Wednesday, March 31, 2010

Research Highlights - April

American Journal of Clinical Nutrition
  • Dietary products [resveratrol, green tea extract, -tocopherol, vitamin C, n–3 (omega-3) polyunsaturated fatty acids, and tomato extract] selected for their evidence-based antiinflammatory properties were combined and given as supplements to 36 healthy overweight men with mildly elevated plasma C-reactive protein concentrations in a double-blind, placebo-controlled, crossover study with treatment periods of 5 wk. Inflammatory and oxidative stress defense markers were quantified in plasma and urine. Furthermore, 120 plasma proteins, 274 plasma metabolites (lipids, free fatty acids, and polar compounds), and the transcriptomes of peripheral blood mononuclear cells and adipose tissue were quantified.

    Plasma adiponectin concentrations increased by 7%, whereas C-reactive protein (principal inflammation marker) was unchanged. However, a multitude of subtle changes were detected by an integrated analysis of the "omics" data, which indicated modulated inflammation of adipose tissue, improved endothelial function, affected oxidative stress, and increased liver fatty acid oxidation.


    An intervention with selected dietary products affected inflammatory processes, oxidative stress, and metabolism in humans, as shown by large-scale profiling of genes, proteins, and metabolites in plasma, urine, and adipose tissue.

  • Healthy boys aged 8–10 y (n = 33) were randomly assigned to receive placebo or 1 of 2 doses of DHA (400 or 1200 mg/d) for 8 wk. Relative changes in cortical activation patterns during sustained attention at baseline and endpoint were determined by functional magnetic resonance imaging. At 8 wk, erythrocyte membrane DHA composition increased significantly from baseline in subjects who received low-dose (by 47%) or high-dose (by 70%) DHA but not in those who received placebo (–11%). During sustained attention, both DHA dose groups had significantly greater changes from baseline in activation of the dorsolateral prefrontal cortex than did the placebo group, and the low-dose and high-dose DHA groups had greater decreases in the occipital cortex and cerebellar cortex, respectively. Relative to low-dose DHA, high-dose DHA resulted in greater decreases in activation of bilateral cerebellum. The erythrocyte DHA composition was positively correlated with dorsolateral prefrontal cortex activation and was inversely correlated with reaction time, at baseline and endpoint. Dietary DHA intake and associated elevations in erythrocyte DHA composition are associated with alterations in functional activity in cortical attention networks during sustained attention in healthy boys.
Nutrition Reviews
  • A substantial body of scientific evidence has shown that by simply varying the macronutrient distribution and composition of dietary factors, weight losses of varying amounts, longer-term body weight maintenance periods, better appetite regulation, and changes in features of the metabolic syndrome can be achieved. At present, renewed efforts are underway to increase the protein content of weight-loss diets, simultaneously restrict fat consumption to no more than 30%, favor polyunsaturated fat, have carbohydrates account for between 40 and 50% of total energy intake, and promote the consumption of low-glycemic foods.
  • The incidence of atopic dermatitis (AD) is increasing worldwide. Clinical studies have observed reduced risks of AD among infants fed with 100% whey infant formula (PHF-W) compared with intact protein cow's milk formula. In this study, the cumulative incidence of AD was significantly lower among infants over at least 3 years of follow-up in the whey group compared with the intact protein cow's milk group. Exclusive breastfeeding should be encouraged as the primary means to prevent atopic risk. However, when infants are not exclusively breastfed, whey may be considered an effective measure to potentially reduce the risk of developing AD.
Journal Nutrition
  • For users, dietary supplements provided the adequate intake (AI) recommendation for calcium intake for 12% of those 71 y. Males and females aged 1–3 y had the highest prevalence of meeting the AI from dietary and total calcium intakes. For total vitamin D intake, males and females 71, and females 14–18 y had the lowest prevalence of meeting the AI. Dietary supplement use is associated with higher prevalence of groups meeting the AI for calcium and vitamin D. Monitoring usual total nutrient intake is necessary to adequately characterize
    and evaluate the population's nutritional status and adherence to recommendations for nutrient intake.
  • DHA deficiency is associated with major aspects of cognitive performance in nonpatient adults under 55 years of age.
  • Evidence supports the proposition that DHA deficiency increases vulnerability to neuronal atrophy in the Pre Frontal Cortex of patients with affective disorders.
Journal of the American Dietetic Association
  • Neither consuming more dairy products, nor switching from whole milk to reduced-fat milk at age 2 years, appears likely to prevent overweight in early childhood.
American Journal of Preventive Medicine
  • This study aimed to study lifestyle changes consistent with reducing diabetes risk and factors associated with their adoption among 1402 adults over age 20 with prediabetes. Almost 30% of the U.S. adult population had prediabetes in 2005–2006, but only 7.3% were aware they had it. About half of adults with prediabetes reported performing diabetes risk reduction behaviors in the past year, but only about one third of adults with prediabetes had received healthcare provider advice about these behaviors in the past year. Adoption of risk reduction behaviors among U.S. adults with prediabetes is suboptimal. Efforts to improve awareness of prediabetes, increase promotion of healthy behaviors, and improve availability of evidence-based lifestyle programs are needed to slow the growth in new cases of diabetes.

Progesterone imbalance key with PCOS and edometriosis

According to Seminars in Reproductive Medicine, progesterone is essential for endometrial receptivity and successful establishment of pregnancy. Either an insufficient progesterone concentration or an insufficient response to progesterone, therefore can lead to infertility and pregnancy loss. Assessment of the role that either progesterone insufficiency or inadequate progesterone response plays in human reproductive failure has been difficult to assess because serum progesterone concentrations fluctuate markedly, limiting the ability to characterize sufficiency of progesterone, and there are no highly reliable markers of endometrial function available.

Recent evidence demonstrates exquisite sensitivity of normal endometrium to very low levels of progesterone stimulation, suggesting that progesterone insufficiency should not be a common cause of reproductive failure. Further evidence suggests that women with endometriosis, and possibly polycystic ovarian syndrome, have an altered progesterone response, which may explain some of the clinical features of these disorders and supports the hypothesis that progesterone resistance underlies some cases of human reproductive failure.

Bonnie - I have found that saliva testing gives a very accurate progesterone reading. I also recommend topical natural progesterone for both conditions.

News flash: dark chocolate good for heart

The largest study so far to examine the association between chocolate consumption and risk of cardiovascular disease has found that of those who ate the most chocolate—around 7.5 g per day—had a 39% lower risk of MI and stroke than individuals who ate almost no chocolate (1.7 g per day). Lead author Dr Brian Buijsse (German Institute of Human Nutrition, Nuthetal, Germany) said: "This shows that habitual consumption of chocolate is related to a lower risk of heart disease and stroke that is partly explained by blood-pressure reduction. The risk reduction is stronger for stroke than for MI, which is logical because it appears that chocolate and cocoa have a pronounced effect on BP, and BP is a higher risk factor for stroke than for MI." Buijsse and colleagues report their findings in the European Heart Journal. Buijsse cautions that only small amounts of chocolate (one square a day or half a small Ester egg in a week), preferably dark variety, were associated with the benefits. "We know it is the cocoa content in chocolate that is important, so the higher the cocoa content, the better." The study followed 19 357 people, aged between 35 and 65, who were participants in the Potsdam arm of the European Prospective Investigation into Cancer.

Bonnie - I only recommend 70% or higher cocoa content minimum.

Medications as Modifiable Contributors to Weight Gain

A Role for Clinical Preventive Medicine (abridged)
Ingrid Kohlstadt, MD, MPH
American College of Preventive Medicine

Introduction

Obesity in the United States has grown by 48% in the past 15 years, offsetting the health gains achieved by a 20% reduction in smoking over the same time period. Obesity is difficult to correct, suggesting an urgent role for prevention of every known risk factor. Although not often considered in the list of risk factors for obesity, the medications taken by many people may be contributing to the population's increasing girth.

Unlike poor diet or lack of exercise, medications alone aren't a separate fast track for obesity. Rather, they undermine a person's efforts at lifestyle modification by raising the incline on the uphill struggle to stick to diet and exercise regimens.

Appetite Deregulation: A Food-Drug Interaction

Several classes of medications act centrally to alter the hypothalamic satiety and appetite centers, through mechanisms not yet fully elucidated. Medications can change the amount and type of food that a person selects. Such food-drug interactions are covered only modestly in the medical literature, suggesting that they may be underrecognized.

Clinicians may hesitate to inform patients of the potential of medications to alter appetite. A patient may conclude erroneously that a drug caused weight gain, and therefore discount the importance of lifestyle modification. Clinicians may also be concerned about the lack of evidence of drug-induced weight gain, because most clinical trials last only 6-8 weeks, a timeframe that may be too short for patients to exhibit weight gain. Additionally, insufficient comparative effectiveness data are available to help clinicians select medications that won't affect a patient's appetite. Perhaps discussion of a medication's potential effect on appetite has simply fallen victim to the practical realities of shorter office visits.

On the other hand, reasons to discuss potential effects of a medication on appetite include:
  • Patients who are obese are more frequently prescribed appetite-increasing medications. Counseling on lifestyle modification or a specialist referral may be indicated on the basis of US Preventive Services Task Force recommendations. Children and people with mental illness are 2 groups at increased risk.
  • Informing patients of the possibility of appetite deregulation may prompt a joint decision to choose another medication, use a lower dose, or modify environmental factors.
  • Collective decision-making can improve adherence to a treatment plan.
  • Forewarned patients may be better able to recognize an increase in caloric intake and take preventive measures before weight gain occurs.
Medications that promote adipose accumulation cross numerous disease and therapeutic categories. Both public health and clinical intervention approaches are available to modify the effects of appetite and avoid weight gain.

Medications for Type 2 Diabetes Mellitus

Insulin increases appetite, whether it is exogenously administered or endogenously synthesized. An endogenous effect can occur when a diet high in refined carbohydrates (high-glycemic index foods) is ingested. These foods rapidly raise blood glucose, which, in turn, induces insulin production. When the blood glucose drops as rapidly as it rose, the lingering insulin stimulates appetite, leading to weight gain.

Exogenous insulin similarly stimulates appetite, and the tighter the glucose control, the greater the effect of insulin on appetite.

Sulfonylureas increase appetite by stimulating insulin secretion.

Thiazolidinediones contribute to adiposity and cardiovascular disease by encouraging the division and differentiation of fat cells.

New therapeutic agents not only need to demonstrate effects on hyperglycemia, but also long-term benefit or neutrality on cardiovascular disease and weight gain.

Medications for Hypertension

Thiazide diuretics, loop diuretics, calcium channel blockers, beta-blockers, and alpha-adrenergic blockers can promote weight gain, generally by increasing appetite. The more centrally acting medications in a class tend to be the more obesogenic.

Angiotensin-converting enzyme inhibitors and angiotensin receptor blockers used to treat hypertension appear to be weight neutral. Combining them with other agents allows lower doses of the appetite-stimulating medications to be used.

Lifestyle modification is another effective option that tends to be underused in reducing a patient's medication requirement. More can be done at the public health level to promote the lifestyle interventions of salt restriction, weight loss, stress reduction, exercise, and a diet rich in fruits and vegetables.

From a clinical perspective, it would be strategic to help patients avoid obesogenic medications, circumventing a vicious cycle of weight gain and hypertension.

Medications for Gastroesophageal Reflux

H2 blockers and proton-pump inhibitors may contribute to obesity indirectly via well-established biological mechanisms that are currently undergoing clinical study. Recent studies suggesting that dietary intake of acidic beverages, such as coffee and vinegar, improves glycemic control may prompt the question: "What are the effects of the converse -- raising gastric pH?"

In many patients, gastroesophageal reflux disease (GERD) is the direct result of a poor diet. In these patients, medication may serve as a substitute for a healthful diet: smaller meals; avoidance of saturated fats; and eating more fruits and vegetables -- all habits that promote weight maintenance.

The mealtime pH induced by medications for GERD reduces absorption of vitamin B12. This may lead to insufficiency for select individuals because a wide range exists between B12 sufficient to prevent anemia and B12 for optimal adherence to diet and exercise. Chromium is one of the minerals requiring a low pH for adequate absorption. Suboptimal levels of chromium are associated with less favorable body composition across mammalian species and may contribute to appetite deregulation in humans.

Antihistamines

Histamine potentiates leptin and its anorexigenic influence.
Medications that block H1 or activate H3 receptors increase appetite by reducing leptin's central activity. From a public health perspective, educating patients about the appetite-stimulating potential of antihistamines can help guide their selection of over-the-counter medications.

My patient Ella's case illustrates approaches that could be used to mitigate symptoms. It is hay-fever season and Ella's allergies are flaring up. Her physician phones in her yearly allergy prescription, and she finds fast relief. However, Ella's weight loss program is becoming increasingly difficult, to the point at which she is discouraged and doubting her self-discipline. Ella's prescription antihistamine medications are potentially contributing to her dieting difficulties. If Ella had known that her prescription could make weight loss more challenging, she might have chosen to reduce her exposure to allergens and build up her body's natural defenses by staying well hydrated, thereby requiring less medication. She would have been more likely to view her weight control setbacks differently, in a way that is more conducive to long-term success.

Steroid Hormones

Corticosteroids have been known to increase appetite by their influence on glucose uptake. They promote fat gain and reduce muscle mass, thereby exerting two unfavorable influences on body composition.

Hormonal Contraceptives

Sex hormone imbalances, caused by disease, toxicity, or medication, exacerbate the normal variation in caloric intake. Therefore, hormonal contraceptives, agents that promote fertility, and medications to prevent prostate or breast cancer recurrence could be anticipated to increase appetite. The public health and clinical implications are many and are not discussed here.

Anticonvulsants
Medications used to treat epilepsy increase appetite. Some newer anticonvulsants can have the opposite effect; they are appetite stabilizing or even appetite suppressing. In theory, genetic tests that are being used to help find the most effective medication for a patient as well as the optimal dose can limit the exposure to obesogenic medications. The ketogenic diet, used to treat epilepsy since the 1920s, is appetite suppressing. Although its mode of action has yet to be elucidated, it was estimated to be effective in approximately half of pediatric patients in a large treatment center. A modified ketogenic diet may be effective, better tolerated, and provide a more balanced nutrient intake.

Psychoactive Medications
Psychotherapeutic agents that act on neurotransmitters cannot be assumed to be appetite neutral, and some can induce profound increases in appetite and subsequent increases in adiposity.

Any medication that alters serotonin or dopamine levels centrally will influence the hypothalamic appetite and satiety centers. The outcomes are appetite stimulation and failure to achieve satiety at a set caloric intake, both of which promote weight gain.

The appetite-stimulating effects of atypical antipsychotics have been a topic of recent public health discussion, especially with respect to the use of these therapeutic agents in children. The pediatric indications for antipsychotics are schizophrenia (ages 13-17 years), bipolar disorder (ages 10-17 years), and irritability in autism (ages 5-16 years). The US Food and Drug Administration's (FDA's) Pediatric Advisory Committee in December 2009 voted unanimously to strengthen the labeling about pediatric weight gain on an atypical antipsychotic medication.

In summary, the treatment options for many patients with mental illness are limited to choosing the effective medication with the least unfavorable metabolic effects, optimizing their physical health so that a lower medication dose may be effective, restricting caloric intake, and promptly treating associated chronic physical diseases.

Summary

A complex system of brain and peripheral signals entwine to create appetite and satiety. At the hypothalamic nexus, the system is precisely regulated down to the kilocalorie. Select medications across disease entities and therapeutic classes disrupt equilibrium and increase appetite. An evolutionary advantage to the response of appetite stimulation may have existed at one time. However, in the modern era of high caloric intake with comparably low nutrient intake, the deck of cards appears to be stacked against weight maintenance. In some patients the resulting adipose accumulation is significant.

Behavior and lifestyle management, such as the techniques offered in a specialized weight management center, may help maintain weight. These techniques include eating more slowly and monitoring and limiting caloric intake; staying well hydrated with noncaloric beverages; eating breakfast but not late-night snacks; choosing foods that meet the daily recommended intake of fiber, vegetables, and fruits; and avoiding foods that contain highly processed fats, sugar, and other refined carbohydrates.

Laboratory and genetic testing make it possible to further study how food and nutrients, such as fish, phytonutrient-rich foods, omega-3 fatty acids, and vitamin D (to list a few), can be combined with medications in weight management.

Methods to improve the uptake of healthful lifestyles can reduce both the need for medications and a medication's obesogenic potential. Such innovations will have a significant impact on public health.

Author Disclaimer This article is the scientific work of the author. No endorsement by the US Food and Drug Administration (FDA) is intended or should be inferred.

References

Stewart ST, Cutler DM, Rosen AB. Forecasting the effects of obesity and smoking on US life expectancy. N Engl J Med. 2009;361:2252-2260.

Abstract Cheskin LJ, Bartlett SJ, Zayas R, Twilley CH, Allison DB, Contoreggi C. Prescription medications: a modifiable contributor to obesity. South Med J. 1999;92:898-904.

Abstract US Preventive Services Task Force. The Guide to Clinical Preventive Services: Recommendations of the US Preventive Services Task Force. Washington, DC: Agency for Healthcare Research and Quality; 2006: xii, 212.

McEvoy JP, Meyer JM, Goff DC, et al. Prevalence of the metabolic syndrome in patients with schizophrenia: baseline results from the Clinical Antipsychotic Trials of Intervention Effectiveness (CATIE) schizophrenia trial and comparison with national estimates from NHANES III. Schizophr Res. 2005;80:19-32.

Abstract Mitri J, Hamdy O. Diabetes medications and body weight. Expert Opin Drug Saf. 2009;8:573-584.

Abstract Cooper-DeHoff RM, Wen S, Beitelshees AL, et al. Impact of abdominal obesity on incidence of adverse metabolic effects associated with antihypertensive medications. Hypertension. 2010;55:61-68.

Abstract Anderson R. Chromium: roles in the regulation of lean body mass and body weight. In: Kohlstadt I, ed. Chromium in Scientific Evidence for Musculoskeletal Bariatric and Sports Nutrition. Boca Raton, Fla: CRC Press; 2006.

Jørgensen EA, Knigge U, Warberg J, Kjaer A. Histamine and the regulation of body weight. Neuroendocrinology. 2007;86:210-214.

Abstract Gong EJ, Garrel D, Calloway DH. Menstrual cycle and voluntary food intake. Am J Clin Nutr. 1989;49:252-258.

Abstract Kane P. Seizures. In: Kohlstadt I, ed. Food and Nutrients in Disease Management. Boca Raton, Fla: CRC Press; 2009:pp 717.

Colton CW, Manderscheid RW. Congruencies in increased mortality rates, years of potential life lost, and causes of death among public mental health clients in eight states. Prev Chronic Dis. 2006;3:A42.

Lieberman JA, Stroup TS, McEvoy JP, et al; Clinical Antipsychotic Trials of Intervention Effectiveness (CATIE) Investigators. Effectiveness of antipsychotic drugs in patients with chronic schizophrenia. N Engl J Med. 2005;353:1209-1223.

Abstract Correll CU. Monitoring and management of antipsychotic-related metabolic and endocrine adverse events in pediatric patients. Int Rev Psychiatry. 2008;20:195-201.

Abstract Kohlstadt I, ed. Food and Nutrients in Disease Management. Boca Raton, Fla: CRC Press; 2009:pp 717.

Authors and Disclosures Author(s) Ingrid Kohlstadt, MD, MPH Office of the Commissioner, Office of Pediatric Therapeutics, US Food and Drug Administration (FDA), Rockville, Maryland

Disclosure: Ingrid Kohlstadt, MD, MPH, has disclosed no relevant financial relationships.

Tuesday, March 30, 2010

Recipe du Jour - April

Artichoke, Asparagus, and Mushroom Quinoa Risotto

*Gluten-free; vegan if replace chicken broth, butter, and cheese; remove and replace any food you may not tolerate

2 T. butter or butter substitute
4 T. olive oil, divided
12 oz. assorted wild mushrooms, thinly sliced
3 garlic cloves, minced
1 c. chopped onion
2 c. quinoa (about 13 oz.), rinsed
½ c. dry white wine
3 ½ c. (or more) vegetable or chicken broth
1 lb. fresh asparagus, trimmed, cut into 1-inch pieces or 16 oz. cut frozen asparagus, thawed
1 8-oz. package frozen artichoke hearts, thawed
½ c. grated Parmesan or Romano cheese
1 c. shaved Manchego cheese

Melt butter with 1 T. oil in heavy large skillet over medium-high heat. Add mushrooms; sauté until brown and tender, about 7 minutes. Add garlic; sauté 2 minutes. Heat remaining 3 T. oil in heavy large saucepan over medium-high heat. Add onion; sauté until translucent, about 5 minutes. Add quinoa: sauté 2 minutes. Add wine; cook until liquid is almost absorbed, about 2 minutes. Add 3 ½ cups broth; cook 10 minutes. Add asparagus and artichoke hearts; simmer until quinoa and vegetables are tender, stirring often and adding more broth by ¼ cupfuls as needed, about 7 minutes. Add Parmesan cheese and reserved mushrooms. Stir until cheese melts and mushrooms are heated through, about 2 minutes. Season to taste with salt and pepper. Divide risotto among bowls, garnish with shaved Manchego cheese and serve. SERVES: 6

Fibromyalgia Symptoms Improved by Lifestyle Adjustments

Short bursts of physical activity can ease fibromyalgia symptoms. Researchers writing in journal Arthritis Research & Therapy have shown that encouraging patients to undertake 'Lifestyle Physical Activity' (LPA) can markedly increase the average number of steps taken per day and produce clinically relevant reductions in perceived disability and pain.

Researchers investigated the effects of 30 minutes of LPA, five to seven days a week, on physical function, pain and other measures of disability in 84 fibromyalgia patients. Although exercise has been shown to be beneficial, the symptoms often create obstacles that deter many from exercising consistently enough to derive benefits. LPA involves moderate-intensity physical activity based around everyday life such as taking the stairs instead of using an elevator, gardening and walking.

In this study, participants were taught to perform LPA intense enough to cause heavy breathing, but not so heavily that they could not hold a conversation. During subsequent sessions participants were taught self-monitoring of LPA, goal setting, dealing with symptom flares, problem solving strategies to overcome barriers to being more physically active, as well as instruction in finding new ways to integrate short bouts of LPA into their daily lives. At the end of the study, the participants randomized to LPA increased their average daily steps by 54%. Compared to the controls, the LPA group also reported significantly less perceived functional deficits and less pain.

Monday, March 29, 2010

High Potential for DNA Damage from Nanoparticles

Nanoparticles may be able to damage the DNA of cells without ever coming into contact with it, according to a study published in the journal Nature Nanotechnology.

Nanoparticles are particles so small that they have fundamentally different physical and chemical properties than the same substances do at more familiar scales. Industry is increasingly adopting nanotechnology for a variety of applications, from consumer products to medicine, but the technology remains unregulated.

Researchers created particles of chromium and cobalt that were either four millionths (micro scale) or 30 billionths (nano scale) of a meter across, then placed them on a thin, artificial membrane composed of human cells. On the other side of the membrane, researchers placed human fibroblast cells, which are important components of connective tissue.

They found that although no particles crossed the cellular membrane, fibroblast cells placed across from the metal particles suffered DNA damage in 10 times as many locations and cells placed next to a membrane with nothing on the other side.

Researchers are unsure how the particles damaged the cells without crossing the membrane, but they believe they may cause changes in the membrane cells, which in turn signal the fibroblast cells and cause DNA damage.

"We used a variety of chemicals to block ... cell-to-cell signaling and found that in the presence of these blockers, the damage we were seeing was completely prevented," lead author Gevdeep Bhabra said.

The experiment was conducted with cobalt and chromium because both of those metals are currently used in medical implants. The researchers noted, however, that it would be unlikely for wear and tear to produce enough nano- or micro-sized particles to reach the concentrations used in the study. The implications of the study center more around the risks of actual nanotechnology.

Nanoparticles are already used in the manufacture of sunscreens, cosmetics, sporting goods and other consumer products. Researchers are also investigating their use as drug-delivery mechanisms.

Steve - we have alerted our clients about the lack of safety studies since we became aware of nanotechnology. To date, there is still very little. Federal regulators are way behind on this. So our suggestion is: any food or dietary supplement products that have anything "nano" on the label, avoid until safety can confirmed.

Omega-3 PUFA protection against recurrent atrial fibrillation

Patients at high risk of relapse after electrical cardioversion of atrial fibrillation (AF) are more likely to stay in sinus rhythm if they take an omega-3 polyunsaturated fatty-acid (PUFA) supplement on top of standard antiarrhythmic therapy, suggests a randomized, placebo-controlled trial with a yearlong follow-up presented at American College of Cardiology 2010 Scientific Sessions. Those taking omega-3 PUFAs in the study--they'd been on them for a month before attempted cardioversion--also required fewer shocks and lower shock energies for successful cardioversion. In multivariate analyses, add-on omega-3 PUFA therapy was associated with a 57% reduced risk of AF recurrence after cardioversion, with a hazard ratio of 0.43 (95% CI 0.28–0.67). The benefit was independent of age, AF duration, and whether the patient had diabetes.

Silymarin supplements don't work?

Steve - a recent piece from the Healthy Skeptic from the New York Times, while lauding the benefits of silymarin injections, questioned the viability oral supplements. For the doctor quoted in the piece who said there is no data supporting its efficacy, he is mistaken.

http://nutritionalconcepts.blogspot.com/2010/03/research-highlights-march.html
http://nutritionalconcepts.blogspot.com/2009/12/milk-thistle-cuts-liver-toxicity-from.html
http://nutritionalconcepts.blogspot.com/2007/11/milk-thistle-may-protect-against-liver.html

Feher J, Deak G, Muzes G, et al. [Liver-protective action of silymarin therapy in chronic alcoholic liver diseases]. [Article in Hungarian]. Orv Hetil 1989;130:2723-7.

Szilard S, Szentgyorgyi D, Demeter I. Protective effect of Legalon in workers exposed to organic solvents. Acta Med Hung 1988;45:249-56.

Ferenci P, Dragosics B, Dittrich H, et al. Randomized controlled trial of silymarin treatment in patients with cirrhosis of the liver. J Hepatol 1989;9:105-13.

Velussi M, Cernigoi AM, De Monte A, et al. Long-term (12 months) treatment with an anti-oxidant drug (silymarin) is effective on hyperinsulinemia, exogenous insulin need and malondialdehyde levels in cirrhotic diabetic patients. J Hepatol 1997;26:871-9.

Salmi HA, Sarna S. Effect of silymarin on chemical, functional, and morphological alterations of the liver. A double-blind, controlled study. Scand J Gastroenterol 1982;17:517-21.

Anon. Milk thistle: Effects on liver disease and cirrhosis and clinical adverse effects. Summary, Evidence Report/Technology Assessment: Number 21, September 2000. Agency for Healthcare Research and Quality, Rockville, MD. Available at: http://www.ahrq.gov/clinic/epcsums/milktsum.htm 7049

Bunout D, Hirsch S, Petermann M. [Controlled study of the effect of silymarin on alcoholic liver disease.] [Article in Spanish]. Rev Med Chil 1992;120:1370-5.

Trinchet JC, Coste T, Levy VG. [Treatment of alcoholic hepatitis with silymarin. A double-blind comparative study in 116 patients]. [Article in French]. Gastroenterol Clin Biol 1989;13:120-4.

Pares A, Planas R, Torres M, et al. Effects of silymarin in alcoholic patients with cirrhosis of the liver: results of a controlled, double-blind, randomized and multicenter trial. J Hepatol 1998;28:615-21.

Buzzelli G, Moscarella S, Giusti A, et al. A pilot study on the liver protective effect of silybin-phosphatidylcholine complex (IdB1016) in chronic active hepatitis. Int J Clin Pharmacol Ther Toxicol 1993;31:456-60.

Boerth J, Strong KM. The clinical utility of milk thistle (Silybum marianum) in cirrhosis of the liver. Journal of Herbal Pharmacotherapy 2002;2:11-7.

Flora K, Hahn M, Rosen H, Benner K. Milk thistle (Silybum marianum) for the therapy of liver disease. Am J Gastroenterol 1998;93:139-43.

Rambaldi A, Jacobs B, Iaquinto G, Gluud C. Milk thistle for alcoholic and/or hepatitis B or C virus liver diseases. Cochrane Database Syst Rev 2005;2:CD003620.

Tanamly MD, Tadros F, Labeeb S, et al. Randomised double-blinded trial evaluating silymarin for chronic hepatitis C in an Egyptian village: study description and 12-month results. Dig Liver Dis 2004;36:752-9.

Study: zinc deficiency seen in ADHD

Zinc deficiency likely impacts the development of attention deficit hyperactivity disorder (ADHD) in children, according to a study in Acta Med Croatica. The research team noted zinc serves as an essential cofactor of more than 100 enzymes that are necessary for basal metabolism, impacts the production and function of neurotransmitters and prostaglandins, and is important to maintaining the structure and function of the brain. Preliminary investigations have shown many children with ADHD have lower concentrations of zinc compared to healthy children, although zinc deficiency may not play a causative role. However, zinc supplementation on its own or combined with ADHD therapy could support brain function, possibly by supporting the production and utilization of dopamine to address hyperactivity. Because zinc also serves as a coenzyme of delta-6 desaturase, an enzyme the supports the anabolism of polyunsaturated long-chain fatty acids, zinc deficiency could impair the production of key fatty acids that support the health of the neuronal membranes.

Bonnie - zinc is one of the first things I test for when presented with a client who has attention deficit disorder.

Multivitamins during pregnancy may boost infant health

Daily supplements of multivitamins during pregnancy may improve the growth of the baby in the womb, says a study with African American women. Women who were taking daily multivitamins in and around the time of conception gave birth to babies who weighed on average half a kilo more than babies from women not taking the supplements, report researchers in the Annals of Epidemiology. “African American women in the United States deliver preterm and low birth weight infants two to three times more frequently than their white counterparts,” explained researchers. Low birth weight has been linked to higher risks of negative health outcomes, including neonatal and infant mortality, poor growth and cognitive development, and higher risks of chronic diseases later in life, like diabetes and heart disease. Furthermore, there was a trend toward increased gestation periods in these women, added the researchers.

Bill on School Lunch Is Scaled Back. Criticism of School Lunch Isn’t.

A client emailed us this link from the New York Times blogger Kim Severson:

It’s been an unusually tough month for the people who make school lunches. Sunday, six million people watched a sneak preview of ABC’s “Food Revolution,’’ a reality series in which the British chef Jamie Oliver storms the kitchens of Huntington, W.Va., to improve the town’s collective diet. (The series begins Friday at 8 p.m.) Mr. Oliver was driven to tears after a humiliating rejection by both pizza-loving students and the women of the lunchroom, or the “lovely girls” as he calls them. The cafeteria workers ended up looking so bad that the national School Nutrition Association followed up with a press release in its defense. That wasn’t the only public thrashing.

Students in Chicago showed up at a Board of Education meeting to demand better food. A blogger from the Midwest who is spending a year eating and publishing photos of awful-looking food at her school cafeteria caught the attention of national news reporters. Meanwhile, in Washington, where Michelle Obama’s anti-obesity campaign continues to point a finger at the school lunch line, a Senate committee on Wednesday cut by more than half President Obama’s proposal to spend a record $10 billion more on child nutrition programs over 10 years, including school food.

Although school food directors and the growing ranks of lunch room reformers are disappointed with the numbers coming out of Washington, people who have been working with the Department of Agriculture and Congress to improve school food say the bill’s $4.5 billion increase is an historic improvement. “It’s critical we get started,” said Senator Blanche Lincoln, a Democrat from Arkansas, chairwoman of the Senate committee on agriculture and the architect of the bill. Senator Lincoln said critics need to understand that the legislation proposes the first real increase over inflation that the school food program has had in several decades. And in the current economic climate, any money is a victory. “We’d all like to do more and we’re going to try but we’ve got to get started,’’ she said. “If we just separate and go to our separate fox holes we don’t get to the end product.”

The Child Nutrition Act comes up for financing every five years. It pays for school food and other nutrition programs for lower-income children. It’s also the mechanism legislators can use to change the rules that govern those programs. The bill headed to the Senate floor would increase by about 6 cents the $2.68 that schools can get for each lunch — far less than the $1 a lunch increase a coalition of school food reform groups have been campaigning for. But Margo Wootan, director of nutrition policy for the Center for Science in the Public Interest, an advocacy group, said the bill was still worth supporting. She has been fighting to improve school nutrition standards for 17 years. “This is the strongest child nutrition reauthorization bill I have ever seen,” she said. “We can’t go from candy bars to apples in one fell swoop.”

In addition to the increase in financing, Ms. Wootan and Department of Agriculture staff members said a number of less obvious changes in nutritional rules and financing for special programs will improve what is served in schools as soon as next year. For example, milk is the biggest single source of saturated fat on the lunch line. The bill would allow only skim milk to be offered, banning whole and 2 percent. And schools will be required to make sure children have water with their meals. At least $40 million is available for farm-to-school programs and school gardens. Another $10 million will go toward pilot programs intended to add organic food. And millions more have been added to train cafeteria staff members.

One of the biggest changes involves food sold in places other than the cafeteria, like vending machines, sporting events and hallway fund-raisers. The law would give the Department of Agriculture power to set limits on nutrients like sodium and fat in all food sold on campus as well as setting limits on the number of bake sales and other food-based fundraisers. “We want to make sure there’s consistency,” Senator Blanchard said in an interview. “This is not only about providing nutritional food for our children but teaching them good life skills and what the right choices are.” If Congress acts before the summer break, some of the nutritional changes could make lunch better as soon as next fall.

The Department of Agriculture is also overhauling all school nutritional guidelines in an effort that is separate from the Child Nutrition Act but is intended to work in concert with the changes it will bring about. The new meal standards, which haven’t been updated for 15 years, are being written by Agriculture Department staff now. Based on a report from the Institutes of Medicine, they will require more fruits, vegetables and whole grains and — for the first time in the national school food program’s history — limit the amount of calories in each meal. “Look at the regulations now,” said Renee Hanks, food service director for the South Colonie School District in Albany. “The U.S.D.A. requires so many carbohydrates that we’re throwing whole wheat bread at them. We’re throwing extra crackers at them. If they aren’t out and active they can’t handle all those calories.” But, she warned, adding new requirements for more expensive foods like fresh fruit had better come with more money.

Changes to the bureaucratic process might free up some money in school budgets, analysts said. For example, the amount of paperwork needed to assure certain lower-income children qualify for a free lunch will be reduced, and the cost of a meal for children who pay full price will probably increase. Extra training money already included in the proposed legislation should also help school kitchens operate more efficiently. But whether more money will be added before the final bill is approved is in question. Officials at the Agriculture Department and various advocacy groups aren’t hopeful. Even if more money for the bill does appear, it will likely go toward the parts of the act that pay for hunger programs, not school lunch.

That doesn’t mean the conversation is necessarily over, said Rochelle Davis, founding executive director of the Healthy Schools Campaign, a national nonprofit organization that advocates for healthy school food. All the new nutritional requirements mean nothing if school districts cannot pay for them. Accepting the small increase in school food financing and calling it a victory lets Congress off the hook, she said. “Look at the agony our country is going through over health care and the struggle to handle a sick nation,” she said. “We just have to connect the dots and get people eating right and get people moving. Healthy school food is a logical part of that.”

Bonnie - I have heard the USDA talk about "baby steps" for 25 years. I'll believe it when I see it. It's nice to see the healthy Schools Campaign quoted, an organization that we have worked with and respect.

Selenium Protective Against Dysglycemia in French Men

Older men with higher plasma selenium levels at baseline are less likely to have impaired fasting glucose levels or type 2 diabetes during the subsequent 9 years. The findings, reported in journal Nutrition & Metabolism, suggest "a sex-specific protective effect of higher selenium status at baseline on later occurrence of dysglycemia," and said the findings "showed a borderline significant effect of lower risk of dysglycemia in men with higher levels of selenium.

Bonnie - selenium is a trace mineral that is especially helpful for men when prescribed properly. Selenium supplementation should NEVER be self-prescribed because it can cause severe side effects if taken excessively.

Coffee Consumption Improves Markers of Inflammation and Oxidative Stress

Courtesy of Heartwire

A small study published
in the April 2010 issue of the American Journal of Clinical Nutrition points again to the beneficial effects of coffee consumption. Researchers showed that drinking coffee led to improved markers of subclinical inflammation and oxidative stress, as well as increases in HDL-cholesterol levels.

Study of habitual coffee drinkers In this study of 47 habitual coffee drinkers, the individuals stopped drinking coffee for one month. In the next month, they drank four cups of coffee per day, followed by eight cups of coffee daily in the second month. Subjects were relatively healthy, younger than 65 years of age, but with an increased risk of diabetes based on a diabetes risk score. After the two months of subjects drinking coffee, the researchers observed significant decreases in markers of subclinical inflammation, including interleukin-18 (IL-18) and adiponectin, but no increases in levels of C-reactive protein (CRP). Markers of oxidative stress, on the other hand, were significantly reduced.

Regarding the lipid parameters, the researchers report that total-cholesterol levels were significantly increased, by 12%, after the second month of drinking coffee. In addition, apolipoprotein A1 levels were also significantly increased. HDL-cholesterol levels were up 7%, from 48 mg/dL to 51 mg/dL, by the end of the second month. There were no changes in any markers of glucose metabolism.

Bonnie - sugar, milk, and other fillers were NOT part of the study. While a small study, I like the design to show cause and effect.

Friday, March 26, 2010

Pfizer guilty for Neurontin racketeering

Courtesy of Business Week

Pfizer Inc. violated U.S. racketeering law in the marketing of its epilepsy drug Neurontin and must pay $142.1 million in damages, a jury decided. Kaiser Foundation Health Plan Inc. and Kaiser Foundation Hospitals claimed in a monthlong trial in federal court in Boston that Pfizer illegally promoted Neurontin for unapproved uses. The insurer said it was misled into believing migraines and bipolar disorder were among the conditions that could be treated effectively with Neurontin, approved in 1993 by the U.S. Food and Drug Administration for epilepsy.

The jury was shocked by evidence that Pfizer knowingly marketed Neurontin for off-label uses without proof that it was effective. All of the five jurors interviewed after the verdict said they agreed that Pfizer had demonstrated “a pattern of fraud” in marketing the drug. Jurors today found that Pfizer violated racketeering laws with respect to four of the five off-label uses in question. The company’s own studies showed that Neurontin was no more effective than a placebo in treating those conditions, though Pfizer never told doctors or patients about the findings, Kaiser said.

The Justice Department claimed in a 2004 sentencing memorandum that Warner-Lambert’s marketing increased off-label sales from 15 percent of all Neurontin prescriptions in 1994, its first year on the market, to 94 percent, or $2.12 billion, of Pfizer’s Neurontin sales in 2002.

Bonnie - racketeering charges are usually reserved for mobsters, are they not? During the period of time where the off-label use of Neurontin was at its zenith, I saw too many clients exhibit awful side effects with no improvement in the symptoms it was supposedly going to ameliorate. I am consistently amazed at the depths that this industry can delve.

Med Diet enhances fertility

Researchers in the Netherlands found that among 161 couples undergoing fertility treatment at their center, women whose eating habits most closely matched the traditional Mediterranean diet were 40 percent more likely to become pregnant than those with the least Mediterranean-like diets. The study, reported in the journal Fertility and Sterility, suggests that couples considering fertility treatment eat a balanced diet that includes healthy doses of vegetable oil, vegetables, beans and fish.

The study included 161 couples undergoing fertility treatment at the university. Two-thirds underwent in-vitro fertilization (IVF), while the rest underwent intracytoplasmic sperm injection, or ICSI. The latter is typically used when the man has a low sperm count or poor sperm quality. It involves isolating a single sperm from the man and injecting it into the woman's egg; if fertilization is successful, the resulting embryo is transferred to the woman's uterus.

The positive results of this study could be explained by the high intake of vegetable oils in the Mediterranean diet, which are precursors to hormone-like substances in the body called prostaglandins. Prostaglandins, in turn, are involved in the menstrual cycle, ovulation and pregnancy maintenance. In addition, the study found that women who most closely adhered to the Mediterranean diet had higher levels of vitamin B6 -- higher than both women whose diets were least Mediterranean-like and those who scored high on the health-conscious diet. One study found that giving vitamin B6 to women who were having difficulty getting pregnant increased their chances of conception.

Bonnie - these results all seem eerily familiar to me. I wonder why?

Thursday, March 25, 2010

Omega-3 may reduce endometriosis risk

A diet rich in foods containing omega-3 oil may reduce a woman’s risk of developing endometriosis, while a diet heavily laden with trans fats might increase the risk of developing the condition, according to a new study published in the journal Human Reproduction. The study found while the total amount of fat in the diet did not matter, the type of fat did. Women who ate the highest amount of long-chain omega-3 fatty acids were 22-percent less likely to be diagnosed with endometriosis than those who ate the least; those who ate the most trans fats had a 48-percent increased risk, compared with those who ate the least.

Wednesday, March 24, 2010

Sneak Peek: Bonnie Unplugged



Bonnie Unplugged




Watch an excerpt from the upcoming four part series with Nutritionist Bonnie Minsky.

Tuesday, March 23, 2010

Calorie listings now required at chain restaurants

A requirement tucked into the massive U.S health care bill will make calorie counts impossible for thousands of restaurants to hide and difficult for consumers to ignore. More than 200,000 fast food and other chain restaurants will have to include calorie counts on menus, menu boards and even drive-throughs.

The new law, which applies to any restaurant with 20 or more locations, directs the Food and Drug Administration to create a new national standard for menu labeling, superseding a growing number of state and city laws. President Barack Obama signed the health care legislation Tuesday.

The idea is to make sure that customers process the calorie information as they are ordering. Many restaurants currently post nutritional information in a hallway, on a hamburger wrapper or on their Web site. The new law will make calories immediately available for most items."The nutrition information is right on the menu or menu board next to the name of the menu item, rather than in a pamphlet or in tiny print on a poster, so that consumers can see it when they are making ordering decisions," says Sen. Tom Harkin, chairman of the Health, Education, Labor and Pensions Committee, who wrote the provision. It was added to the health bill with the support of the restaurant industry, which is facing different laws from cities and states.

The law will also apply to foods sold in vending machines, specifically those that do not have visible calorie listings on the front of the package. The requirements will be enforced by the FDA, with the possibility of criminal penalties if operations do not comply.New York City was the first in the country to put a calorie posting law in place. Since then, California, Seattle and other places have done so.

The FDA will have a year to write the new rules, which health advocates have been pushing for years.

FDA warning about Rotarix Rotavirus vaccine

U.S. health officials urged pediatricians Monday to temporarily stop using one of two vaccines against a leading cause of diarrhea in babies, after discovering that doses of GlaxoSmithKline's Rotarix were contaminated with bits of an apparently benign pig virus. Glaxo's vaccine has been used in millions of children worldwide, including 1 million in the U.S., with no signs of safety problems — and the pig virus isn't known to cause any kind of illness in people or animals, said Dr. Margaret Hamburg, commissioner of the Food and Drug Administration. But vaccines are supposed to be sterile, and because there is a competing vaccine against diarrhea-causing rotavirus that has tested clean — Merck's RotaTeq — the FDA decided to err on the side of caution. "We don't want to scare parents," Hamburg told reporters. "This was a difficult decision for us to make because there is no evidence at this time that there is a risk to patients who have received this vaccine, and we know there are real benefits for children to be vaccinated against rotavirus."

Monday, March 22, 2010

Dark roast coffee better for those who are intolerant

Stomach irritation prevents almost two out of every 10 people from enjoying coffee. A report presented at the 239th National Meeting of the American Chemical Society in San Francisco included the counter-intuitive finding that espresso, French roast, and other dark-roasted coffee may be easier on the tummy because these roasts contain a substance that tells the stomach to reduce production of acid.

Doctors think that chemicals in coffee cause the stomach to overproduce acid. Some coffee drinkers take antacids or drink decaffeinated coffee in an effort to reduce this effect. Others turn to a small but growing number of specialty coffee brews marketed as stomach friendly.

To study the irritants in coffee, the scientists exposed cultures of human stomach cells to a variety of different coffee preparations, including regular, dark-roast, mild, decaffeinated, and stomach-friendly. "Our data show, for the first time, that caffeine, catechols and N-alkanoly-5-hydroxytryptamides are those coffee components that stimulate molecular mechanisms of stomach acid secretion in human stomach cells," the researchers said. Most of them are indeed removed by steam or solvent treatment of the raw coffee bean.

The scientists unexpectedly found that one of the coffee components, N-methylpyridium (NMP), could reduce or avoid stomach irritation. Since NMP is generated only upon roasting and not found in raw coffee beans, darker-roasted coffees contain higher amounts of this stomach-friendly coffee ingredient.

Eosinophilic Oesophagitis and Environmental Allergen Connection

Alimentary Pharmacology & Therapeutics

Environmental allergens have been implicated in the pathogenesis of eosinophilic oesophagitis. To determine whether a seasonal variation exists in the diagnoses of eosinophilic oesophagitis and whether there is a correlation with seasonal pollen count, daily pollen counts for grass, trees and weeds were obtained from a certified counting station. Per cent of eosinophilic oesophagitis cases were collated seasonally and compared with mean pollen counts for grass, trees and weeds during the same time period.

A total of 127 eosinophilic oesophagitis cases were identified. The highest percentage of cases was diagnosed in the spring, while the least percentage occurred in the winter. There was a significant association between per cent eosinophilic oesophagitis cases diagnosed seasonally and mean grass pollen count, but not with trees or weeds.

A seasonal variation was seen in the diagnosis of eosinophilic oesophagitis which correlated with pollen counts. These findings have important implications regarding the pathogenesis of eosinophilic oesophagitis.

Five questions to ask before you fill that prescription

Steve - the information in this piece is very good advice for anyone considering a medication or dietary supplement.

Courtesy of US News & World Report

Don't just swallow every pill your doctor orders without a second thought. Make an effort to educate yourself. Start by asking these questions.

1. Why am I getting this drug?
Place the emphasis on the "I" when asking this question. Your doctor should consider your personal risk factors when prescribing a drug, not the previous patient he treated who may have been helped enormously by the medicine but also may have been far sicker to begin with. If you're considering a cholesterol-lowering statin, for instance, ask, "Has this drug been shown to prevent real clinical events like heart attacks or strokes in patients my age and gender with a cholesterol profile like mine?" says Jerry Avorn, a professor of medicine at Harvard Medical School and author of "Powerful Medicines: The Benefits, Risks and Costs of Prescription Drugs" (Random House, 2004). Ditto for bone-building drugs, which are being given more and more frequently to those with some bone loss, called osteopenia, but not full-blown osteoporosis. Ask, Avorn says, "Will this drug prevent fractures in those with bone measurements like I have?"

2. What are the risks vs. the benefits?
Your doctor should be able to tick off the side effects of any drug she's prescribing as well as serious adverse events associated with the drug and how commonly those occur, says Lisa Schwartz, an associate professor of medicine at the Dartmouth Institute for Health Policy and Clinical Practice, Lebanon, N. H. You should also have a clear understanding of the benefits. Even in severe cases of depression, antidepressants significantly help one third of patients who take them, mildly help another third, and don't do much good for an additional third - information that has become known in research studies but isn't featured prominently on manufacturer's Web sites. Schwartz and her colleagues at Dartmouth/VA Outcomes Group would like the U.S. Food and Drug Administration to begin offering consumer-friendly information on the risks and benefits of every drug it approves.

3. Is there an older drug or lifestyle alteration that works just as well?
Every time your doctor accepts a free lunch, a fruit basket, heck, even a ballpoint pen from a drugmaker, you can bet that it's for a drug that's new, expensive, and still on patent (which means there's no cheap generic available). "There's no question that doctors are more likely to prescribe drugs that they're being lobbied on," says Avorn, "new ones being heavily marketed by pharmaceutical firms." The trouble with a new medication? "We might not know its long-term benefits or its track record for risks," explains Schwartz. "It's one thing if there's no other treatment available for your condition, but it's quite another if there are a lot of other treatments that have stood the test of time." If your doctor can't make a strong case for why a new treatment may be better, take the older one, says Schwartz. Ditto for lifestyle changes. For those with mild depression, exercise can work just as well as an antidepressant. Salt-sensitive folks with high blood pressure may be able to reduce hypertension simply by lowering their sodium intake. And many of those with type 2 diabetes can reverse their condition by losing weight, increasing their activity, and cutting back on carbohydrates.

4. Will it interfere with other medications I'm taking?
While one fifth of Americans have taken three or more drugs for chronic conditions in the past year, many of them get their prescriptions from different specialists who are supposed to check for medication interactions but often do not. Pharmacies also alert you to dangerous drug-drug interactions, but this may not happen if you don't get all your medications from the same place. Also, it's important to factor in all those over-the-counter medications you may be on like acid blockers, allergy medications, or pain relievers.

5. Has this drug been shown to prevent real clinical events?
You might think that any drug approved by the FDA would have to meet that criterion. But that's not the case. The diabetes drugs Avandia and Actos, for example, were approved "to help improve blood sugar control in adults with type 2 diabetes." These drugs don't, though, actually prevent heart disease, the leading killer of diabetics. "It's not enough to show that a drug lowers blood sugar; does it, in fact, improve clinical outcomes and not cause harm?" says Steven Nissen, head of cardiovascular medicine at the Cleveland Clinic in Cleveland, Ohio, who published a study two years ago showing that Avandia was associated with an increased risk of heart attacks and deaths from heart disease. Nissen and the other experts who spoke with U.S. News would like to see the FDA approve only drugs that clearly show a benefit to the patient, rather than just improving lab test measurements like cholesterol, blood sugar and bone density scores. Schwartz sums it up this way: "Your doctor should be able to explain why you're taking this drug right now. Will it make you feel better? If not, will it prevent something bad from happening in the future? How big is your chance that you'll actually have that bad outcome if you don't take this drug?"

Friday, March 19, 2010

FDA issues warning on the statin Zocor

Patients on the highest approved dose of the cholesterol-lowering drug Zocor may be at increased risk of muscle injury, U.S. regulators warned. Made by Merck & Co and sold under the brand name Zocor, simvastatin is also is sold in combination with ezetimibe as Vytorin, and in combination with niacin as Abbott Laboratories Simcor. Simvastatin also is available as a single-ingredient generic medication. The FDA said its review of simvastatin is part of an ongoing effort to evaluate the risk of statin-associated muscle injury. "Although muscle injury ... is a known side effect with all statins, the warning highlights the greater risk of developing muscle injury, including rhabdomyolysis, for patients when they are prescribed and use higher doses of this drug," the agency said in a statement.

The warning follows an FDA review of new information on the risk of muscle injury from clinical trials, studies, adverse event reports and prescription use data, the FDA said. The FDA said it was also reviewing data from a clinical trial which studied cardiovascular disease in patients prescribed 80 milligrams of simvastatin compared to those on 20 milligrams. Rhabdomyolysis is the most serious form of muscle disease and can lead to severe kidney damage, kidney failure, and sometimes death, the agency said. "It's important for patients and healthcare professionals to consider all the potential risks and known benefits of any drug before deciding on any one therapy or dose of therapy," said Dr. Eric Colman, deputy director of FDA's Division of Metabolism and Endocrinology Products.

Bonnie - well, well, well, the chickens have come to roost! Expect a lot more to come.

Low-fat does not equal low-cholesterol

A low-fat diet had almost no effect on cholesterol levels, according to a report in the April issue of the American Journal of Clinical Nutrition on the Women's Health Initiative (WHI), a national trial that gave some women intensive training and education on eating a low-fat diet and compared their health with women who didn't change their eating habits. The best that study author could say for a low-fat diet was that it didn't make things worse as far as affecting blood levels of good fats, such as HDL cholesterol, and bad fats, such as triglycerides.

In the trial, women who followed the low-fat regimen consumed 29.3 percent of their calories as fat, compared with 37 percent of those in the comparison group. But the low-fat diet did not affect blood triglyceride, HDL cholesterol or other lipoprotein levels.

Bonnie - have you heard somebody say this before?

Shantha's 4 in 1 vaccine quarantined

The World Health Organization (WHO) and UNICEF have suspended the use and purchase of the Shan5 vaccine from Sanofi Aventis owned Shantha Biotechnics pending a quality investigation. The combination vaccine is given to prevent diphtheria, pertussis, tetanus, haemophilus influenza B, and hepatitis B. "Countries are advised to put any remaining vaccine in quarantine until further notice," the joint WHO-UNICEF statement said. The investigation was launched after reports "of a white sediment which sticks to the glass of the vaccine vial that is difficult or impossible to re-suspend with vigorous shaking (flocculation)," the statement says. WHO has received no reports of adverse reactions so far in those who have been given the vaccine. An Economic Times report said the pending investigation threatens a three-year contract worth $350 million.

Omega-3 supplements may help curb colon polyps

Omega-3 supplements may help curb colon polyps by cutting the number and size of precancerous colon growths in people genetically predisposed to them. The study, published ahead of print in the journal Gut, was based on 55 patients who had previously undergone surgery for familial adenomatous polyposis and were being monitored. Twenty-eight of the patients were randomly assigned to six months of omega 3 supplement treatment and the other 27 were given a placebo. The researchers found the number of polyps increased by almost 10 percent in the placebo group but fell by more than 12 percent among those treated with the Omega 3 -- representing a difference of almost 22.5 percent. Also, polyp size increased by more than 17 percent among those in the placebo group but fell by more than 12.5 percent in the eicosapentaenoic acid group -- representing a difference of just under 30 percent.

Bonnie - a small study to say the least, but significant results nonetheless.

Thursday, March 18, 2010

Concern over nutrition training

Nutrition needs to be made a more important part of the doctor training system in the UK, a leading expert has said. Gastroenterologist Dr Penny Neild, who works at London's St George's Hospital, said training on how to spot and tackle malnutrition was "patchy". She said medical schools and junior doctor programs were focusing too much on the science of being a doctor rather than basic care. The issue of malnutrition has been a long-running concern in the NHS. Up to one in four patients may be at risk, research shows.

However, she accepted progress was being made. The introduction of nutrition in the first year of junior doctor training has only been rolled out in recent years, while the royal colleges are looking at devising a standardized curriculum for medical schools which may well have more emphasis on nutrition.

Statin impairs ability to fight infection

Simvastatin might help us control our cholesterol, but when it comes to infection, it's an entirely different story says a new research study published in the Journal of Leukocyte Biology. In the research report, scientists from Italy show that simvastatin delivers a one-two punch to the immune system. First it impairs the ability of specialized immune cells, called macrophages, to kill pathogens. Then, it enhances production of molecules, called cytokines, which trigger and sustain inflammation.

The researchers conducted experiments using human cells and then followed up by conducting additional experiments in mice. They used human macrophages derived from blood samples of healthy donors and murine (mouse) macrophages. The macrophages were incubated with Staphlococcus aureus, a pathogen commonly found on the skin and in the upper airways. Once the infection manifested, researchers analyzed the bactericidal response of macrophages treated with simvastatin. Results showed that the treated macrophages were significantly impaired in both the removal of the pathogen and related cell debris and the killing of ingested bacteria compared to untreated cells. Additionally, the treated cells produced higher amounts of cytokines, which are responsible for triggering and sustaining inflammation. The same experiment was conducted in vivo, using mouse models, with similar results. "Statins are lifesavers, but there might be room for improvement," said John Wherry, Ph.D., Deputy Editor of the Journal of Leukocyte Biology.

Hypnotherapy can ease IBS

Hypnotherapy seems to be very effective for easing the distressing symptoms of irritable bowel syndrome (IBS), and in a goodly proportion of cases, clears up symptoms altogether, reveal experts during a wide ranging discussion of the condition in a Frontline Gastroenterology podcast.

Researchers using hypnotherapy in the first 100 IBS patients treated with it showed that it significantly improved symptoms in nine out of 10 of them. It stopped symptoms altogether in four out of 10, while the remainder said they felt more in control of their symptoms.

Bonnie - hypnotherapy can be very helpful in this regard.

Wednesday, March 17, 2010

Healthy Heart = Sufficient Vitamin D

Preventing and treating heart disease in some patients could be as simple as supplementing their diet with extra vitamin D, according to two new studies at the Intermountain Medical Center Heart Institute in Murray, Utah. Researchers at the Intermountain Medical Center Heart Institute last fall demonstrated the link between vitamin D deficiency and increased risk for coronary artery disease.

These new studies show that treating vitamin D deficiency with supplements may help to prevent or reduce a person's risk for cardiovascular disease and a host of other chronic conditions. They also establish what level of vitamin D further enhances that risk reduction. Study findings were presented at the American College of Cardiology 59th annual scientific session.

"Vitamin D replacement therapy has long been associated with reducing the risk of fractures and diseases of the bone," says researchers. "But our findings show that vitamin D could have far greater implications in the treatment and reduction of cardiovascular disease and other chronic conditions than we previously thought." For the first study, researchers followed two groups of patients for an average of one year each.

In the first study group, over 9,400 patients, mostly female, reported low initial vitamin D levels, and had at least one follow up exam during that time period. Researchers found that 47 percent of the patients who increased their levels of vitamin D between the two visits showed a reduced risk for cardiovascular disease.

In the second study, researchers placed over 31,000 patients into three categories based on their levels of vitamin D. The patients in each category who increased their vitamin D levels to 43 nanograms per milliliter of blood or higher had lower rates of death, diabetes, cardiovascular disease, myocardial infarction, heart failure, high blood pressure, depression, and kidney failure. Currently, a level of 30 nanograms per milliliter is considered "normal."

The lead physician says the results of these studies will change the way he treats his patients. "Although randomized trials would be useful and are coming, I feel there is enough information here for me to start treatment based on these findings," he says. Treatment options in this case are simple, starting with a blood test to determine a patient's vitamin D level. If low levels are detected, supplements and/or increased exposure to sunlight may be prescribed. Increasing vitamin D intake by 1000 to 5000 international units (IU) a day may be appropriate, depending on a patient's health and genetic risk, says Dr. Muhlestein. He says supplements are the best source of vitamin D because they are relatively inexpensive. While exposure to 20-30 minutes of sunlight can provide up to 10,000 IU, Dr. Muhlestein says it is important to use sunscreen and avoid the hottest parts of the day in order to avoid sunburn and the harmful UV rays associated with skin cancer.

GM crops cause liver and kidney damage: study

A report published in the International Journal of Microbiology has verified once again that Monsanto's genetically modified (GM) crops are causing severe health problems. A legal challenge issued against Monsanto forced the multi-national agriculture giant to release raw data revealing that animals fed its patented GM corn suffered liver and kidney damage within just three months.

Adding to the mounting evidence that GM crops are dangerous all around, this information provides a damning indictment against Monsanto which continually insists that its GM products are safe. Not only are GM crops proving disastrous for the environment, but study after study, including those conducted by Monsanto itself, is showing that GM foods are detrimental to health.

Monsanto's data indicated that the company had conducted tests on three varieties of its GM corn, two of which contain the dangerous Bt protein, and one designed specifically to resist Monsanto's Roundup herbicide. All three are widely grown in the United States while only one is currently grown in Europe.

Dr. Gilles-Eric Seralini, a French researcher from the University of Caen, was tasked with examining the data and providing a review. While stopping short of declaring GM crops to be toxic, he did emphasize that chronic negative effects were apparent and that there were "statistically significant" indications of kidney and liver damage.

The specific effects observed in test rats included a buildup of hormones in the blood, indicating that their liver and kidneys were not functioning properly. One variety of the corn led to elevated blood sugar levels and increased triglyceride levels in female rats given it.

Dr. Seralini concluded that, because GM crops are foreign substances that have never been a part of a normal diet, there is no telling what the long-term effects of consumption will be on people. In animals, significant disruption of normal bodily function has been observed even in the short term.

Steve - anyone out there care to comment?

Pfizer knew of HRT's cancer risk

A Philadelphia jury has found drug giant Pfizer Inc. guilty of deliberately ignoring evidence that hormone replacement therapy (HRT) drug Prempro increased women's risk of breast cancer, ordering it to pay unspecified damages to defendant Connie Barton.

Millions of women used Prempro and other HRT drugs up until 2002, when the groundbreaking Women's Health Initiative study found that taking the drugs significantly increased women's risk of breast cancer and death from cardiovascular disease. The risk was so striking that researchers called an early halt to the study out of concern for participants' lives. The drugs were -- and still are -- marketed to relieve the symptoms of menopause, such as hot flashes, mood swings and night sweats.

More recent research suggests that HRT drugs also increase women's risk of dying from lung cancer.

According to Barton's lawyers, Wyeth was aware of the risks of Prempro well before the release of the Women's Health Initiative results, but made no efforts to withdraw the drug from the market or warn women or doctors of its effects.

"They knew back in the 1970s that these drugs had the potential to cause breast cancer," said attorney Esther Berezofsky, "so they didn't have the studies done." When negative results began to emerge, Berezofsky said, Wyeth attempted to downplay them.

The jury agreed, ruling not only that Prempro had caused Barton's case of invasive breast cancer, but that the drug company was to blame.

Before its acquisition, Wyeth also admitted to practices such as ghostwriting articles for publication in medical journals, promoting off-label (unapproved) uses of drugs and making lavish gifts to doctors. Pfizer claims the company has since abandoned these policies.

The Barton case is only one of 9,000 Prempro-related lawsuits filed in the United States to date. Of eight cases to go to trial, five have ended in "guilty" verdicts for the company. Pfizer has appealed all five.

Bonnie - it is hard to believe that we keep seeing this over and over again. Are we becoming numb to the fact that this just comes with the territory when dealing with pharmaceuticals? After reading about this, instead of feeling outrage, I was unconventionally blase. Snap out of it!

Tuesday, March 16, 2010

Gene testing helps get warfarin dose right

Checking patients' DNA before starting them on a warfarin (sold as Coumadin in generic form) helps get the tricky dose right and keep them out of the hospital. About 2 million Americans start on it each year to prevent blood clots after surgery or for other medical conditions.However, the world's most common blood thinner is also one of its most dangerous drugs. One person's ideal dose can be 10 times that of another's. Even certain foods can throw it off. Too much warfarin can lead to bleeding, too little can lead to clots, and either one can kill. Up to 20 percent of patients wind up in the hospital in their first six months on the drug.

Patients given gene tests to set their initial warfarin dose had about a 30 percent lower risk of being hospitalized than similar patients whose doses were set by trial and error."If we reduce just two hospitalizations per 100 patients tested, that more than compensates for the cost of the test," said the study's leader, Dr. Robert Epstein.

Bonnie - this test has been around for a few years but is seldom used. It is an exciting development that should be implemented for as many efficacious drugs as possible. I have always recommend that my clients get a genetic test for aspirin before taking it. Of course, it is costly.

Study: Vitamin B-6 may reduce colorectal cancer risk

Vitamin B6 appears to play a beneficial role in preventing colon cancer. Researchers led by Susanna Larsson of Sweden's National Institute of Environmental medicine traced the beneficial effects to pyridoxal-phosphate, the main active coenzyme form of vitamin B6. The Journal of American Medical Association study states that 20 percent of men and 40 percent of women over the age of 50 do not take in sufficient vitamin B6. Taking vitamin B6 supplements increased the level of Vitamin B-6 in the bloodstream, inversely lowering the risk of colorectal cancer. The effects of taking weak to high doses of vitamin B6 also showed "a statistically significant 21 percent reduction in colorectal cancer risk" at higher doses.

Does Cholesterol Really Matter?

by Julian Whitaker, MD

I'd like to shine the spotlight on one of medicine's sacred cows- the belief that lowering cholesterol with drugs protects against heart attacks and premature death. Our obsession with cholesterol began in the 1950s when studies linked high consumption of animal fat with high rates of heart disease. This opened the door for clinical trials that laid the foundation of a new paradigm: the cholesterol theory of cardiovascular disease.

This theory has had profound ramifications. It changed the way we eat (fats bad, carbohydrates good) and contributed to our problems with obesity and diabetes. It wormed its way into "clinical practice guidelines"- cholesterol management has become a "standard of care" that doctors are expected to follow. It spawned the invasive heart surgery industry, based on the presumption that cholesterol-laden blockages must be bypassed or propped open. And it led to the creation of the best-selling class of medications in history: cholesterol-lowering statin drugs, which generate more than $15 billion in worldwide sales every year.

But it's all a house of cards. No matter what you've been led to believe, a high cholesterol level is not a reliable sign of an impending heart attack. In fact, growing numbers of experts question whether cholesterol matters at all. As for statin drugs, for most of the 40-plus million Americans recommended to take them for the rest of their lives, they're an ineffective, expensive, side effect- riddled fraud.

Statin-Free Zone

When a patient taking Lipitor, Zocor, or another statin drug comes to Whitaker Wellness, we discontinue it at once. "But my cholesterol level is 240." "My doctor told me I'll have a heart attack if I don't take this drug."My father died of heart disease, so I have to take it." I've heard all these justifications and more, and I still recommend that my patients get off statins. Here's why.

First, they're not very effective. These drugs do lower cholesterol, but so what? We're not treating lab numbers. We're treating patients, and the ultimate goal in cholesterol management is to reduce risk of cardiovascular disease. Except for a very limited number of people, there is absolutely no evidence that statins protect against heart attack or premature death.

Are you over age 65? Not a single study suggests you'll receive any benefits, even if your cholesterol goes down substantially. A woman of any age? Same story. A man younger than 65 who has never had a heart attack? Ditto, no help at all. For middle-aged men who have had a heart attack, statins may lower risk of a repeat heart attack, but that's the extent of it.

I know this is hard to buy in light of the multiple drug advertisements and glowing endorsements from doctors. But keep in mind that pharmaceutical companies do a superb job of pulling the wool over the eyes of consumers and physicians alike by withholding unfavorable study results and making false, misleading, and often deceptive claims.

A Statistic We Can Understand

That's why I want to step around confusing statistics and tell you about an easy-to-understand measure that you'll never hear about in drug ads. It's called "number needed to treat," or NNT, and it describes the number of patients who would need to be treated with a medical therapy in order to prevent one bad outcome. Experts consider an NNT over 50 to be "worse than a lottery ticket."

Lipitor ads claim that it reduces risk of heart attack by 36 percent. Sounds pretty good until you look at the fine print, do the math (which John Carey did in a great article in Business Week), and figure out that the drug's NNT is 100. This means that 100 people must be treated with Lipitor in order for just one heart attack to be prevented. The other 99 people taking the drug receive no benefit.

To put this into perspective, the NNT of antibiotics for treating H. pylori, the underlying cause of stomach ulcers, is 1.1. These drugs knock out the bacteria in 10 out of 11 people who take it, making them a reliable, cost-effective therapy. At the other end of the spectrum are statins, which as a class have an NNT of 250, 500, or higher depending on the study you look at. What a deal for drugs that can cost more than a thousand bucks a year and are almost guaranteed to cause problems.

Goodbye Drugs, So Long Symptoms

Statins lower cholesterol by suppressing the activity of an enzyme in the liver involved in the production of cholesterol. But this enzyme has multiple functions, including the synthesis of coenzyme Q10. CoQ10 is a key player in the metabolic processes that energize our cells. No wonder statin users often suffer from fatigue, muscle pain and weakness, and even heart failure- the cells are simply running out of juice.

The second most frequent adverse effects of statins are problems with memory, mood, suicidal behavior, and neurological issues. Other common complaints include sexual dysfunction, and liver and digestive problems. Symptoms range from minor (achiness, forgetfulness) to serious (complete but temporary amnesia, permanent memory loss) to lethal (congestive heart failure, rhabdomyolysis or complete muscle breakdown). One statin drug, Baycol, was taken off the market a few years ago after it caused dozens of deaths from rhabdomyolysis. Several studies have also linked statin drugs with an increased risk of cancer.

Because physicians rarely warn of these side effects, few patients suspect their drugs may be the reason they begin feeling bad- and it's often a revelation when they put two and two together. Simply discontinuing these medications can result in tremendous improvements in health and well-being. Texas cardiologist Peter Langsjoen, MD, published a study showing that when symptomatic patients got off their statins and started taking 240 mg of CoQ10 per day, they had significant decreases in fatigue, myalgias (muscle aches), dyspnea (shortness of breath), memory loss, and/or peripheral neuropathy.

Not a Drug But a Program

As you can see, we need to shift away from this myopic focus on statin drugs and lowering cholesterol, and take a more holistic view. Folks, you don't need statins- you need a program that addresses all the known risk factors for heart attack, stroke, and other cardiovascular disorders.

Inflammation, not high cholesterol, is the primary cause of heart disease. Harvard researchers have discovered that a high blood level of C-reactive protein, a marker of inflammation, is more predictive of heart disease than cholesterol.

In short, do what you can to manage your cholesterol, but don't worry about it if your level is particularly stubborn. The average cholesterol of people who have heart disease isn't much higher than the level of those who don't. If high cholesterol runs in your family, concentrate on what you can control, and remember, numbers aren't everything.

Study: Doctors need tools to help patients slim down

Excerpts Courtesy of USA Today

Physicians know they're on the front lines in the fight against obesity, but many say they don't have staff able to help patients with weight loss, according to a survey of 290 primary-care physicians by Harris Interactive. Among the findings:

• 89% of doctors believe it's their responsibility to help patients lose weight.
• 72% say no one in their office has been trained to deal with weight problems.
• 87% weigh patients at every office visit.
• 45% say they regularly discuss weight with their patients.
• 86% say they find it easy to discuss weight with their patients.

In a separate telephone survey of 1,002 adults in the USA, also by Harris Interactive, only about one-third of those who are obese — roughly 30 or more pounds over a healthy weight — say they have been told by a health care professional they are too heavy. Of the patients who were told they are obese, most (90%) were advised to lose weight. Of those advised to lose weight, 36% say the medical professional never discussed ways to achieve a healthier weight.

Bonnie - if doctors are the first line of defense against obesity, and 89% surveyed say it is their responsibility to help patients lose weight, why are we not seeing results? I venture to say that if insurance companies reimbursed doctor-assisted weight-loss counseling as much as they do tests and procedures, the doctors would be singing a different tune.

Of course, I am here for the public. However, many are reluctant to see me because they have to pay out of pocket and submit to insurance themselves. Over the last several years, it is encouraging to see that clients who do submit to insurance after my visit (along with a diagnosis from their doctor) are getting reimbursed.