Table 39–6. Evidence for nutrients and vitamins
Bacci-Ballerini et al. 1983
DBRPC study of 30 TBI patients given SAMe: 28 during
acute phase and 2 at 1 month post-TBI. SAMe 100 mg iv plus 50 mg
im daily for 30 days reduced mean postconcussion symptom scores by
77% vs. 49% on placebo. SAMe improved headache
and vertigo (P <0.05)
vs. placebo. Two subjects had allergic reaction to iv SAMe.
Small number of subjects. Low dose of SAMe used. Nonstandard
4- point rating scale.
Monaco et al. 1996
DBRPC study of 41 patients within 24 hours of ischemic
or hemorrhagic stroke given standard therapy with SAMe 2,400 mg/day
iv, SAMe 3,200 mg/day iv, or placebo for 14 days. SAMe significantly
improved survival (P = 0.017).
Sakellaris et al. 2008
6-month randomized controlled trial of 39 children
(ages 1–18 years) with TBI (Glasgow Coma Scale 3–9
and Pediatric Trauma Score 4–12): 19 given standard treatment
alone vs. 20 given standard treatment plus creatine (0.4 g/kg/day
oral suspension) initiated within 4 hours of injury. Children given
creatine had better short-term outcomes than control group: duration posttraumatic
amnesia (21.40 vs. 81.50 days, P <0.019),
intubation (4.10 vs. 8.89 days, P <0.051),
intensive care stay (7.08 vs. 32.84 days, P <0.056).
Proportion of children having symptoms was significantly greater
in controls than in those given creatine: headache (93.8% vs. 11.1%, P <0.001),
dizziness (56.3% vs. 11.1%, P <0.005),
and fatigue (88.9% vs. 17.6%, P <0.001).
No side effects with creatine.
Ihara et al. 1989
Two patients with MELAS: addition of idebenone to CoQ10
improved EEG, Wechsler Adult Intelligence Scale score, muscular
weakness, peripheral nerve damage, and (cerebrospinal fluid) monoamines.
Ikejiri et al. 1996
36-year-old man with MELAS: 5-month high-dose idebenone
increased markedly cerebral metabolic ratio of oxygen and oxygen
extraction fraction without increased cerebral blood flow on positron
emission tomography, indicating idebenone improves mitochondrial
oxidative metabolism in the brain.
Seki et al. 1997
16-year-old boy with MELAS: EEG markedly improved after
addition of idebenone to CoQ10. No progression of clinical abnormalities
for 16 months.
Napolitano et al. 2000
One patient with MELAS treated 24 months with idebenone
and riboflavin, during which no strokelike episodes occurred. Neurological
symptoms improved with recovery of brain magnetic resonance imaging
and EEG abnormalities.
Nakano et al. 1989
Nine patients with cerebrovascular disorders (arteriosclerosis
or infarction) given idebenone 30 mg tid. Five patients showed improvements
in EEG related to improvements in anxiety, irritation, restlessness,
sleep, depression, and volition.
Open trial. Small number of subjects.
Bergamasco et al. 1992
DBRPCMC study of 97 patients with mild to moderate
multi-infarct dementia. Those given idebenone 90 mg/day
for 90 days showed greater improvements in memory, attention, orientation,
vigilance, and verbal comprehension vs. placebo.
Gutzmann and Hadler 1998
DBRPCMC 2-year study of 450 patients with mild to moderate
Alzheimer's disease. Idebenone 270–360 mg/day
statistically significant dose-dependent improvement on ADAS total
score and all secondary measures vs. placebo. During the second
year, further improvements occurred. Safety and tolerability comparable
ApoE status not reported.
Gutzmann et al. 2002
DBRPCMC 60-week study of 203 patients with mild to
moderate Alzheimer's disease. Intent-to-treat analysis:
Idebenone (260 mg/day) performed better than tacrine (up
to 160 mg/day). At 60 weeks, dropouts: 71.2% on
idebenone and 90.9% on tacrine.
Large dropout rate. ApoE status not reported.
Thal et al. 2003
DBRPCMC 1-year study of 536 patients with mild to moderate
Alzheimer's disease. Three different doses of idebenone
failed to significantly slow cognitive decline (ADAS) compared with
ApoE status not reported.
Pelka and Leuchtgens 1995
DBRPC 3-month study of 75 patients with mild dementia
ages 55–85 years. Bio-Strath (B vitamins, antioxidants)
double usual adult dose. Placebo group deteriorated. Bio-Strath
group improved short-term memory, physical and emotional benefits.