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NIH Halts Use of COX-2 (Celebrex) Inhibitor in Large Cancer Prevention Trial

The National Institutes of Health (NIH) announced today that it has suspended the use of COX-2 inhibitor celecoxib (Celebrex™ Pfizer, Inc.) for all participants in a large colorectal cancer prevention clinical trial conducted by the National Cancer Institute (NCI). The study, called the Adenoma Prevention with Celecoxib (APC) trial, was stopped because analysis by an independent Data Safety and Monitoring Board (DSMB) showed a 2.5-fold increased risk of major fatal and non-fatal cardiovascular events for participants taking the drug compared to those on a placebo. Additional cardiovascular expertise was added to the safety monitoring committees at the request of the Steering Committees for this trial after a September 2004 report that the COX-2 inhibitor rofecoxib (Vioxx™) caused a two-fold increased risk of cardiovascular toxicities in a trial to prevent adenomas. The APC is a study of more than 2,000 people who have had a precancerous growth (adenomatous polyp) removed. They were randomized to take either 200 mg of celecoxib twice a day, 400 mg of celecoxib twice a day, or a placebo for three years. The trial began in early 2000 and is scheduled to have been completed by Spring 2005. Investigators at the 100 sites in the APC trial located primarily in the United States, with a few additional sites in the United Kingdom, Australia, and Canada, have been instructed to immediately suspend study drug use for all participants on the trial, although the participants will remain under observation for the planned remainder of the study. "Data from the report on rofecoxib (Vioxx) informed us of the need to focus on specific cardiovascular issues, and our Institutes brought in the experts to do so, said Elias A. Zerhouni, M.D., NIH Director. "Our overwhelming commitment is to advance the health and to protect the safety of participants in clinical trials. We are examining the use of these agents in all NIH-sponsored clinical studies. In addition, we are working closely with our colleagues at FDA to ensure that the public has the information they need to make informed decisions about the use of this class of drug." "The rigor of our clinical trials system has allowed us to find this problem," said NCI Director Andrew C. von Eschenbach, M.D. "We have a strong system that provides us with the opportunity to both find ways to effectively treat and prevent disease and to do so in a way that protects the lives and safety of the participants." NIH sponsors over 40 studies using celecoxib for the prevention and treatment of cancer, dementia and other diseases. In light of these new findings, NIH Director Zerhouni requested: • a full review of all NIH-supported studies involving this class of drug. • NIH Institutes to inform the principal investigators for all of these studies and will ask them to communicate directly with their study participants and explain the risks and benefits • NIH to ask each investigator to inform us of the their plan to analyze their data in light of the information • the Institutional Review Boards (IRBs) for all related trials to assess the new information and to conduct a safety review as well For Questions and Answers regarding this study, please go to:

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Discovery Shows New Vitamin C Health Benefits

CORVALLIS – Researchers in the Linus Pauling Institute at Oregon State University have made a major discovery about the way vitamin C functions in the human body – a breakthrough that may help explain its possible value in preventing cancer and heart disease. The study, which explores the role of vitamin C in dealing with the toxins that result from fat metabolism, was just published in a professional journal, Proceedings of the National Academy of Sciences. It contradicts the conclusions of some research that was widely publicized three years ago, which had suggested that this essential nutrient might actually have toxic effects. The new OSU study confirmed some of the results of that earlier laboratory study, which had found vitamin C to be involved in the formation of compounds potentially damaging to DNA. But that research, scientists say, only provided part of the story about what actually happens in the human body. The newest findings explain for the first time how vitamin C can react with and neutralize the toxic byproducts of human fat metabolism. “This is a previously unrecognized function for vitamin C in the human body,” said Fred Stevens, an assistant professor in the Linus Pauling Institute. “We knew that vitamin C is an antioxidant that can help neutralize free radicals. But the new discovery indicates it has a complex protective role against toxic compounds formed from oxidized lipids, preventing the genetic damage or inflammation they can cause.” Some earlier studies done in another laboratory had exposed oxidized lipids – which essentially are rancid fats – to vitamin C, and found some reaction products that can cause DNA damage. These test tube studies suggested that vitamin C could actually form “genotoxins” that damage genes and DNA, the types of biological mutations that can precede cancer. But that study, while valid, does not tell the whole story, the OSU researchers say. “It’s true that vitamin C does react with oxidized lipids to form potential genotoxins,” said Balz Frei, professor and director of the Linus Pauling Institute, and co-author on this study. “But the process does not stop there. We found in human studies that the remaining vitamin C in the body continues to react with these toxins to form conjugates - different types of molecules with a covalent bond - that appear to be harmless.” In human tests, the OSU scientists found in blood plasma extraordinarily high levels of these conjugates, which show this protective effect of vitamin C against toxic lipids. “Prior to this, we never knew what indicators to look for that would demonstrate the protective role of vitamin C against oxidized lipids,” Stevens said. “Now that we see them, it becomes very clear how vitamin C can provide a protective role against these oxidized lipids and the toxins derived from them. And this isn’t just test tube chemistry, this is the way our bodies work. “This discovery of a new class of lipid metabolites could be very important in our understanding of this vitamin and the metabolic role it plays,” Stevens said. “This appears to be a major pathway by which the body can get rid of the toxic byproducts of fat metabolism, and it clearly could relate to cancer prevention.” Oxidation of lipids has been the focus of considerable research in recent years, the scientists say, not just for the role it may play in cancer but also in other chronic diseases such as heart disease, Alzheimer’s disease, and autoimmune disorders. The toxic products produced by fat oxidation may not only be relevant to genetic damage and cancer, researchers believe, but are also very reactive compounds that damage proteins. For instance, there’s a protein in LDL, the “bad” cholesterol in your blood, which if damaged by toxic lipids can increase the chance of atherosclerotic lesions. In continuing research, the OSU team plans to study the role of this newly understood reaction between vitamin C and toxic lipids in atherosclerosis. In clinical studies they plan to examine the blood chemistry of patients who have been diagnosed with coronary artery disease, compared to a healthy control group. “In the early stages of atherosclerosis, it appears that some of these toxic lipids make white blood cells stick to the arterial wall, and start an inflammatory process that ultimately can lead to heart disease or stroke,” Frei said. “When we better understand that process and the role that micronutrients such as vitamin C play in it, there may be strategies we can suggest to prevent this from happening.” The new findings, the OSU scientists say, also point to new biomarkers that can be useful in identifying oxidative stress in the human body. They may provide an indicator of people who may be at special risk of chronic disease. By David Stauth, 541-737-0787 SOURCES: Fred Stevens, 541-737-9534 Balz Frei, 541-737-5078

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Vitamin E Supplements May Decrease the Risk of Lou Gehrig’s Disease (ALS)

Long-term use of vitamin E supplements may decrease the risk of amyotrophic lateral sclerosis (ALS), according to a study published online in the Annals of Neurology on November 4, 2004. ALS, also known as Lou Gehrig’s disease, is a neurodegenerative disease characterized by the death of motor neurons, which are nerves that control the movement of all voluntary muscles. This loss of motor neurons results in progressive muscle weakness, muscle atrophy, spastic paralysis and death within 1-5 years. More than 5,000 people in the U.S. are diagnosed with ALS each year, and currently there is no cure. Although the cause of motor neuron death in ALS is unknown, oxidative stress may play a role. Researchers from the Harvard School of Public Health and the American Cancer Society followed more than 900,000 men and women for sixteen years to determine whether antioxidant supplement use was associated with a decreased risk of developing ALS. They found that people who reported taking vitamin E supplements regularly for more than 10 years when the study began were 60% less likely to die from ALS than those who did not take vitamin E supplements. Participants in the study did not provide any information about the dose of the vitamin E supplements they took, but a typical vitamin E supplement contains 400 IU of synthetic d,l-alpha-tocopherol, which is equivalent to 200 IU of natural d-alpha-tocopherol. In contrast, vitamin C and multivitamin supplement use were not associated with ALS risk. Although these results need confirmation by future studies, they suggest that vitamin E may play a role in the prevention of ALS. Maret Traber, the Linus Pauling Institute’s vitamin E expert, notes that long-term use of vitamin E supplements can double vitamin E concentrations in the brain. Her work indicates that absorption of this fat-soluble antioxidant vitamin can be maximized by taking vitamin E supplements with dinner. More information on vitamin E can be found in the Linus Pauling Institute's Micronutrient Information Center. According to Joe Beckman, a scientist who studies ALS at the Linus Pauling Institute, taking vitamin E does not extend life once ALS is diagnosed, but the progression of the disease may be slowed, according to a recent clinical study. In such studies, patients are not instructed on how to best take vitamin E to maximize absorption. Dr. Beckman hopes that these new results will encourage further trials with more rapid and efficacious supplementation. He also notes that this study provides more convincing evidence for a pathogenic role of oxidative stress in ALS. Vitamin E may also protect against Alzheimer’s disease. A cross sectional study conducted in Cache County, Utah, and published in Annals of Neurology earlier this year showed that high intake of vitamin E and C together was associated with a substantially reduced incidence of Alzheimer’s disease. These two studies on ALS and Alzheimer’s provide accumulating evidence that antioxidant vitamins are important in the prevention of neurodegenerative diseases.

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Asthma exacerbations in children immediately following stressful life events: a Cox’s hierarchical regression

ABSTRACT Background: A recent prospective study of children with asthma employing a within subject, over time analysis using dynamic logistic regression showed that severely negative life events significantly increased the risk of an acute exacerbation during the subsequent 6 week period. The timing of the maximum risk depended on the degree of chronic psychosocial stress also present. A hierarchical Cox regression analysis was undertaken to examine whether there were any immediate effects of negative life events in children without a background of high chronic stress. Methods: Sixty children with verified chronic asthma were followed prospectively for 18 months with continuous monitoring of asthma by daily symptom diaries and peak flow measurements, accompanied by repeated interview assessments of life events. The key outcome measures were asthma exacerbations and severely negative life events. Results: An immediate effect evident within the first 2 days following a severely negative life event increased the risk of a new asthma attack by a factor of 4.69 (p = 0.00). In the period 3–10 days after a severe event there was no increased risk of an asthma attack (p = 0.5). In addition to the immediate effect, an increased risk of 1.81 was found 5–7 weeks after a severe event (p = 0.002). This is consistent with earlier findings. There was a statistically significant variation due to unobserved factors in the incidence of asthma attacks between the children. Conclusion: The use of statistical methods capable of investigating short time lags showed that stressful life events significantly increase the risk of a new asthma attack immediately after the event; a more delayed increase in risk was also evident 5–7 weeks later. Thorax 2004;59:1046-1051 © 2004 BMJ Publishing Group Ltd & British Thoracic Society

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Chinese herb Berberine lowers cholesterol in new way

Berberine, a Chinese herb lowers LDL ("bad") cholesterol in anew way from drugs like Lipitor or Zocor, a new study shows. The herb has a history of medicinal use in both Ayurvedic and Chinese medicine. Click on the link below for more:

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Footwear Style and Risk of Falls in Older Adults

ABSTRACT Objectives: To determine how the risk of a fall in an older adult varies in relation to style of footwear worn. Design: Nested case-control study. Setting: Group Health Cooperative, a large health maintenance organization in Washington state. Participants: A total of 1,371 adults aged 65 and older were monitored for falls over a 2-year period; 327 qualifying fall cases were compared with 327 controls matched on age and sex. Measurements: Standardized in-person examinations before fall occurrence, interviews about fall risk factors after the fall occurred, and direct examination of footwear were conducted. Questions for controls referred to the last time they engaged in an activity broadly similar to what the case was doing at the time of the fall. Results: Athletic and canvas shoes (sneakers) were the styles of footwear associated with lowest risk of a fall. Going barefoot or in stocking feet was associated with sharply increased risk, even after controlling for measures of health status (adjusted odds ratio=11.2, 95% confidence interval (CI)=2.4-51.8). Relative to athletic/canvas shoes, other footwear was associated with a 1.3-fold increase in the risk of a fall (95% CI=0.9-1.9), varying somewhat by style. Conclusion: Contrary to findings from gait-laboratory studies, athletic shoes were associated with relatively low risk of a fall in older adults during everyday activities. Fall risk was markedly increased when participants were not wearing shoes. Journal of the American Geriatrics Society Volume 52 Issue 9 Page 1495 - September 2004

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Dairy intakes affect bone density in the elderly

ABSTRACT Background: Race and sex differences in the effect of diet on bone mineral density (BMD) at the hip in the elderly are unknown. Objectives: This study related cross-sectional nutrient and dairy product consumption to hip BMD in white and black men and women aged >60 y and evaluated the influence of nutrient and dairy product consumption on changes in BMD in a white cohort participating in a calcium, vitamin D, or placebo trial. Design: The Health Habits and History Questionnaire was used in 289 white women and 116 white men who participated in the trial and in 265 black women and 75 black men to predict total hip and femoral neck BMD or changes in BMD. Results: Blacks had higher calcium intakes than did whites (700 and 654 mg/d, respectively; P = 0.0094), and men had higher calcium intakes than did women (735 and 655 mg/d, respectively; P = 0.0007). For men, the correlation between total hip BMD and dairy calcium intake after adjustment for age, race, and weight was 0.23 (P < 0.005); this relation was not significant in women (r = 0.02, P = 0.12). Similar results were found for femoral neck BMD. In the longitudinal study, calcium supplementation reduced bone loss from the total hip and femoral neck in those who consumed Conclusions: Cross-sectional results indicated that higher dairy product consumption is associated with greater hip BMD in men, but not in women. Calcium supplementation protected both men and women from bone loss in the longitudinal study of whites. American Journal of Clinical Nutrition, Vol. 80, No. 4, 1066-1074, October 2004

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Risk of Community-Acquired Pneumonia and Use of Gastric Acid–Suppressive Drugs

ABSTRACT Context Reduction of gastric acid secretion by acid-suppressive therapy allows pathogen colonization from the upper gastrointestinal tract. The bacteria and viruses in the contaminated stomach have been identified as species from the oral cavity. Objective To examine the association between the use of acid-suppressive drugs and occurrence of community-acquired pneumonia. Design, Setting, and Participants Incident acid-suppressive drug users with at least 1 year of valid database history were identified from the Integrated Primary Care Information database between January 1, 1995, and December 31, 2002. Incidence rates for pneumonia were calculated for unexposed and exposed individuals. To reduce confounding by indication, a case-control analysis was conducted nested in a cohort of incident users of acid-suppressive drugs. Cases were all individuals with incident pneumonia during or after stopping use of acid-suppressive drugs. Up to 10 controls were matched to each case for practice, year of birth, sex, and index date. Conditional logistic regression was used to compare the risk of community-acquired pneumonia between use of proton pump inhibitors (PPIs) and H2-receptor antagonists. Main Outcome Measure Community-acquired pneumonia defined as certain (proven by radiography or sputum culture) or probable (clinical symptoms consistent with pneumonia). Results The study population comprised 364 683 individuals who developed 5551 first occurrences of pneumonia during follow-up. The incidence rates of pneumonia in non–acid-suppressive drug users and acid-suppressive drug users were 0.6 and 2.45 per 100 person-years, respectively. The adjusted relative risk for pneumonia among persons currently using PPIs compared with those who stopped using PPIs was 1.89 (95% confidence interval, 1.36-2.62). Current users of H2-receptor antagonists had a 1.63-fold increased risk of pneumonia (95% confidence interval, 1.07-2.48) compared with those who stopped use. For current PPI users, a significant positive dose-response relationship was observed. For H2-receptor antagonist users, the variation in dose was restricted. Conclusion Current use of gastric acid–suppressive therapy was associated with an increased risk of community-acquired pneumonia. Author Affiliations: Department of Gastroenterology, University Medical Center St. Radboud, Nijmegen, the Netherlands (Drs Laheij and Jansen); and Department of Medical Informatics (Drs Laheij, Sturkenboom, Dieleman, and Stricker and Mr Hassing), Pharmacoepidemiology Unit, Department of Epidemiology and Biostatistics (Drs Sturkenboom and Stricker), and Internal Medicine (Dr Dieleman), Erasmus MC University, Medical Center Rotterdam, Rotterdam, the Netherlands. JAMA. 2004;292:2012-2013.

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A Randomized Trial of Medical Care With and Without Physical Therapy and Chiropractic Care With and Without Physical Modalities for Patients With Low Back Pain: 6-Month Follow-Up Outcomes From the UCLA Low Back Pain Study

 

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Folic acid supplementation enhances repair of the adult central nervous system

ABSTRACT Folic acid supplementation has proved to be extremely effective in reducing the occurrence of neural tube defects (NTDs) and other congenital abnormalities in humans, suggesting that folic acid can modulate key mechanisms for growth and differentiation in the central nervous system (CNS). To prevent NTDs, however, supplemental folate must be provided early in gestation. This suggests that the ability of folic acid to activate growth and differentiation mechanisms may be confined to the early embryonic period. Here, we show that folic acid can enhance growth and repair mechanisms even in the adult CNS. Using lesion models of CNS injury, we found that intraperitoneal treatment of adult rats with folic acid significantly improves the regrowth of sensory spinal axons into a grafted segment of peripheral nerve in vivo. Regrowth of retinal ganglion cell (RGC) axons into a similar graft also was enhanced, although to a smaller extent than spinal axons. Furthermore, folic acid supplementation enhances neurological recovery from a spinal cord contusion injury, showing its potential clinical impact. The results show that the effects of folic acid supplementation on CNS growth processes are not restricted to the embryonic period, but can also be effective for enhancing growth, repair, and recovery in the injured adult CNS. Ann Neurol 2004;56:221-227

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The Relation of Breastfeeding and Body Mass Index to Asthma and Atopy in Children: A Prospective Cohort Study to Age 6 Years

ABSTRACT Objectives We investigated the relationship between breastfeeding, asthma and atopy, and child body mass index (BMI). Methods From a prospective birth cohort (n = 2860) in Perth, Western Australia, 2195 children were followed up to age 6 years. Asthma was defined as doctor-diagnosed asthma and wheeze in the last year, and atopy was determined by skin prick test of 1596 children. Breastfeeding, BMI, asthma, and atopy were regressed allowing for confounders and the propensity score for overweight. Results Using fractional polynomials, we found no association between breastfeeding and overweight. Less exclusive breastfeeding was associated with increased asthma and atopy, and BMI increased with asthma. Conclusions Less exclusive breastfeeding leads to increases in child asthma and atopy and a higher BMI is a risk factor for asthma. Wendy H. Oddy and Jill L. Sherriff are with the Department of Nutrition, Dietetics and Food Science, Curtin University of Technology, Perth, Australia. Wendy H. Oddy, Nicholas H. de Klerk, Garth E. Kendall, Peter D. Sly, and Fiona J. Stanley are with the Centre for Child Health Research, University of Western Australia, Telethon Institute for Child Health Research, West Perth, Australia. Lawrence J. Beilin, Kevin B. Blake, and Louis I. Landau are with the Faculty of Medicine and Dentistry, University of Western Australia, West Perth. Correspondence: Requests for reprints should be sent to Wendy H. Oddy, PhD, MPH, Telethon Institute for Child Health Research, PO Box 855, West Perth, Western Australia 6872, Australia (e-mail: [email protected]).

A Potential Natural Treatment for Attention-Deficit/Hyperactivity Disorder: Evidence From a National Study

ABSTRACT Objective We examined the impact of relatively "green" or natural settings on attention-deficit/hyperactivity disorder (ADHD) symptoms across diverse subpopulations of children. Methods Parents nationwide rated the aftereffects of 49 common after-school and weekend activities on children’s symptoms. Aftereffects were compared for activities conducted in green outdoor settings versus those conducted in both built outdoor and indoor settings. Results In this national, nonprobability sample, green outdoor activities reduced symptoms significantly more than did activities conducted in other settings, even when activities were matched across settings. Findings were consistent across age, gender, and income groups; community types; geographic regions; and diagnoses. Conclusions Green outdoor settings appear to reduce ADHD symptoms in children across a wide range of individual, residential, and case character Frances E. Kuo is with the Department of Natural Resources and Environmental Sciences and the Department of Psychology, University of Illinois at Urbana-Champaign. Andrea Faber Taylor is with the Department of Natural Resources and Environmental Sciences, University of Illinois at Urbana-Champaign. Correspondence: Requests for reprints should be sent to Frances E. Kuo, PhD, Human Environment Research Laboratory, University of Illinois at Urbana-Champaign, 1103 S Dorner Dr, Urbana, IL 61801 (e-mail: [email protected]).

Oral Erythromycin and the Risk of Sudden Death from Cardiac Causes

Wayne A. Ray, Ph.D., Katherine T. Murray, M.D., Sarah Meredith, M.B., B.S., Sukumar Suguna Narasimhulu, M.B., B.S., M.P.H., Kathi Hall, M.S., and C. Michael Stein, M.B., Ch.B. ABSTRACT Background Oral erythromycin prolongs cardiac repolarization and is associated with case reports of torsades de pointes. Because erythromycin is extensively metabolized by cytochrome P-450 3A (CYP3A) isozymes, commonly used medications that inhibit the effects of CYP3A may increase plasma erythromycin concentrations, thereby increasing the risk of ventricular arrhythmias and sudden death. We studied the association between the use of erythromycin and the risk of sudden death from cardiac causes and whether this risk was increased with the concurrent use of strong inhibitors of CYP3A. Methods We studied a previously identified Tennessee Medicaid cohort that included 1,249,943 person-years of follow-up and 1476 cases of confirmed sudden death from cardiac causes. The CYP3A inhibitors used in the study were nitroimidazole antifungal agents, diltiazem, verapamil, and troleandomycin; each doubles, at least, the area under the time–concentration curve for a CYP3A substrate. Amoxicillin, an antimicrobial agent with similar indications but which does not prolong cardiac repolarization, and former use of erythromycin also were studied, to assess possible confounding by indication Results The multivariate adjusted rate of sudden death from cardiac causes among patients currently using erythromycin was twice as high (incidence-rate ratio, 2.01; 95 percent confidence interval, 1.08 to 3.75; P=0.03) as that among those who had not used any of the study antibiotic medications. There was no significant increase in the risk of sudden death among former users of erythromycin (incidence-rate ratio, 0.89; 95 percent confidence interval, 0.72 to 1.09; P=0.26) or among those who were currently using amoxicillin (incidence-rate ratio, 1.18; 95 percent confidence interval, 0.59 to 2.36; P=0.65). The adjusted rate of sudden death from cardiac causes was five times as high (incidence-rate ratio, 5.35; 95 percent confidence interval, 1.72 to 16.64; P=0.004) among those who concurrently used CYP3A inhibitors and erythromycin as that among those who had used neither CYP3A inhibitors nor any of the study antibiotic medications. In contrast, there was no increase in the risk of sudden death among those who concurrently used amoxicillin and CYP3A inhibitors or those currently using any of the study antibiotic medications who had formerly used CYP3A inhibitors. Conclusions The concurrent use of erythromycin and strong inhibitors of CYP3A should be avoided. Source Information: From the Division of Pharmacoepidemiology, Department of Preventive Medicine (W.A.R., S.M., K.H.), and the Departments of Medicine and Pharmacology, Divisions of Cardiology (K.T.M.), Clinical Pharmacology (K.T.M., S.S.N., C.M.S.), and Rheumatology (C.M.S.), Vanderbilt University School of Medicine; and the Geriatric Research, Education, and Clinical Center, Nashville Veterans Affairs Medical Center (W.A.R.) — both in Nashville. Address reprint requests to Dr. Ray at [email protected]

Lighten the Load: Backpack Strategies for Parents From the American Chiropractic Association

ARLINGTON, Va. -- As students savor the last precious days of summer vacation, parents are out making the final run for school supplies. So, parents, take note -- when back to school shopping this year there is one essential item that requires very special attention: your child's backpack. Backpack weight is becoming an increasing problem, and studies show that heavy backpacks can lead to both back pain and poor posture, noted the American Chiropractic Association (ACA). In fact, in 2001 backpacks were the cause of 7,000 emergency room visits and countless complaints of muscle spasms, neck and shoulder pain. "In my own practice, I have noticed a marked increase in the number of young children who are complaining about back, neck and shoulder pain," said Dr. Scott Bautch, a chiropractor from Wausau, Wis., and noted ergonomics expert. "The first question I ask these patients is, 'Do you carry a backpack to school?' Almost always, the answer is 'yes.'" This painful trend among youngsters isn't surprising when you consider the disproportionate amounts of weight they carry in their backpacks -- often slung over just one shoulder. According to Dr. Bautch, "Many of these kids are carrying a quarter of their body weight over their shoulders for a large portion of the day. That's equivalent to a 180-pound man carrying around a 45- pound load." Thankfully, backpacks have undergone a radical evolution in recent years and now many are designed to be ergonomic while remaining fashionable. Not to mention, the backpack of today has adapted to keep up with our changing lives. Children not only pack heavy schoolbooks, band instruments and running shoes into their backpacks, many of them also tuck away popular electronics -- such as laptops, cellular phones, MP3 players, CD players and personal digital assistants (PDA) -- into specially designed compartments inside their backpacks. Bulging backpacks offer a significant risk to children, but parents can help limit the strain on young necks, backs and shoulders. The ACA offers the following tips to help prevent the pain caused by backpack misuse. --- Make sure your child's backpack weighs no more than 10 percent of his or her body weight. A heavier backpack will cause your child to stoop forward in an attempt to support the additional weight. --- The backpack should never hang more than 4 inches below the waistline. A backpack that hangs too low increases the weight on the shoulders, causing your child to lean forward when walking. --- A backpack with individualized compartments helps position the contents most effectively. Make sure that pointy or bulky objects are packed away from the area that will rest on your child's back, and try to place the heaviest items closet to the body. --- Bigger is not necessarily better. The more room there is in a backpack, the more your child will carry and the heavier the backpack will be. --- Urge your child to wear both shoulder straps. Lugging the backpack around by one strap can cause a disproportionate shift of weight to one side, leading to neck and muscle spasms, as well as low-back pain. --- Wide, padded straps are very important. Non-padded straps are uncomfortable, and can dig into your child's shoulders. --- The shoulder straps should be adjustable so the backpack can be fitted to your child's body. Straps that are too loose can cause the backpack to dangle uncomfortably and cause spinal misalignment and pain. --- If the backpack is still too heavy, talk to your child's teacher. Ask if your child could leave the heaviest books at school, and bring home only lighter handout materials or workbooks. Ask the teacher for a set oftext books to keep at home. Chiropractic has been practiced in the United States for more than 100 years, and each year, millions of Americans trust their health to one of the nation's 60,000 doctors of chiropractic. To read research studies about the effectiveness of chiropractic care, visit ACA's website at:

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Survey: Chronic Back Pain Sufferers Prefer Drug Free Pain Management

ARLINGTON, Va. -- More than 80 percent of chronic back pain sufferers surveyed would prefer to avoid the use of medication to treat their ailments, yet ironically, a majority are taking either narcotics, muscle relaxants or over-the-counter medications to deal with their pain, according to a study conducted for the American Chiropractic Association (ACA) by a national market research firm. In addition, more than 64 percent of survey respondents reported that they would consider seeking the professional health care services of a doctor of chiropractic (DC), health care providers who offer a drugless approach to pain relief. The omnibus survey, conducted in the spring of 2004 for ACA by I/H/R Research Group, a full service market research firm that includes experienced health care managers, interviewed 800 adults nationwide. The survey was conducted to gain insight into the treatment methods used by those with chronic back pain and to better understand the amount of relief experienced from various treatment options. Survey results did indicate that while millions of Americans trust their health care to one of the nation's 60,000 doctors of chiropractic, only 13.8 percent of respondents were currently seeking health care from a DC. However, when survey participants were asked if they felt their pain was under control as a result of their current treatment, 30 percent indicated their pain was not, and an additional 39.3 percent said their pain was only moderately under control. Furthermore, more than 27 percent of respondents reported that they were taking a form of analgesic or narcotic for their chronic back pain; 25 percent indicated they relied on over-the-counter medications; and 19.6 percent used muscle relaxants. "The survey results reiterate that chiropractic care offers the treatment options desired by patients -- compassionate health care that works safely without drugs or surgery," said American Chiropractic Association (ACA) President Donald J. Krippendorf, DC. "However, the information provided also shows that more needs to be done to educate patients, physicians and the health community about the benefits of chiropractic care and its ability to manage pain effectively." Other survey highlights include: * 18 percent of all chronic back pain was reported as the result of an accident or injury * Almost 40 percent reported their pain as very severe or severe at the time of the survey * 71 percent of respondents said they had suffered from chronic back pain for five or more years Eighty percent of Americans suffer from back pain at some point in their lives, and back pain is the second most common reason for visits to the doctor's office, outnumbered only by upper-respiratory infections. "Given the physical and mental demands of the fast-paced, active lifestyles that many Americans lead, it is essential that we keep ourselves in good physical condition without overusing medications that can negatively affect our health. Some medications can induce drowsiness and impair judgment," Dr. Krippendorf said. "You can achieve an improved level of medication-free wellness with the help of your doctor of chiropractic." Recent evidence supporting the efficacy of chiropractic care comes from a study published in the July 15, 2003, edition of the journal Spine, which found that manual manipulation -- the primary form of treatment performed by doctors of chiropractic -- provides better relief of chronic spinal pain than does acupuncture or even a variety of medications. Additional research The ACA offers the following tips for choosing a doctor of chiropractic. * Be sure the chiropractor has attended an accredited chiropractic college. A list can be found on ACA's Web site: http://www.acatoday.com/media/whatis/careers/cce_accredited.shtml * Be sure the chiropractor is licensed to practice in your state. After graduating from an accredited chiropractic college, chiropractors must pass rigorous state and national board exams before they can practice. * The chiropractor should be willing to answer your questions and should talk freely with you about your concerns and your course of treatment. * Talk to your friends, family and co-workers. The best referrals often come from satisfied patients.

Vitamin E may help upper respiratory track infection

ABSTRACT Vitamin E and Respiratory Tract Infections in Elderly Nursing Home Residents A Randomized Controlled Trial Simin Nikbin Meydani, DVM; Lynette S. Leka, BS; Basil C. Fine, MD; Gerard E. Dallal, PhD; Gerald T. Keusch, MD; Maria Fiatarone Singh, MD; Davidson H. Hamer, MD Context -- Respiratory tract infections are prevalent in elderly individuals, resulting in increased morbidity, mortality, and use of health care services. Vitamin E supplementation has been shown to improve immune response in elderly persons. However, the clinical importance of these findings has not been determined. Objective -- To determine the effect of 1 year of vitamin E supplementation on respiratory tract infections in elderly nursing home residents. Design, Setting, and Participants -- A randomized, double-blind, placebo-controlled trial was conducted from April 1998 to August 2001 at 33 long-term care facilities in the Boston, Mass, area. A total of 617 persons aged at least 65 years and who met the study's eligibility criteria were enrolled; 451 (73%) completed the study. Intervention -- Vitamin E (200 IU) or placebo capsule administered daily; all participants received a capsule containing half the recommended daily allowance of essential vitamins and minerals. Main Outcome Measures -- Incidence of respiratory tract infections, number of persons and number of days with respiratory tract infections (upper and lower), and number of new antibiotic prescriptions for respiratory tract infections among all participants randomized and those who completed the study. Results -- Vitamin E had no significant effect on incidence or number of days with infection for all, upper, or lower respiratory tract infections. However, fewer participants receiving vitamin E acquired 1 or more respiratory tract infections (60% vs 68%; risk ratio [RR], 0.88; 95% confidence interval [CI], 0.76-1.00; P = .048 for all participants; and 65% vs 74%; RR, 0.88; 95% CI, 0.75-0.99; P = .04 for completing participants), or upper respiratory tract infections (44% vs 52%; RR, 0.84; 95% CI, 0.69-1.00; P = .05 for all participants; and 50% vs 62%; RR, 0.81; 95% CI, 0.66-0.96; P = .01 for completing participants). When common colds were analyzed in a post hoc subgroup analysis, the vitamin E group had a lower incidence of common cold (0.67 vs 0.81 per person-year; RR, 0.83; 95% CI, 0.68-1.01; P = .06 for all participants; and 0.66 vs 0.83 per person-year; RR, 0.80; 95% CI, 0.64-0.98; P = .04 for completing participants) and fewer participants in the vitamin E group acquired 1 or more colds (40% vs 48%; RR, 0.83; 95% CI, 0.67-1.00; P = .05 for all participants; and 46% vs 57%; RR, 0.80; 95% CI, 0.64-0.96; P = .02 for completing participants). Vitamin E had no significant effect on antibiotic use. Conclusions -- Supplementation with 200 IU per day of vitamin E did not have a statistically significant effect on lower respiratory tract infections in elderly nursing home residents. However, we observed a protective effect of vitamin E supplementation on upper respiratory tract infections, particularly the common cold, that merits further investigation. JAMA. 2004;292:828-836. Read the full text at:

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In-Hospital Deaths from Medical Errors at 195,000 per Year, HealthGrades' Study Finds

Little Progress Seen Since 1999 IOM Report on Medical Errors Lakewood, CO – An average of 195,000 people in the U.S. died due to potentially preventable, in-hospital medical errors in each of the years 2000, 2001 and 2002, according to a new study of 37 million patient records that was released today by HealthGrades, the healthcare quality company. The HealthGrades Patient Safety in American Hospitals study is the first to look at the mortality and economic impact of medical errors and injuries that occurred during Medicare hospital admissions nationwide from 2000 to 2002. The HealthGrades study applied the mortality and economic impact models developed by Dr. Chunliu Zhan and Dr. Marlene R. Miller in a research study published in the Journal of the American Medical Association (JAMA) in October of 2003. The Zhan and Miller study supported the Institute of Medicine’s (IOM) 1999 report conclusion, which found that medical errors caused up to 98,000 deaths annually and should be considered a national epidemic. The HealthGrades study finds nearly double the number of deaths from medical errors found by the 1999 IOM report “To Err is Human,” with an associated cost of more than $6 billion per year. Whereas the IOM study extrapolated national findings based on data from three states, and the Zhan and Miller study looked at 7.5 million patient records from 28 states over one year, HealthGrades looked at three years of Medicare data in all 50 states and D.C. This Medicare population represented approximately 45 percent of all hospital admissions (excluding obstetric patients) in the U.S. from 2000 to 2002. “The HealthGrades study shows that the IOM report may have underestimated the number of deaths due to medical errors, and, moreover, that there is little evidence that patient safety has improved in the last five years,” said Dr. Samantha Collier, HealthGrades’ vice president of medical affairs. “The equivalent of 390 jumbo jets full of people are dying each year due to likely preventable, in-hospital medical errors, making this one of the leading killers in the U.S.” HealthGrades examined 16 of the 20 patient-safety indicators defined by the Agency for Healthcare Research and Quality (AHRQ) – from bedsores to post-operative sepsis – omitting four obstetrics-related incidents not represented in the Medicare data used in the study. Of these sixteen, the mortality associated with two, failure to rescue and death in low risk hospital admissions, accounted for the majority of deaths that were associated with these patient safety incidents. These two categories of patients were not evaluated in the IOM or JAMA analyses, accounting for the variation in the number of annual deaths attributable to medical errors. However, the magnitude of the problem is evident in all three studies. “If we could focus our efforts on just four key areas – failure to rescue, bed sores, postoperative sepsis, and postoperative pulmonary embolism – and reduce these incidents by just 20 percent, we could save 39,000 people from dying every year,” said Dr. Collier. The HealthGrades study was released in conjunction with the company’s first annual Distinguished Hospital Award for Patient SafetyTM, which honors hospitals with the best records of patient safety. Eighty-eight hospitals in 23 states were given the award for having the nation’s lowest patient-safety incidence rates. A list of winners can be found at http://www.healthgrades.com. Study Highlights

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Dietary niacin may protect against Alzheimer’s disease

ABSTRACT Dietary niacin and the risk of incident Alzheimer’s disease and of cognitive decline M C Morris, D A Evans, J L Bienias, P A Scherr, C C Tangney, L E Hebert, D A Bennett, R S Wilson and N Aggarwal Background: Dementia can be caused by severe niacin insufficiency, but it is unknown whether variation in intake of niacin in the usual diet is linked to neurodegenerative decline. We examined whether dietary intake of niacin was associated with incident Alzheimer’s disease (AD) and cognitive decline in a large, prospective study. Methods: This study was conducted in 1993–2002 in a geographically defined Chicago community of 6158 residents aged 65 years and older. Nutrient intake was determined by food frequency questionnaire. Four cognitive tests were administered to all study participants at 3 year intervals in a 6 year follow up. A total of 3718 participants had dietary data and at least two cognitive assessments for analyses of cognitive change over a median 5.5 years. Clinical evaluations were performed on a stratified random sample of 815 participants initially unaffected by AD, and 131 participants were diagnosed with 4 year incident AD by standardised criteria. Results: Energy adjusted niacin intake had a protective effect on development of AD and cognitive decline. In a logistic regression model, relative risks (95% confidence intervals) for incident AD from lowest to highest quintiles of total niacin intake were: 1.0 (referent) 0.3 (0.1 to 0.6), 0.3 (0.1 to 0.7), 0.6 (0.3 to 1.3), and 0.3 (0.1 to 0.7) adjusted for age, sex, race, education, and ApoE e4 status. Niacin intake from foods was also inversely associated with AD (p for linear trend = 0.002 in the adjusted model). In an adjusted random effects model, higher food intake of niacin was associated with a slower annual rate of cognitive decline, by 0.019 standardised units (SU) per natural log increase in intake (mg) (p = 0.05). Stronger associations were observed in analyses that excluded participants with a history of cardiovascular disease (ß = 0.028 SU/year; p = 0.008), those with low baseline cognitive scores (ß = 0.023 SU/year; p = 0.02), or those with fewer than 12 years’ education (ß = 0.035 SU/year; p = 0.002) Conclusion: Dietary niacin may protect against AD and age related cognitive decline. SOURCE: Morris, M.C. Journal of Neurology, Neurosurgery, and Psychiatry, August 2004; vol 75: pp 1093-1099.

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For a child’s cough, sugar water no better then cough syrup

ABSTRACT Effect of Dextromethorphan, Diphenhydramine, and Placebo on Nocturnal Cough and Sleep Quality for Coughing Children and Their Parents Objectives. To determine whether the commonly used over-the-counter medications dextromethorphan and diphenhydramine are superior to placebo for the treatment of nocturnal cough and sleep difficulty associated with upper respiratory infections and to determine whether parents have improved sleep quality when their children receive the medications when compared with placebo. Methods. Parents of 100 children with upper respiratory infections were questioned to assess the frequency, severity, and bothersome nature of the nocturnal cough. Their answers were recorded on 2 consecutive days, initially on the day of presentation, when no medication had been given the previous evening, and then again on the subsequent day, when either medication or placebo was given before bedtime. Sleep quality for both the child and the parent were also assessed for both nights. Results. For the entire cohort, all outcomes were significantly improved on the second night of the study when either medication or placebo was given. However, neither diphenhydramine nor dextromethorphan produced a superior benefit when compared with placebo for any of the outcomes studied. Insomnia was reported more frequently in those who were given dextromethorphan, and drowsiness was reported more commonly in those who were given diphenhydramine. Conclusions. Diphenhydramine and dextromethorphan are not superior to placebo in providing nocturnal symptom relief for children with cough and sleep difficulty as a result of an upper respiratory infection. Furthermore, the medications given to children do not result in improved quality of sleep for their parents when compared with placebo. Each clinician should consider these findings, the potential for adverse effects, and the individual and cumulative costs of the drugs before recommending them to families. Ian M. Paul, MD, MSc, Katharine E. Yoder, Kathryn R. Crowell, MD, Michele L. Shaffer, PhD, Heidi S. McMillan, MD, Lisa C. Carlson, MD, Deborah A. Dilworth, RN and Cheston M. Berlin, Jr., MD Pediatrics 2004; 114: e85-e90.

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New Facts About Alternative Health Use In US Revealed In CDC Study

Centers for Disease Control and Prevention (CDC) released study on the use of complementary and alternative medicine (CAM) in U.S. The study involved more then 31,000 U.S. adults and appears to be one of the most comprehensive to date. To view the study click on the link below: