Editors Top Five:
1. More evidence that caffeine lowers risk of skin cancer
2. Saffron shows promise in preventing liver cancer
3. Coriander oil could tackle food poisoning and drug-resistant infections
4. Eradicating dangerous bacteria may cause permanent harm
5. Vitamin A supplements for children could save 600,000 lives a year
In This Issue:
1. Chinese Herb Works as Well as Oseltamivir for Shortening Flu Duration
2. How a virus causes skin cancer
3. Exercise may help prevent brain damage caused by Alzheimer’s disease
4. Daily TV quota of 6 hours could shorten life expectancy by 5 years
5. Researchers Demonstrate Green Tea Compound is Effective in Treating Genetic Disorder and Two Types of Tumors
6. More evidence that caffeine lowers risk of skin cancer
7. Garlic Doesn’t Just Repel Vampires
8. Study finds 15 minutes of moderate daily exercise lengthens life
9. Moderate drinking protects against Alzheimer’s and cognitive impairment
10. No bones about it: Eating dried plums helps prevent fractures and osteoporosis
11. Study finds majority of pharmaceutical ads do not adhere to FDA guidelines
12. Toxicity of aromatase inhibitors may explain lack of overall survival improvement
13. Saffron shows promise in preventing liver cancer
14. 17 percent of cancer nurses unintentionally exposed to chemotherapy, U-M study finds
15. Coriander oil could tackle food poisoning and drug-resistant infections
16. Deaths from strong prescription painkillers are on the increase
17. Eradicating dangerous bacteria may cause permanent harm
18. Scented laundry products emit hazardous chemicals through dryer vents
19. Vitamin A supplements for children could save 600,000 lives a year
20. Omega-3s reduce stroke severity
21. Aerobic exercise bests resistance training at burning belly fat
22. The malaria mosquito is disappearing — but it is not just good news
23. Research shows heat in chili peppers can ease sinus problems
24. Results of medication studies in top medical journals may be misleading to readers
25. 65 million more obese adults in the US and 11 million more in the UK
Public release date: 15-Aug-2011
Chinese Herb Works as Well as Oseltamivir for Shortening Flu Duration
The antiviral, oseltamivir has been used to reduce severity of and mortality from H1N1 influenza. In rural China, where there is limited access to medications such as oseltamivir, traditional Chinese medicine has been used to treat seasonal flu. To compare the efficacy and safety of oseltamivir and maxingshigan-yinqiaosan (a Chinese herbal remedy) for treating uncomplicated H1N1 influenza, researchers assigned 410 young adult patients in 11 Chinese hospitals to receive either oseltamivir alone, oseltamivir plus maxinghigan- yingiaosan, maxinghigan-yingiaosan alone, or no treatment for five days. Fever resolved sooner in all three therapeutic groups compared with the group that received no treatment. Among patients with mild H1N1 infection, the Chinese herb maxingshigan-yinqiaosan can be used as an alternative treatment to oseltamivir.
Public release date: 15-Aug-2011
How a virus causes skin cancer
Merkel cell carcinoma (MCC) is a rare but aggressive form of skin cancer. It was recently found that most cases of MCC are caused by Merkel cell polyomavirus (MCV). However, the mechanisms by which this virus causes MCC are unknown. Insight into this has now been provided by the work of Patrick Moore, Yuan Chang, and colleagues, at the University of Pittsburgh, Pittsburgh, who found that the MCV protein sT is required for tumor cell growth. Detailed analysis by these researchers outlined the molecular mechanism by which MCV sT contributes to MCC and led them to suggest that MCV sT has potential as a diagnostic marker and therapeutic target for MCC
Public release date: 15-Aug-2011
Exercise may help prevent brain damage caused by Alzheimer’s disease
New York, NY, August 15, 2011 – Regular exercise could help prevent brain damage associated with neurodegenerative diseases like Alzheimer’s, according to research published this month in Elsevier’s journal Brain, Behavior, and Immunity.
“Exercise allows the brain to rapidly produce chemicals that prevent damaging inflammation”, said Professor Jean Harry, who led the study at the National Institute of Environmental Health Sciences in the United States. “This could help us develop a therapeutic approach for early intervention in preventing damage to the brain.”
Previous research has already demonstrated that exercise after brain injury can help the repair mechanisms. This new study shows that exercise before the onset of damage modifies the brain environment in such a way that the neurons are protected from severe insults. The study used an experimental model of brain damage, in which mice are exposed to a chemical that destroys the hippocampus, an area of the brain which controls learning and memory. Mice that were exercised regularly prior to exposure produced an immune messenger called interleukin-6 in the brain, which dampens the harmful inflammatory response to this damage, and prevents the loss of function that is usually observed.
Pharmacological therapies to downregulate inflammation and address cognitive decline in older adults, and those with Alzheimer’s disease, have been less successful. This research helps understand how exercise could be used to affect the path of many human conditions, such as neurodevelopmental disorders and neurodegenerative diseases. In addition, as a chemical model of neuronal damage was used, it also raises the possibility that exercise could offer protection against the potentially harmful effects of environmental toxins.
“This elegant series of experiments reveals an alternative pathway by which voluntary physical exercise may protect hippocampal neurons”, said Dr. Ruth Barrientos from the Department of Psychology and Neuroscience at the University of Colorado. “The study on the role of exercise as a therapeutic intervention will undoubtedly get a workout in the years to come. Perhaps the greatest challenge with this line of research will not be more discoveries of compelling evidence of the anti-neuroinflammatory effects of exercise, but instead, getting humans to exercise voluntarily and regularly.”
Public release date: 15-Aug-2011
Daily TV quota of 6 hours could shorten life expectancy by 5 years
Television viewing time and reduced life expectancy: A life table analysis
Watching TV for an average of six hours a day could shorten the viewer’s life expectancy by almost five years, indicates research published online in the British Journal of Sports Medicine.
The impact rivals that of other well known behavioural risk factors, such as smoking and lack of exercise, the study suggests.
Sedentary behaviour – as distinct from too little exercise – is associated with a higher risk of death, particularly from heart attack or stroke. Watching TV accounts for a substantial amount of sedentary activity, but its impact on life expectancy has not been assessed, say the authors.
They used previously published data on the relationship between TV viewing time and death from analyses of the Australian Diabetes, Obesity and Lifestyle Study (AusDiab), as well as Australian national population and mortality figures for 2008, to construct a lifetime risk framework.
AusDiab is a national survey of a representative sample of the population, starting in 1999-2000, and involving more than 11,000 adults aged 25 or older.
The authors then constructed a risk framework for the Australian population in 2008, based on the answers the survey participants had given, when quizzed about the total amount of time they had spent in the previous week watching TV or videos.
In 2008 the authors estimated that Australian adults aged 25 and older watched 9.8 billion hours of TV, which led them to calculate that every single hour of TV watched after the age of 25 shortened the viewer’s life expectancy by just under 22 minutes.
Based on these figures, and expected deaths from all causes, the authors calculated that an individual who spends a lifetime average of six hours a day watching TV can expect to live just under five fewer years than someone who does not watch TV.
These figures compare with the impact of other well known lifestyle factors on the risk of death from cardiovascular disease after the age of 50, including physical activity and obesity.
For example, other research has shown that lifelong smoking is associated with the shortening of life expectancy by more than 4 years after the age of 50, with the average loss of life from one cigarette calculated to be 11 minutes – equivalent to half an hour of TV watching, according to the authors’ risk framework.
Their findings “suggest that substantial loss of life may be associated with prolonged TV viewing,” say the authors. And they add: “While we used Australian data, the effects in other industrialised and developing countries are likely to be comparable, given the typically large amounts of time spent watching TV and similarities in disease patterns.”
They conclude: “If these [figures] are confirmed and shown to reflect a causal association, TV viewing is a public health problem comparable in size to established behavioural risk factors.”
Public release date: 15-Aug-2011
Researchers Demonstrate Green Tea Compound is Effective in Treating Genetic Disorder and Two Types of Tumors
ST. LOUIS, MO, August 15, 2011—A compound found in green tea shows great promise for the development of drugs to treat two types of tumors and a deadly congenital disease. The discovery is the result of research led by Principal Investigator, Dr. Thomas Smith at The Donald Danforth Plant Science Center and his colleagues at The Children’s Hospital of Philadelphia. Their findings are published in the recent article, “Green Tea Polyphenols Control Dysregulated Glutamate Dehydrogenase In Transgenic Mice By Hijacking The ADP Activation Site” in The Journal of Biological Chemistry.
Glutamate dehydrogenase (GDH) is found in all living organisms and is responsible for the digestion of amino acids. In animals, GDH is controlled by a complex network of metabolites. For decades it was not clear why animals required such regulation but other kingdoms did not. This was partially answered by the Stanley group’s finding that a deadly congenital disease, hyperinsulinism/hyperammonemia (HHS), is caused by the loss of some of this regulation. In this disorder, patients (typically children) respond to the consumption of protein by over secreting insulin, becoming severely hypoglycemic, often leading to death.
Using atomic structures to understand the differences between animals and plants, Dr. Smith and his colleagues discovered that two compounds found naturally in green tea are able to compensate for this genetic disorder by turning off GDH in isolated and when the green tea compounds were administered orally. The Smith lab also used X-ray crystallography to determine the atomic structure of these green tea compounds bound to the enzyme. With this atomic information, they hope to be able to modify these natural compounds to design and develop better drugs.
Interestingly, two other research groups have validated and extended these findings to demonstrate that blocking GDH with green tea is very effective at killing two different kinds of tumors; glioblastomas, an aggressive type of brain tumor, and tuberous sclerosis complex disorder, a genetic disease that causes non- malignant tumors to grow on a number of organs.
Also shown is the location of ECG, a major compound found in green tea. From this structure, it appears that ECG inhibits GDH by binding to the back of the active site and forcing it open. This effectively shuts the enzyme down. Our other studies have shown that these green tea compounds are effective at shutting down the enzyme in tissue and in whole animals. This not only treats a deadly congenital disorder but is also useful in treating at least two types of tumors.
“While these compounds from green tea are extremely safe and consumed by millions every day, they have a number of properties that make them difficult to use as actual drugs. Nevertheless, our ongoing collaboration with the Stanley lab shows that there are natural compounds from plants that can control this deadly disorder and, with the atomic structure in hand, can be used as a starting point for further drug design.”
Public release date: 15-Aug-2011
More evidence that caffeine lowers risk of skin cancer
There might be a time when instead of just drinking that morning cup of coffee you lather it on your skin as a way of preventing harmful sun damage or skin cancer.
A new Rutgers study strengthens the theory that caffeine guards against certain skin cancers at the molecular level by inhibiting a protein enzyme in the skin, known as ATR. Scientists believe that based on what they have learned studying mice, caffeine applied directly to the skin might help prevent damaging UV light from causing skin cancer.
Prior research indicated that mice that were fed caffeinated water and exposed to lamps that generated UVB radiation that damaged the DNA in their skin cells were able to kill off a greater percentage of their badly damaged cells and reduce the risk of cells becoming cancerous.
“Although it is known that coffee drinking is associated with a decreased risk of non-melanoma skin
cancer, there now needs to be studies to determine whether topical caffeine inhibits sunlight-induced skin cancer,” said Allan Conney, director of the Susan Lehman Cullman Laboratory for Cancer Research.
In this newly-published study, instead of inhibiting ATR with caffeinated water, Rutgers researchers, in collaboration with researchers from the University of Washington, genetically modified and diminished ATR in one group of mice. The results: the genetically modified mice developed tumors more slowly than the unmodified mice, had 69 percent fewer tumors than regular mice and developed four times fewer invasive tumors.
The study also found, however, that when both groups of mice were exposed to chronic ultraviolet rays for an extended period of time, tumor development occurred in both the genetically modified and regular mice. What this seems to indicate, says Conney, is that inhibiting the ATR enzyme works best at the pre- cancerous stage before UV-induced skin cancers are fully developed.
According to the National Cancer Institute, sunlight-induced skin cancer is the most prevalent cancer in the United States with more than 1 million new cases each year. Although multiple human epidemiologic studies link caffeinated beverage intake with significant decreases in several different types of cancer, including skin cancer, just how and why coffee protects against the disease is unknown.
“Caffeine might become a weapon in prevention because it inhibits ATR and also acts ad as a sunscreen and directly absorbs damaging UV light,” said Conney.
Public release date: 15-Aug-2011
Garlic Doesn’t Just Repel Vampires
The folk wisdom that eating garlic fights illness is ancient. In these more modern times, fruit and vegetable extracts that can inhibit the growth of pathogenic and spoilage microorganisms are actually being evaluated as food preservatives, in part because consumers are demanding fewer synthetic chemical food preservatives. Now, a team led by researchers from Washington State University, Pullman, has found, contrary to expectations, that a group of garlic-derived organosulfur compounds has greater antimicrobial activity than garlic-derived phenolic compounds. The research is published in the August 2011 issue of the journal Applied and Environmental Microbiology.
“The novelty of this paper is that we found that diallyl sulfides contribute more to antimicrobial activity of garlic extract than do phenolic compounds,” says coauthor Xiaonan Lu. “We used biophysical techniques, namely infrared and Raman spectroscopy, to demonstrate that diallyl sulfide can freely penetrate bacterial membranes and combine with sulfur containing proteins and enzymes, which is the major antimicrobial mechanism of these organosulfur compounds.”
“This is the first time researchers have combined infrared spectroscopy and Raman spectroscopy, which are complementary techniques, to study the mechanisms of bacterial injury and inactivation,” says Lu. “While previous studies have validated that volatile thiosulfinates, a group of intermediate, unstable and volatile bioactive sulfur-containing compounds, have antimicrobial activity against Helicobacter pylori, our result demonstrated that the garlic-derived organosulfur compounds have the potential to be used as antimicrobial agents.”
Campylobacter jejuni, the target microbe in this study, is thought to be the most prevalent cause of bacterial food-borne illness in the world, causing abdominal cramps, fever, and diarrhea accompanied by gross blood and leukocytes. There are no previous reported studies investigating the ability of allium
species, including garlic, to control the growth of C. jejuni.
The history of using garlic to fight disease goes back several thousand years, says Lu. That history probably contributed to the notion that garlic could repel vampires, which predates Bram Stoker’s Dracula, according to the website garlic-central.com. “In ancient society,” says Lu, “people used garlic to cure diseases; however, they did not know why it worked.” Now we are finding out.
(X. Lu, B.A. Rasco, J.M.F. Jabal, D.E. Aston, M. Lin, and M.E. Konkel, 2011. Investigating antibacterial effectxs of garlic (Allium sativum) concentrate and garlic-derived organosulfur compounds on Campylobacter jejuni by using Fourier transform infrared spectroscopy, Raman spectroscopy, and electron microscopy. Appl. Environ. Microbiol. 77:5257-5269.)
Public release date: 15-Aug-2011
Study finds 15 minutes of moderate daily exercise lengthens life
Health benefits of physical activity found to begin before people reach the half-hour standard
HOUSTON — Taiwanese who exercise for 15 minutes a day, or 92 minutes per week, extended their expected lifespan by three years compared to people who are inactive, according to a study published today in The Lancet.
“Exercising at very light levels reduced deaths from any cause by 14 percent,” said study senior author Xifeng Wu, M.D., Ph.D., professor and chair of The University of Texas MD Anderson Cancer Center Department of Epidemiology. “The benefits of exercise appear to be significant even without reaching the recommended 150 minutes per week based on results of previous research.”
Lead author Chi-Pang Wen, M.D., of the National Health Research Institutes of Taiwan, and colleagues also found that a person’s risk of death from any cause decreased by 4 percent for every additional 15 minutes of exercise up to 100 minutes a day over the course of the study. Those exercising for 30 minutes daily added about four years to life expectancy.
“These benefits were applicable to all age groups, both sexes and those with cardiovascular disease risk,” the authors note.
If inactive people in Taiwan were to do low-volume daily exercise, one in six deaths could be postponed by their reduced risk of dying, the authors report. It would be an estimated reduction in mortality similar to that from a successful tobacco control program.
The prospective observational study involved 416,175 Taiwanese who participated in a standard medical screening program run by MJ Health Management Institution between 1996 and 2008. Participants were followed for an average of eight years.
For the exercise study, participants completed a questionnaire covering their medical history and lifestyle information. They characterized their weekly physical activity for the previous month by intensity — light (walking), moderate (brisk walking), vigorous (jogging) or high vigorous (running) – and time.
To account for occupational effects, participants also characterized their physical activity at work, ranging from sedentary to hard physical labor.
Those who reported less than one hour a week of leisure time physical activity were classified as inactive – 54 percent of all participants. Others were classified as low, medium, high or very high based on the duration and intensity of their exercise. Researchers calculated mortality risk and life expectancy for each group.
Thirteen other variables were analyzed: age, sex, education level, physical labor at work, smoking, alcohol use, fasting blood sugar, systolic blood pressure, total cholesterol, body mass index, diabetes, hypertension and history of cancer.
Those who engaged in low-volume exercise had lower death rates than inactive people regardless of age, gender, health status, tobacco use, alcohol consumption or cardiovascular disease risk.
The researchers note that the World Health Organization and the U.S. Centers for Disease Control and Prevention recommend at least 150 minutes of moderate-intensity exercise per week. A third of U.S. adults meet that guideline; about 20 percent of adults in China, Japan or Taiwan meet it.
“A recommendation of 15 minutes of daily exercise should be promoted to East Asian populations,” the authors note.
The study’s findings of reduced mortality through even moderately intense exercise are likely to hold true for other populations, Wu said, even though the total amount of time spent or workout intensity required for a health benefit might differ. “These findings can stimulate people to exercise as much as they can and to not be frustrated that they can’t reach the 30 minute per day guideline.”
This is the first collaboration between Wu, Wen and the MJ Health Group, a major health screening company with more than 600,000 participants in its health database. They have formed the Asian Health Screening Cohort to conduct major research projects. Wu provides scientific expertise with Wen, who also is based at China Medical University Hospital, while MJ Health Group contributes patient epidemiological and clinical data as well as a biobank of tissue samples.
Two other ongoing collaborative projects include development of a liver cancer risk prediction model and a study of telomere length, genetic variation and cancer risk. The second project is funded by an MD Anderson Sister Institute Network Fund Grant. MD Anderson and China Medical University Hospital have a sister institution agreement.
Public Release: 15-Aug-2011
Moderate drinking protects against Alzheimer’s and cognitive impairment
Researchers review 143 studies
MAYWOOD, Ill. — Moderate social drinking significantly reduces the risk of dementia and cognitive impairment, according to an analysis of 143 studies by Loyola University Chicago Stritch School of Medicine researchers.
Researchers reviewed studies dating to 1977 that included more than 365,000 participants. Moderate drinkers were 23 percent less likely to develop cognitive impairment or Alzheimer’s disease and other forms of dementia.
Wine was more beneficial than beer or spirits. But this finding was based on a relatively small number of studies, because most papers did not distinguish among different types of alcohol.
Results are reported in the journal Neuropsychiatric Disease and Treatment. The authors are Edward J. Neafsey, PhD. and Michael A. Collins, PhD., professors in the Department of Molecular Pharmacology and Therapeutics.
Heavy drinking (more than 3 to 5 drinks per day) was associated with a higher risk of cognitive impairment and dementia, but this finding was not statistically significant.
“We don’t recommend that nondrinkers start drinking,” Neafsey said. “But moderate drinking — if it is truly moderate — can be beneficial.” Moderate drinking is defined as a maximum of two drinks per day for men and 1 drink per day for women.
Among the studies reviewed, 74 papers calculated the ratios of risk between drinkers and non-drinkers, while 69 papers simply stated whether cognition in drinkers was better, the same or worse than cognition in nondrinkers. Neafsey and Collins did a meta-analysis of the studies that calculated risk ratios and found that moderate drinkers were 23 percent less likely to develop dementia or cognitive decline.
The protective effect of moderate drinking held up after adjusting for age, education, sex and smoking.
There was no difference in the effects of alcohol on men and women.
The beneficial effect of moderate drinking was seen in 14 of 19 countries, including the United States. In 3 of the remaining 5 countries, researchers also found a benefit, but it was not strong enough to be statistically significant.
The findings were similar across different types of studies (longitudinal cohort studies, case-control studies and cross-sectional studies).
It is unknown why moderate drinking can have a beneficial effect. One theory suggests that the well- known cardiovascular benefits of moderate alcohol consumption, such as raising good HDL cholesterol, also can improve blood flow in the brain and thus brain metabolism.
A second possible explanation involves “sick quitters.” According to this theory, nondrinkers have a higher risk of cognitive impairment and dementia because the group includes former heavy drinkers who damaged their brain cells before quitting. But the analysis by Neafsey and Collins did not support this explanation. They found that in studies that excluded former heavy drinkers, the protective effect of moderate drinking still held up.
Neafsey and Collins suggest a third possible explanation: Small amounts of alcohol might, in effect, make brain cells more fit. Alcohol in moderate amounts stresses cells and thus toughens them up to cope with major stresses down the road that could cause dementia.
For people who drink responsibly and in moderation, there’s probably no reason to quit. But because of the potential for alcohol to be abused, Neafsey and Collins do not recommend that abstainers begin drinking.
The researchers note that there are other things besides moderate drinking that can reduce the risk of dementia, including exercise, education and a Mediterranean diet high in fruits, vegetables, cereals, beans, nuts and seeds. Even gardening has been shown to reduce the risk of dementia.
Moreover, there are times when people should never drink, including adolescence, pregnancy and before driving, the researchers said.
Public release date: 17-Aug-2011
No bones about it: Eating dried plums helps prevent fractures and osteoporosis
When it comes to improving bone health in postmenopausal women — and people of all ages, actually — a Florida State University researcher has found a simple, proactive solution to help prevent fractures and osteoporosis: eating dried plums.
“Over my career, I have tested numerous fruits, including figs, dates, strawberries and raisins, and none of them come anywhere close to having the effect on bone density that dried plums, or prunes, have,” said Bahram H. Arjmandi, Florida State’s Margaret A. Sitton Professor and chairman of the Department of Nutrition, Food and Exercise Sciences (http://www.chs.fsu.edu/nfes/) in the College of Human Sciences. “All fruits and vegetables have a positive effect on nutrition, but in terms of bone health, this particular food is exceptional.”
Arjmandi and a group of researchers from Florida State and Oklahoma State University tested two groups of postmenopausal women. Over a 12-month period, the first group, consisting of 55 women, was instructed to consume 100 grams of dried plums (about 10 prunes) each day, while the second — a comparative control group of 45 women — was told to consume 100 grams of dried apples. All of the study’s participants also received daily doses of calcium (500 milligrams) and vitamin D (400 international units).
The group that consumed dried plums had significantly higher bone mineral density in the ulna (one of two long bones in the forearm) and spine, in comparison with the group that ate dried apples.
This, according to Arjmandi, was due in part to the ability of dried plums to suppress the rate of bone resorption, or the breakdown of bone, which tends to exceed the rate of new bone growth as people age.
The group’s research, “Comparative Effects of Dried Plum and Dried Apple on Bone in Post Menopausal Women of the Department of Geriatrics in the College of Medicine; and Oklahoma State University statistics Professor Mark E. Payton.
In the United States, about 8 million women have osteoporosis because of the sudden cessation of ovarian hormone production at the onset of menopause. What’s more, about 2 million men also have osteoporosis.
“In the first five to seven postmenopausal years, women are at risk of losing bone at a rate of 3 to 5 percent per year,” Arjmandi said. “However, osteoporosis is not exclusive to women and, indeed, around the age of 65, men start losing bone with the same rapidity as women.”
Arjmandi encourages people who are interested in maintaining or improving their bone health to take note of the extraordinarily positive effect that dried plums have on bone density.
“Don’t wait until you get a fracture or you are diagnosed with osteoporosis and have to have prescribed medicine,” Arjmandi said. “Do something meaningful and practical beforehand. People could start eating two to three dried plums per day and increase gradually to perhaps six to 10 per day. Prunes can be eaten in all forms and can be included in a variety of recipes
Public release date: 17-Aug-2011
Study finds majority of pharmaceutical ads do not adhere to FDA guidelines
A study led by Mount Sinai School of Medicine researchers of 192 pharmaceutical advertisements in biomedical journals found that only 18 percent were compliant with Food and Drug Administration (FDA) guidelines, and over half failed to quantify serious risks including death. The study, is published online today in the journal Public Library of Science (PLoS) One.
“Marketing research has consistently shown that journal advertising is the most profitable form of drug marketing, with an estimated return on investment of five dollars for every dollar spent,” said Dr. Deborah Korenstein, lead author of the study and Associate Professor of Medicine at Mount Sinai School of Medicine. “Our study, the first in nearly 20 years to provide a systematic assessment of the adherence of US advertisements to FDA guidance, shows that the current system is not in the best interest of the health of the public.”
Researchers performed a cross-sectional analysis of prescription pharmaceutical advertisements published in nine journals in November 2008. They evaluated adherence to FDA standards and the presence of content that is important for physicians to use when safely prescribing the drugs. Of the 192 advertisements for 82 unique products, only 15 fully adhered to all 20 FDA Prescription Drug Advertising Guidelines. In addition, 57.8 percent of the advertisements did not quantify serious risks, 48.2 percent lacked verifiable references, and 28.9 percent failed to present adequate efficacy quantification.
“The limited resources of the FDA’s Division of Drug Marketing and Advertising are a major barrier to successful regulation of the pharmaceutical industry’s multi-billion dollar marketing budget,” said Dr. Korenstein. “We are hopeful that an update in FDA regulations, with increased emphasis on the transparent presentation of basic safety and efficacy information, might improve the quality of information provided in physician-directed pharmaceutical advertisements.”
Public release date: 22-Aug-2011
Toxicity of aromatase inhibitors may explain lack of overall survival improvement
The toxicities associated with aromatase inhibitors (AIs) may explain the lack of overall survival improvement compared with tamoxifen, according to a study published August 22 in the Journal of The National Cancer Institute.
AIs are a class of drugs used to treat breast cancer in postmenopausal women. The drugs are normally
taken as an alternative to tamoxifen or after initial treatment with tamoxifen. In general, they are associated with as reduction in breast cancer recurrence but not in improved survival. Furthermore, the drugs are associated with a number of concerning adverse toxic effects compared with tamoxifen.
To examine whether the relative toxicity of AIs versus tamoxifen may explain the lack of overall survival benefit in postmenopausal breast cancer patients, Eitan Amir, MB ChB, of the Division of Medical Oncology and Hematology at Princess Margaret Hospital in Toronto, Ontario and colleagues conducted a systematic review to identify all randomized trials which compared AIs and tamoxifen in postmenopausal women. They then performed a meta-analysis of the data from the selected randomized trials. Their meta- analysis used data from seven trials enrolling 30,023 patients.
The researchers found that compared to tamoxifen, longer use of AIs was associated with increased heart disease and bone fractures, but lower rates of blood clots and cancer of the womb. There were no differences in the risk of stroke or other types of cancer. Furthermore, use of AIs for 2-3 years after initial treatment with tamoxifen was associated with a lower risk of death unrelated to breast cancer compared to the use of either AIs or tamoxifen alone. The authors therefore concluded that the toxicity of AIs when used for longer periods of treatment may explain the lack of overall survival benefit while still having a positive effect on breast cancer recurrence.
The researchers write, “The cumulative toxicity of aromatase inhibitors when used as up-front treatment may explain the lack of overall survival benefit despite improvements in disease-free survival. Switching from tamoxifen to aromatase inhibitors reduces this toxicity and is likely the best balance between efficacy and toxicity.”
In an accompanying editorial, Nancy E. Davidson, M.D., Shannon Puhalla, M.D., and Rachel C. Jankowitz, M.D., of the UPMC Cancer Center at Magee-Womens Hospital, write that, “survival benefits with adjuvant tamoxifen were not truly evident until after 5 years of follow-up. Thus, it is conceivable that a late survival advantage with aromatase inhibitors over tamoxifen may also emerge over time.”
The editorialists conclude that doctors should, “choose initial endocrine therapy for the individual patient with careful attention to the risk of breast cancer recurrence, the risk of toxicity, and comorbidities.”
Public release date: 22-Aug-2011
Saffron shows promise in preventing liver cancer
Spice promotes apoptosis and inhibits growth of cancerous cells in animal models
New research suggests that saffron provides a significant chemopreventive effect against liver cancer in animal models. When saffron was administered to rats with diethylnitrosamine (DEN)-induced liver cancer an inhibition of cell proliferation and stimulation of apoptosis was observed. Full findings appear in the September issue of Hepatology, a journal published by Wiley Blackwell on behalf of the American Association for the Study of Liver Diseases.
Hepatocellular carcinoma (HCC), or liver cancer, is the fifth most common cancer and the third leading cause of cancer mortality in the world. Medical evidence has shown that chronic infection with hepatitis B and C are major risk factors for HCC, and exposure to environmental carcinogens, iron overload, fatty liver disease and alcohol abuse can also contribute to development of liver cancer. DEN, an environmental carcinogen, is found in tobacco-smoke, cosmetics, gasoline, and processed foods including milk and meat products.
“In the fight against cancer, there has been much interest in chemopreventive properties of natural herbs and plants,” said Prof. Amr Amin from United Arab Emirates University. “With limited treatment options, approaches that prevent cancer development are among the best strategies to protect against the disease.” Prior studies have shown that saffron, a naturally derived plant product, possesses antioxidant, anti-cancer, and anti-inflammatory properties. Saffron is a commonly used spice, adding flavor and color to foods, and a possible cancer-fighting substance that is readily available.
In order to further explore the potential of saffron in preventing the development and progression of HCC, DEN was used to induce lesions in rats, mimicking benign and malignant tumors in humans. The research team administered saffron to the animals at 75mg/kg, 150 mg/kg, and 300 mg/kg per day two weeks prior to DEN injection and continued the regimen for 22 weeks.
Results show saffron significantly reduced the number and the incidence of liver nodules, with animals receiving the highest dose of saffron showing complete inhibition of hepatic nodules. Animals that received pre-treatment with saffron displayed a decrease in the elevation of gamma glutamyl transpeptidase, alanine aminotransferase and alpha- fetoprotein (GGT, ALT, αFP)—proteins which indicate liver damage. Furthermore, saffron inhibited the elevation of cells positive for Ki-67, cyclooxygenase 2, inducible nitric oxide synthase, nuclear factor- kappa Bp-65 and the phosphorylated tumor necrosis factor receptor, all of which have respective roles in the development and progression of cancerous cells.
“Our findings suggest that saffron provides an anti-cancer protective effect by promoting cell death (apoptosis), inhibiting proliferation of cancerous cells, and blocking inflammation,” concluded Prof. Amin. “Further investigation of saffron extract and its mechanism of action in HCC is currently underway.”
Public release date: 22-Aug-2011
17 percent of cancer nurses unintentionally exposed to chemotherapy, U- M study finds
Researchers stress importance of implementing nurse safety measures around these highly toxic drugs
ANN ARBOR, Mich. — Nearly 17 percent of nurses who work in outpatient chemotherapy infusion centers reported being exposed on their skin or eyes to the toxic drugs they deliver, according to a new study from the University of Michigan Comprehensive Cancer Center.
The study surveyed 1,339 oncology nurses from one state who did not work in inpatient hospital units. About 84 percent of chemotherapy is delivered in outpatient settings, largely by nurses. Results appear online in the journal BMJ Quality and Safety.
“Any unintentional exposure to the skin or eyes could be just as dangerous as a needle stick,” says lead study author Christopher Friese, R.N., Ph.D., assistant professor at the U-M School of Nursing.
“We have minimized needle stick incidents so that they are rare events that elicit a robust response from administrators. Nurses go immediately for evaluation and prophylactic treatment. But we don’t have that with chemotherapy exposure,” Friese says.
Safety guidelines for chemotherapy drug administration have been issued by organizations such as the National Institute for Occupational Safety and Health. But these guidelines are not mandatory. Guidelines include recommendations for using gowns, gloves and other protective gear when handling chemotherapy drugs.
The U-M Comprehensive Cancer Center adheres to these safety guidelines and has procedures in place to implement and enforce them for all staff who administer chemotherapy drugs. U-M nurses did not participate in this study.
The study authors found that practices that had more staffing and resources reported fewer exposures. Also, practices in which two or more nurses were required to verify chemotherapy orders – part of the suggested guidelines – had fewer exposures.
“This research shows that paying attention to the workload, the health of an organization, and the quality of working conditions pays off. It’s not just about job satisfaction – it’s likely to lower the risk of these occupational hazards,” Friese says.
Unlike needle sticks where a specific virus is involved and preventive treatments can be given, it’s more difficult to link chemotherapy exposure to a direct health effect. That makes it more difficult for health care systems to respond to these incidents. Unintentional chemotherapy exposure can affect the nervous system, impair the reproductive system and confer a future risk of blood cancers.
Friese collaborated in this study with the U-M School of Nursing’s Occupational Health Nursing Program, which focuses on training nurses to promote injury prevention and protect against work-related injuries and environmental hazards on the job. By combining this practical occupational health perspective with the expertise of quality and safety researchers, the team hopes to better understand what happens during chemotherapy exposure and what can be done in the work place to prevent it.
“If we ensure patient safety, we should also ensure employee safety by strictly adhering to the national safety guidelines and providing staff education on these guidelines,” Friese says.
Public release date: 23-Aug-2011
Coriander oil could tackle food poisoning and drug-resistant infections
Coriander oil has been shown to be toxic to a broad range of harmful bacteria. Its use in foods and in clinical agents could prevent food-borne illnesses and even treat antibiotic-resistant infections, according to the authors of a study published in the Journal of Medical Microbiology.
The researchers from the University of Beira Interior in Portugal tested coriander oil against 12 bacterial strains, including Escherichia coli, Salmonella enterica, Bacillus cereus and meticillin-resistant Staphylococcus aureus (MRSA). Of the tested strains, all showed reduced growth, and most were killed, by solutions containing 1.6% coriander oil or less.
Coriander is an aromatic plant widely used in Mediterranean cuisine. Coriander oil is one of the 20 most-used essential oils in the world and is already used as a food additive. Coriander oil is produced from the seeds of the coriander plant and numerous health benefits have been associated with using this herb over the centuries. These include pain relief, ease of cramps and convulsions, cure of nausea, aid of digestion and treatment of fungal infections.
This study not only shows that coriander oil also has an antibacterial effect, but provides an explanation for how it works, which was not previously understood. “The results indicate that coriander oil damages the membrane surrounding the bacterial cell. This disrupts the barrier between the cell and its environment and inhibits essential processes including respiration, which ultimately leads to death of the bacterial cell,” explained Dr Fernanda Domingues who led the study.
The researchers suggest that coriander oil could have important applications in the food and medical industries. “In developed countries, up to 30% of the population suffers from food-borne illness each year. This research encourages the design of new food additives containing coriander oil that would combat food-borne pathogens and prevent bacterial spoilage,” said Dr Domingues. “Coriander oil could also become a natural alternative to common antibiotics. We envisage the use of coriander in clinical drugs in the form of lotions, mouth rinses and even pills; to fight multidrug-resistant bacterial infections that otherwise could not be treated. This would significantly improve people’s quality of life.”
Public release date: 23-Aug-2011
Deaths from strong prescription painkillers are on the increase
Analysis: Facing up to the prescription opioid crisis
Action is needed to tackle the increasing number of deaths in the United States and Canada from prescription painkillers known as opioids, say experts on bmj.com today.
Opioids are prescription painkillers that contain compounds derived from the opium poppy.
While they have long been used to control the symptoms of cancer and acute medical conditions, they are increasingly being used to control chronic pain, for example in patients suffering from osteoarthritis, say Dr Irfan Dhalla and colleagues at the University of Toronto.
They describe how in the US, deaths involving opioid painkillers increased from 4,041 in 1999 to 14,459 in 2007 and are now more common than deaths from skin cancer, HIV and alcoholic liver disease. They add that between 1.4 million and 1.9 million Germans are addicted to prescription drugs and that some authorities have suggested that the UK may face a similar epidemic to that of North America in five to ten years time. Indeed, the use of strong opioids for chronic non-cancer pain in the UK has been described as a “disaster in the making” by Dr. Des Spence previously on bmj.com.
Dr. Dhalla and colleagues add that “deaths involving methadone and codeine roughly doubled in England and Wales between 2005 and 2009, while deaths involving heroin or morphine remained unchanged.”
In order to tackle the crisis in the US and Canada, the authors put forward several strategies.
They say staff working for drug companies should not get commission for marketing prescription opioid drugs and that regulators should evaluate adverts for them before they are disseminated. Another initiative would be to introduce real-time electronic databases to reduce the frequency with which opioids are obtained from multiple doctors or pharmacies.
Dhalla and colleagues also call for educational outreach programmes for doctors to improve opioid prescribing, as well as more research to guide practice. They note that the evidence for the use of opioids to control chronic pain is very limited and the risks may outweigh the benefits.
In conclusion, they say that maintaining access to opioids for appropriately selected patients while striving for major reductions in overdose deaths must be a major priority for physicians and policymakers.
Public release date: 24-Aug-2011
Eradicating dangerous bacteria may cause permanent harm
Researcher urges immediate investigation of widespread antibiotic use and overuse
New York, August 25, 2011 – In the zeal to eliminate dangerous bacteria, it is possible that we are also permanently killing off beneficial bacteria as well, posits Martin Blaser, MD, Frederick H. King Professor of Medicine, professor of Microbiology and chair of the Department of Medicine at NYU Langone Medical Center. His commentary is published in the August 25 edition of the journal Nature.
Dr. Blaser sounded the alarm to the medical community and to the general public, that the widespread use of antibiotics may be having unintended consequences causing permanent changes in the body’s protective, friendly flora and causing harm to the body’s natural defense system. This may be even more dangerous to health than the creation of resistant “superbugs,” which have garnered much attention over the last few years.
By the time a child in the US or other developed countries reaches the age of 18, s/he has already had on average 10-20 doses of antibiotics. These are in addition to the antibiotics that may be given to women while they are pregnant, and which may affect the normal bacteria that mothers transmit to their children.
The discovery and use of antibiotics has helped to increase life expectancy. However they are non- discriminatory and destroy even friendly bacteria, not just harmful ones. Scientists have found that some of the beneficial bacteria may never recover and that these extinctions may lead to increased susceptibility to infections and disease. As a result, antibiotic use could be contributing to the increases in obesity, allergies and asthma, inflammatory bowel disease, and type 1 diabetes that are occurring throughout the developed world.
Dr. Blaser urges physicians to curtail the use of these drugs immediately, and recommends that narrow spectrum, and more targeted drugs be used in their place. To be successful, this shift will require a significant effort to develop new antibacterials and new diagnostic tests that will permit the use of targeted agents.
“I believe that doctors of the future will be replacing “lost” members of our normal flora in young children to diminish the risk of development of these important and chronic diseases,” said Dr.
Public release date: 24-Aug-2011
Scented laundry products emit hazardous chemicals through dryer vents
The same University of Washington researcher who used chemical sleuthing to deduce what’s in fragranced consumer products now has turned her attention to the scented air wafting from household
Findings, published online this week in the journal Air Quality, Atmosphere and Health, show that air vented from machines using the top-selling scented liquid laundry detergent and scented dryer sheet contains hazardous chemicals, including two that are classified as carcinogens.
“This is an interesting source of pollution because emissions from dryer vents are essentially unregulated and unmonitored,” said lead author Anne Steinemann, a UW professor of civil and environmental engineering and of public affairs. “If they’re coming out of a smokestack or tail pipe, they’re regulated, but if they’re coming out of a dryer vent, they’re not.”
The research builds on earlier work that looked at what chemicals are released by laundry products, air fresheners, cleaners, lotions and other fragranced consumer products. Manufacturers are not required to disclose the ingredients used in fragrances, or in laundry products.
For the new study, which focuses on chemicals emitted through laundry vents, researchers first purchased and pre-rinsed new, organic cotton towels. They asked two homeowners to volunteer their washers and dryers, cleaned the inside of the machines with vinegar, and ran full cycles using only water to eliminate as much residue as possible.
At the first home, they ran a regular laundry cycle and analyzed the vent fumes for three cases: once with no products, once with the leading brand of scented liquid laundry detergent, and finally with both the detergent and a leading brand of scented dryer sheets. A canister placed inside the dryer vent opening captured the exhaust 15 minutes into each drying cycle. Researchers then repeated the procedure with a different washer and dryer at a second home.
Analysis of the captured gases found more than 25 volatile organic compounds, including seven hazardous air pollutants, coming out of the vents. Of those, two chemicals – acetaldehyde and benzene – are classified by the Environmental Protection Agency as carcinogens, for which the agency has established no safe exposure level.
“These products can affect not only personal health, but also public and environmental health. The chemicals can go into the air, down the drain and into water bodies,” Steinemann said.
The researchers estimate that in the Seattle area, where the study was conducted, acetaldehyde emissions from this brand of laundry detergent would be equivalent to 3 percent of the total acetaldehyde emissions coming from automobiles. Emissions from the top five brands, they estimate, would constitute about 6 percent of automobiles’ acetaldehyde emissions.
“We focus a lot of attention on how to reduce emissions of pollutants from automobiles,” Steinemann said. “And here’s one source of pollutants that could be reduced.”
Public release date: 25-Aug-2011
Vitamin A supplements for children could save 600,000 lives a year
Children in low and middle income countries should be given vitamin A supplements to prevent death and illness, concludes a study published on bmj.com today.
The researchers argue that the effectiveness of vitamin A supplementation is now so well-established that further trials would be unethical, and they urge policymakers to provide supplements for all children at risk of deficiency.
Vitamin A is an essential nutrient that must be obtained through diet. Vitamin A deficiency in children increases vulnerability to infections like diarrhoea and measles and may also lead to blindness. Globally, the World Health Organisation estimates that 190 million children under the age of 5 may be vitamin A deficient. But, despite widespread efforts, vitamin A programmes do not reach all children who could benefit.
So a team of researchers based in the UK and Pakistan analysed the results of 43 trials of vitamin A supplementation involving over 200,000 children aged 6 months to 5 years. Differences in study design and quality were taken into account to minimise bias.
They found vitamin A supplements reduced child mortality by 24% in low and middle income countries. It may also reduce mortality and disability by preventing measles, diarrhoea and vision problems, including night blindness.
The authors say that, if the risk of death for 190 million vitamin A deficient children were reduced by 24%, over 600,000 lives would be saved each year and 20 million disability-adjusted life years (a measure of quantity and quality of life) would be gained.
Based on these results, the authors strongly recommend supplementation for children under 5 in areas at risk of vitamin A deficiency. They conclude: “The evidence for vitamin A is compelling and clear. Further trials comparing vitamin A with placebo would be unethical.”
This view is supported in an accompanying editorial by two experts at Harvard School of Public Health, who say “effort should now focus on finding ways to sustain this important child survival initiative and fine tune it to maximise the number of lives saved.”
Public release date: 25-Aug-2011
Omega-3s reduce stroke severity
This press release is available in French.
Quebec City, August 25, 2011—A diet rich in omega-3s reduces the severity of brain damage after a stroke, according to a study conducted by Université Laval researchers. The team, co-directed by professors Jasna Kriz and Frédéric Calon, showed that the extent of brain damage following a stroke was reduced by 25% in mice that consumed DHA type omega-3s daily. Details of the study can be found on the website of the journal Stroke.
Researchers observed that the effects of stroke were less severe in mice that had been fed a diet rich in DHA for three months than in mice fed a control diet. In mice from the DHA group, they saw a reduction in the concentrations of molecules that stimulate tissue inflammation and, conversely, a larger quantity of molecules that prevent the activation of cell death.
“This is the first convincing demonstration of the powerful anti-inflammatory effect of DHA in the brain,”
underscored Frédéric Calon of Université Laval’s Faculty of Pharmacy. This protective effect results from the substitution of molecules in the neuronal membrane: DHA partially replaces arachidonic acid, an omega-6 fatty acid known for its inflammatory properties.
“The consumption of omega-3s creates an anti-inflammatory and neuroprotective environment in the brain that mitigates damage following a stroke,” summarized Jasna Kriz, of Université Laval’s Faculty of Medicine. “It prevents an acute inflammatory response that, if not controlled, is harmful to brain tissue.”
Professor Calon believes that this anti-inflammatory effect is likely transferable to humans. “Since DHA is readily available, inexpensive, and reduces the risk of a number of health problems without causing significant side effects, the risk–benefit ratio tends to favor the regular consumption of fish or DHA,” he concluded.
Public release date: 25-Aug-2011
Aerobic exercise bests resistance training at burning belly fat
DURHAM, N.C.— Aerobic exercise is your best bet when it comes to losing that dreaded belly fat, a new study finds.
When Duke University Medical Center researchers conducted a head-to-head comparison of aerobic exercise, resistance training, and a combination of the two, they found aerobic exercise to be the most efficient and most effective way to lose the belly fat that’s most damaging to your health.
This isn’t the fat that lies just under your skin and causes the dreaded muffin top. Belly or abdominal fat – known in scientific communities as visceral fat and liver fat — is located deep within the abdominal cavity and fills the spaces between internal organs. It’s been associated with increased risk for heart disease, diabetes, and certain kinds of cancer.
“When it comes to increased health risks, where fat is deposited in the body is more important than how much fat you have,” says Duke exercise physiologist Cris Slentz, Ph.D., lead author of the study published in the American Journal of Physiology. “Our study sought to identify the most effective form of exercise to get rid of that unhealthy fat.”
The Duke study showed aerobic training significantly reduced visceral fat and liver fat, the culprit in nonalcoholic fatty liver disease. Aerobic exercise also did a better job than resistance training at improving fasting insulin resistance, and reducing liver enzymes and fasting triglyceride levels. All are known risk factors for diabetes and heart disease.
Resistance training achieved no significant reductions in visceral fat, liver fat, liver enzyme levels or improvements in insulin resistance. The combination of aerobic with resistance training achieved results similar to aerobic training alone.
“Resistance training is great for improving strength and increasing lean body mass,” says Slentz. “But if you are overweight, which two thirds of the population is, and you want to lose belly fat, aerobic exercise is the better choice because it burns more calories.” Aerobic training burned 67% more calories in the study when compared to resistance training.
The eight-month study followed 196 overweight, sedentary adults (ages 18-70) who were randomized to
one of three groups: aerobic training; resistance training or a combination of the two. The aerobic group performed exercises equivalent to 12 miles of jogging per week at 80% maximum heart rate. The resistance group performed three sets of 8 – 12 repetitions three times per week. All programs were closely supervised and monitored to ensure maximum effort in participation.
While the training programs were rigorous and substantial, Slentz says their previous research leads him to believe similar results could be achieved with a more moderate aerobic exercise program.
“What really counts is how much exercise you do, how many miles you walk and how many calories you burn,” he says. “If you choose to work at a lower aerobic intensity, it will simply take longer to burn the same amount of unhealthy fat.”
Public release date: 25-Aug-2011
The malaria mosquito is disappearing — but it is not just good news
The incidence of malaria in many African countries south of the Sahara is falling rapidly. A Danish- Tanzanian research group has discovered that the mosquito carrying the malaria parasite has practically disappeared from villages without organized mosquito control, and the researchers do not know why.
There are several hypotheses but without proper data they cannot say whether malaria is being eradicated or whether it is just resting up before returning with renewed vigour.
“Many of our fellow malaria researchers think that the fall in countries such as Tanzania, Eritrea, Rwanda, Kenya and Zambia shows that all the control programmes are working, particularly the use of mosquito nets,” says Associate Professor Dan Meyrowitsch from the Department of Health Services Research at the University of Copenhagen, and continues:
“That just isn’t the whole story. For more than ten years we have been collecting and counting the number of mosquitoes in Tanzanian villages. The number in our traps fell from 5300 in 2004 to just 14 in 2009, and these were from villages without mosquito nets.”
Dan Meyrowitsch explains that the 99 % fall in the malaria mosquito population during the end of the 1990s seems to be connected to a fall in precipitation. This may be due to global climate changes.
“From 2003 to 2009 the volume of precipitation was more stable, but the rain was more chaotic and fell outside the rainy season. And this may have disturbed the natural cycle of mosquito development,” he says.
“Of course it is great that the number of malaria-related fatalities among children has fallen drastically in the last five or six years, but we need to know why!”
Since the researchers can discount mosquito nets, the question is whether the mosquitoes have succumbed to disease, or communities have been using pesticides, or whether the fall is due to the chaotic new precipitation patterns.
“Unless we find the answer we will not be able to predict when the malaria mosquitoes will come back, and that could rapidly prove critical,” Dan Meyrowitsch explains.
Many children and adults have not been exposed to malaria in the last five or six years, and so have lost or
failed to develop immunity to the parasite.
When the mosquitoes suddenly come back this may mean dramatic malaria epidemics with many fatalities unless the population and the health authorities are ready for them.
Public release date: 25-Aug-2011
Research shows heat in chili peppers can ease sinus problems
CINCINNATI—Hot chili peppers are known to make people “tear up,” but a new study led by University of Cincinnati allergy researcher Jonathan Bernstein, MD, found that a nasal spray containing an ingredient derived from hot chili peppers (Capsicum annum) may help people “clear up” certain types of sinus inflammation.
The study, which appears in the August 2011 edition of Annals of Allergy, Asthma & Immunology, compares the use of the Capsicum annum nasal spray to a placebo nasal spray in 44 subjects with a significant component of nonallergic rhinitis (i.e., nasal congestion, sinus pain, sinus pressure) for a period of two weeks.
Capsicum annum contains capsaicin, which is the main component of chili peppers and produces a hot sensation. Capsaicin is also the active ingredient in several topical medications used for temporary pain relief. It is approved for use by the U.S. Food and Drug Administration and is available over the counter.
“Basically, we concluded that the spray was safe and effective on non-allergic rhinitis,” Bernstein says of the study which showed that participants who used a nasal spray with Capsicum reported a faster onset of action or relief, on average within a minute of using the spray, than the control group.
Non-allergic rhinitis is an upper respiratory condition not caused by allergies but instead caused by environmental factors such as weather, household chemicals or perfumes; however, there are some people who have no triggers or don’t know what triggers are causing the inflammation, Bernstein says.
This is the first controlled trial where capsaicin was able to be used on a continuous basis to control symptoms. It is considered a significant advance, “because we don’t really have good therapies for non- allergic rhinitis,” says Bernstein, adding that in previous trials the ingredient was too hot to administer without anesthesia.
Public release date: 25-Aug-2011
Results of medication studies in top medical journals may be misleading to readers
UCLA-Harvard study highlights 3 types of confusing outcome measures
Studies about medications published in the most influential medical journals are frequently designed in a way that yields misleading or confusing results, new research suggests.
Investigators from the medical schools at UCLA and Harvard analyzed all the randomized medication trials published in the six highest-impact general medicine journals between June 1, 2008, and Sept. 30,
2010, to determine the prevalence of three types of outcome measures that make data interpretation difficult.
In addition, they reviewed each study’s abstract to determine the percentage that reported results using relative rather than absolute numbers, which can also be a misleading.
The findings are published online in the Journal of General Internal Medicine.
The six journals examined by the investigators— the New England Journal of Medicine, the Journal of the American Medical Association, The Lancet, the Annals of Internal Medicine, the British Medical Journal and the Archives of Internal Medicine — included studies that used the following types of outcome measures, which have received increasing criticism from scientific experts:
Surrogate outcomes (37 percent of studies), which refer to intermediate markers, such as a heart medication’s ability to lower blood pressure, but which may not be a good indicator of the medication’s impact on more important clinical outcomes, like heart attacks.
Composite outcomes (34 percent), which consist of multiple individual outcomes of unequal importance lumped together — such as hospitalizations and mortality — making it difficult to understand the effects on each outcome individually.
Disease-specific mortality (27 percent), which measures deaths from a specific cause rather than from any cause; this may be a misleading measure because, even if a given treatment reduces one type of death, it could increase the risk of dying from another cause, to an equal or greater extent.
“Patients and doctors care less about whether a medication lowers blood pressure than they do about whether it prevents heart attacks and strokes or decreases the risk of premature death,” said the study’s lead author, Dr. Michael Hochman, a fellow in the Robert Wood Johnson Foundation Clinical Scholars Program at the David Geffen School of Medicine at UCLA’s division of general internal medicine and health services research, and at the U.S. Department of Veterans Affairs’ Los Angeles Medical Center.
“Knowing the effects of a medication on blood pressure does not always tell you what the effect will be on the things that are really important, like heart attacks or strokes,” Hochman said. “Similarly, patients don’t care if a medication prevents deaths from heart disease if it leads to an equivalent increase in deaths from cancer.”
Dr. Danny McCormick, the study’s senior author and a physician at the Cambridge Health Alliance and Harvard Medical School, added: “Patients also want to know, in as much detail as possible, what the effects of a treatment are, and this can be difficult when multiple outcomes of unequal importance are lumped together.”
The authors also found that trials that used surrogate outcomes and disease-specific mortality were more likely to be exclusively commercially funded — for instance, by a pharmaceutical company.
While 45 percent of exclusively commercially funded trials used surrogate endpoints, only 29 percent of trials receiving non-commercial funding did. And while 39 percent of exclusively commercially funded trials used disease-specific mortality, only 16 percent of trials receiving non-commercial funding did.
The researchers suggest that commercial sponsors of research may promote the use of outcomes that are most likely to indicate favorable results for their products, Hochman said.
“For example, it may be easier to show that a commercial product has a beneficial effect on a surrogate marker like blood pressure than on a hard outcome like heart attacks,” he said. “In fact, studies in our analysis using surrogate outcomes were more likely to report positive results than those using hard outcomes like heart attacks.”
The new study also shows that 44 percent of study abstracts reported study results exclusively in relative — rather than absolute — numbers, which can be misleading.
“The way in which study results are presented is critical,” McCormick said. “It’s one thing to say a medication lowers your risk of heart attacks from two-in-a-million to one-in-a-million, and something completely different to say a medication lowers your risk of heart attacks by 50 percent. Both ways of presenting the data are technically correct, but the second way, using relative numbers, could be misleading.”
Still, the authors acknowledge that the use of surrogate and composite outcomes and disease-specific mortality is appropriate in some cases. For example, these outcomes may be preferable in early-phase studies in which researchers hope to quickly determine whether a new treatment has the potential to help patients.
To remedy the problems identified by their analysis, Hochman and McCormick believe that studies should report results in absolute numbers, either instead of or in addition to relative numbers, and that committees overseeing research studies should closely scrutinize study outcomes to ensure that lower- quality outcomes, like surrogate makers, are only used in appropriate circumstances.
“Finally, medical journals should ensure that authors clearly indicate the limitations of lower-quality endpoints when they are used — something that does not always occur,” McCormick said.
Public release date: 26-Aug-2011
65 million more obese adults in the US and 11 million more in the UK expected by 2030
Resulting rise in US medical costs estimated to reach up to $66 billion a year
August 26, 2011 — The rising prevalence of obesity around the globe places an increasing burden on the health of populations, on healthcare systems and on overall economies. A major challenge for researchers is to quantify the effect of these burdens to inform public policies. Using a simulation model to project the probable health and economic consequences from rising obesity rates in the United States and the United Kingdom, researchers at Columbia University’s Mailman School of Public Health and Oxford University forecast 65 million more obese adults in the U. S. and 11 million more in the U.K. by 2030, leading to millions of additional cases of diabetes, heart disease, stroke, and cancer. The findings suggest that medical costs associated with treatment of these preventable diseases in the U.S. alone will increase by
$48-66 billion per year.
The paper, “Health and Economic Burden of the Projected Obesity Trends in the USA and the UK,” is part of a series of articles on obesity published in the August 27 issue of Lancet. The research was led by
Y. Claire Wang, MD, ScD, Mailman School assistant professor of Health Policy and Management, with colleagues from Oxford University.
To construct historic trends in BMI the researchers analyzed data from two nationally representative
surveys: the U.S. National Health and Nutrition Examination Survey (NHANES) from 1988 to 2008, and the Healthy Survey for England (HSE) from 1993 to 2008. The U.S. and U.K. have the highest obesity rates among the countries belonging to the Organization for Economic Cooperation and Development.
Projecting from these data sets: the researchers predicted the following impacts for the U.S. by 2030: Obesity prevalence among men would rise from 32% in 2008 to approximately 50% and from 35% to between 45% and 52% among women.
7.8 million extra cases of diabetes
6.8 million more cases of coronary heart disease and stroke 539,000 additional cases of cancer
Annual spending on obesity-related diseases would rise by 13-16%, leading to 2.6% increase in national health spending.
Total medical costs associated with treatment of these preventable diseases are estimated to increase by
For the U.K., researchers predicted the following developments by 2030:
Prevalence of obesity among men would increase from 26% to between 41—48%, and among women from 26% to 35-43%.
668 000 more cases of diabetes
461,000 more cases of heart disease and stroke 139,000 additional cases of cancer.
In the U.K., annual spending on obesity-related health would increase even more rapidly than in the U.S. due to its older population, rising 25%.
“Many chronic and acute health disorders associated with excess bodyweight burden society—not only by negatively affecting the health-related quality of life but also by incurring significant costs,” says Dr.
Wang. These stem not only from increased healthcare expenditures but also from worker absenteeism, disability pensions, less productivity at work due to poor health, and earlier retirement.”
The new study shows that even a small drop in average body mass index (BMI) would have a major health and economic impacts. They therefore recommend action to promote healthier body weights.
“Taking no action would have the catastrophic consequences described in our study, but a population level decrease in BMI by 1% would avoid as many as 2.4 million cases of diabetes, 1.7 million cases of heart disease and stroke, and up to 127 000 cases of cancer in the U.S. alone .”
There are currently 99 million obese individuals in the U.S and 15 million in the U.K. The distribution of obesity is somewhat different in the two nations. In the U.S. about one-quarter of all men are obese regardless of ethnicity. Almost half of black American women (46%) are obese, compared with a third of Hispanic women and 30% of white women. In the U.K., the proportion of obese white men (19%) is slightly higher than black men (17%) and much higher than Asian men (11%). One-third of black women in the U.K. are obese, compared with 1 in 5 white women and 1 in 6 Asian women.
While there is some evidence that the rise in obesity is levelling off in some nations and possibly in the U.S., the jury is still out, says Dr. Wang. “Population weight changes are slow to manifest. Whether or not the U.S. and UK have turned a corner or plateaued will not be clear until survey results over the next few years provide additional data points.”
The suggestion that obese people die earlier, thus saving the likely expected social and healthcare
costs if that person survives to old age, is also discussed in the paper. However the authors conclude, “Without a doubt, healthcare expenditure is high for elderly people, but these costs should not be used to justify the cost-savings of dying younger, or to suggest that obesity prevention has no benefit.”