Research Reports - Enzogenol for cognitive functioning in traumatic brain injury
Eur J Neurol. 2013 Aug;20(8):1135-44
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.