Research Reports - Enzogenol for cognitive functioning in traumatic brain injury

Eur J Neurol. 2013 Feb 5

Theadom A, Mahon S, Barker-Collo S, McPherson K, Rush E, Vandal AC, Feigin VL

BACKGROUND AND PURPOSE: Enzogenol, a flavonoid-rich extract from Pinus 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
Enzogenol 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
Enzogenol (1000 mg/day) or matching placebo for 6 weeks. Subsequently, all
participants received Enzogenol 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, Enzogenol 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: Enzogenol 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 Enzogenol is well
tolerated and may reduce self-perceived cognitive failures in patients
3-12 months post-mild TBI.

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