Archive for July, 2009

Baa Baa Blood Test? Rare Sheep Could Be Key to Better Diagnostic Tests in Developing World, Says Stanford Study

The newest revolution in microbiology testing walks on four legs and says “baa.” It’s the hair sheep, a less-hirsute version of the familiar woolly barnyard resident. A new study from the Stanford University School of Medicine, which is to be published July 3 in PLoS ONE, finds that not only are these ruminants low-maintenance and parasite-resistant, they’re also perfect blood donors for the microbiology tests necessary to diagnose infectious disease in the developing world.

Identifying microbes from a patient’s urine or sputum requires growing those microbes in culture dishes filled with gelatinous agar and a small amount of blood. The blood provides nutrients to the growing bugs and also provides clues as to the microbes’ identities: Microbiologists can rule out or identify certain strains of bacteria based on how the organisms interact with the blood cells in culture.

In the developed world, microbiologists use sheep or horse blood. But in many parts of the developing world, horses are prohibitively expensive, and regular sheep, with their constant need for shearing and tendency to get infections, are difficult to keep alive. Importing animal blood isn’t feasible either, as shipping is costly and often unreliable.

Many labs in the developing world use human blood, often donated by lab technicians themselves. But diagnostic tests aren’t standardized for human blood, said Ellen Yeh, MD, a resident in pathology at Stanford and first author on the paper. “You don’t get the same test results when you use human blood versus sheep blood,” she said. In addition, the use of human donors increases technicians’ risk of infection with blood-borne diseases.

Ellen Jo Baron, PhD, professor of pathology at the medical school and senior author on the paper, wanted to do better. She’s a veteran of overseas microbiology, having trained lab technicians from Botswana to Cambodia for more than a decade.

“Up until the time I saw a hair sheep—which I first saw in Botswana—I had no idea there was even such a thing,” said Baron, who is associate director of Stanford’s clinical microbiology lab, interim director of the clinical virology lab, and associate chair of pathology for faculty development. She wasted no time in learning about the animals, finding that they resist parasites, don’t need to be sheared, and do well in the tropical climes prevalent in much of the developing world.

But no one had tested whether their blood was equivalent to horse or sheep blood. So, calling in a favor from a colleague with a hobby farm near Walnut Creek, Calif., Baron and her colleagues collected blood from hair sheep—the animals are remarkably mellow about the donations, she said—and created test cultures using the blood. Then, they ran a series of common diagnostic tests.

“It worked for every single thing,” Baron said.

The researchers also found that they could collect the blood in donation bags, much like those human donors might see at the Red Cross. That’s a big advantage over the defibrination process the developed world uses. To defibrinate blood, technicians must shake the samples in a glass jar filled with hundreds of tiny glass beads constantly during and after the donation. That’s fine in a lab with machines to do the shaking and autoclaves to sterilize all of those beads, but it’s an enormous burden in labs without that equipment. Fortunately, Baron found, hair sheep blood collected in donation bags performed the same as defibrinated blood.

“It’s very important,” said Bruce Hanna, PhD, professor of pathology and microbiology at the New York University School of Medicine, who was not involved in the study. “This paper found an alternative that is able to be produced in Africa and provides identical results to the standardized products that are used in this country.”

Michele Barry, MD, senior associate dean for global health at Stanford medical school, added: “Diagnosis of bacterial diseases and antibiotic sensitivity in low resource settings is often infeasible due to cost, access to diagnostics or manpower. Ellen Jo Baron and colleagues have uniquely decided to combine veterinary health science and human blood banking to develop a blood agar from hair sheep as medium to grow bacteria. This sheep is a low-maintenance animal adopted for hot climates. The technology, which they are modeling in Botswana, is an example of a practical ‘can do’ innovation in microbiology that will save lives in the tropics at low cost by quickly identifying bacteria to tailor cost-effective antibiotic use—a precious commodity overseas.”

Now, said Baron and Yeh, the only hurdle is getting the sheep to the labs that need them. Two veterinary labs in Botswana already provide hair sheep blood to local labs based on Baron’s initial results. Baron is now lobbying the charity Heifer International to add hair sheep to its catalogue so microbiologists can donate and send the animals to the developing world. After all, she said, the sheep can provide milk and meat—and that’s on top of their role as donors of blood that, in her words, “works perfectly for every microbiology test that a laboratory would need to do.”

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Cardiologists’ Study Shows Red Yeast Rice Cuts Cholesterol

New research from two Philadelphia-area cardiologists finds that an over-the-counter dietary supplement sold at pharmacies and health food stores may be an alternative for patients who cannot take traditional statin medications to lower cholesterol because of statin-related muscle pain. The findings of their study, “Red Yeast Rice for Dyslipidemia in Statin-Intolerant Patients,” appear in the June 16, 2009 issue of Annals of Internal Medicine.

Cardiologists David Becker, M.D., and Ram Gordon, M.D., Chestnut Hill Cardiology, studied 62 patients with high cholesterol in the first randomized, double-blinded placebo-controlled trial to evaluate red yeast rice in patients with a history of statin-associated myalgias (side effects that include muscle pain and weakness). Thirty-one of the patients took three 600-mg capsules of red yeast rice twice per day over the course of six months, and the other half received identical placebo tablets. The red yeast rice patients also participated in weekly meetings for the first three months, where they were taught about heart disease and how to incorporate heart-healthy nutrition, exercise and stress management into their lives.

At the conclusion of the study, the research found:

  • Low-density lipoprotein cholesterol (also known as “bad cholesterol”) levels decreased more in the patients receiving the red yeast rice (average decrease, 35 mg/dL) than in patients receiving the placebo (average decrease, 15 mg/dL).
  • Total cholesterol levels improved more in the red yeast rice group than in the placebo group.
  • Muscle pain scores, weight loss, HDL cholesterol (high-density lipoprotein or “good cholesterol”) and liver or muscle enzyme levels did not differ between the two groups.

Red Yeast Rice, a staple of Chinese medicine for more than a thousand years, is derived from a fungus that grows on rice. A series of compounds within the red yeast rice have been found to slow the production of cholesterol in the liver. The medical community, however, has been slow to consider its potential use as an alternative treatment therapy for patients with statin-associated myalgias because the supplement is not regulated by the Food and Drug Administration.

“Every physician has patients who refuse to take statins or have significant side effects from them,” says Dr. Becker. “One of the largest challenges in the medical community has been that there is no agreement or consensus on how to treat these patients. We are convinced that our research may lead to some answers.”

Dr. Gordon remarked, “Statins have revolutionized the way doctors have taken care of cardiac patients over the past two decades. But for patients that cannot tolerate them, the side effects are considerable.” Some studies have estimated that up to 15% of patients taking the cholesterol-lowering drugs have to stop because of muscle pain. According to IMS Health, a drug tracking company, more than 200 million statin prescriptions were filled in 2008.

Dr. Gordon added, “While red yeast rice isn’t appropriate for everyone, the goal of our research was to see if it has potential to be an option for those patients who discontinue their statins because of the side effects. Often these patients with high cholesterol are left without lipid-lowering therapy. This is especially worrisome if the patient has a history of heart attacks, stents, bypass surgery or strokes.”

Dr. Becker and Dr. Gordon are in private practice at Chestnut Hill Cardiology in Flourtown, Pennsylvania, a suburb of Philadelphia and are on the staff of Chestnut Hill Hospital and Abington Memorial Hospital. They also conduct an innovative cardiac prevention program called “Change of Heart,” which was developed by Dr. Becker in 1993. The 10-week program takes a holistic approach to cardiac wellness, utilizing diet, exercise, stress management and traditional and alternative treatment therapies to help people reduce and even reverse the effects of coronary artery disease.

Dr. Becker said, “Our present medical system places very little emphasis on educating patients. We employ a team approach. Patients work closely with dietitians, fitness experts and stress management counselors, and we provide the physician perspective to help them evaluate and consider traditional treatment and alternative therapies. We passionately believe that patients need to take control of their cardiac destiny.”

“Aside from its findings, this study is unique because it is truly rooted in our community rather than the commercial interests of pharmaceutical companies,” says Brooks Turkel, CEO of Chestnut Hill Hospital. “The premise of the research was established because local patients inquired about alternatives to cholesterol lowering drugs and the potential undesirable side effects. Our cardiologists, motivated to provide their patients with alternatives, developed a life-style modification program, Change of Heart, which has served as a springboard for further research involving natural supplements. We at Chestnut Hill Hospital are very proud that the research by Drs. Becker, Gordon and their team has gained the recognition of the national medical community.”

“Chestnut Hill Hospital has received funding for this study through a grant from the Commonwealth of Pennsylvania,” notes Mr. Turkel. “We are grateful that our state representatives saw the value of the Change of Heart program.”

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U.S. Dieters Look Online for Guidance: 65% Influenced by Online Comments, Reviews

Online comments and product reviews influenced 65% of U.S. adults who recently used a diet or weight loss program, according to the Spring 2009 Ad-ology Media Influence on Consumer Choice survey.  These consumers are very interested in the effectiveness of diet programs and are actively seeking out the opinions of other users.

Online media also impacts health/fitness club choice, especially among the 18-to-24-year-old demographic (60.8%).

Of health club members, 89% say variety of equipment is an important factor in their selection decision, and 88% say the same for quality of equipment. Looking at factors by gender, women are more interested in the variety and availability of classes, while noticeably more men want to work out where their friends/family go, perhaps because men view working out as a social experience.

For the vitamin and nutritional supplement market, one in five consumers prefers to shop at a specialty health food/vitamin store, with 35-to-44-year-olds most likely to seek out these stores. More than 60% of that age group cite brand name as an important factor in their purchase decision and are most likely to be influenced by manufacturer Web sites.

“Consumers are researching diet and other wellness topics online much like they would research a consumer electronics purchase,” said C. Lee Smith, president and CEO of Ad-ology Research. “Anybody in this industry must maintain a strong online presence to provide the information these health-conscious consumers crave,” Smith said.

Other key findings from the survey:

  • For health/fitness clubs or gym choice, direct mail was the most influential traditional media type
  • Television was the most influential traditional media for 18-to-24-year-olds looking for diet and weight loss products and services
  • Of traditional media, newspapers had the most influence (35.3%) on recent over-the-counter vitamin or nutritional supplement purchasers
  • 12% of Hispanics researched personal trainers online, the most among all ethnic groups

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Expedition to Mount Everest Offers New Insights into Chronic Disease

Results of the HIGHCARE2008 Project were announced during the recent 19th Scientific Meeting of the European Society of Hypertension (ESH), Milan, Italy. The first-ever ambulatory blood pressure (ABPM) study conducted at high and very high altitude investigated treatment with telmisartan and showed that:

  • in conditions of hypobaric hypoxia (oxygen deficiency), 24-hour blood pressure increased in a sustained manner proportional to the altitude reached
  • the effects of hypobaric hypoxia at high altitude are similar to the effects of reduced oxygen availability observed in diseases associated with respiratory disorders, such as chronic heart failure (CHF), chronic obstructive pulmonary disease (COPD), arterial hypertension related to sleep apnea syndrome and/or severe obesity.2-5 Together, these diseases affect more than 600 million people worldwide6,7 giving the study results great significance
  • treatment with telmisartan, a modern angiotensin II receptor blocker, reduces blood pressure compared with placebo at high altitude, up to at least 3500m above sea level, demonstrating potential control of hypoxia-induced blood pressure alterations
  • at very high altitude, 5400m above sea level, blood pressure effects between the telmisartan and placebo groups was comparable, consistent with changes in the functioning of the renin-angiotensin-aldosterone system (RAAS).

Physiological changes occurring at high altitude are mainly due to decreased atmospheric pressure leading to hypoxia (deprivation of adequate oxygen supply) and hypoxemia (decreased partial pressure of oxygen in blood).

Professor Gianfranco Parati, Chairman and Principle Investigator of the HIGHCARE2008 Project and Professor of Medicine at the Department of Clinical Medicine and Prevention, University of Milano-Bicocca commented, “People with sleep apnea syndrome develop high blood pressure in response to hypoxia, a lack of oxygen in their blood. In the HIGHCARE2008 Project, this condition has been simulated by hypobaric hypoxia, often associated with sleep-related breathing disorders, which occurs at high altitude. We found that telmisartan – the antihypertensive drug we tested – was able to control this effect at altitudes of up to 3500m, at which the lack of oxygen is similar to the degree of hypoxemia most commonly experienced by sleep apnea sufferers.”

The randomised, parallel group, double-blind, placebo-controlled trial with telmisartan 80mg was conducted in 38 healthy subjects with a moderate level of physical fitness. The effects of telmisartan on 24-hour ambulatory blood pressure were measured under acute and prolonged exposure to high altitude hypoxia. Key results showed that:1

  • following treatment with telmisartan for six weeks at sea level and also following acute exposure to high altitude (3500m):
  • 24-hour SBP/DBP** at sea level were significantly reduced with telmisartan compared with placebo (SBP: 112.0±7.8 vs. 116.4±8.6, p=0.0025; DBP: 69.0±5.8 vs. 74.0±5.8, p=0.002)
  • 24-hour SBP/DBP at 3500m were also significantly reduced with telmisartan compared with placebo (SBP: 120.0±9.7 vs. 125.0±8.7,p=0.0056; DBP: 75.7±6.5 vs. 81.1±5.7, p=0.009)
  • at very high altitude, 5400m, 24-hour SBP/DBP was comparable between the telmisartan and placebo groups (SBP: 130.1±11.1 vs. 130.7±11.2, p=NS; DBP: 82.1±7.1 vs. 84.2±6.6, p=NS), consistent with changes in functioning of the RAAS. These changes may explain why a treatment that works on the RAAS may not provide benefits at very high altitude.

The RAAS is involved in the occurrence of a number of cardiovascular (CV) conditions, including hypertension and heart failure. Therapeutic agents acting on the RAAS, including angiotensin II receptor blockers such as telmisartan, have beneficial CV effects.

Dr. Grzegorz Bilo, Istituto Auxologico Italiano and Department of Clinical Medicine and Prevention, University of Milano-Bicocca, commented, “When moving to an even higher altitude, and thus further increasing the hypoxia above the levels often experienced in sleep apnea, the blockade of the RAAS was no longer able to control the hypoxia-induced blood pressure increase. This suggests that other mechanisms were involved and could explain the blood pressure changes observed. Even though this is an artificial setting, the data we have collected will provide important insights into the physiological and molecular basis of hypoxia induced hypertension.”

Professor Gianfranco Parati concluded, “While the data that we have collected need to be confirmed by further studies, what we can take away from this expedition is that although Everest is one of the most hostile places on earth, it might actually help us save lives by giving us a better understanding of the changes induced by hypoxia in the human body”.

* HIGHCARE = HIGH altitude CArdiovascular REsearch

** SBP – systolic blood pressure; DBP – diastolic blood pressure

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