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From the Townsend Letter
July 2011
Literature Review & Commentary
by Alan R. Gaby, MD
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Probiotic Improves Irritable Bowel Syndrome
Fifty-nine children (aged 4–18 years; mean, 12.5 years) with irritable bowel syndrome were randomly assigned to receive, in double-blind fashion, VSL#3 (a probiotic) or placebo for 6 weeks. After a 2-week washout period, each child received the alternate treatment for an additional 6 weeks. The dosage of VSL#3 was 1 sachet per day for ages 4 through 11 and 1 sachet twice a day for ages 12 through 18. Compared with placebo, active treatment resulted in a significant improvement in symptoms, as measured by the global assessment of relief (p < 0.05). In addition, active treatment was significantly more effective than placebo for 3 of 4 secondary endpoints: abdominal pain/discomfort, abdominal bloating/gassiness, and family assessment of life disruption. Active treatment was nonsignificantly more effective than placebo for improving stool pattern.

Comment: Studies on the use of probiotics for the treatment of irritable bowel syndrome have produced conflicting results. While additional research is needed to determine which patients are most likely to benefit and what the optimal probiotic strains are, VSL#3 has shown promise for various gastrointestinal conditions. This probiotic preparation consists of 4 strains of lactobacilli, 3 strains of bifidobacteria, and 1 strain of Streptococcus salivarius subsp. thermophilus. In previous studies, VSL#3 was found to be useful for patients with ulcerative colitis and for those with chronic pouchitis (a long-term complication after ileal pouch-anal anastomosis for ulcerative colitis).

Guandalini S et al. VSL#3 improves symptoms in children with irritable bowel syndrome: a multicenter, randomized, placebo-controlled, double-blind, crossover study.
J Pediatr Gastroenterol Nutr. 2010;51:24–30.

Gymnema Sylvestre for Diabetes
Eleven patients with type 2 diabetes received 1 g per day of a high-molecular-weight Gymnema sylvestre extract (Om Santal Adivasi) for 60 days. Fasting blood glucose levels fell in 10 of the 11 patients, with a mean reduction from 162 mg/dl to 119 mg/dl. Significant increases in circulating levels of insulin and C-peptide were also seen. There was no change in body weight. In an in vitro study, the Gymnema extract stimulated insulin secretion from human pancreatic beta cells.

Comment: This study confirms previous reports indicating that Gymnema extracts can improve glycemic control in patients with type 2 diabetes. Gymnema may work in part by stimulating insulin secretion from pancreatic beta calls, as suggested by the in vitro research mentioned above. In addition, earlier studies suggested that Gymnema may promote the regeneration or repair of pancreatic beta cells.

Al-Romaiyan A et al. A novel Gymnema sylvestre extract stimulates insulin secretion from human islets in vivo and in vitro.
Phytother Res. 2010;24:1370–1376.

Is Calcium Harmful for Pregnant Women?
One hundred twenty-five pregnant women living in Gambia, West Africa, who had low calcium intake (approximately 350 mg per day) were randomly assigned to receive, in double-blind fashion, 1500 mg per day of calcium (as calcium carbonate) or placebo from 20 weeks of gestation until delivery. The women did not receive the supplement during lactation. Compared with women in the placebo group, women in the calcium group had significantly lower bone mineral content, bone area, and bone mineral density at the hip during 12 months of lactation. During lactation, the calcium-supplemented women also had greater loss of bone at the lumbar spine and distal radius and had biochemical changes consistent with greater bone mineral mobilization.

Comment: There is evidence that calcium supplementation interferes with the absorption of magnesium, manganese, zinc, phosphorus, and silicon, each of which plays a role in maintaining bone health. In countries such as Gambia, where there is a high prevalence of chronic malnutrition, supplementation with calcium by itself could exacerbate other nutritional deficiencies, with potential adverse effects on bone. Interactions between calcium and other minerals may also have clinical implications in countries where malnutrition is uncommon. A recent meta-analysis found that calcium supplementation was associated with a significant increase in the incidence of myocardial infarctions. That finding might be due to calcium-induced depletion of cardioprotective nutrients such as magnesium and silicon. It would seem reasonable to expect that the deleterious effects of calcium supplementation could be prevented by coadministration of a multimineral preparation.

Jarjou LMA et al. Effect of calcium supplementation in pregnancy on maternal bone outcomes in women with a low calcium intake. Am J Clin Nutr. 2010;92:450–457.

Choline Requirements Are Influenced by Menopausal Status and Genetic Factors
Twenty-seven premenopausal women consumed a choline-sufficient diet (550 mg per 70 kg of body weight per day) followed by a very low-choline diet (< 50 mg/70 kg/day) until they developed organ dysfunction (or for 6 weeks), and then a high-choline diet. Twenty-two postmenopausal women were placed on the same diets but were first randomly assigned to receive 0.625 mg per day of conjugated equine estrogens or placebo. Organ dysfunction was defined as a >1.5-fold increase in the level of aspartate aminotransferase (AST) or alanine aminotransferase (ALT), a >5-fold increase in creatine phosphokinase (CPK), or a >28% increase in liver fat content, provided that these changes occurred on the low-choline diet and resolved after resumption of a high-choline diet. Participants were also examined for a common polymorphism (rs12325817) of the phosphatidylethanolamine-N-methyltransferase (PEMT) gene, a polymorphism that is known to increase choline requirements.

A dose-response effect of rs12325817 on the risk of choline deficiency-related organ dysfunction was observed in premenopausal women: 80%, 43%, and 13% of women with 2, 1, or 0 alleles, respectively, developed organ dysfunction. Among postmenopausal women, 73% who received placebo but only 18% who received estrogen developed organ dysfunction during the low-choline diet.

Background: Severe choline deficiency can lead to liver dysfunction (including fatty liver) and muscle abnormalities. While severe choline deficiency is uncommon in otherwise healthy individuals, a substantial majority of the adult population consumes less than the Adequate Intake level for choline (550 mg per day for men, 425 mg per day for women). Postmenopausal women and individuals with the common genetic polymorphism mentioned above (nearly 75% of the population is heterozygous or homozygous for this polymorphism) may be at increased risk of suffering adverse effects from suboptimal choline status. The potential value of choline supplementation for patients with liver and muscle disorders warrants further investigation.

Fischer LM et al. Dietary choline requirements of women: effects of estrogen and genetic variation. Am J Clin Nutr. 2010;92:1113–1119.

Arginine Beneficial for Patients with Head and Neck Cancer
Thirty-two severely malnourished patients with head and neck cancer were randomly assigned to receive, in double-blind fashion, a standard perioperative enteral nutrition formula (control group) or an isonitrogenous, isocaloric arginine-supplemented formula, in which 41% of the casein in the standard formula was replaced by arginine. The assigned treatments were given for 10 days. The median survival time was significantly longer in the arginine-supplemented group than in the control group (34.3 vs. 20.7 months; p < 0.02). In addition, the time before local cancer recurrence was significantly longer in the arginine group than in the control group (p < 0.03).

The results of this study indicate that short-term (perioperative) administration of arginine significantly improved long-term survival in malnourished patients with head and neck cancer.

Arginine may work by preventing the decline in immune function that typically occurs in the postoperative period, thereby minimizing the postoperative spread of residual cancer cells.

Buijs N et al. Perioperative arginine-supplemented nutrition in malnourished patients with head and neck cancer improves long-term survival. Am J Clin Nutr. 2010;92:1151–1156.

Food Allergy Causes Physical Symptoms in Children With ADHD
Twenty-seven children (aged 3.8–8.5 years; mean, 6.3 years) with attention deficit-hyperactivity disorder (ADHD) were randomly assigned to an experimental group that followed a 5-week elimination diet or to a control group that followed their usual diet. If there was no improvement on the elimination diet after the second week, the diet was restricted further to a few-foods diet. The mean percent improvement in physical and sleep complaints (as determined by parent ratings on a Physical Complaints Questionnaire) was significantly greater in the experimental group than in the control group (77% vs. 17%; p < 0.001). Specific complaints that were significantly reduced were in three domains: headaches or bellyaches, unusual thirst or unusual perspiration, and sleep complaints. There was a positive correlation between the reduction of physical and behavioral symptoms (p < 0.01). The improvement did not differ between children with and without an atopic constitution (p = 0.7).

Comment: Since the 1970s, there have been dozens of articles published in medical journals indicating that identifying and avoiding allergenic foods can improve both physical and mental symptoms in children. Unfortunately, this approach to managing common pediatric disorders remains outside the medical mainstream. Perhaps one day the average doctor will realize that the main stream is somewhat polluted, and he or she will begin to wade into cleaner and more promising tributaries.

Pelsser LM et al. Effects of food on physical and sleep complaints in children with ADHD: a randomised controlled pilot study. Eur J Pediatr. 2010;169:1129–1138.

Vitamin D Produces Modest Improvement in Fibromyalgia
Serum 25-hydroxyvitamin D levels were measured in 610 patients (mean age, 59 years) living in Duluth, Minnesota. Forty-six percent of the patients were deficient in vitamin D (<26 ng/ml), and 38 patients (6.3%) were severely deficient (<10 ng/ml). One hundred patients with mild or moderate vitamin D deficiency (10–25 ng/ml) were randomly assigned to receive, in double-blind fashion, 50,000 IU of vitamin D3 once a week or placebo for 8 weeks. Patients with severe deficiency received vitamin D3 in open-label fashion (50,000 IU once a week for 8 weeks, then monthly for one year). In the double-blind trial, symptoms of fibromyalgia (as determined by the Fibromyalgia Impact Questionnaire) improved by a mean of 11% in the active-treatment group and worsened by a mean of 7% in the placebo group (p = 0.03 for the difference in the change between groups). In the severely deficient patients, no significant improvement was seen in symptoms related to fibromyalgia or in depression after 8 weeks or after one year of treatment, even though the 25-hydroxyvitamin D level increased by an average of 35.7 ng/ml).

Comment: These results suggest that vitamin D supplementation produces modest improvement in symptoms of fibromyalgia in patients with mild-to-moderate vitamin D deficiency, but not in patients with severe vitamin D deficiency. It is not clear why patients with severe deficiency did not respond to supplementation, although one possible explanation is that they had various comorbid conditions that were major contributing factors to the fibromyalgia.

Arvold DS et al. Correlation of symptoms with vitamin D deficiency and symptom response to cholecalciferol treatment: a randomized controlled trial. Endocr Pract. 2009;15:202–211.

Another Obscenely Priced, Moderately Effective New Drug
Four hundred nineteen inner-city children, adolescents, and young adults with asthma that had failed to respond adequately to conventional therapy were randomly assigned to receive, in double-blind fashion, omalizumab or placebo for 60 weeks. Compared with placebo, omalizumab treatment resulted in a 24.5% decrease in the number of days with asthma symptoms (p < 0.001) and reduced the proportion of participants who had one or more exacerbations (from 48.8% to 30.3%; p < 0.001).

Comment: Omalizumab (Xolair) is a recombinant DNA-derived monoclonal antibody that inhibits the binding of IgE to the IgE receptor. While this drug appears to be moderately effective for some patients with refractory asthma, it is absurdly expensive (average cost, $12,000 per year). In contrast, oral magnesium supplementation, which also appears to be moderately effective for improving asthma symptoms, costs only about $20 per year. Other nutritional supplements that have been found to improve asthma (e.g., vitamin B6 and vitamin C) are also quite inexpensive. Of course, because the FDA has approved Xolair as a treatment for asthma, but has not approved magnesium, vitamin B6, or vitamin C, it is illegal for nutritional supplement companies to tell anyone that these nutrients may be effective. Consequently, few people with refractory asthma are aware that they have choices other than to go bankrupt or to stop breathing. This is another example of how misguided FDA regulations demote (rather than promote) the general welfare.

Busse WW et al. Randomized trial of omalizumab (anti-IgE) for asthma in inner city children. N Engl J Med. 2011;364:1005–1015.

Alan R. Gaby, MD


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