Health Technology Research Synopsis
43rd Issue Date 11 NOV 2008
Compiled By Ralph Turchiano
Editors Top Five:
1. Optimal Dose of Vitamin E Maximizes Benefits, Minimizes Risk
2. Study shows pine bark reduces jetlag
3. Vitamin B3 reduces Alzheimer’s symptoms, lesions
4. The upside to allergies: cancer prevention
5. Can rectal vitamin E induce remission in patients with mild to moderate ulcerative colitis?
In this Issue:
1. Eating red meat sets up target for disease-causing bacteria
2. Grapes may aid a bunch of heart risk factors, animal study finds
3. The upside to allergies: cancer prevention
4. New MU Study Indicates that Exercise Prevents Fatty Liver Disease
5. Vigorous activity protects against breast cancer
6. Optimal Dose of Vitamin E Maximizes Benefits, Minimizes Risk
7. Drinking milk to ease milk allergy
8. Can rectal vitamin E induce remission in patients with mild to moderate ulcerative colitis?
9. How did glycine significantly decrease liver injury?
10. Fibromyalgia can no longer be called the ‘invisible’ syndrome
11. New evidence for homeopathy
12. Vitamin B3 reduces Alzheimer’s symptoms, lesions
13. Study shows pine bark reduces jetlag
14. Dietary sport supplement shows strong effects in the elderly
15. UC Davis researchers discover Achilles’ heel in pancreatic cancer
16. Could vitamin D save us from radiation?
17. LOW POTASSIUM LINKED TO HIGH BLOOD PRESSURE
18. Doctors should disclose off-label prescribing to their patients
19. Can vitamins and minerals prevent hearing loss?
Public release date: 29-Oct-2008
Eating red meat sets up target for disease-causing bacteria
Non-human molecules absorbed by eating red meat increase risk of food poisoning in humans
Offering another reason why eating red meat could be bad for you, an international research team, including University of California, San Diego School of Medicine professor Ajit Varki, M.D., has uncovered the first example of a bacterium that causes food poisoning in humans when it targets a non-human molecule absorbed into the body through red meats such as lamb, pork and beef.
In findings to be published on line October 29th in advance of print in the journal Nature, the scientists discovered that a potent bacterial toxin called subtilase cytotoxin specifically targets human cells that have a non-human, cellular molecule on their surface. The molecule –N-glycolylneuraminic acid (Neu5Gc) – is a type of glycan, or sugar molecule, that humans don’t naturally produce.
Subtilase cytotoxin is produced by certain kinds of E. coli bacteria, causing bloody diarrhea and a potentially fatal disease called haemolytic uraemic syndrome (HUS) in humans. Humans usually become infected after eating contaminated red meat, which is why this is also known as “hamburger” disease.
Varki, UC San Diego School of Medicine distinguished professor of medicine and cellular and molecular medicine, and co-director of the UCSD Glycobiology Research and Training Center, previously discovered that humans don’t produce Neu5Gc because they lack the gene responsible for its production. Therefore, it was thought that humans should be resistant to the toxin.
“Ironically, humans may set themselves up for an increased risk of illness from this kind of E. coli bacteria present in contaminated red meat or dairy, because these very same products have high-levels of Neu5Gc,” Varki explained. “The Neu5Gc molecule is absorbed into the body, making it a target for the toxin produced by E. coli.”
In the Nature study, the researchers discovered that sites where the Neu5Gc has been incorporated into the human body coincide with toxin binding. “When the toxin binds to the non-human Neu5Gc receptors, it can result in serious food-poisoning and other symptoms in humans,” said Varki. The research emphasizes the need for people to eat only well-cook meat or pasteurized dairy products, processes that destroy contaminating bacteria.
Five years ago, Varki and his colleagues at the UC San Diego School of Medicine published a paper in the Proceedings of the National Academy of Sciences describing how Neu5Gc is absorbed into human tissues – including the surface of cells lining the intestines and blood vessels – as a result of eating red meat and milk products. At the time, the researchers also showed that this foreign molecule generates an immune response that could potentially lead to inflammation in human tissues. The UC San Diego study was the first to investigate human dietary absorption of the Neu5Gc glycans which, while not produced in humans, does occur naturally in red meats. Levels are very low or undetectable in fruits, vegetables, eggs, poultry and fish. The researchers proved that people who ingest Neu5Gc incorporate some of it into their tissues, and demonstrated that many generated an immune response against the molecule, conjecturing that a lifetime of gradual incorporation of this glycan “invader” could result in disease.
Public release date: 29-Oct-2008
Grapes may aid a bunch of heart risk factors, animal study finds
Research shows that grape intake lowered blood pressure and signs of heart muscle damage, and improved heart function in lab rats
ANN ARBOR, Mich. — Could eating grapes help fight high blood pressure related to a salty diet? And could grapes calm other factors that are also related to heart diseases such as heart failure? A new University of Michigan Cardiovascular Center study suggests so.
The new study, published in the October issue of the Journal of Gerontology: Biological Sciences, gives tantalizing clues to the potential of grapes in reducing cardiovascular risk. The effect is thought to be due to the high level of phytochemicals – naturally occurring antioxidants – that grapes contain.
The study was performed in laboratory rats. The researchers noted that while these study results are extremely encouraging, more research needs to be done.
The researchers studied the effect of regular table grapes (a blend of green, red, and black grapes) that were mixed into the rat diet in a powdered form, as part of either a high- or low-salt diet. They performed many comparisons between the rats consuming the test diet and the control rats receiving no grape powder — including some that received a mild dose of a common blood-pressure drug. All the rats were from a research breed that develops high blood pressure when fed a salty diet.
In all, after 18 weeks, the rats that received the grape-enriched diet powder had lower blood pressure, better heart function, reduced inflammation throughout their bodies, and fewer signs of heart muscle damage than the rats that ate the same salty diet but didn’t receive grapes. The rats that received the blood-pressure medicine, hydrazine, along with a salty diet also had lower blood pressure, but their hearts were not protected from damage as they were in the grape-fed group.
Says Mitchell Seymour, M.S., who led the research as part of his doctoral work in nutrition science at Michigan State University, “These findings support our theory that something within the grapes themselves has a direct impact on cardiovascular risk, beyond the simple blood pressure-lowering impact that we already know can come from a diet rich in fruits and vegetables.” Seymour manages the U-M Cardioprotection Research Laboratory, which is headed by U-M heart surgeon Steven Bolling, M.D.
Bolling, who is a professor of cardiac surgery at the U-M Medical School, notes that the animals in the study were in a similar situation to millions of Americans, who have high blood pressure related to diet, and who develop heart failure over time because of prolonged hypertension.
“The inevitable downhill sequence to hypertension and heart failure was changed by the addition of grape powder to a high-salt diet,” he says.
“Although there are many natural compounds in the grape powder itself that may have an effect, the things that we think are having an effect against the hypertension may be the flavanoids – either by direct antioxidant effects, by indirect effects on cell function, or both. These flavanoids are rich in all parts of the grape – skin, flesh and seed, all of which were in our powder.” Bolling explains.
Such naturally occurring chemicals have already been shown in other research, including previous U-M studies, to reduce other potentially harmful molecular and cellular activity in the body.
Although the current study was supported in part by the California Table Grape Commission, which also supplied the grape powder, the authors note that the commission played no role in the study’s design, conduct, analysis or the preparation of the journal article for publication. Seymour also receives funding from the National Heart, Lung and Blood Institute, part of the National Institutes of Health, through a National Research Service Award.
“Though it’s true that your mom told you to eat all your fruits and your vegetables, and that we are learning a lot about what fruits, including grapes, can do in this particular model of hypertension and heart failure, we would not directly tell patients to throw all their pills away and just eat grapes,” says Bolling.
However, research on grapes and other fruits containing high levels of antioxidant phytochemicals continues to show promise. So does research on the impact of red wine on heart health, though that issue is also far from settled.
The U-M team notes that a clinical research on grapes may be a possibility in the future, but is not currently planned.
In the meantime, Bolling says, people who want to lower their blood pressure, reduce the risk of heart failure, or help their weakened hearts retain as much pumping power as possible should follow tried-and-true advice: Cut down on the amount of salt you get through your food and drink.
“There is, as we now know, a great variability, perhaps genetic even, in sensitivity to salt and causing hypertension,” he says. “Some people are very sensitive to salt intake, some are only moderately so, and there are perhaps some people who are salt resistant. But in general we say stay away from excess salt.”
He notes that the popular DASH diet, which is low in salt and high in fruits and vegetables, has been proven to reduce mild high blood pressure without medication. The dose of whole table grape powder that was consumed in the study was roughly equivalent to a person eating nine human-sized servings of grapes a day. Currently, five to nine servings of fruits and vegetables are recommended as part of the DASH diet.
The rats in the study were from a strain called Dahl rats, which have been specially bred to all be susceptible to salt-induced hypertension. This allowed the researchers to look at a uniform sample of rats that would be affected in the same way by their diet, so that the effects of the salt level, grape powder and hydrazine could be seen clearly.
Each group of 12 rats was fed the same weight of food each day, with powdered grapes making up 3 percent of the diet (by weight) for rats that received grapes as part of either a low-salt or high-salt diet. The rats that received hydrazine were fed it through their water supply in a dose that has been previously shown to be effective in reducing blood pressure.
The rats in the high-salt grape and high-salt hydrazine groups did develop high blood pressure over time, but they had lower systolic blood pressures than the high-salt rats that did not receive grapes.
The researchers also measured the distortion of the heart size, weight and function that occurred over time – characteristics of heart failure – and found that the high-salt grape group had less of a change than the high-salt hydrazine group. Parameters related to the diastolic blood pressure – an important factor in human heart failure — and to the heart’s relaxation during the diastolic phase also changed in just the high-salt grape group. Finally, the grape-fed rats had improved cardiac output, or more blood pumped per unit of time.
The researchers also looked for signs of inflammation, oxidative damage and other molecular indicators of cardiac stress. Again, the rats that received the high-salt grape diet had lower levels of these markers than rats that received the high-salt diet with hydrazine – and even the low-salt grape-eating rats had lower levels than the rats that received a low-salt diet alone.
In all, the researchers say, the study demonstrates that a grape-enriched diet can have broad effects on the development of hypertension and the risk factors that go along with it. Whether the effect can be replicated in humans, they say, remains to be seen.
Public release date: 29-Oct-2008
The upside to allergies: cancer prevention
A new article in the December issue of The Quarterly Review of Biology provides strong evidence that allergies are much more than just an annoying immune malfunction. They may protect against certain types of cancer.
The article, by researchers Paul Sherman, Erica Holland and Janet Shellman Sherman from Cornell University, suggests that allergy symptoms may protect against cancer by expelling foreign particles, some of which may be carcinogenic or carry absorbed carcinogens, from the organs most likely to come in with contact them. In addition, allergies may serve as early warning devices that let people know when there are substances in the air that should be avoided.
Medical researchers have long suspected an association between allergies and cancer, but extensive study on the subject has yielded mixed, and often contradictory, results. Many studies have found inverse associations between the two, meaning cancer patients tended to have fewer allergies in their medical history. Other studies have found positive associations, and still others found no association at all.
In an attempt to explain these contradictions, the Cornell team reexamined nearly 650 previous studies from the past five decades. They found that inverse allergy-cancer associations are far more common with cancers of organ systems that come in direct contact with matter from the external environment—the mouth and throat, colon and rectum, skin, cervix, pancreas and glial brain cells. Likewise, only allergies associated with tissues that are directly exposed to environmental assaults—eczema, hives, hay fever and animal and food allergies—had inverse relationships to cancers.
Such inverse associations were found to be far less likely for cancers of more isolated tissues like the breast, meningeal brain cells and prostate, as well as for myeloma, non-Hodgkins lymphoma and myelocytic leukemia.
The relationship between asthma and lung cancer, however, is a special case. A majority of the studies that the Cornell team examined found that asthma correlates to higher rates of lung cancer. “Essentially, asthma obstructs clearance of pulmonary mucous, blocking any potentially prophylactic benefit of allergic expulsion,” they explain. By contrast, allergies that affect the lungs other than asthma seem to retain the protective effect.
So if allergies are part of the body’s defense against foreign particle invaders, is it wise to turn them off with antihistamines and other suppressants? The Cornell team says that studies specifically designed to answer this question are needed.
“We hope that our analyses and arguments will encourage such cost/benefit analyses,” they write. “More importantly, we hope that our work will stimulate reconsideration…of the current prevailing view … that allergies are merely disorders of the immune system which, therefore, can be suppressed with impunity.”
Public release date: 29-Oct-2008
New MU Study Indicates that Exercise Prevents Fatty Liver Disease
COLUMBIA, Mo. – It’s easy to go to the gym on a regular basis right after a person buys the gym membership. It’s also easy to skip the gym one day, then the next day and the day after that. A new University of Missouri study indicates that the negative effects of skipping exercise can occur in a short period. The researchers found that a sudden transition to a sedentary lifestyle can quickly lead to symptoms of nonalcoholic fatty liver disease (hepatic steatosis), which affects at least 75 percent of obese people.
“We found that the cessation of daily exercise dramatically activates specific precursors known to promote hepatic steatosis,” said Jamal Ibdah, professor of medicine and medical pharmacology and physiology in the MU School of Medicine. “This study has important implications for obese humans who continually stop and start exercise programs. Our findings strongly suggest that a sudden transition to a sedentary lifestyle increases susceptibility to nonalcoholic fatty liver disease.”
Nonalcoholic fatty liver disease is a reversible condition that causes fat to accumulate in liver cells of obese people. As Westernized societies are experiencing a weight gain epidemic, the prevalence of the disease is growing, Ibdah said.
In the study, researchers gave obese rats access to voluntary running wheels for 16 weeks. Scientists then locked the wheels, and transitioned the animals to a sedentary condition. After 173 hours, or about seven days, the rats began showing signs of factors responsible for promoting hepatic steatosis. In the animals tested immediately at the end of 16 weeks of voluntary running, there were no signs of hepatic steatosis.
“Physical activity prevented fatty liver disease by 100 percent in an animal model of fatty liver disease,” said Frank Booth, a professor in the MU College of Veterinary Medicine and the MU School of Medicine and a research investigator in the Dalton Cardiovascular Research Center. “In contrast, 100 percent of the group that did not have physical activity had fatty liver disease. This is a remarkable event. It is rare in medicine for any treatment to prevent any disease by 100 percent.”
Public release date: 30-Oct-2008
Vigorous activity protects against breast cancer
Normal-weight women who carry out lots of vigorous exercise are approximately 30% less likely to develop breast cancer than those who don’t exercise vigorously. A study of more than thirty thousand postmenopausal American women, reported in BioMed Central’s open access journal Breast Cancer Research, has revealed that a sedentary lifestyle can be a risk factor for the disease – even in women who are not overweight.
While an Investigator at the National Cancer Institute of the U.S. National Institutes of Health, Michael F. Leitzmann led a team of researchers who followed the 32,269 women for eleven years and found that vigorous activity may protect against breast cancer, independent of body weight control. Vigorous activity was judged to include things like heavy housework (scrubbing floors, washing windows, heavy yard-work, digging, chopping wood) and strenuous sports or exercise (running, fast jogging, competitive tennis; aerobics, bicycling on hills, and fast dancing).
Leitzmann said, “Notable strengths of our study include its large sample size, prospective design, high follow-up rate, and availability of relevant known or suspected breast cancer risk factors. These features enabled us to minimize any effects from other factors apart from exercise.”
Interestingly, the authors found that non-vigorous activity, such as light housework (vacuuming, washing clothes, painting, general gardening) and light sports or exercise (walking, hiking, light jogging, recreational tennis, bowling) was not protective. Furthermore, vigorous activity was only protective in lean women and not those who were overweight or obese. According to Leitzmann, “Possible mechanisms through which physical activity may protect against breast cancer that are independent of body mass include reduced exposure to growth factors, enhanced immune function, and decreased chronic inflammation, variables that are related both to greater physical activity and to lower breast cancer risk”.
The authors added, “An alternative explanation for the stronger apparent effect of vigorous activity among lean over heavy women is that heavier women may misreport non-vigorous activities as vigorous ones”.
Public release date: 30-Oct-2008
Optimal Dose of Vitamin E Maximizes Benefits, Minimizes Risk
Corvallis, Oregon – October 29, 2008 — Vitamin E has been heralded for its ability to reduce the risk of blood clots, heart attack, and sudden death. Yet in some people, vitamin E causes bleeding. Scientists have known for more than 50 years that excess vitamin E promotes bleeding by interfering with vitamin K, which is essential in blood clotting. However, they haven’t been able to pinpoint how the two vitamins interact. Nutrition researcher Maret Traber of Oregon State University reviews studies of possible explanations of the interaction in an article published recently in Nutrition Reviews.
One of the most compelling studies of the benefits of vitamin E is the Women’s Health Study, in which 40,000 healthy women, 45 and older, took 600 IU vitamin E supplements or a placebo every other day for 10 years. Women taking the supplements had 24 percent fewer deaths from heart disease. Vitamin E’s protective effect appeared even stronger in women 65 and older. Those taking the vitamin experienced a 26 percent reduction in cardiovascular events and a 49 percent reduction in cardiovascular deaths.
“That’s a significant benefit,” Traber said. Yet, she added, “In some people high doses of vitamin E increase the tendency to bleed. Women enrolled in the study had an increase in nose bleeds.”
To lessen the bleeding risk, the U.S.-based Food and Nutrition Board in 2000 set the upper tolerable limit for daily vitamin E intake at 1500 I.U.
Research Traber reviewed suggests that a shared metabolic pathway in the liver causes vitamins E and K to interact. Vitamin K in the liver appears to diminish as vitamin E increases.
“Several different explanations could account for the interaction between the two vitamins,” Traber said. “We need more research to understand the delicate balance between vitamins E and K.”
Public release date: 30-Oct-2008
Drinking milk to ease milk allergy?
Hopkins Children’s oral immunotherapy study shows promise, but do not try this at home
Giving children with milk allergies increasingly higher doses of milk over time may ease, and even help them completely overcome, their allergic reactions, according to the results of a study led by the Johns Hopkins Children’s Center and conducted jointly with Duke University.
Despite the small number of patients in the trial – 19 – the findings are illuminating and encouraging, investigators say, because this is the first-ever double-blinded and placebo-controlled study of milk immunotherapy. In the study, the researchers compared a group of children receiving milk powder to a group of children receiving placebo identical in appearance and taste to real milk powder. Neither the patients nor the investigators knew which child received which powder, a rigorous research setup that minimizes the chance for error and bias.
The findings of the study are reported online ahead of print, Oct. 28, in the Journal of Allergy & Clinical Immunology
“Our findings suggest that oral immunotherapy gradually retrains the immune system to completely disregard or to better tolerate the allergens in milk that previously caused allergic reactions,” says Robert Wood, M.D., senior investigator on the study and director of Allergy & Immunology at Hopkins Children’s. “Albeit preliminary and requiring further study, these results suggest that oral immunotherapy may be the closest thing yet to a ‘true’ treatment for food allergy.”
Currently, food allergy management involves complete avoidance of the trigger foods, waiting for the child to outgrow the allergy or treating allergic reactions if and when they occur. The latter could be dangerous, investigators say, because these common foods are difficult to avoid and some reactions can be severe and even life-threatening.
In a report released Oct. 22, the Centers for Disease Control and Prevention estimates that food allergies are on the rise with three million children in the United States now having at least one food allergy, an 18 percent jump from 10 years ago. Milk allergy is the most prevalent type of food allergy.
“Given that the quality of life of a child with a food allergy is comparable to the quality of life of a child with diabetes, we urgently need therapies that go beyond strict food avoidance or waiting for the child to outgrow the allergy,” Wood says.
Researchers followed allergic reactions over four months among 19 children with severe and persistent milk allergy, 6 to 17 years of age. Of the 19 patients, 12 received progressively higher doses of milk protein, and seven received placebo. At the beginning of the study, the children were able to tolerate on average only 40 mg (.04 ounces or a quarter of a teaspoon) of milk.
At the end of the four-month study, both groups were given milk powder as a “challenge” to see what dose would cause reaction after the treatment. The children who had been receiving increasingly higher doses of milk protein over a few months were able to tolerate a median dose of 5, 140 mg (over 5 ounces) of milk without having any allergic reaction or with mild symptoms, such as mouth itching and minor abdominal discomfort. Those who had been getting the placebo remained unable to tolerate doses higher than the 40 mg of milk powder without having an allergic reaction. In the group receiving milk protein, the lowest tolerance dose was 2, 540 mg (2.5 ounces) and the highest was 8,140 mg (8 ounces). Lab tests showed the children who regularly drank or ate milk had more antibodies to milk in their blood, yet were able to better tolerate milk than those who took the placebo. Researchers say, tolerance in children treated with milk continued to build over time, and recommend that these children continue to consume milk daily to maintain their resistance. The researchers caution that it remains unclear whether the children would maintain their tolerance once they stop consuming milk regularly. “It may very well be that this tolerance is lost once the immune system is no longer exposed to the allergen daily,” Wood says.
The Hopkins group is currently studying oral immunotherapy in children with egg allergy to determine whether increasingly higher doses of egg protein can help resolve their allergy, and have recently started another study of milk immunotherapy.
Wood emphasizes the findings require further research and advises parents and caregivers not to try oral immunotherapy without medical supervision
Public release date: 31-Oct-2008
Can rectal vitamin E induce remission in patients with mild to moderate ulcerative colitis?
It is believed that the generation of an exaggerated intestinal immune response to otherwise innocuous stimuli along with generation of oxygen free radicals plays a key role in the pathophysiology of UC. However, no disease-specific treatment for UC has yet emerged. Vitamin E is a major lipophilic antioxidant in cellular membranes with excellent antioxidant activities which protects membrane lipids from peroxidation by scavenging not only chain carrying peroxyl radicals but also singlet oxygen and superoxide anion radicals. This is especially interesting in case of UC, considering the pivotal role of oxygen free radicals in the genesis of mucosal damage. Given the recent evidence suggesting anti-inflammatory properties for Vitamin E, one may ask whether d-alpha tocopherol, as the dominant vitamin E isomer in plasma with the highest biopotency, can be expected to reduce the development of tissue injury in UC.
A research article to be published on October 21, 2008 in the World Journal of Gastroenterology addresses this question. The research team led by Dr. Mirbagheri from Department of Internal Medicine of Amir Alam hospital in Tehran-Iran, report for the first time the preliminary results of an on-going open-label case-series study on clinical and endoscopic changes of disease severity in patients with active UC who received daily rectal doses of d-alpha tocopherol for at least 12 wk.
All 15 participating patients responded dramatically to therapy after 12 weeks, with 9 of them going to clinical remission. The average score of Mayo disease activity index (DAI) started to decrease after second week and remained significantly lower for the remainder of the study. Besides, there was no case of worsening disease activity or report of serious adverse event during the course of study. The observed effect are probably due to antioxidant and anti-inflammatory effects of vitamin E which potently takes effect by local route of administration. At the end of this interesting article the authors suggest that rectal administration of d-alpha tocopherol might be used safely as a new therapeutic modality to reduce the clinical severity of ulcerative colitis without major side effects or complications of current therapies.
Public release date: 31-Oct-2008
How did glycine significantly decrease liver injury?
The nonessential amino acid glycine has been shown to be anti-inflammatory in several animal injury models. Recent studies demonstrated that dietary glycine protected both the lung and liver against lethal doses of endotoxin in rat or other animals and improved graft survival after liver transplantation. The influence of dietary glycine on oxidant-induced or cholestatic liver injury was not known.
A research article to be published on October 21, 2008 in the World Journal of Gastroenterology addresses this question. The research team led by Prof. Thurman from the University of North Carolina used a dietary and cholestatic model thru BDL in rats to address this question. They could demonstrate that hepatic injury due to BDL is significantly reduced by dietary glycine in rats. Moreover, the data indicated that glycine decreases liver injury under the conditions of experimental cholestasis thru a direct effect on hepatocytes. Surprisingly, Kupffer cells did not appear to play a major role in the pathological changes caused by cholestasis.
It is best known that Kupffer cells, the resident macrophages of the liver, are involved in several disease states, such as endotoxin shock, alcoholic liver diseases, and other toxicant-induced liver injury by releasing eicosanoids, inflammatory cytokines, and free radical species. Furthermore, in previous studies of the research team, a glycine-dependent chloride channel on the cell membrane of Kupffer cells and other macrophages that influence the activation process of these cells could be detected. But in the actual used cholestatic model no significant influence of this cell line on liver injury could be detected.
Public release date: 3-Nov-2008
Fibromyalgia can no longer be called the ‘invisible’ syndrome
Molecular imaging uncovers evidence that symptoms are related to functional brain abnormalities, according to article in the Journal of Nuclear Medicine
Reston, Va.—Using single photon emission computed tomography (SPECT), researchers in France were able to detect functional abnormalities in certain regions in the brains of patients diagnosed with fibromyalgia, reinforcing the idea that symptoms of the disorder are related to a dysfunction in those parts of the brain where pain is processed.
“Fibromyalgia is frequently considered an ‘invisible syndrome’ since musculoskeletal imaging is negative,” said Eric Guedj, M.D., and lead author of the study. “Past imaging studies of patients with the syndrome, however, have shown above-normal cerebral blood flow (brain perfusion) in some areas of the brain and below-normal in other areas. After performing whole-brain scans on the participants, we used a statistical analysis to study the relationship between functional activity in even the smallest area of the brain and various parameters related to pain, disability and anxiety/depression.”
In the study, which was reported in the November issue of The Journal of Nuclear Medicine, 20 women diagnosed with fibromyalgia and 10 healthy women as a control group responded to questionnaires to determine levels of pain, disability, anxiety and depression. SPECT was then performed, and positive and negative correlations were determined.
The researchers confirmed that patients with the syndrome exhibited brain perfusion abnormalities in comparison to the healthy subjects. Further, these abnormalities were found to be directly correlated with the severity of the disease. An increase in perfusion (hyperperfusion) was found in that region of the brain known to discriminate pain intensity, and a decrease (hypoperfusion) was found within those areas thought to be involved in emotional responses to pain.
In the past, some researchers have thought that the pain reported by fibromyalgia patients was the result of depression rather than symptoms of a disorder. “Interestingly, we found that these functional abnormalities were independent of anxiety and depression status,” Guedj said.
According to Guedj, disability is frequently used in controlled clinical trials to evaluate response to treatment. Because molecular imaging techniques such as SPECT can help predict a patient’s response to a specific treatment and evaluate brain-processing recovery during follow-up, it could prove useful when integrated into future pharmacological controlled trials.
“Fibromyalgia may be related to a global dysfunction of cerebral pain-processing,” Guedj added. “This study demonstrates that these patients exhibit modifications of brain perfusion not found in healthy subjects and reinforces the idea that fibromyalgia is a ‘real disease/disorder.'”
According to the National Institute of Arthritis and Musculoskeletal and Skin Diseases, fibromyalgia syndrome is a common and chronic disorder characterized by widespread muscle pain, fatigue and multiple tender points. Tender points are specific places—for example, on the neck, shoulders, back, hips, and upper and lower extremities—where people with fibromyalgia feel pain in response to slight pressure. The syndrome is one of the most common causes of musculoskeletal pain and disability and affects three to six million, or as many as one in 50, Americans. Between 80 and 90 percent of those diagnosed are women.
Although fibromyalgia is often considered an arthritis-related condition, it does not cause inflammation or damage to the joints, muscles or other tissues. Like arthritis, however, the significant pain and fatigue caused by fibromyalgia can interfere with a person’s ability to carry out daily activities.
Public release date: 3-Nov-2008
New evidence for homeopathy
Two new studies conclude that a review which claimed that homeopathy is just a placebo, published in The Lancet, was seriously flawed.
George Lewith, Professor of Health Research at Southampton University comments: ‘The review gave no indication of which trials were analysed nor of the various vital assumptions made about the data. This is not usual scientific practice. If we presume that homeopathy works for some conditions but not others, or change the definition of a ‘larger trial’, the conclusions change. This indicates a fundamental weakness in the conclusions: they are NOT reliable.’
The background to the ongoing debate is as follows:
In August 2005, The Lancet published an editorial entitled ‘The End of Homeopathy’, prompted by a review comparing clinical trials of homeopathy with trials of conventional medicine. The claim that homeopathic medicines are just placebo was based on 6 clinical trials of conventional medicine and 8 studies of homeopathy but did not reveal the identity of these trials. The review was criticised for its opacity as it gave no indication of which trials were analysed and the various assumptions made about the data.
Sufficient detail to enable a reconstruction was eventually published and two recently published scientific papers based on such a reconstruction challenge the Lancet review, showing that:
Analysis of all high quality trials of homeopathy yields a positive conclusion.
The 8 larger higher quality trials of homeopathy were all for different conditions; if homeopathy works for some of these but not others the result changes, implying that it is not placebo.
The comparison with conventional medicine was meaningless.
Doubts remain about the opaque, unpublished criteria used in the review, including the definition of ‘higher quality’.
The Lancet review, led by Prof Matthias Egger of the Department of Social and Preventive Medicine at the University of Berne, started with 110 matched clinical trials of homeopathy and conventional medicine, reduced these to ‘higher quality trials’ and then to 8 and 6 respectively ‘larger higher quality trials’. Based on these 14 studies the review concluded that there is ‘weak evidence for a specific effect of homoeopathic remedies, but strong evidence for specific effects of conventional interventions’.
There are a limited number of homeopathic studies so it is quite possible to interpret these data selectively and unfavourably, which is what appears to have been done in the Lancet paper. If we assume that homeopathy does not work for just one condition (Arnica for post-exercise muscle stiffness), or alter the definition of ‘larger trial’, the results are positive. The comparison with conventional medicine was meaningless: the original 110 trials were matched, but matching was lost after they were reduced to 8 and 6. But the quality of homeopathic trials was better than conventional trials.
This reconstruction casts serious doubts on the review, showing that it was based on a series of hidden judgments unfavourable to homeopathy. An open assessment of the current evidence suggests that homeopathy is probably effective for a number of conditions including allergies, upper respiratory tract infections and ‘flu, but more research is desperately needed.
Prof Egger has declined to comment on these findings.
Public release date: 4-Nov-2008
Vitamin B3 reduces Alzheimer’s symptoms, lesions
UC Irvine starts clinical trial on nicotinamide effect in Alzheimer’s patients
Irvine, Calif. — An over-the-counter vitamin in high doses prevented memory loss in mice with Alzheimer’s disease, and UC Irvine scientists now are conducting a clinical trial to determine its effect in humans.
Nicotinamide, a form of vitamin B3, lowered levels of a protein called phosphorylated tau that leads to the development of tangles, one of two brain lesions associated with Alzheimer’s disease. The vitamin also strengthened scaffolding along which information travels in brain cells, helping to keep neurons alive and further preventing symptoms in mice genetically wired to develop Alzheimer’s.
“Nicotinamide has a very robust effect on neurons,” said Kim Green, UCI scientist and lead author of the study. “Nicotinamide prevents loss of cognition in mice with Alzheimer’s disease, and the beauty of it is we already are moving forward with a clinical trial.”
The study appears online Nov. 5 in the Journal of Neuroscience.
Nicotinamide is a water-soluble vitamin sold in health food stores. It generally is safe but can be toxic in very high doses. Clinical trials have shown it benefits people with diabetes complications and has anti-inflammatory properties that may help people with skin conditions.
Nicotinamide belongs to a class of compounds called HDAC inhibitors, which have been shown to protect the central nervous system in rodent models of Parkinson’s and Huntington’s diseases and amyotrophic lateral sclerosis. Clinical trials are underway to learn whether HDAC inhibitors help ALS and Huntington’s patients.
In the nicotinamide study, Green and his colleague, Frank LaFerla, added the vitamin to drinking water fed to mice. They tested the rodents’ short-term and long-term memory over time using water-maze and object-recognition tasks and found that treated Alzheimer’s mice performed at the same level as normal mice, while untreated Alzheimer’s mice experienced memory loss.
The nicotinamide, in fact, slightly enhanced cognitive abilities in normal mice. “This suggests that not only is it good for Alzheimer’s disease, but if normal people take it, some aspects of their memory might improve,” said LaFerla, UCI neurobiology and behavior professor.
Scientists also found that the nicotinamide-treated animals had dramatically lower levels of the tau protein that leads to the Alzheimer’s tangle lesion. The vitamin did not affect levels of the protein beta amyloid, which clumps in the brain to form plaques, the second type of Alzheimer’s lesion.
Nicotinamide, they found, led to an increase in proteins that strengthen microtubules, the scaffolding within brain cells along which information travels. When this scaffolding breaks down, the brain cells can die. Neuronal death leads to dementia experienced by Alzheimer’s patients.
“Microtubules are like highways inside cells. What we’re doing with nicotinamide is making a wider, more stable highway,” Green said. “In Alzheimer’s disease, this highway breaks down. We are preventing that from happening.”
Public release date: 5-Nov-2008
Study shows pine bark reduces jetlag
Pycnogenol cut jetlag symptoms in half for passengers taking 7- to 9-hour flights
A new study published in the journal of Minerva Cardioangiologica reveals Pycnogenol, pine bark extract from the French maritime pine tree, reduces jetlag in passengers by nearly 50 percent. The two-part study, consisting of a brain CT scan and a scoring system, showed Pycnogenol lowered symptoms of jetlag such as fatigue, headaches, insomnia and brain edema (swelling) in both healthy individuals and hypertensive patients. Passengers also experienced minimal lower leg edema, a common condition associated with long flights.
Jetlag, also called desynchronosis, is a temporary disorder that causes a variety of temporary mental and physical impairments as a result of air travel across time zones – common in flights to Asia and Europe, but also observed in travelers between West and East coast. It is caused due to the body’s inability to immediately adjust to the time in a different zone while travelling. As the body struggles to cope with the new schedule, temporary conditions such as insomnia, fatigue, irritability and an impaired ability to concentrate may set in.
“This study could not have come at a better time for the upcoming holiday travel season,” said Dr. Gianni Belcaro, a lead researcher of the study. Belcaro attributes Pycnogenol’s combined activities for better circulation and antioxidant potency to such remarkable results. “Previous Pycnogenol flight studies have shown a reduction in jetlag; however this was the first study to solely focus on the condition.”
The study, conducted at the G. D’Annunzio University in Pescara, Italy, consisted of 133 passengers who took flights that were seven to nine hours in length. Fifty mg of oral Pycnogenol was administered three times daily, for seven days, starting two days prior to the flight.
Patients in the first part of the study were evaluated with a rating scale consisting of a scoring system. Thirty-eight Pycnogenol-treated and 30 control patients were rated on the most common complaints of jetlag: dehydration and loss of appetite; headaches and/or sinus irritation; fatigue; disorientation and/or grogginess; nausea and/or upset stomach; insomnia and/or highly irregular sleep patterns; irritability; irrational behavior; alternation in mental performance (easy crossword); alternations in general wellbeing; hours of duration of any signs/symptoms; and nights of altered/disturbed sleep. Observations were measured and taken within 48 hours after the end of the flights. Results showed a significantly lower score (56 percent) in the Pycnogenol group for all items rated, amounting in a significant reduction of all jetlag signs and symptoms. Moreover, symptoms lasted only for an average of 18.2 hours in the Pycnogenol group as compared to 39.3 hours in the control group.
In a second group of flight passengers, a brain CT scan was performed after the flight in order to assess brain alterations after flights. The study consisted of 34 Pycnogenol-treated patients and 31 controlled patients. Jetlag symptoms were evaluated using a rating scale providing scores according to the severity. The first observation was performed within 28 hours from the end of the flight. Sleep alterations, short-term memory alterations, disorientation, neurological signs/symptoms of instability, anxiety, minor cardiac alterations (heart rate, blood pressure), lower limb swelling, fatigue and other, a-specific signs/symptoms (cramps, joints/muscular pain, blurred vision, vertigo, mild sickness, increase in body temperature, appetite loss, headache, mild tongue swelling) were all significantly lower by in average 61.5% in the Pycnogenol group compared to the untreated control group.
“This is the first study describing diffuse subliminal swellings of the brain after long haul flights, which we found to be reduced to less than half in the Pycnogenol group,” said Dr. Belcaro
“I’m encouraged by the results of the study as Pycnogenol was effective in preventing jetlag related effects without any side-effects,” said Dr. Belcaro. While more research needs to be conducted on this topic, Pycnogenol is emerging as natural, yet safe option for long distance travelers.
Pycnogenol has been shown to be beneficial for flight travel in previous studies pertaining to edema, deep vein thrombosis (DVT) and blood circulation improvement. A study published in Clinical Applied Thrombosis/Hemostasis recorded passengers supplementing with Pycnogenol on long distance flights lasting 7-12 hours were significantly protected from thrombotic events, complications resulting from deep vein thrombosis (DVT) and superficial vein thrombosis (SVT). In 2005, a study published in Clinical and Applied Thrombosis/Hemostasis showed Pycnogenol to be effective in reducing leg and ankle swelling (edema) during long airplane flights lasting seven to 12 hours.
Public release date: 6-Nov-2008
Dietary sport supplement shows strong effects in the elderly
Beta-alanine (BA), a dietary supplement widely used by athletes and body builders, has been proven to increase the fitness levels of a group of elderly men and women. The research, published in BioMed Central’s open access Journal of the International Society of Sports Nutrition, suggests that BA supplementation improves muscle endurance in the elderly.
The research was carried out by Jeffrey Stout, PhD from the University of Oklahoma, USA, and a team of colleagues. According to Dr. Stout, “This could have importance in the prevention of falls, and the maintenance of health and independent living in elderly men and women.”
BA is an amino acid that, together with histidine, forms the dipeptide carnosine. Carnosine is found in muscle tissue and makes an important contribution to the maintenance of intracellular pH, which is vital for normal muscle function during intense exercise. An increased intake of BA significantly raises muscle carnosine levels.
In this double-blind, randomized controlled trial, 26 elderly men and women were given a 90-day course of BA supplementation or placebo pills. Their fitness levels were tested before and after the course. In the treatment group, 67% of the subjects showed an improvement in their fitness levels, compared to 21.5% of the people receiving the placebo treatment.
The researchers write, “Our data suggest that 90 days of BA supplementation increases physical working capacity in elderly men and women. These findings are clinically significant, as a decrease in functional capacity to perform daily living tasks has been associated with an increase in mortality, primarily due to increased risk of falls.”
Public release date: 6-Nov-2008
UC Davis researchers discover Achilles’ heel in pancreatic cancer
Starving cancer cells of arginine cuts proliferation in half
UC Davis Cancer Center researchers have discovered a metabolic deficiency in pancreatic cancer cells that can be used to slow the progress of the deadliest of all cancers.
Published in the October issue of the International Journal of Cancer, study results indicate that pancreatic cancer cells cannot produce the amino acid arginine, which plays an essential role in cell division, immune function and hormone regulation. By depleting arginine levels in cell cultures and animal models, the team was able to significantly reduce pancreatic cancer-cell proliferation.
“There have been few significant advances in 15 years of testing available chemotherapy to treat pancreatic cancer,” said Richard Bold, chief of surgical oncology at UC Davis and senior author of the study. “The lack of progress is particularly frustrating because most patients are diagnosed after the disease has spread to other organs, eliminating surgery as an option. We have to turn back to basic science to come up with new treatments.”
Bold explained that average survival time for those diagnosed with pancreatic cancer is just four-and-a-half months, although chemotherapy can extend that prognosis up to six months.
“There is a dire need to find new options for these patients. While our findings do not suggest a cure for pancreatic cancer, they do promise a possible way to extend the life expectancies of those diagnosed with it,” Bold said.
Bold and his colleagues hypothesized that pancreatic cancer cells lack the ability to produce arginine. In human pancreatic tumors, they measured levels of an enzyme — argininosuccinate synthetase — required to synthesize arginine.
The enzyme was not detected in 87 percent of the 47 tumor specimens examined, suggesting that the majority of pancreatic cancers require arginine for cell growth because of an inability to synthesize the amino acid.
The researchers then conducted further tests using pancreatic cell lines that represent the varying levels of argininosuccinate synthetase observed in human tumor specimens. Focusing on the lines with lowest levels, the researchers depleted arginine levels in cultures of pancreatic cell lines using arginine deiminase, an enzyme isolated from a Mycoplasma bacteria.
The enzyme was modified by adding polyethylene glycol chains to increase size and circulatory time.
The researchers found that exposing the pancreatic cancer cell lines to the modified arginine deiminase enzyme inhibited cancer-cell proliferation by 50 percent. They then treated mice bearing pancreatic tumors with the same compound and found an identical outcome: a 50 percent reduction in tumor growth. According to Bold, the current study represents a unique approach to cancer treatment in that it is one of the first to identify a metabolic pathway that can be leveraged to interrupt cancer growth.
“Instead of killing cells as with typical chemotherapy, we instead removed one of the key building blocks that cancer cells need to function,” Bold said.
Metabolic interruptions like this one are also being studied for their potential in treating cancers of the blood, such as leukemia and lymphoma. In those cases, depleting the amino acid asparagine may be used in slowing cancer-cell growth.
Bold and his colleagues are continuing their laboratory work on the effects of arginine deprivation on pancreatic cancer. They will next be looking for ways to increase pancreatic cell sensitivity to arginine deprivation.
The researchers have also begun designing human clinical trials in cooperation with the manufacturer of arginine deiminase, Polaris Pharmaceuticals.
“We’re looking at whether we can combine this treatment with certain kinds of chemotherapy,” Bold said. “This additional research is needed to inform the clinical work and move it forward more quickly. The better we understand this process, the more we can use it in the fight against pancreatic cancer.”
Public release date: 7-Nov-2008
Could vitamin D save us from radiation?
Radiological health expert Daniel Hayes, Ph.D., of the New York City Department of Health and Mental Hygiene suggests that a form of vitamin D could be one of our body’s main protections against damage from low levels of radiation. Writing in the International Journal of Low Radiation, Hayes explains that calcitriol, the active form of vitamin D, may protect us from background radiation and could be used as a safe protective agent before or after a low-level nuclear incident.
Biologists and pharmacologists who specialize in radiation and health are keen to find an effective agent that could be given by mouth, have few side effects and would protect us against a suspected or impending nuclear event, whether an accident, terrorist attack, or other incident.
In terms of protecting people from the long-term effects of radiation, cancer formation would be the main focus. The ideal agent would act by blocking DNA damage or by halting the progression of damaged cells that might eventually grow into cancers.
While a drug is yet to be found with such ideal radio-protective properties, other researchers have demonstrated that certain dietary supplements have at least some of the desired properties. Hayes argues that vitamin D, and in particular its biologically active form, could be the key ingredient in radiological protection.
“Our general understanding and appreciation of the multifaceted protective actions of vitamin D have recently entered a new era,” says Hayes, “It is now becoming recognized that its most active molecular form, 1,25-dihydroxyvitamin D3, may offer protection against a variety of radiation- and otherwise-induced damages.”
Hayes has reviewed the various biochemical mechanisms by which vitamin D protects users_ from the low levels of natural radiation released by the rocks on which we stand and the skies above us. He points out that calcitriol is involved in cell cycle regulation and control of proliferation, cellular differentiation and communication between cells, as well as programmed cell death (apoptosis and autophagy) and antiangiogenesis.
Calcitriol is the form of vitamin D that activates the body’s Vitamin D Receptor (VDR), which allows gene transcription to take place and the activation of the innate immune response.
It is possible that several of the transcribed by the VDR will help transcribe proteins that protect the body against radiation.
“Vitamin D by its preventive/ameliorating actions should be given serious consideration as a protective agent against sublethal radiation injury, and in particular that induced by low-level radiation,” concludes Hayes.
Public release date: 10-Nov-2008
LOW POTASSIUM LINKED TO HIGH BLOOD PRESSURE
Getting More Potassium May Be Especially Important for African Americans, Study Suggests
As a risk factor for high blood pressure, low levels of potassium in the diet may be as important as high levels of sodium—especially among African Americans, according to research being presented at the American Society of Nephrology’s 41st Annual Meeting and Scientific
Exposition in Philadelphia, Pennsylvania.
“There has been a lot of publicity about lowering salt or sodium in the diet in order to lower blood pressure, but not enough on increasing dietary potassium,” comments lead author Susan Hedayati, MD, of the University of Texas Southwestern Medical Center in Dallas, Texas, and the Dallas VA Medical Center.
The new study suggests that low potassium may be a particularly important contributor to high blood pressure among African Americans, and also identifies a gene that may influence potassium’s effects on blood pressure.
The researchers analyzed data on approximately 3,300 subjects from the Dallas Heart Study, about half of whom were African American. The results showed that the amount of potassium in urine samples was strongly related to blood pressure. “The lower the potassium in the urine, hence the lower the potassium in the diet, the higher the blood pressure,” says Dr. Hedayati. “This effect was even stronger than the effect of sodium on blood pressure.”
The relationship between low potassium and high blood pressure remained significant even when
age, race, and other cardiovascular risk factors—including high cholesterol, diabetes, and smoking—were taken into account.
Previous studies, including the landmark “Dietary Approaches to Stop Hypertension” study
(DASH), have linked potassium deficiency to high blood pressure. The new results support this conclusion, and provide important new data on the relationship between potassium and blood pressure in a sample tha twas 50% African American. “Our study included a high percentage of African-Americans, who are known to consume the lowest amounts of potassium in the diet,” according to Dr. Hedayati. Research performed in the laboratory of Dr. Chou-Long Huang, a co-author of this study, has found evidence that a specific gene, called WNK1, may be responsible for potassium’s effects on blood pressure.
“We are currently doing more research to test how low potassium in the diet affects blood pressure through the activity of this gene,” adds Dr. Hedayati.
The conclusions are limited by the fact that people in the Dallas Heart Study weren’t following any specific diet. The researchers are currently performing a study in which participants are on fixed potassium diets while measuring the activity of the WNK1 gene to see if WNK1 is responsible for this phenomenon.
Meanwhile, they urge efforts to increase the amount of potassium in the diet, as well as lowering
sodium. “High-potassium foods include fruits such as bananas and citrus fruits and vegetables,” says Dr, Hedayati. “Consuming a larger amount of these foods in the diet may lower blood pressure.”
Public release date: 10-Nov-2008
Doctors should disclose off-label prescribing to their patients
Doctors should be required to disclose when they are prescribing drugs off-label, argues a new article in this week’s PLoS Medicine. Michael Wilkes and Margaret Johns from the University of California Davis argue that the ethics related to informed consent and shared decision-making provide an imperative for doctors to inform patients about the risks of a medical treatment when their use has not been approved by regulators.
Off-label prescriptions are those that do not comply with the use approved by the Food and Drug Administration (FDA) for the drug. While off-label prescribing is legal and accounts for roughly half of all prescriptions currently written in the US, it is often not supported by sound scientific evidence. Worse, say the authors, off-label prescribing can put patients at risk and drive up healthcare costs.
The public often assumes that all common uses of prescription drugs have been approved by the FDA, say the authors. But current law does not prevent doctors from prescribing a drug to any patient for any use whether it was approved for this use or not.
And while off-label prescribing is common and sometimes necessary (as in the area of paediatrics where many drugs have not been tested on children), Wilkes and Johns argue that off-label prescribing can also pose potentially serious risks. By definition no governmental body has conducted a review of the effectiveness or safety of the drug for the off-label use, they say. As a result, an off-label prescription may be ineffective or detrimental, and could be more costly than existing drugs.
Wilkes and Johns argue that the strict requirement that doctors obtain informed consent from patients before enrolling in a research study means they should obtain the same consent when a drug is being prescribed off-label as each such prescription is just like a mini research study. The contemporary expectation for shared decision-making between doctors and patients also supports full disclosure about off-label prescribing, leaving the option open for patients to opt for a drug which has received FDA approval for the condition in question.
“From an ethical perspective,” say Wilkes and Johns, “[what is required is] open, honest discussions where doctors tell their patients that the use of the drug will be off-label and thus not approved for this indication, explain the risks, potential benefits, and alternatives, and then ask patients for their permission to proceed.”
A recent PLoS Medicine paper (http://medicine.plosjournals.org/perlserv/?request=get-document&doi=10.1371/journal.pmed.0050210) described techniques by which drug companies covertly promote off-label use. Adriane Fugh-Berman (Georgetown University Medical Center, Washington DC) and Douglas Melnick (a preventive medicine physician working in North Hollywood, California) discussed the use of “decoy indications” and drug representatives to engage in illegal pharmaceutical marketing. Pharmaceutical marketing, they say, has “distorted the discourse on off-label uses and encouraged the unmonitored, potentially dangerous use of drugs by patients for whom risks and benefits are unknown.”
“Companies that engage in off-label promotion should be heavily fined and their future marketing practices subject to increased scrutiny by regulatory agencies,” say Fugh-Berman and Melnick.
Public release date: 10-Nov-2008
Can vitamins and minerals prevent hearing loss?
ANN ARBOR, Mich. — About 10 million people in the United States alone—from troops returning from war to students with music blasting through headphones—are suffering from impairing noise-induced hearing loss.
The rising trend is something that researchers and physicians at the University of Michigan Kresge Hearing Research Institute are hoping to reverse, with a cocktail of vitamins and the mineral magnesium that has shown promise as a possible way to prevent hearing loss caused by loud noises. The nutrients were successful in laboratory tests, and now researchers are testing whether humans will benefit as well.
“The prevention of noise induced hearing loss is key,” says Glenn E. Green, M.D., assistant professor of otolaryngology at the U-M Health System and director of the U-M Children’s Hearing Laboratory.
“When we can’t prevent noise-induced hearing loss through screening programs and use of hearing protection, then we really need to come up with some way of protecting people who are still going to have noise exposure. My hope is that this medication will give people a richer, fuller life.”
The combination of vitamins A, C and E, plus magnesium, is given in pill form to patients who are participating in the research. Developed at the U-M Kresge Hearing Research Institute, the medication, called AuraQuell, is designed to be taken before a person is exposed to loud noises. In earlier testing at U-M on guinea pigs, the combination of the four micronutrients blocked about 80 percent of the noise-induced hearing impairment.
Now, AuraQuell is being tested in a set of fourmultinational human clinical trials: military trials in Sweden and Spain, an industrial trial in Spain, and a trial involving students at the University of Florida who listen to music at high volumes on their iPods and other PDAs, funded by the National Institutes of Health (NIH). This is the first NIH-funded clinical trial involving the prevention of noise-induced hearing loss.
“If we can even see 50 percent of the effectiveness in humans that we saw in our animal trials, we will have an effective treatment that will very significantly reduce noise-induced hearing impairment in humans. That would be a remarkable dream,” says co-lead researcher Josef M. Miller, Ph.D., the Lynn and Ruth Townsend Professor of Communication Disorders and director of the Center for Hearing Disorders at the U-M Department of Otolaryngology’s Kresge Hearing Research Institute. Miller is leading the research along with colleagues at Karolinska Institute, where Miller also has an appointment; the University of Florida; and the University Castille de La Mancha.
Until a decade ago, it was thought that noise damaged hearing by intense mechanical vibrations that destroyed the delicate structures of the inner ear. There was no intervention to protect the inner ear other than reducing then intensity of sound reaching it, such as ear plugs, which are not always effective. It was then discovered that noise caused intense metabolic activity in the inner ear and the production of molecules that damage the inner ear cells; and that allowed the discovery of an intervention to prevent these effects.
The laboratory research that led to a new understanding of the mechanisms underlying noise induce hearing loss was funded by the NIH; the preclinical translational research that led to the formulation of AuraQuell as an effective preventative was funded by General Motors and the United Auto Workers.
Miller notes that the military tests in the new study could be of particular importance because of the high number of soldiers who develop hearing loss in the line of duty, due to improvised explosive devices (IEDs) and other noises.
Last year, he says, the Department of Defense spent approximately $1.5 billion in compensation for hearing impairment, and Veterans Affairs hospitals spent close to $1 billion for clinical care and treatment of hearing impairment. The most recent figures in a report by the Institute of Medicine indicated that one-third of returning soldiers fighting in Afghanistan and Iraq cannot be redeployed specifically because of hearing impairment.
“Not only is it an enormous factor in quality of life for the individual affected, in cost to society for health care and compensation,” Miller says, “but it fundamentally compromises the effectiveness of our military at this time.” Miller has launched a U-M startup company called OtoMedicine, which holds the license to developed the vitamin-and-magnesium pill for human application.
Hearing loss commonly occurs, Green says, when loud noises trigger the formation of molecules inside the ear and these molecules cause damage to the hair cells of the inner ear. The cells then shut down and scar, and they cannot grow back.
The U-M researchers discovered that this new combination of vitamins, when mixed with magnesium, can prevent noise-induced damage to the ears by blocking some of these complex cellular reactions. Read more about the science of hearing loss, free radicals in hearing loss, and the science behind the effectiveness of these nutrients, in this press release.
These reports are done with the appreciation of all the Doctors, Scientist, and other Medical Researchers who sacrificed their time and effort. In order to give people the ability to empower themselves. Without the base aspirations for fame, or fortune. Just honorable people, doing honorable things.