo −6.9 (−10.8 to −4.1)]. Improvements in the frequency of self‐reported cognitive failures were estimated to continue until week 11 before stabilizing. Other outcome measures showed some positive trends but no significant treatment effects. Conclusions E nzogenol supplementation is safe and well tolerated in people after mild TBI , and may improve cognitive functioning in this patient population. This study provides Class IIB evidence that E nzogenol is well tolerated and may reduce self‐perceived cognitive failures in patients 3–12 months post‐mild TBI .