News Author: Laurie Barclay, MD

April 25, 2006 — Coffee does not increase the risk for coronary heart disease (CHD) in men or women, according to the results of a large, prospective cohort study reported in the April 24 Rapid Access issue of Circulation.

"We found that coffee consumption was not associated with an increased risk of CHD," lead author Esther Lopez-Garcia, DrPH, from the Universidad Autonoma de Madrid in Spain, said in a news release. "This lack of effect is good news, because coffee is one of the most widely consumed beverages in the world.... The length of follow up is important because it allowed us to examine the long-term effects of coffee consumption."

The study cohort consisted of 44 005 men and 84 488 women without history of cardiovascular disease or cancer. The investigators first evaluated coffee consumption in 1986 for men and in 1980 for women and then repeatedly every 2 to 4 years. During follow-up through 2000, there were 2173 incident cases of CHD in men, including 1449 nonfatal myocardial infarctions and 724 fatal cases of CHD; and 2254 cases in women, including 1561 nonfatal myocardial infarctions and 693 fatal cases of CHD.

After adjustment for age, smoking, and other CHD risk factors, the relative risks (RRs) of CHD for men across categories of cumulative coffee consumption were 1.0 for less than 1 cup/month; 1.04 (95% confidence interval [CI], 0.91 - 1.17) for 1 cup/month to 4 cups/week; 1.02 (95% CI, 0.91 - 1.155 for 7 cups/week; 1.07 (95% CI, 0.88 - 1.31) for 2 to 3 cups/day; 0.97 (95% CI, 0.86 - 1.11) for 4 to 5 cups/day, and 0.72 (95% CI, 0.49 - 1.07) for more than 6 cups/day (P for trend = .41). For women, the corresponding RRs were 1.0, 0.97 (95% CI, 0.83 - 1.14), 1.02 (95% CI, 0.90 - 1.17), 0.84 (95% CI, 0.74 - 0.97), 0.99 (95% CI, 0.83 - 1.17), and 0.87 (95% CI, 0.68 - 1.11; P for trend = .08).

Stratification by smoking status, alcohol consumption, history of type 2 diabetes mellitus, and body mass index did not alter the findings nor did examining the most recent coffee consumption. RRs for quintiles of caffeine intake ranged from 0.97 (95% CI, 0.84 - 1.10) in the second quintile to 0.97 (85% CI, 0.84 - 1.11) in the highest quintile (P for trend = 0.82) in men and from 1.02 (0.90 - 1.16) to 0.97 (0.85 - 1.11; P for trend = 0.37) in women.

"We believe this study clearly shows there is no association between filtered coffee consumption and CHD," Dr. Lopez-Garcia says. "However, because of the modest consumption of non-filtered coffee among participants, this study does not exclude a relationship between high non-filtered consumption and increased CHD risk."

Frequent or heavy coffee consumption was strongly associated with smoking cigarettes, drinking alcohol, and using aspirin and with lower frequency of tea drinking, exercise, and use of multivitamin and vitamin E supplements. Risk for CHD was not significantly different in women who frequently drank decaffeinated coffee and in those who did not. Total cholesterol, low-density and high-density lipoprotein cholesterol levels in men and women coffee drinkers did not differ in those who drank caffeinated or decaffeinated coffee. CHD risk associated with drinking coffee did not differ in people with or without type 2 diabetes.

"We can't exclude the association between coffee consumption and the risk of CHD in small groups of people," says coauthor Rob van Dam, PhD, from Harvard University School of Public Health in Boston, Mass. "For example, a recent study suggested coffee could be detrimental in people with certain genotypes, although that finding requires confirmation."

The National Institutes of Health funded this study. Two authors have disclosed that they are supported by Ministerio de Educacion y Cultura de España, Fondo Social Europeo, and/or the American Heart Association. The authors have disclosed no financial relationships.

By Karla Gale

NEW YORK (Reuters Health) May 02 - Despite greater health care expenditures in the US, middle-aged Americans have a higher prevalence of diseases than residents of the UK, according to a report in the Journal of the American Medical Association for May 3.

"There have been surprisingly few attempts to compare the likelihood of illness between the US and England, and almost no attempt to look at a comparison of the social gradient in health between the two countries," co-author Dr. Michael Marmot told Reuters Health. "Data show that mortality rates for adults are higher in the US than in England. Now we show that morbidity rates are higher too."

Dr. Marmot, from University College London, and his team analyzed US data from the Health and Retirement Survey for 2002 and from the National Health and Nutrition Examination Survey (NHANES) for 1999-2002. For the UK, they used data from the 2002 English Longitudinal Survey of Aging and the Health Survey for England for 2003.

They restricted their analyses to non-Hispanic whites. Self-reported illness data included that from subjects ages 55 to 64 years, and data for biological markers included subjects ages 40 to 70 years. The surveys included 2097 to 5526 participants each.

The authors note that smoking behaviors were similar in the two countries, but that England had more heavy drinkers and that rates of obesity were higher in the US.

For all seven conditions - diabetes, hypertension, all heart disease, MI, stroke, lung disease, and cancer -- the US residents reported significantly higher prevalence than did British residents, even after adjusting for age, smoking status, BMI, and heavy drinking, with p < 0.01 for each comparison. This suggests that health behaviors do not fully account for the significant differences between countries.

For example, US residents reported an adjusted diabetes prevalence of 12.5% versus 7.2% for the English. Rates for all heart disease were 15.1% and 10.1%, respectively, while those for cancer were 9.5% and 5.4%.

They also observed pronounced gradients of self-reported disease in both countries, with disparities largest among those with the least education and the lowest incomes.

To check the accuracy of the self-reports, the authors also examined biological markers of disease risk - glycosylated hemoglobin, blood pressure, C-reactive protein, fibrinogen, and HDL cholesterol. Again, the same patterns of more ill health among US residents emerged, although the presence of hypertension was not statistically significant.

"The US spends approximately twice as much per capita on health care as the UK (in purchasing power parities)," Dr. Marmot noted. "Although there is concern that a large proportion of Americans do not have access to this expenditure because of uninsurance or under- insurance, this is unlikely to apply to people of high education or high income. "

"Yet our study shows that it is not only the lowest socio-economic groups where Americans have worse health than in England, but at each point along the socio-economic spectrum," he continued. "So health care cannot be the main explanation of the higher rate of illness in the US. It is much more likely to be related to social and economic factors."

Reuters Health Information 2006. © 2006 Reuters Ltd.
Republication or redistribution of Reuters content, including by framing or similar means, is expressly prohibited without the prior written consent of Reuters. Reuters shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon. Reuters and the Reuters sphere logo are registered trademarks and trademarks of the Reuters group of companies around the world.

News Author: Laurie Barclay, MD

April 27, 2006 — Breast-feeding for more than 3 months may reduce the risk for childhood obesity in offspring of women with gestational diabetes mellitus (GDM), according to the results of a brief report in the May issue of Diabetes Care.

"Previous studies reported a high risk of obesity in children of mothers who have diabetes during pregnancy," write Ute M. Schaefer-Graf, MD, from the Vivantes Medical Center in Berlin, Germany, and colleagues. "Reports pertaining to the effects of breast-feeding following a pregnancy complicated by diabetes have focused on the delay or prevention of the appearance of islet autoimmunity among children of mothers who have type 1 diabetes. Conflicting results have been reported from short-term observations regarding the effect of breastfeeding on obesity of offspring."

From 1995 through 2000, women with GDM followed at a diabetes prenatal care clinic were asked to return for an anthropometric examination of their children between ages 2 and 8 years. The investigators collected data on maternal body mass index (BMI) before pregnancy, birth weight, and length, as well as weight and height of children and parents at the follow-up examination.

Of 324 children studied, 54% were boys and 46% were girls; 241 (74.4%) were breast-fed; and median duration of breast-feeding was 4.0 months (range, 0 - 20 months). Duration of breast-feeding was up to 3 months in 77 infants (23.8%) and more than 3 months in 164 infants (50.6%). Duration of breast-feeding was correlated negatively with prepregnancy maternal BMI (r = -0.197; P = .001). Of 85 obese mothers, 34 (40.0%) never breast-fed their infants compared with 49 (20.5%) of 239 nonobese women (P = .002).

At follow-up, mean age was 5.4 ± 1.6 years (range, 2.5 - 8.5 years). Of 324 children, 92 (28.4%) were overweight. BMI at follow-up was significantly negatively correlated with duration of breast-feeding (r = -0.130; P = .019). Prevalence of overweight status was 37.3% for non–breast-fed children, 32.5% for children breast-fed for up to 3 months, and 22.0% for children breast-fed for more than 3 months (P = .008).

Subgroup analyses revealed that childhood overweight status was significantly linked to breast-feeding duration in obese women (P = .042) but not in those with BMI less than 30 kg/m². Exclusive breast-feeding was an independent predictor of reduced risk for childhood overweight after adjustment for confounding factors, including parental obesity and high birth weight. These data suggest that the risk for childhood overweight may be reduced by 40% to 50% when breast-feeding is continued for more than 3 months.

"In children of mothers who have GDM, a population previously shown to have a high risk of infant overweight, we found that breast-feeding for >3 months appears to be negatively associated with overweight in early childhood," the authors write. "In our study, the prevalence of childhood overweight decreased with increased duration of nursing.... Women whose pregnancies were complicated by GDM, particularly those who are obese, should be encouraged to nurse for at least 3 months, since our data indicate that breast-feeding may be associated with childhood somatic development."

Novo Nordisk supported this study. The costs of publication of this article were defrayed in part by the payment of page charges, mandating that it must be marked "advertisement" solely to indicate this fact.

May 1, 2006 -- A new type of asthma treatment may help people with hard-to-control forms of the disease breathe easier.

The results of a small study showed that treatment with bronchial thermoplasty, a procedure designed to reduce airway narrowing, significantly improved breathing in people with asthma that is uncontrolled by conventional treatments.

Bronchial thermoplasty involves delivering radio-frequency energy to the smooth muscle that lines the airway walls. The energy heats the tissue to about 149 degrees Fahrenheit. This reduces muscle mass, but doesn't destroy or scar the muscle. With less muscle, the airway can't narrow as much in response to irritants that often trigger asthma. Airway narrowing is a hallmark of asthma.

The results of the study appear in the American Journal of Respiratory and Critical Care Medicine.

New Option in Asthma Treatment?

In the study, researchers evaluated the safety and effectiveness of bronchial thermoplasty in 16 adults with mild to moderate asthma that was not adequately controlled by asthma medications.

Each participant received three, 30-minute bronchial thermoplasty sessions to treat all accessible airways in the lungs.

After two years of follow-up, the results showed the procedure was well-tolerated and side effects were minimal.

All of the asthma patients reported an increase in the number of days without symptoms as well as fewer problems with triggers that worsened their asthma.

Researchers say this is only the first study to test the new treatment and they will continue to monitor the study participants for five years.

In an editorial that accompanies the study, Elisabeth H. Bel, MD, PhD, of Leiden University Medical Center in the Netherlands, says the study provides a unique insight into the mechanisms of airway responsiveness in asthma.

"The ability of asthmatic airways to constrict more promptly and excessively to inhaled stimuli than is the case for normal airways is considered a key factor of the disease," writes Bel.

"Whether bronchial thermoplasty will earn a place in the treatment of asthma remains to be determined," says Bel. "However, this study shows the potential for a completely new approach of treating asthma and stimulates the development of new hypotheses.""

SOURCES: Cox, G. American Journal of Respiratory and Critical Care Medicine, May 1, 2006; vol 173: pp 965-969. News release, American Thoracic Society.

News Author: Laurie Barclay, MD

May 2, 2005 — Calcium and vitamin D₃ supplementation do not reduce fractures in those at risk, according to the results of two studies, one published in the April 28 Early Online Publication issue of The Lancet and the other in the April 30 issue of the BMJ. The findings do not support routine oral supplementation, with either supplement alone or in combination, to prevent further fractures in previously mobile elderly people. The commentator points out a study limitation of not measuring vitamin D₃ levels in the study population.

"Policies for secondary prevention should therefore consider other strategies," Adrian M. Grant, MD, lead author of The Lancet study, from the University of Aberdeen, U.K., said in a news release. "The main pharmacological intervention is antiresorptive drugs, such as bisphosphonates, which have rarely been assessed in patients who have not been taking calcium or vitamin D."

The authors note that vitamin D₃ and calcium, alone or in combination, are often recommended for prevention of osteoporotic fractures. Inadequate intake of vitamin D₃ and calcium intake might increase fracture risk by increasing bone resorption and loss from secondary hyperparathyroidism, and vitamin D₃ may also protect against falls resulting in fracture. Data from randomized trials suggest that the combination of calcium and vitamin D₃ may be helpful.

In the factorial-design Randomised Evaluation of Calcium Or vitamin D₃ (RECORD) trial, 5,292 elderly people who were mobile before developing a low-trauma fracture were randomized to receive 800 IU per day of oral vitamin D₃, 1,000 mg of calcium, 800 IU daily of oral vitamin D₃ combined with 1,000 mg per day of calcium, or placebo. Of the 5,292 subjects, 4,481 (85%) were women; all were 70 years or older. Follow-up for participants recruited from 21 U.K. hospitals ranged from 24 to 62 months. The main outcome measure was new low-energy fractures, and analysis was by intent-to-treat.

Of 5,292 participants, 698 (13%) had a new low-trauma fracture, of which 183 (26%) were of the hip. The incidence of new, low-trauma fractures was not significantly different between participants receiving calcium and those who did not (331 [12.6%] of 2,617 vs 367 [13.7%] of 2,675; hazard ratio [HR], 0.94; 95% confidence interval [CI], 0.81 - 1.09]); between participants receiving vitamin D₃ and those who did not (353 [13.3%] of 2,649 vs 345 [13.1%] of 2,643; HR,1.02; 95% CI, [0.88 - 1.19]); or between those receiving combination treatment and those receiving placebo (165 [12.6%] of 1,306 vs 179 [13.4%] of 1,332; HR for interaction term, 1.01 [0.75 - 1.36]).

Incidence of all new fractures, fractures confirmed by radiography, hip fractures, death, number of falls, or quality of life did not differ between groups.

At 24-month follow-up, 2,886 (54.5%) of 5,292 were still taking their assigned tablets, 451 (8.5%) had died, 58 (1.1%) had withdrawn from the study, and 1,897 (35.8%) had stopped taking their assigned tablets but were still providing data for at least the main outcomes. Compliance with consumption of calcium tablets was significantly lower (difference, 9.4% [95% CI, 6.6 - 12.2]), in part due to gastrointestinal tract symptoms, but potentially serious adverse events were uncommon and no different between groups.

"Our trial indicates that routine supplementation with calcium and vitamin D₃, either alone or in combination, is not effective in the prevention of further fractures in people who had a recent low-trauma fracture," Dr. Grant said.

Study limitations include possible underestimation of true differences because of chance, difficulty in maintaining compliance, different rates of questionnaire response in the trial groups, and inability to directly address whether supplementation should be used as a primary prevention measure or for those who live in a care-home environment.

The Shire Pharmaceuticals Group supported this study and has various financial arrangements with three of its authors, one of whom also has financial arrangements with Nycomed, supplier of vitamin supplements.

In an accompanying comment, Philip N. Sambrook, from Royal North Shore Hospital in Sydney, Australia, notes that interpretation of these findings is limited by two main factors.

"First, compliance with medication was only moderate. It declined to 63% after 2 years and might have been as low as 45% when non-responders to the questionnaire about compliance were included," Dr. Sambrook writes. "Second, the study perpetuates the limitations of most previous studies by measuring 25-hydroxyvitamin D in only a small sample. Thus the vitamin D status of the trial population at baseline remains largely unknown, although, because the patients were younger than in other studies, ambulatory, and living in the community, they were less likely to have vitamin D deficiency."

Dr. Sambrook reports no conflict of interest.

The objective of the second randomized trial, led by Jill Porthouse, MD, from the University of York, England, U.K., was to determine whether supplementation with calcium and cholecalciferol (vitamin D₃) reduces fracture risk in community-dwelling older women with one or more risk factors for hip fracture.

At nurse-led clinics in primary care, 3,314 women aged 70 years and older with one or more risk factors for hip fracture were randomized to receive or not to receive daily oral supplementation with 1,000 mg of calcium and 800 IU of cholecalciferol. Both groups received an information leaflet on dietary calcium intake and fall prevention. Risk factors were defined as any previous fracture, low body weight (< 58 kg), smoking, family history of hip fracture, or fair or poor self-reported health. The primary outcome was all clinical fractures, and secondary outcomes were treatment adherence, falls, and quality of life measured with the Short-Form 12.

At 24 months, 69% of women who completed the follow-up questionnaire were still taking supplements (55% when randomized participants known to be alive were included). After a median follow-up period of 25 months (range, 18 - 42 months), clinical fracture rates were lower than expected in both groups. However, the rate for all clinical fractures was not significantly different between groups (odds ratio [OR] for fracture in supplemented group, 1.01; 95% CI, 0.71 - 1.43).

The OR for hip fracture was 0.75 (95% CI, 0.31 - 1.78). The odds of a woman having a fall at six months was 0.99, and at 12 months was 0.98. Quality of life did not significantly differ between the groups.

Study limitations include lack of placebo control; fewer fractures than anticipated, reducing the power to detect modest differences between groups; and treatment adherence rates of approximately 60% at 12 months.

"Although we found no evidence of a benefit on fractures in older community dwelling women given calcium and vitamin D supplementation, we cannot exclude a clinically significant benefit of supplementation owing to the relatively wide confidence intervals around our estimate of effect," the authors write.

Northern and Yorkshire National Health Service research and development, healthy ageing programme, Shire, and Nycomed funded this study. Shire supplied the calcium and vitamin D₃ supplements and has financial arrangements with three of the authors, one of whom also has financial arrangements with Nycomed.

NEW YORK (Reuters Health) May 01 - Laparoscopic adjustable gastric banding appears to be more effective in reducing weight and improving health and quality of life than behavioral modification plus pharmacotherapy among patients with mild to moderate obesity, Australian investigators report in the May 2nd issue of the Annals of Internal Medicine.

Low-calorie diets and increased physical activity combined with medication tend to have modest and transient effects on weight reduction, lead author Dr. Paul E. O'Brien and his associates note. And while observational studies have demonstrated the efficacy of bariatric surgery for obesity, there are few randomized controlled trials comparing the two strategies, and none that include patients with no more than moderate obesity.

Dr. O'Brien, of the Alfred Hospital, Melbourne, and colleagues in Australia recognize that current guidelines regarding bariatric surgery do not include patients without severe obesity. However, they note that "revision of those guidelines can only occur once data from this group are published."

They therefore recruited 80 patients with BMIs of 30 to 35 kg/m, who had comorbid conditions, severe physical limitations, or psychosocial problems related to their obesity, and who had made prior attempts to reduce weight. The metabolic syndrome was present in 37.5% of patients in each group at baseline.

Forty patients were randomized to the nonsurgical group, which included a very-low-calorie diet, advice for exercise, and treatment with orlistat over a 6-month period. Physicians saw each patient every 2 weeks during the first 6 months, then every 4 to 6 weeks, during which they continued to advise lifestyle changes.

The other 40 subjects underwent gastric banding, with the band placed along the perigastric pathway. These patients were also seen every 4 to 6 weeks. Thirty-nine patients in the surgery group and 33 in the nonsurgical group completed the 2-year study.

After 6 months, Dr. O'Brien's group reports that both groups had lost the same amount of weight (13.8%).

After 2 years, patients who underwent gastric banding had a mean loss of 21.6% of their initial weight and 87.2% of their excess weight. Metabolic syndrome remained in only one patient.

However, the nonsurgical group showed progressive weight gain after 6 months. By the end of 2 years, they maintained an average loss of 5.5% of their initial weight and 21.8% of their excess weight. Metabolic syndrome was still diagnosed in eight patients (24%).

At 2-year follow-up, those who underwent gastric banding also had significant improvements in all eight domain scores of the SF-36 questionnaire, while the behavioral therapy group had improvements in three domain scores.

The authors of an accompanying editorial have some reservations about Dr. O'Brien's study. Drs. Thomas A. Wadden and Adam Gilden Tsai, from the University of Pennsylvania in Philadelphia, point out that the researchers neglected to provide a structured weight loss maintenance program, including patient contact every 2 weeks, after the first 6 months, to the diet and exercise group.

They also consider it inappropriate to base treatment on "significant psychosocial problems associated with obesity." The physicians wonder if the patients realized that current guidelines do not recommend surgery for persons in this weight range.

Their recommendations include trials that track long-term outcomes and costs to determine which patients with mild to moderate obesity would benefit most from surgery.

Finally, they state, "We need to expend far more resources on preventing these individuals, particularly children, from becoming obese."

NEW YORK (Reuters Health) May 01 - Findings from a new study suggest that about 2.8 million adolescents in the US may have impaired fasting glucose levels and another 39,000 have overt type 2 diabetes.

"These estimates have important implications for public health because of the high rate of conversion from impaired fasting glucose level to type 2 diabetes in adults and the increased risk of cardiovascular disease in individuals with type 2 diabetes," study author Dr. Glen E. Duncan, from the University of Washington in Seattle, comments.

The results, which appear in the Archives of Pediatrics and Adolescent Medicine for May, are based on an analysis of data from the National Health and Nutrition Examination Survey (NHANES) for 1999 through 2002.

The study focused on 4370 adolescents with self-reported diabetes and 1496 teens who denied having the disease, but had undergone fasting blood glucose testing. Self-reported diabetics who used insulin were classified as type 1 diabetics, while all others were assumed to have type 2 disease. Among the teens without self-reported diabetes, a fasting blood glucose level of 100 mg/dL or higher indicated an impaired level.

The overall prevalence of diabetes among teens in NHANES was 0.5%. Of these individuals, 71% had type 1 diabetes and 29% had type 2 disease. Eleven percent of teens who reported no diabetes had impaired fasting glucose levels.

Extrapolating the current data to the entire US population suggests that 39,005 teens have type 2 diabetes and 2,769,736 have impaired fasting glucose levels.

"It is to be hoped that the recognition of the public health time bomb reflected in the report by Duncan will lead to a pervasive societal effort to prevent obesity, a daunting task of such magnitude that enormous community and governmental commitments will be required," Dr. Arlan L. Rosenbloom, from the Children's Medical Services Center in Gainesville, Florida, comments in a related editorial.

Reuters Health Information 2006. © 2006 Reuters Ltd.
Republication or redistribution of Reuters content, including by framing or similar means, is expressly prohibited without the prior written consent of Reuters. Reuters shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon. Reuters and the Reuters sphere logo are registered trademarks and trademarks of the Reuters group of companies around the world.

News Author: Emma Hitt, PhD

May 1, 2006 — Low serum estradiol levels in men may be associated with an increased risk for low-trauma hip fracture, and risk may be even greater for those who also have low testosterone levels, according to the findings of a new analysis in the May issue of The American Journal of Medicine.

The analysis, led by Shreyasee Amin, MD, now with the Mayo Clinic in Rochester, Minn, included 793 men from the National Heart, Lung, and Blood Institute's Framingham Heart Study http://www.framingham.com/heart.

Participants included in the analysis had undergone measurement of their estradiol and testosterone levels between 1981 and 1983. Participants had no prior hip fracture and were followed until 1999.

Estradiol levels were classified as low (2.0 - 18.1 pg/mL), medium (18.2 - 34.2 pg/mL), or high (>/= 34.3 pg/mL). The researchers also distinguished between high-trauma and low-trauma hip fractures. An example of a low-trauma fracture would be one that resulted from a fall from a standing height or less.

The hazard ratio (HR) was adjusted for age, body mass index, height, and smoking status. For men in the low estradiol group relative to the high estradiol group, the HR was 3.1 (95% confidence interval [CI], 1.4 - 6.9). No difference in risk was observed for medium- vs high-level groups (HR, 0.9; 95% CI, 0.4 - 2.0).

"The smoothed dose-response curve also suggested that the increased risk for hip fracture exponentially changed below serum estradiol levels of roughly 20.0 pg/mL," the authors write.

Men were also evaluated on the basis of their testosterone levels. No difference in adjusted risk was found on the basis of testosterone levels alone. However, low testosterone levels in addition to low estradiol levels appeared to compound the risk of hip fracture (adjusted HR, 6.5; 95% CI, 2.9 - 14.3).

"While the key role of estradiol is increasingly recognized among researchers in bone metabolism, it is an under-recognized risk factor in clinical general medicine," the authors write.

"These findings add further evidence to the important role of estrogen in the bone health of older men," notes Dr Amin in a written release. "It's important for us to know what puts men at risk for hip fracture so that we can better determine how we may prevent these fractures."

The researchers note that further work is needed to validate the potential clinical application of these findings but that the "results also raise the novel possibility that low testosterone levels may have a synergistic effect with low estradiol levels on hip fracture risk."

News Author: Laurie Barclay, MD

May 1, 2006 — A diet high in omega-3 polyunsaturated fatty acids (PUFAs) and vitamin E reduces the risk for amyotrophic lateral sclerosis (ALS), according to the results of a case-control study reported in the April 28 Online First issue of the Journal of Neurology, Neurosurgery, and Psychiatry.

"Despite several studies that investigated environmental exposures in relation to ALS, age, gender and smoking are the only established risk factors," write J. H. Veldink, MD, from the University Medical Center Utrecht in The Netherlands, and colleagues. "Several, not mutually exclusive, pathological processes may contribute to motor neurone death in ALS in a so-called convergence model, including oxidative stress, mitochondrial dysfunction, protein misfolding, axonal strangulation, apoptosis, inflammation, glutamate excitotoxicity and defects in neurotrophin biology. Nutrients are factors that could influence these processes and thereby the risk of developing ALS or its clinical expression."

During 2001-2002, 132 patients referred to the authors' clinic with definite, probable, or possible ALS according to El Escorial criteria, but without a familial history of ALS, were enrolled in a case-control study and matched with 220 healthy controls. All subjects completed a food frequency questionnaire, and multivariate logistic regression analysis was performed with adjustment for confounding factors, including sex, age, level of education, energy intake, body mass index, and smoking.

High PUFA and vitamin E intake was associated with a reduced risk of developing ALS (PUFA: odds ratio [OR], 0.4; 95% confidence interval [CI], 0.2 - 0.7; P = .001; vitamin E: OR, 0.4; 95% CI, 0.2 - 0.7; P = .001). PUFA and vitamin E appeared to act synergistically. In a combined analysis, the trend OR for vitamin E was further reduced from 0.67 to 0.37 (P = .02) and PUFA from 0.60 to 0.26 (P = .005), with a significant interaction term (P = .03). The intake of flavonols, lycopene, vitamin C, vitamin B₂, glutamate, calcium, or phytoestrogens did not affect the risk of developing ALS.

"A high intake of PUFAs and vitamin E is associated with a 50-60% decreased risk of developing ALS, and these nutrients appear to act synergistically," the authors write. "Vitamin E may act directly to reduce the risk of ALS as a known inhibitor of lipid peroxidation, but it could also act indirectly through inhibition of peroxidation of nutritional PUFAs."

Study limitations include the possible influence of overmatching of controls, recall bias, and the non–population-based design.

"Importantly, this case-control study took into account the possible influence of preclinical disease in assessing dietary intake and adjusted for important confounders, including total energy intake, according to the residual method," the authors write. "A population-based case-control study is presently being conducted to generate class I evidence."

ZonMw, The Netherlands Organization for Health Research and Development, supported this study. The authors have disclosed no relevant financial disclosures.

April 28, 2006 -- The U.S. government reports that most adults with diabetes aren't getting three annual medical tests recommended for diabetes patients.

Those three tests are:

• Hemoglobin A1c: A blood test that checks average blood sugar level for the past two to three months.
• Dilated eye exam: An eye care professional uses eye drops to temporarily widen, or dilate, the black part of the patient's eyes (pupils) to see inside the eyes. Uncontrolled diabetes can damage the eyes, harming vision and possibly leading to blindness. Diabetes is the leading cause of adult blindness in the U.S.
• Foot exam: A check of the foot's nerves and blood circulation. Uncontrolled diabetes can lead to foot problems that may eventually require amputation. Diabetes causes most of the nontraumatic amputations in the U.S.

Who Got Tested

In 2003, about 14 million civilian, noninstitutionalized U.S. adults were reported to have diabetes diagnosed by their doctor. Nearly 42% of them got all three tests, the researchers estimate.

About 50% got one or two tests. About 5% didn't get any of the tests. The rest didn't know if they had gotten those tests or not.

So says a report by Anita Soni, PhD, of the Agency for Healthcare Research and Quality (AHRQ). The AHRQ is part of the U.S. Department of Health and Human Services.

People who got all three tests were more likely to be white, to have medical insurance, and to be 65 or older, the report shows.

As of 2005, about 6 million people in the U.S. didn't know they had diabetes, according to the National Diabetes Information Clearinghouse, a service of the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). The NIDDK is a branch of the National Institutes of Health.

Doctors can check for diabetes with a simple blood test. Being overweight and having a family history of diabetes may make diabetes more likely.

Must-Have Medical Tests for People With Diabetes

The NIDDK lists these tests that people with diabetes should get:

• Hemoglobin A1c test: Get this test at least twice a year. It checks your average blood sugar over the past two to three months.
• Blood lipid (fats) test: A blood test of cholesterol and triglycerides.
• Kidney function tests: Get a urine test that checks for protein in urine at least once a year. Get a blood test for creatinine, a waste product, at least once a year. These tests screen for kidney problems.
• Blood pressure: Get your blood pressure checked at every medical appointment.
• Dilated eye exam: See an eye care professional once a year for a complete eye exam.
• Foot exam: At every medical appointment, get your feet's nerves and blood circulation.

Caring for your teeth and monitoring your weight are also important for people with diabetes (and for everyone else).

SOURCES: Soni, A. Medical Expenditure Panel Survey Statistical Brief #105, December 2005, Agency for Healthcare Research and Quality. National Diabetes Information Clearinghouse: "Prevent Diabetes Problems: Keep Your Eyes Healthy." National Diabetes Information Clearinghouse: "National Diabetes Statistics." National Diabetes Information Clearinghouse: "Prevent Diabetes Problems: Keep Your Diabetes Under Control." News release, Agency on Healthcare Research and Quality.

News Author: Anthony J. Brown, MD

April 28, 2006 — Sexual intercourse during early pregnancy does not significantly affect the risk of a recurrence of preterm birth for women with a prior spontaneous preterm delivery, new research shows. However, possibly due to infectious mechanisms, an increasing number of lifetime sexual partners do raise the risk.

Decreased physical activity, including sexual intercourse, during pregnancy is often recommended to prevent or treat preterm labor symptoms, note the authors of the study in the April issue of Obstetrics and Gynecology. Women with a prior spontaneous birth are known to be at increased risk for recurrent preterm birth and, therefore, could be prime targets for such advice.

Still, data are lacking on the effect of sexual intercourse, particularly past behavior, on the risk of recurrent preterm delivery.

In the present study, Dr. Nicole P. Yost, from Emory University School of Medicine in Atlanta, and colleagues looked at the effect of coitus on the risk of preterm birth in 187 women with singleton pregnancies who had a previous preterm birth.

The subjects' sexual history was obtained at 16 to 18 weeks of gestation by a research nurse. Data from 165 of the women were available for analysis.

Thirty-six percent of women had a spontaneous preterm birth at less than 37 weeks of gestation, the report indicates.

The number of sexual partners during the current pregnancy had no bearing on the risk of recurrent preterm birth, whereas the number of lifetime partners did. Regarding the latter finding, the rate of recurrent preterm birth ranged from 19% for women with one lifetime partner to 44% for those with at least four partners (p = 0.007).

The incidence of recurrent preterm birth among women reporting some sexual intercourse during pregnancy was 38% — higher, but not significantly different from the 28% rate seen in women who reported little or no intercourse during pregnancy.

Dr. Jeanne Sheffield, an obstetrician-gynecologist not affiliated with the present study, told Reuters Health that although many clinicians recommend against sexual intercourse during pregnancy, "every large study that has looked at coitus and preterm labor has not found an association."

As to how the number of lifetime sexual partners may impact the risk of preterm birth, Dr. Sheffield, a professor at UT Southwestern Medical Center at Dallas, said it may relate to infectious mechanisms. "The greater the number of lifetime sexual partners, the greater the risk of introducing abnormal bacteria that could potentially promote preterm labor."

The message from the present study is that sexual intercourse during pregnancy is probably okay for women who have a history of preterm birth, Dr. Sheffield said. "A possible exception is the small group of women who have a cerclage in place, ruptured membranes, or are already dilated and still preterm. For these women, we often recommend decreasing or abstaining from sexual intercourse."

News Author: Laurie Barclay, MD

April 28, 2006 — Ximelagatran is associated with less bleeding then warfarin for patients with nonvalvular atrial fibrillation, according to the results of a pooled analysis of the Stroke Prevention Using Oral Thrombin Inhibitor in Atrial Fibrillation (SPORTIF) III and V participants reported in the April 24 issue of the Archives of Internal Medicine.

"Ximelagatran is a novel direct thrombin inhibitor that can be administered as a fixed oral dose, without the need for anticoagulant monitoring," write James D. Douketis, MD, from McMaster University in Hamilton, Ontario, and colleagues. "Managing warfarin therapy is problematic because of the need for anticoagulant monitoring, with INR [International Normalized Ratio] testing required every 1 to 4 weeks for dose adjustments. Warfarin also interacts with other drugs, food, genetic polymorphisms, and acute illness, with the potential to cause excessive anticoagulation and bleeding."

This pooled analysis included 7329 patients with nonvalvular atrial fibrillation enrolled in the SPORTIF III and V trials to compare bleeding outcomes in patients who received ximelagatran, 36 mg twice daily, or warfarin sodium (target INR, 2.0 - 3.0). Outcome measures included annual risk of any and major bleeding, case-fatality rate, time course and anatomic sites of major bleeding, and risk factors for major bleeding with ximelagatran and warfarin treatment.

The annual incidence of any bleeding was 31.75% for ximelagatran and 38.82% for warfarin (relative risk reduction, 18.2%; 95% confidence interval [CI], 13.0 - 23.1; P < .001); and incidence of major bleeding was 2.01% vs 2.68% (relative risk reduction, 25.1%; 95% CI, 3.2 - 42.1; P = .03). The case-fatality rate of bleeding was similar with ximelagatran and warfarin (8.16% vs 8.09%; P = .98). After 24 months of treatment, the cumulative incidence of major bleeding was higher with warfarin than with ximelagatran (4.7% vs 3.7%; P = .04). Both treatments were similar in terms of anatomic sites of bleeding.

Risk factors for bleeding with ximelagatran treatment were diabetes mellitus (hazard ratio [HR], 1.81; 95% CI, 1.19 - 2.77; P = .006), previous stroke or transient ischemic attack (HR, 1.78; 95% CI, 1.16 - 2.73; P = .008), age 75 years or older (HR, 1.70; 95% CI, 1.33 - 2.18; P < .001), and aspirin use (HR, 1.68; 95% CI, 1.08 - 2.59; P = .02). In warfarin-treated patients, risk factors for bleeding were previous liver disease (HR, 4.88; 95% CI, 1.55 - 15.39; P = .007); aspirin use (HR, 2.41; 95% CI, 1.69 - 3.43; P < .001); and age 75 years or older (HR, 1.26; 95% CI, 1.03 - 1.52; P = .02).

Study limitations include pooling of the study sample from 2 studies of different design; the inclusion of intracerebral bleeding episodes as major episodes, which might have exaggerated the number of major bleeding episodes if some intracerebral episodes initially were ischemic strokes with subsequent hemorrhagic transformation; and lack of evidence of causality.

"Treatment with ximelagatran, 36 mg twice daily, is associated with a lower risk of bleeding than warfarin in patients with nonvalvular atrial fibrillation," the authors write. "Aspirin use and increasing age were associated with an increased risk of bleeding in ximelagatran- and warfarin-treated patients.... These potential benefits of ximelagatran therapy should be weighed against potential risks of treatment, which include elevated serum liver enzyme levels in approximately 6% of patients with atrial fibrillation and, rarely, severe and possibly fatal hepatitis."

AstraZeneca, the maker of ximelagatran, employs one of the authors. The other authors have disclosed no relevant financial relationships.

News Author: Laurie Barclay, MD

April 28, 2006 — Disinfecting computer keyboards is effective and should typically be done daily, according to the results of a study reported in the April issue of Infection Control and Hospital Epidemiology. However, the investigators suggest that this would not be necessary if handwashing guidelines were followed.

"Computers are ubiquitous in the healthcare setting and have been shown to be contaminated with potentially pathogenic microorganisms," write William A. Rutala, PhD, MPH, from the University of North Carolina Health Care System in Chapel Hill, and colleagues. "The risk of transmission of pathogens from computer keyboards to patients would be prevented by compliance with current hand hygiene guidelines.... This study was performed to determine the degree of microbial contamination, the efficacy of different disinfectants, and the cosmetic and functional effects of the disinfectants on the computer keyboards."

The investigators evaluated the efficacy of 6 different disinfectants (1 each containing chlorine, alcohol, or phenol and 3 containing quaternary ammonium) against 3 test organisms (oxacillin-resistant Staphylococcus aureus [ORSA], Pseudomonas aeruginosa, and vancomycin-resistant Enterococcus species) inoculated onto study computer keyboards. They also determined functional and cosmetic damage to the computer keyboards after disinfectant use.

More than half of the keyboards harbored coagulase-negative staphylococci (100% of keyboards), diphtheroids (80%), Micrococcus species (72%), and Bacillus species (64%). Other pathogens cultured were ORSA (4% of keyboards), oxacillin-susceptible S. aureus (4%), vancomycin-susceptible Enterococcus species (12%), and nonfermentative Gram-negative rods (36%).

All disinfectants and even the sterile water control were effective at removing or inactivating more than 95% of the test bacteria, without functional or cosmetic damage to the keyboards after 300 disinfection cycles.

"Our data suggest that microbial contamination of keyboards is prevalent and that keyboards may be successfully decontaminated with disinfectants," the authors write. "Keyboards should be disinfected daily or when visibly soiled or if they become contaminated with blood.... We agree with other investigators who have recommended that routine disinfection be performed on computer keyboards that are used in patient care areas."

The North Carolina Statewide Program for Infection Control and Epidemiology and the University of North Carolina Health Care System supported this study. Two of the authors have disclosed various financial relationships with Clorox and/or Metrex.