Red yeast rice saves lives
Fourteen hundred forty-five Chinese patients (aged 65-75 years)
with a history of myocardial infarction were randomly assigned to
receive, in double-blind fashion, 600 mg twice a day of xuezhikang
(a red yeast rice product, apparently the same product previously
marketed in the United States as Cholestin) or placebo for four
years. Compared with placebo, xuezhikang reduced the incidence of
recurrent coronary events by 36.9% (p = 0.001), death from coronary
heart disease (CHD) by 31.0% (p = 0.04), all-cause mortality by
31.9% (p = 0.01), stroke by 44.1% (p = 0.04), the need for a percutaneous
coronary intervention or coronary artery bypass grafting by 48.6%
(p = 0.07), and cancer by 51.4% (p = 0.03).
Based on the treatment of elderly patients with xuezhikang for an
average of four years, the number needed to treat (NNT) to prevent
one coronary event, one coronary death, and one death due to any
cause was estimated to be 18, 33, and 23, respectively. In a group
of patients younger than 65 with a history of myocardial infarction
who participated in the same study (data not presented in this paper),
the estimated NNT to prevent one coronary event, one coronary death,
and one death due to any cause was 23, 82, and 51, respectively.
Myalgias occurred in three patients in the active-treatment group
and in four patients in the placebo group. An increase in the alanine
aminotransferase level to more than three times the upper limit
of normal occurred in two patients in each group.
Comment: The results of this study
indicate that this particular strain of red yeast rice is safe and
effective for secondary prevention of coronary heart disease in
elderly Chinese people. The reductions in CHD events and CHD mortality
seen in this study were comparable to the benefits reported in the
same age group with statin therapy (red yeast rice was more effective
than statins in two studies and less effective than statins in one
study). In addition, this preparation appeared to be safer than
statin drugs, as demonstrated by a very low incidence of muscle
symptoms and hepatic toxicity.
Although the red yeast rice preparation used in this study contains
lovastatin and other statin-like substances (called monacolins),
all of them are present in amounts lower than the doses of statins
typically used to treat hypercholesterolemia. Administration of
low doses of a wide range of monacolins might be safer than using
a high dose of a single one, as is done in conventional cardiology.
Another possible explanation for the greater safety of red yeast
rice compared with conventional statins is that the former might
contain naturally occurring substances that decrease the toxicity
of the monacolins.
Xuezhikang was banned by the Food and Drug Administration after
Merck and Company filed a lawsuit alleging infringement on its lovastatin
patent. Other red yeast products are still on the market in the
US, but their safety and efficacy have not been well studied. The
banning of xuezhikang in the US is an example of why the health
care system in this country is collapsing. Americans do not have
access to a natural product that is safer, less expensive, and at
least as effective as statin drugs. As a result, we are forced to
spend billions of dollars on patented prescription statins and to
suffer from painful, weak muscles and unhappy livers.
Ye P, et al. Effect of xuezhikang on cardiovascular events and mortality
in elderly patients with a history of myocardial infarction: a subgroup
analysis of elderly subjects from the China Coronary Secondary Prevention
Study. J Am Geriatr Soc. 2007;55:1015-1022.
Case report: Intravenous
nutrients enhance athletic performance
An 18-year-old, 235-pound high-school wrestler developed a flu-like
illness four days before a major tournament. Two days before the
tournament, when it appeared that he might have to miss the event,
I administered an intravenous infusion that contained 3.5 g of vitamin
C, 1 g of magnesium chloride hexahydrate, 2.5 ml of 10% calcium
gluconate, 1,000 mcg of hydroxocobalamin, 100 mg of pyridoxine,
250 mg of dexpanthenol, and 1 ml of "B-complex 100" (a
commercially available B-vitamin preparation). The next morning,
he remarked that he had more energy than he had ever had in his
life. This energy boost persisted for the duration of the three-day
tournament, at which he took second place, far above everyone's
expectations and far above any of his past performances.
Comment: This young man probably had
mild intracellular deficiencies of various nutrients as a result
of consuming a typical nutrient-depleted Western diet and repeatedly
losing minerals through sweat during his wrestling workouts. However,
the beneficial effect of the nutrient injection may have been due
to more than just correcting simple deficiencies. Some individuals
appear to have a genetic weakness in their capacity to transport
magnesium (and presumably other nutrients) from the bloodstream
into the cells. In those individuals, this weakness can be overcome
by markedly increasing the serum concentrations of nutrients by
means of an intravenous infusion.
In this era in which many athletes are using performance-enhancing
drugs, it is not my intention to encourage athletes to seek another
"boost" with intravenous nutrients. However, this case
does demonstrate that nutritional factors can play an important
role in athletic performance.
Gaby AR. Intravenous nutrient therapy: the "Myers' cocktail."
Altern Med Rev. 2002;7:389-403.
Quercetin prevents infections
Forty trained male cyclists (mean age, 28 years) were randomly assigned
to receive, in double-blind fashion, quercetin (500 mg twice a day)
or placebo for three weeks before, during, and two weeks after a
three-day period of intensive exercise (three hours per day of cycling
at approximately 57% of maximal work capacity). The incidence of
upper respiratory tract infections during the two weeks after the
intensive exercise was 5% in the quercetin group and 45% in the
placebo group (p = 0.004). There was no difference between treatments
in various measure of immune function (natural killer cell activity,
phytohemagglutinin-stimulated lymphocyte proliferation, polymorphonuclear
oxidative-burst activity, and salivary IgA output).
Comment: Respiratory infections occur
frequently after periods of intensive exercise, such as running
a marathon. The results of this study indicate that quercetin supplementation
can greatly reduce the incidence of such infections. In vitro studies
have shown that quercetin inhibits the replication of a number of
different viruses, an effect that might explain its mechanism of
action in preventing respiratory infections. In a previous study,
supplementation of marathon runners with L-glutamine (5 g at the
end of the marathon and, again, two hours later) reduced the frequency
of post-race respiratory infections from 51% in the placebo group
to 19% in the L-glutamine group. L-glutamine probably works by enhancing
immune function, a mechanism of action that probably differs from
that of quercetin. Additional research is needed to determine whether
the combination of quercetin and L-glutamine would be more effective
than either substance alone.
Nieman DC, et al. Quercetin reduces illness but not immune perturbations
after intensive exercise. Med Sci Sports
Folic acid prevents
A meta-analysis was performed of eight randomized trials that examined
the efficacy of folic acid supplementation (0.5-15 mg/day) in the
prevention of stroke. Folic acid supplementation significantly reduced
the risk of stroke by 18% (relative risk [RR] = 0.82; 95% CI, 0.68-1.00;
p < 0.05). A greater beneficial effect was seen in trials with
a treatment duration of more than 36 months (RR = 0.71; p = 0.001),
a decrease in the concentration of homocysteine of more than 20%
(RR = 0.77; p = 0.012), no fortification or partly fortified grain
(RR = 0.75; p = 0.003), and no history of stroke (R = 0.75; p =
0.002). In the corresponding comparison groups, the relative risks
were attenuated and not statistically significant.
Comment: Numerous studies have demonstrated
that an elevated plasma homocysteine concentration is an independent
risk factor for stroke. The possibility that this association represents
a cause-and-effect relationship is supported by genetic studies,
in which homozygotes for a polymorphism that leads to high homocysteine
levels had an increased incidence of stroke. Folic acid, vitamin
B12, and vitamin B6 have been shown to reduce homocysteine levels
and might therefore be useful for preventing stroke. The results
of this meta-analysis demonstrated that folic acid supplementation
is effective for the primary prevention of stroke.
Wang X, et al. Efficacy of folic acid supplementation in stroke
prevention: a meta-analysis. Lancet.
Are we diagnosing vitamin
D deficiency correctly?
Serum 25-hydroxyvitamin D (25[OH]D) levels were measured in 93 adults
(mean age, 24 years) living in Honolulu, Hawaii (21 degrees latitude)
whose mean self-reported sun exposure was 28.9 hours per week. The
mean sun exposure index (hours per week of total body exposure with
no sunscreen used) was 11.1 hours. Using the high-performance liquid
chromatography (HPLC) assay and applying a widely recommended cutoff
point of 30 ng/ml, 51% of this population had low vitamin D status.
Serum 25(OH)D levels measured by radio-immunoassay (RIA) were approximately
6.8 ng/ml higher than those measured by HPLC. Using the RIA measurements,
25% of this population had low vitamin D status. Even using a cutoff
point of 20 ng/ml, about ten percent of the individuals in this
study would be classified as vitamin D-deficient. There was no correlation
between serum parathyroid hormone levels and 25(OH)D levels.
Comment: It has been suggested that
a 25(OH)D level less than 30 ng/ml is indicative of vitamin D deficiency,
because at 25(OH)D levels below 30 ng/ml serum parathyroid hormone
levels begin to rise. However, in the present study, there was no
correlation between serum levels of parathyroid hormone and 25(OH)D.
What that suggests is that in the population being studied, serum
25(OH)D levels less than 30 ng/ml are consistent with normal vitamin
D status. The same may be true for other subsets of the population.
In the past five years or so, the pendulum has swung among nutrition-oriented
doctors from ignoring vitamin D deficiency to diagnosing and treating
it aggressively, perhaps too aggressively. Some doctors are routinely
prescribing large vitamin D doses (such as 4,000 IU/day or more)
in an attempt to achieve serum 25(OH)D that are claimed by some
investigators to be optimal. Considering the uncertainty introduced
by the present study regarding the reliability of serum 25(OH)D
levels, it is important to remember that high-dose vitamin D can
be toxic. We should not use massive doses of this vitamin for the
sole purpose of raising 25(OH)D to levels that we believe to be
Binkley N, et al. Low vitamin D status despite abundant sun exposure.
J Clin Endocrinol Metab. 2007;92:2130-2135.
Eating late makes esophageal
Thirty patients with gastroesophageal reflux (GERD) symptoms were
randomly assigned to consume a standard meal either six hours or
two hours prior to going to bed. The next night they consumed the
same meal at the alternate time. The meal contained 900 kcal and
consisted of a McDonald's Big Mac, French fries, and 600 ml
of a carbonated soft drink. Acid exposure was measured for 48 hours
using a Bravo wireless pH system. The mean amount of supine acid
reflux was significantly greater after the late evening meal than
after the earlier evening meal (p = 0.002). There was no significant
difference in total symptom score between the two days.
Comment: The results of this study
indicate that, if you have GERD and plan to eat a large junk-food
meal, you probably should eat it far away from bedtime. It is noteworthy
that the researchers considered a large hamburger, fried potatoes,
and a glass of sugar-water infused with carbon dioxide a "standard
meal." Maybe if patients with GERD raised their standards,
they wouldn't have GERD anymore. Nevertheless, it seems logical
that reflux would be less likely to occur if dinner were given ample
time to enter the small intestine prior to lying down for the night.
Piesman M, et al. Nocturnal reflux episodes following the administration
of a standardized meal. Does timing matter? Am
J Gastroenterol. 2007;102:2128-2134.
Vitamin E prevents thromboembolism
Some 39,876 women (aged 45 years or older) participating in the
Women's Health Study were randomly assigned to receive, in
double-blind fashion, 600 IU of vitamin E every other day or placebo
for a median of 10.2 years. Venous thromboembolism (VTE) occurred
in 213 women in the vitamin E group and in 269 of those in the placebo
group for a 21% risk reduction (p = 0.01). Among the three percent
of participants with a prior history of VTE, the risk reduction
was 44% (p < 0.05) with vitamin E, whereas women without prior
VTE had an 18% risk reduction (p = 0.04) with vitamin E. Women with
either factor V Leiden or the prothrombin mutation had a 49% risk
reduction associated with vitamin E treatment (p < 0.02).
Comment: The results of this study
indicate that supplementation with vitamin E can reduce the risk
of VTE. Women with a prior history or a genetic predisposition to
the disease appeared to receive the greatest benefit. Vitamin E
probably works by inhibiting platelet aggregation. In recent years,
a number of studies have questioned whether vitamin E is beneficial
for preventing or treating cardiovascular disease. While vitamin
E may not be effective for preventing myocardial infarction or death
due to cardiovascular disease, the evidence indicates that it is
effective for treating intermittent claudication and preventing
thromboembolism. In addition, as noted in my recent editorial ("Vitamin
E and Cardiovascular Disease: A Genetic Factor," Townsend
Letter, April 2008),
vitamin E has been shown to prevent cardiovascular events in diabetic
patients with the haptoglobin 2-2 genotype.
Glynn RJ, et al. Effects of random allocation to vitamin E supplementation
on the occurrence of venous thromboembolism: report from the Women's
Health Study. Circulation. 2007;116:1497-1503.
Levothyroxine "augmentation" for
Seventeen euthyroid women (aged 30-60 years) with depression that
had failed to respond to serotonergic antidepressants (tricyclic
or selective serotonin-reuptake inhibitors) received 100 mcg/day
of levothyroxine for four weeks while continuing their previous
medication. After four weeks, 11 women (65%) were in remission,
defined as a score of 7 or less on the Hamilton Depression Rating
Scale (HDRS). Five other patients showed a decrease of more than
50% on the HDRS. Thus, 94% of the patients showed improvement or
resolution of symptoms. The efficacy of levothyroxine augmentation
did not correlate with pretreatment laboratory tests results for
thyroid function (T3, T4, TSH, and TRH stimulation test), all of
which were normal.
studies have shown that the addition of triiodothyronine (T3) to
standard therapy is often effective for depressed patients who have
failed to respond to antidepressant drugs alone. The present study
suggests that a moderate dose of levothyroxine (T4) is also effective
when used as adjunctive therapy. In most of these studies, the investigators
assumed that thyroid hormone somehow caused the antidepressants
to work better. An alternative explanation is that some of the successfully
treated patients were clinically hypothyroid and that they would
have improved with thyroid hormone alone, without the use of antidepressants.
Although the patients in the present study were euthyroid according
to standard laboratory tests, it is my belief that these tests fail
to identify a large proportion of patients who are clinically hypothyroid
(see Gaby AR. "Sub-laboratory" hypothyroidism and the
empirical use of Armour thyroid. Altern
Med Rev. 2004;9:157-179.)
Lojko D, Rybakowski JK. L-thyroxine augmentation of serotonergic
antidepressants in female patients with refractory depression. J
Affect Disord. 2007;103:253-256.
Alan R. Gaby