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From the Townsend Letter
June 2008


Literature Review & Commentary
by Alan R. Gaby, MD

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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 in athletes
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 Exerc. 2007;39:1561-1569.

Folic acid prevents strokes
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. 2007;369:1876-1882.

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 optimal.

Binkley N, et al. Low vitamin D status despite abundant sun exposure. J Clin Endocrinol Metab. 2007;92:2130-2135.

Eating late makes esophageal reflux worse
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 depression
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.

Comment: Previous 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


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