More physical activity, higher intensity may significantly reduce risk of death in older women in the short term

More physical activity and at higher intensities could lead to a big drop in the risk of death in older women from any cause, according to new research in the American Heart Association's journal Circulation.

07 nov 2017--Researchers found the volume of light intensity physical activity or sedentary behavior was not associated with death rate. However, light intensity activity may be beneficial for other health outcomes not studied in this research.
Previous studies, which used self-reports, showed that active people have about 20 percent to 30 percent lower death rates compared to their least active counterparts.
This research, conducted from 2011 to 2015, is among the first to investigate physical activity, measured using a wearable device called a triaxial accelerometer, and a clinical outcome. The device is capable of measuring activity along three planes: up and down, front to back and side to side. These capabilities increase sensitivity to detect physical activity and allow for more precise measurements.
"We used devices to better measure not only higher intensity physical activities, but also lower intensity activities and sedentary behavior, which has become of great interest in the last few years," said I-Min Lee, M.B.B.S., Sc.D., the study's first author and professor of medicine and epidemiology at Harvard University's medical and public health schools in Boston, Massachusetts.
More than 17,700 women (average age 72) who were asked to wear the device for seven days, when awake, returned their devices. Data were analyzed from 16,741 compliant participants (i.e., their devices showed it was worn for at least 10 hours a day, on at least four days). During an average follow-up of approximately two-and-a-half years, 207 women died.
Researchers found:

• More moderate to vigorous intensity physical activity (such as brisk walking) was associated with roughly a 60 percent to 70 percent lower risk of death at the end of the study among the most active women, compared to the least active.
• More light intensity activity (such as housework and slow walking - e.g., window shopping in a mall), or more sedentary behavior was not independently associated with death risk at the study's end. Researchers stressed this finding does not mean light activity isn't beneficial for other health outcomes not studied here.

Researchers chose this study population to begin addressing knowledge gaps, said Lee who is also an associate epidemiologist at Brigham and Women's Hospital in Boston. "Younger people in their 20s and 30s generally can participate in vigorous intensity activities, such as running or playing basketball. But for older people, vigorous intensity activity may be impossible, and moderate intensity activity may not even be achievable. So, we were interested in studying potential health benefits associated with light intensity activities that most older people can do."
The study's participants, selected from the Women's Health Study, were relatively healthy, and mostly white women, therefore the findings may have limited generalizability to other groups of people.
The findings support 2008 federal guidelines and American Heart Association that suggest at least 150 minutes a week of moderate intensity or 75 minutes a week of vigorous-intensity aerobic physical activity (or a combination of the two) and muscle-strengthening exercises two or more days a week.
"We hope to continue this study in the future to examine other health outcomes, and particularly to investigate the details of how much and what kinds of activity are healthful. What is irrefutable is the fact that physical activity is good for your health," Lee said.

More information: Circulation (2017). DOI: 10.1161/CIRCULATIONAHA.117.031300


Provided by American Heart Association

Colorectal cancer screening should start at 45, new research shows

Infographic on CRC. 

Screening for colorectal cancer (CRC) should begin at 45 years of age to match rising mortality rates in young adults, research presented today at the 25th UEG Week Barcelona reveals.

Scientists in France analysed 6,027 colonoscopies and found a 400% increase in the detection of neoplasia (the new, uncontrolled growth of abnormal tissue) in patients aged between 45-49 in comparison to patients aged 40-44. The neoplasia detection rate was also 8% higher in people aged between 45-49 than it was between 50-54, leading to calls for CRC screening programmes to begin at 45 years of age.
The mean number of polyps (growths on the inner lining of the colon that can turn cancerous if left untreated) and the adenoma detection rate (proportion of individuals undergoing a colonoscopy who have one or more adenomas detected) also increased by 95.8% and 95.4% respectively between the 40-44 and 45-49 age groups. This was far more substantial than the increase between the 45-49 and 50-54 age groups, which was 19.1% and 11.5% respectively.
Lead researcher, Dr David Karsenti, who will present the findings for the first time today at UEG Week, explains; "These findings demonstrate that it is at 45 years old that a remarkable increase in the colorectal lesions frequency is shown, especially in the detection rate of early neoplasia. Even when patients with a familial and personal history of polyps or cancer are excluded from the findings, there is still a noticeable increase in detection rates in patients from the age of 45."

The mean number of polyps, adenoma detection rate and neoplasia detection rate by age. Credit: UEG

CRC is the second most common cause of cancer-related death in Europe, killing 215,000 Europeans every year, with research recently revealing that three in ten CRC diagnoses are now among people younger than 55. There is strong evidence to demonstrate that screening for CRC reduces incidence and mortality rates, yet there are vast inequalities in CRC screening across Europe with both organised and opportunistic schemes, different types of tests and varying participation and detection rates. Despite the dramatic rise of CRC in young adults, the vast majority of screening programmes throughout Europe commence between the ages of 50 and 55, with some not beginning until the age of 60.
Dr Karsenti adds "Regardless of the type of screening that is in place, the results of our research strongly indicate that screening for colorectal cancer should begin at the age of 45. This will this help us to increase the early detection of colorectal cancer in young adults and also enable the identification and safe removal of polyps that may become cancerous at a later date."

The neoplasia detection rate by age. Credit: UEG

More information: 1. Karsenti, D. et al (2017), Adenoma detection rate according to age: colonoscopy screening should start at 45 years old, Presented at the 25th UEG Week Barcelona, October 30, 2017.
2. Epidemiology of colorectal cancer: international comparison, 4th European Colorectal Cancer Days 2015. Available at: www.crcprevention.eu/index.php … -cancer-epidemiology
3. Dramatic rise in colorectal cancer in younger adults (2017), Medscape. Available at: www.medscape.com/viewarticle/876409


Provided by United European Gastroenterology

Research lays groundwork for promising Alzheimer's-fighting drink

A nutrient mix based in part on research from the lab of MIT Professor Emeritus Richard Wurtman has shown promise in treating the early stages of Alzheimer’s disease. 

Much of Professor Emeritus Richard Wurtman's career in MIT's Department of Brain and Cognitive Sciences revolved around developing new treatments for diseases and conditions by modifying chemicals produced in the brain.

01 nov 2017--Since coming to MIT in 1970, Wurtman and his research group have generated more than 1,000 research articles and 200 patents, laying the groundwork for numerous successful medical products.
 "I'm very interested in using basic knowledge to ameliorate the human condition, to make living better," says Wurtman, who is also a medical doctor.
Now a nutrient mix based on essential research contributions by Wurtman has shown promise in treating the early stages of Alzheimer's disease, according to a new clinical trial funded by the European Union.
In the mid-2000s, Wurtman developed a nutrient cocktail aimed at treating what he considers "the root cause" of Alzheimer's: loss of brain synapses. The mixture increases production of new synapses and restores connectivity between brain regions, improving memory and other cognitive functions. A French company then combined this research with a multinutrient it was developing along with the LipiDiDiet consortium—a European collaboration of 16 universities and research centers—to create a drink, called Souvenaid, for Alzheimer's patients.
Over the years, Souvenaid has been the focus on several clinical trials to validate its efficacy. The mixture is not yet available in the United States, but it is being sold as a "medical food"—a category of regulated and safe foods that are designed for dietary management of diseases—in a number of countries across the globe.
In the new clinical trial, published in today's issue of Lancet Neurology, patients with prodromal Alzheimer's—the predementia stage of Alzheimer's with mild symptoms—were given either Souvenaid or a placebo. Compared to people who drank the placebo, patients who drank Souvenaid throughout the trial showed less worsening in everyday cognitive and functional performance and significantly less atrophy of the hippocampus, which is caused early in Alzheimer's by brain tissue loss.
"It feels like science-fiction, where you can take a drink of Souvenaid and you get more synapses … for improved cognitive function," Wurtman says. "But it works."
The co-authors of the study are from the University of Eastern Finland, Kuopio University Hospital, Karolinska Institutet and Karolinska University Hospital, the University of Masstricht, the VU University Medical Centre, Pentara Corporation, the University of Gothenburg, Sahlgrenska University Hospital, and Saarland University and the LipiDiDiet study group.

Making Souvenaid

Souvenaid's popularity may be on the rise today, but the product would not be possible without years of MIT research, Wurtman says.
In the mid-2000s, Wurtman's research led him to seek the mechanisms behind the body's production of phosphatides, a class of lipids that, along with proteins, form biological membranes. Production of these phosphatides, Wurtman discovered, depends on a set of nutrient precursors.
Specifically, Wurtman homed in on three naturally occurring dietary compounds: choline, uridine, and the omega-3 fatty acid DHA. Choline is found in meats, nuts, and eggs. Fish, flaxseeds, and certain meats contain omega-3 fatty acids. Uridine is mostly produced in the liver.
All those compounds taken simultaneously boost production of phosphatides, encouraging membrane development, which is critical in creating new synapses. Knowing that Alzheimer's-affected brains continuously lose synapses, Wurtman patented the work through MIT's Technology Licensing Office in hopes of using some version of the cocktail to treat Alzheimer's and any disease that leads to loss of synapses.
Then, in 2003, Wurtman presented the work at a meeting in Europe. Attending the event was a representative from Nutricia—a unit of Danone, a French company known as Dannon in the United States—which was experienced in making medical foods. Wurtman was invited to the company's headquarters, where a deal was hashed out to combine Wurtman's findings with a multinutrient the company was working on to create a new treatment for Alzheimer's.
By 2008, Danone had licensed the patent and Souvenaid was already a product. But Wurtman and several graduate students continued basic research behind Souvenaid, which gave the product a boost. "We were much more able to do the basic research at MIT," Wurtman says. "As soon as we found something in the research, we'd patent it. We never had the lag time. If you work in entrepreneurship and innovation that lag time could be the downfall of a prospective product."
Among the group's key discoveries was the finding that Souvenaid boosted the number of structures called dendritic spines, found in brain cells. When spines from one neuron contact another, a synapse is formed.
A 2010 study detailing those findings in Alzheimer's and Dementia indicated that Souvenaid improved verbal memory in patients with mild Alzheimer's. A 2012 study published in the Journal of Alzheimer's Disease confirmed and expanded these findings. Over six months, patients with mild Alzheimer's were given Souvenaid or a placebo. Patients taking the placebo deteriorated in their verbal-memory performance in the final three months of the study, while the Souvenaid patients continued to improve. Both trials were conducted by Philip Scheltens of the Alzheimer Center of the VU University Medical Centre in Amsterdam.

Future of Souvenaid

In the new clinical trial by the LipiDiDiet consortium, researchers conducted a 24-month trial, where more than 300 patients with prodromal Alzheimer's were randomly assigned Souvenaid or a placebo. The patients taking Souvenaid showed about 45 percent less cognitive decline than people taking the placebo, according to a measure known as the clinical dementia rating sum of boxes.
But the surprising finding, Wurtman says, is that the patients taking Souvenaid showed a substantial reduction is the loss of hippocampal volume. In early stages of Alzheimer's, the hippocampus—which plays an important role in memory—shrinks as tissue is destroyed. But rates of deterioration for those taking Souvenaid were about 26 percent lower than the control group.
"That's remarkable," Wurtman says. "I never would have guessed that something like that could happen. But if you suppress the loss of the hippocampus, it makes sense that you'd have better retention of cognitive function."
The results indicate that Souvenaid may be able to slow or stop full progression of very early Alzheimer's into full-blown Alzheimer's, Wurtman says.
With this new study, Wurtman has high hopes for Souvenaid. First, he says the findings could encourage more researchers to view synapse restoration as a treatment for Alzheimer's, which isn't a popular area of study. Most research today, he says, focuses on reducing the accumulation of amyloid plaques or minimizing damage caused by toxic metabolites in Alzheimer's-affected brains.
"Everyone who writes about Alzheimer's knows there's a synapse deficiency, and this impairs connections between brain regions," he says. "Even if the amyloid or another problem gets solved, one way or another, you'll have to replace these synapses."
Wurtman also hopes the study will "catalyze the rapid appearance of Souvenaid in the American market" and become a very early treatment for suspected Alzheimer's patients. Several potential biomarkers are being studied as indicators of early Alzheimer's. But it's somewhat useless to detect these biomarkers if nothing can be done about the disease at that point, Wurtman says. With Souvenaid, he says, that can change.
"Most people don't do a biomarker test, because … there's been nowhere to go from there. Now, it will be possible, I believe, for a doctor to tell a patient that, even though they have early Alzheimer's, they can take Souvenaid chronically to suppress the development of the disease."

This story is republished courtesy of MIT News (web.mit.edu/newsoffice/), a popular site that covers news about MIT research, innovation and teaching.

Provided by Massachusetts Institute of Technology

Research consortium LipiDiDiet finds a way to impact Alzheimer's disease before it's too late

Professor Tobias Hartmann, Saarland University in Germany.

The pioneering clinical trial is part of a large European Union funded project and involved 311 patients across 11 sites in four countries (Finland, Germany, the Netherlands and Sweden). The trial involved patients with prodromal Alzheimer's (often referred to as Mild Cognitive Impairment or MCI). Patients were randomised to receive either the nutritional intervention or an iso-caloric control drink for 24 months.

31 oct 2017--The study's primary endpoint, impact on NTB, was not met. The decline in the NTB of the control group was less than anticipated rendering this analysis statistically underpowered. However, key secondary endpoints showed significant advantages for nutrient-treated patients with 45% less worsening in the Clinical Dementia Rating-Sum of Box (CDR-SB). This measure is especially important because it tracks the patient's disease progression based on performance in managing everyday life, such as handling household emergencies, handling financial transactions or forgetting a major event. Furthermore, there was less brain atrophy in the active group, with 26% difference for the hippocampus and 16% for the ventricular volume. Progressive brain degeneration is typical for Alzheimer's, with hippocampal damage being responsible for many of the associated memory deficits. Over the 24-month period the incidence of any adverse events were similar between the active and control groups.
Professor Hilkka Soininen, Professor in Neurology MD, PhD from the University of Eastern Finland, who headed the clinical trial as part of the LipiDiDiet project, said: "Today's results, published in The Lancet Neurology, are extremely valuable as they bring us closer to understanding the impact of nutritional interventions on prodromal Alzheimer's, which we are now better at diagnosing but unable to treat due to a lack of approved pharmaceutical options. The LipiDiDiet study illustrates that this nutritional intervention can help to conserve brain tissue and also memory and patients' ability to perform everyday tasks - possibly the most troubling aspects of the disease."
The LipiDiDiet trial is now the third clinical trial on this nutritional intervention to show favourable effects on memory performance. The two previous clinical trials involved patients with mild Alzheimer's dementia and reported that daily intake of the nutritional intervention improved memory performance and increased measures of synaptic and functional connectivity in the brain.
Professor Tobias Hartmann, the project's coordinator, said: "While this nutritional intervention is not a cure for Alzheimer's, it effectively shows that the earlier in the disease process we intervene, the greater the advantage for the patient. Importantly, reduced atrophy in the patient's brain shows that the benefit extends beyond symptomatic effects, something never before achieved."

More information: The Lancet (2017). DOI: 10.1016/S147


Provided by Saarland University

Panel recommends new, better shingles shot over old version

This image provided by GlaxoSmithKline in October 2017 shows the company's Shingrix vaccine. On Wednesday, Oct. 25, 2017, a federal panel of experts recommended that as many as 20 million Americans who were vaccinated against shingles get revaccinated with a new shot. The panel said doctors should first opt for Shingrix, licensed a week earlier, which uses a new ingredient to boost immunity. 

27 oct 2017--A federal panel recommended Wednesday that older people already vaccinated for shingles get a new, better shot.
The advisory group said the just-approved vaccine made by GlaxoSmithKline works better at preventing shingles and may last longer than the one that's been sold in the U.S. since 2006.
Shingles, a painful condition that causes blisters, occurs when the chickenpox virus resurfaces decades later, often when people are in their 60s or older. About 1 in 3 U.S. residents will get it during their lifetime, according to the Centers for Disease Control and Prevention.
At a meeting in Atlanta, the Advisory Committee on Immunization Practices said doctors should first opt for Glaxo's two-dose Shingrix, which uses a new ingredient to boost its effectiveness. It was approved in the U.S. last week, and the committee recommended it for adults 50 and older.
Shingrix has been shown to be 90 percent effective and last at least four years in company-sponsored studies.
"It performs in very superior fashion and will prevent more disease than the other vaccine available," said panel member Dr. Kelly Moore, director of the Tennessee health department's immunization program.
The vote recommending a preference for Glaxo's vaccine over Merck's single-dose Zostavax was unusually close, 8-7. Panel members noted that the two vaccines have not been tested head-to-head yet, and some wanted to wait for more long-term safety information about the new additive used by Glaxo.
But other panel members worried that without citing a preference, many doctors and pharmacies may decide to stock Merck's less expensive vaccine, which costs $232 compared to $280 for the Glaxo vaccination.
Merck's single-dose Zostavax vaccine is recommended for people 60 and older. It reduces the risk by about half, though health officials say its effectiveness drops sharply after about five years.
The panel didn't suggest a time frame when it recommended a Glaxo vaccine for anyone previously vaccinated. Health officials say as many as 20 million Americans would be eligible for a second round.
The shingles vaccine hasn't been very popular; only about 30 percent of those over 60 got it.
The panel's recommendations are almost always adopted by the CDC. But in a statement, Merck officials said they hope the agency will consider some of the issues raised at the meeting and not give a preferential recommendation to Shingrix

'Choosing Wisely' movement: Off to a good start, but change needed for continued success

Five years ago, a group of medical organizations did something they'd never done before: give doctors a list of things they shouldn't do for their patients. Their goal: to empower doctors and patients to start a conversation about avoiding unnecessary care.

24 oct 2017--Now, the momentum behind this campaign, called "Choosing Wisely", has snowballed. The list of things doctors shouldn't do has grown to more than 500 items - from specific uses of blood tests and scans, to particular prescription drugs and medical devices. Behind each one lies a body of evidence showing that it's not necessary for specific patients - or that it may even harm them.
But if the world wants to eliminate unnecessary care, the Choosing Wisely movement needs to evolve, say a trio of University of Michigan and VA researchers in a new analysis published in Health Affairs and discussed at a briefing in Washington, D.C. today.
Even after a Choosing Wisely recommendation comes out, the actual use of that type of care may go down only slightly, according to several studies. This shows how hard it is to help doctors stop doing things they may have done for years, for patients with particular symptoms or health risks.
The campaign has succeeded tremendously in starting the conversation about low value care, say the authors of the new paper. But it does need to take specific next steps to continue to move forward.
"We need to get more rigorous, and more innovative," says Eve Kerr, M.D., M.P.H., lead author of the paper and a longtime researcher on appropriate and low-value care. "The recommendations so far are a great start and laid the foundation, but we need to focus on using strong methods to identify ones that will make the most difference in quality and value in healthcare, and innovate in the way we change clinical practice and culture."
Some specific recommendations that Kerr and her colleagues make include:

• Prioritize recommendations: New recommendations should focus on the most-overused practices, based on actual clinical data, so as to make the biggest impact on care
• Consolidate recommendations: Groups of professional societies should work together to create recommendations for the care of patients seeking care for the same complaint. For instance, many current recommendations address back pain.
• Evaluate efforts: Researchers should evaluate the impact of recommendations more rigorously, using methods that can truly let them see if the recommendations are making a difference and if any they led to any unintended consequences. They should also try to identify barriers to success. While this kind of evaluation should include cost-related impacts, cost reduction is not the key goal of Choosing Wisely.
• Consider patient preferences: Recommendations should take into account patient priorities, and preferred outcomes, front and center with guidelines and in evaluations, and make sure they can understand the recommendations that affect them.
• Share best practices: Health care and government organizations should partner with institutions that are making serious efforts to help their providers follow Choosing Wisely recommendations, and with researchers who can help enhance the innovation and rigor of interventions and evaluations.

"Choosing Wisely has changed the game in terms of getting people to think about healthcare services that don't help people, could hurt them and add excess cost to our health system," says Jeff Kullgren, M.D., M.S., M.P.H., a co-author of the new paper and an assistant professor of internal medicine at U-M. "We hope that this synthesis of the evidence will point us in a clear direction for how to make our health care system more efficient."
The authors note that Choosing Wisely has made great inroads in awareness and provider buy-in over a short period. It represents an evolution in medical thinking, because just 20 years ago, the medical community was most focused on making sure that more patients got more of the types of care they needed the most, such as as regular blood sugar tests for people with diabetes.
That's still important, says Kerr, but now "we need to also focus on making sure patients don't get care they don't need. This is about patients and physicians having conversations to help them make the right decisions."
Says co-author Sameer Saini, M.D., M.S., "The key is to get the right care to the right patient at the right time. But changing the behavior of patients, providers, and health systems is not easy. We need to be more thoughtful about how we design programs and interventions to reduce the use of low-value care and be more rigorous and complete in how we assess whether these programs actually worked. At the same time, we need to think about how we will sustain what has been achieved once a program ends. Doing this well is going to require that clinicians, health system leaders, and researchers work together."
Kerr, a professor of internal medicine at U-M and director of the VA Center for Clinical Management Research, heads an effort called the Michigan Program on Value Enhancement that's working to do many of the things the team recommends in the new paper. MPrOVE brings researchers and clinicians together to identify, implement and evaluate specific projects focused on improving quality and demonstrating the value of care at Michigan Medicine, U-M's academic medical center.
Kullgren, who specializes in studying consumer behavior around use of health services, notes that Consumer Reports has done a good job of creating materials aimed at patients for each of the Choosing Wisely recommendations.
He has even used them in his own research, which is funded by the Donaghue Foundation and seeks to assess the impact of having providers make specific commitments to applying Choosing Wisely guidelines for diabetes care, sleep medication and prostate cancer screening in their own practice. He is also holds a Career Development Award from the VA to bring behavioral economics approaches to clinical care practice.
"How we go about changing the hearts and minds of patients, as well as doctors, still holds a lot of unknowns," he says. "We have an opportunity to move things forward."

More information: Health Affairs (2017). DOI: 10.1377/hlthaff.2017.0953


Provided by University of Michigan

New teleneurology curriculum provides guidelines for care

Researchers recommend protocols to tame ‘Wild West’ landscape of teleneurology.

Health professionals can deliver quality neurological care remotely to patients through the emerging field of teleneurology. However, medical training has not caught up with the field, and a lack of formalized education for teleneurology doesn't exist. Now, a researcher at the University of Missouri School of Medicine, as part of an American Academy of Neurology (AAN) team, has developed a standardized curriculum for providing remote neurology care via telecommunication.

22 oct 2017--"We're facing a shortage of neurologists in both rural and urban areas, compounded by the fact that more patients now have insurance and are able to seek care," said Raghav Govindarajan, M.D., assistant professor of clinical neurology at the MU School of Medicine and lead author of the study. "Through teleneurology, we're able to virtually treat patients using technologies such as two-way video conferencing, wireless sensors, and text- and image-based communication. This has shown tremendous promise and has already played a major role in acute stroke care. Despite this, teleneurology training in residency programs is currently non-existent, or it is sporadic and inconsistent at best."
An AAN workgroup comprised of 12 specialists developed a curriculum to train students, resident physicians, fellows, faculty and other health care providers in both academic medicine and private practice. While it is designed for teleneurology, the tenets of the program can be applied to other fields of medicine as well, according to the researchers. The curriculum has been endorsed by the American Telemedicine Association.
The team identified five main areas that providers need to understand before practicing teleneurology:
1. Introduction to technology, basic implementation and limitations: A strong foundation of technical knowledge is essential for safe and effective care. The provider must be comfortable with using technology to review the patient's medical records, move cameras and perform other functions. Health professionals must be able to troubleshoot technological issues that arise.
2. Licensure, medical legal issues and ethics: Licensing requirements vary from state to state and are continuously evolving. Participants must have a foundational understanding of these requirements to avoid potential legal ramifications.
3. "Webside" manners: Developing a provider-patient relationship is an important part of the healing process in face-to-face visits. A video screen and camera can make this difficult, and providers must overcome this barrier to connect with their patients.
4. Informed consent, patient privacy and disclosure: Neurologists must be trained to inform their patients of the security of their personal data in accordance with the Health Insurance Portability and Accountability Act and the Health Information Technology for Economic and Clinical Health Act.
5. Neurology-specific clinical skills: Patients must receive the same standard of care that they would with an in-person provider. The provider must discuss expectations with the patient to ensure their health concerns can be properly addressed.
"Unfortunately, teleneurology is akin to the Wild West," Govindarajan said. "Many practitioners may be operating without the necessary skills and expertise to best care for patients. They're putting their patients and themselves at unnecessary risk. Our outline for a teleneurology curriculum is meant to be an evolving document that will continue to be adapted to best practices in the field. It's our hope that it will be implemented at organizations across the country and internationally."
The study, "Developing an Outline for Teleneurology Curriculum," recently was published in Neurology, the official journal of the American Academy of Neurology. Research reported in this study was supported by the American Academy of Neurology.


Provided by University of Missouri-Columbia

New IOF Compendium documents osteoporosis, its management and global burden

A new referenced report on osteoporosis, its management and global burden published by the International Osteoporosis Foundation (IOF) 

Today, on the occasion of World Osteoporosis Day, the International Osteoporosis Foundation (IOF) has issued the first edition of a comprehensive and scientifically referenced report on osteoporosis.
The 'IOF Compendium of Osteoporosis' will be available in five languages, is to be periodically updated, and is intended as an authoritative reference document for all key stakeholders in the field of musculoskeletal health.

20 oct 2017--In addition to providing a concise overview of the pathophysiology, risk factors, prevention and management of the disease, the Compendium documents the prevalence of osteoporosis and related fractures both globally and regionally. It outlines current research on the epidemiology, mortality, health expenditure, and access to/reimbursement for diagnosis and treatment for each respective region of the world. The cycle of impairment and fracture in osteoporosis is also shown, illustrating the correlation between the number of fractures an individual suffers and the decline in physical function and health-related quality of life.
The projected increase in osteoporosis and fragility fractures documented in the Compendium is dramatic and is expected to pose a huge and growing challenge on healthcare systems. In 2010 the number of individuals aged 50 years and over at high risk of osteoporotic fracture worldwide was estimated at 158 million and this is set to double by 2040. The numbers of hip fractures - the fractures which result in the most morbidity, mortality, and healthcare costs - is set to more than double in populous countries such as Brazil and China by 2040 and 2050 respectively. In the USA, by 2025, the annual incidence of fragility fractures is projected to exceed 3 million cases, at a cost of USD 25 billion.
IOF President Professor Cyrus Cooper stated, "Fragility fractures, the clinically significant consequence of osteoporosis, impose a tremendous human and socioeconomic burden in all regions of the world. However, as documented in the 'IOF Compendium of Osteoporosis', there is persistent under-diagnosis and -treatment of individuals at high risk of fracture, including those who have already sustained a first fracture. Given the projected increase in fragility fractures in the coming decades, this is of great concern, both from a human and socio-economic perspective."
The 'IOF Compendium of Osteoporosis' proposes eight key priority actions which should be initiated by healthcare authorities, healthcare professionals, and concerned stakeholders in order to stem the burden of osteoporosis and fragility fractures. These include, first and foremost, the provision of Orthogeriatric and Fracture Liaison Services for all older patients who sustain fragility fractures to prevent a cycle of potentially debilitating and life-threatening secondary fractures.
The IOF Compendium of Osteoporosis is available in English as well as in other languages on the World Osteoporosis Day website.


Provided by International Osteoporosis Foundation

Confusion about long-term treatment of osteoporosis clarified

Osteoporosis is a common disorder among postmenopausal women which results in an increased risk of fractures. While several therapies improve bone strength and reduce the risk of spine and hip fracture, there is no cure for osteoporosis, and long-term treatment is needed. An upcoming presentation at The North American Menopause Society (NAMS) Annual Meeting in Philadelphia October  is scheduled to present new evidence about the long-term effectiveness and safety of treatment with bisphosphonates and denosumab.

06 oct 2017--Bisphosphonates and denosumab are the most commonly prescribed treatments for osteoporosis. Protection from fractures occurs within the first few months of treatment and persists as long as treatment is continued. Upon stopping bisphosphonate therapy, protection from fractures is gradually lost over three to five years. Treatment for more than three years has been associated with an increasing risk of unusual or "atypical" fractures of the femur (thigh bone). After five years of treatment, the risk of these atypical fractures is about 20 per 100,000 patients and increases to about 1/1,000 patients after eight to ten years of treatment.
The combination of increased risk of atypical fracture along with a relatively slow offset of the protection from fractures due to osteoporosis led to the confusing concept of a "bisphosphonate holiday." The American Society for Bone and Mineral Research has recently provided clear recommendations about "bisphosphonate holidays." After three to five years of bisphosphonate treatment, a patient's risk of fracture should be reevaluated. For patients remaining at high risk of fracture (those with previous hip, spine, or multiple other fractures or with bone density values remaining in the osteoporosis range), continuing treatment or changing to a different drug like denosumab is important. For patients whose risk of fracture is lower, stopping treatment for two to three years (the "holiday") can be considered but is not mandatory.
It's important to note that the concept of a "holiday" from therapy applies only to the bisphosphonates and not to any of the other drugs used to treat osteoporosis. The beneficial effects of these other medicines, including raloxifene, teriparatide, and denosumab, are lost quickly when treatment is stopped.
"Because protection from fractures disappears quickly if denosumab treatment is stopped, and since there are no currently known safety issues that limit the duration of denosumab therapy, there is no justification for a drug holiday with this treatment," says Dr. Michael McClung of the Oregon Osteoporosis Center in Portland, Oregon, who will be presenting his recommendations on long-term osteoporosis therapy at the NAMS Annual Meeting. "Just as we do not recommend stopping treatment for high blood pressure or diabetes, it is necessary to have a long-term treatment plan for postmenopausal women with osteoporosis if the benefits of our therapies are to be realized."
"Prevention of osteoporosis should be a goal for those treating menopausal women, as up to 20% of bone loss occurs within the first five years of menopause. Once diagnosed with osteoporosis, the goal becomes lowering the risk of fractures as fractures can be life changing or life limiting. This presentation will offer valuable insights about the need for long-term treatment and will change the way health care providers approach long-term osteoporosis management," says Dr. JoAnn Pinkerton, NAMS executive director.
Drs. McClung and Pinkerton are available for interviews before the presentation at the Annual Meeting.


Provided by The North American Menopause Society

What is mindfulness? Nobody really knows, and that's a problem

You've probably heard of mindfulness. These days, it's everywhere, like many ideas and practices drawn from Buddhist texts that have become part of mainstream Western culture.

15 oct 2017--But a review published today in the journal Perspectives on Psychological Science shows the hype is ahead of the evidence. Some reviews of studies on mindfulness suggest it may help with psychological problems such as anxiety, depression, and stress. But it's not clear what type of mindfulness or meditation we need and for what specific problem.
The study, involving a large group of researchers, clinicians and meditators, found a clear-cut definition of mindfulness doesn't exist. This has potentially serious implications. If vastly different treatments and practices are considered the same, then research evidence for one may be wrongly taken as support for another.
At the same time, if we move the goalposts too far or in the wrong direction, we might lose the potential benefits of mindfulness altogether.

So, what is mindfulness?

Mindfulness receives a bewildering assortment of definitions. Psychologists measure the concept in differing combinations of acceptance, attentiveness, awareness, body focus, curiosity, nonjudgmental attitude, focus on the present, and others.
It's equally ill-defined as a set of practices. A brief exercise in self-reflection prompted by a smart-phone app on your daily commute may be considered the same as a months-long meditation retreat. Mindfulness can both refer to what Buddhist monks do and what your yoga instructor does for five minutes at the start and end of a class.
To be clear, mindfulness and meditation are not the same thing. There are types of meditation that are mindful, but not all mindfulness involves meditation and not all meditation is mindfulness-based.
Mindfulness mainly refers to the idea of focusing on the present moment, but it's not quite that simple. It also refers to several forms of meditation practices that aim to develop skills of awareness of the world around you and of your behavioral patterns and habits. In truth, many disagree about its actual purpose and what is and isn't mindfulness.

What's it for?

Mindfulness has been applied to just about any problem you can think up - from relationship issues, problems with alcohol or drugs, to enhancing leadership skills. It's being used by sportsmen to find "clarity" on and off the field and mindfulness programs are being offered at school. You can find it in workplaces, medical clinics, and old age homes.
More than a few popular books have been written touting the benefits of mindfulness and meditation. For example, in a supposedly critical review Altered Traits: Science Reveals How Meditation Changes your Mind, Brain and Body, Daniel Goleman argues one of the four benefits of mindfulness is improved working memory. Yet, a recent review of about 18 studies exploring the effect of mindfulness-based therapies on attention and memory calls into question these ideas.
Another common claim is that mindfulness reduces stress, for which there is limited evidence. Other promises, such as improved mood and attention, better eating habits, improved sleep, and better weight control are not fully supported by the science either.
And while benefits have limited evidence, mindfulness and meditation can sometimes be harmful and can lead to psychosis, mania, loss of personal identity, anxiety, panic, and re-experiencing traumatic memories. Experts have suggested mindfulness is not for everyone, especially those suffering from several serious mental health problems such as schizophrenia or bipolar disorder.

Research on mindfulness

Another problem with mindfulness literature is that it often suffers from poor research methodology. Ways of measuring mindfulness are highly variable, assessing quite different phenomena while using the same label. This lack of equivalence among measures and individuals makes it challenging to generalise from one study to another.
Mindfulness researchers rely too much on questionnaires, which require people to introspect and report on mental states that may be slippery and fleeting. These reports are notoriously vulnerable to biases. For example, people who aspire to mindfulness may report being mindful because they see it as desirable, not because they have actually achieved it.
Only a tiny minority of attempts to examine whether these treatments work compare them against another treatment that is known to work – which is the primary means by which clinical science can show added value of new treatments. And a minority of these studies are conducted in regular clinical practices rather than in specialist research contexts.
A recent review of studies, commissioned by the US Agency for Healthcare Research and Quality, found many studies were too poorly conducted to include in the review and that mindfulness treatments were moderately effective, at best, for anxiety, depression, and pain. There was no evidence of efficacy for attention problems, positive mood, substance abuse, eating habits, sleep or weight control.

What should be done?

Mindfulness is definitely a useful concept and a promising set of practices. It may help prevent psychological problems and could be useful as an addition to existing treatments. It may also be helpful for general mental functioning and well-being. But the promise will not be realised if problems are not addressed.
The mindfulness community must agree to key features that are essential to mindfulness and researchers should be clear how their measures and practices include these. Media reports should be equally specific about what states of mind and practices mindfulness includes, rather than using it as a broad term.
Mindfulness might be assessed, not through self-reporting, but in part using more objective neurobiological and behavioural measures, such as breath counting. This is where random tones could be used to "ask" participants if they are focused on the breath (press left button) or if their mind had wandered (press right button).
Researchers studying the efficacy of mindfulness treatments should compare them to credible alternative treatments, whenever possible. Development of new mindfulness approaches should be avoided until we know more about the ones we already have. Scientists and clinicians should use rigorous randomised control trials and work with researchers from outside the mindfulness tradition.
And lastly, mindfulness researchers and practitioners should acknowledge the reality of occasional negative effects. Just as medications must declare potential side effects, so should mindfulness treatments. Researchers should systematically assess potential side effects when studying mindfulness treatments. Practitioners should be alert to them and not recommend mindfulness treatments as a first approach if safer ones with stronger evidence of efficacy are available.

'Ridiculously healthy' elderly have the same gut microbiome as healthy 30 year-olds

In one of the largest microbiota studies conducted in humans, researchers at Western University, Lawson Health Research Institute and Tianyi Health Science Institute in Zhenjiang, Jiangsu, China have shown a potential link between healthy aging and a healthy gut.

13 oct 2017--With the establishment of the China-Canada Institute, the researchers studied the gut bacteria in a cohort of more than 1,000 Chinese individuals in a variety of age-ranges from 3 to over 100 years-old who were self-selected to be extremely healthy with no known health issues and no family history of disease. The results showed a direct correlation between health and the microbes in the intestine.
"The aim is to bring novel microbiome diagnostic systems to populations, then use food and probiotics to try and improve biomarkers of health," said Gregor Reid, professor at Western's Schulich School of Medicine & Dentistry and Scientist at Lawson Health Research Institute. "It begs the question - if you can stay active and eat well, will you age better, or is healthy ageing predicated by the bacteria in your gut?"
The study, published this month in the journal mSphere, showed that the overall microbiota composition of the healthy elderly group was similar to that of people decades younger, and that the gut microbiota differed little between individuals from the ages of 30 to over 100.
"The main conclusion is that if you are ridiculously healthy and 90 years old, your gut microbiota is not that different from a healthy 30 year old in the same population," said Greg Gloor, the principal investigator on the study and also a professor at Western's Schulich School of Medicine & Dentistry and Scientist at Lawson Health Research Institute. Whether this is cause or effect is unknown, but the study authors point out that it is the diversity of the gut microbiota that remained the same through their study group.
"This demonstrates that maintaining diversity of your gut as you age is a biomarker of healthy aging, just like low-cholesterol is a biomarker of a healthy circulatory system," Gloor said. The researchers suggest that resetting an elderly microbiota to that of a 30-year-old might help promote health.
"By studying healthy people, we hope to know what we are striving for when people get sick," said Reid.
The study also found a distinct anomaly in the group aged 19 to 24 that has not been observed in large-scale analyses of other populations and they suspect may be unique to this healthy cohort in China. The distinct gut microbiota of this group was a surprising finding and requires further study.

More information: Gaorui Bian et al, The Gut Microbiota of Healthy Aged Chinese Is Similar to That of the Healthy Young, mSphere (2017). DOI: 10.1128/mSphere.00327-17


Provided by University of Western Ontario

The benefits of 'being in the present'

When you have a full schedule, multitasking might seem like the best way to finish your endless to-do list. But the brain actually benefits from focusing on one activity at a time.
When you commit to training your attention and exerting control over your mind, you're practicing mindfulness. 

10 oct 2017--While it has become a popular psychotherapy technique, mindfulness originated in Buddhism over 2,000 years ago.
The idea of mindfulness is that life should be lived in the present moment. In addition to improving your focus, the practice can bring stress and insomnia relief, and pain reduction.
How?
One explanation comes from a study published in the journal Psychiatry Research. The study found that mindfulness can change the concentration of gray matter in areas of the brain involved in learning, memory, regulating emotion and more.
Yoga and tai chi are two mind-body practices that help increase mindfulness along with their physical and relaxation benefits.
There's also mindfulness meditation, a very focused approach developed by Jon Kabat-Zinn. He is creator of the Stress Reduction Clinic and the Center for Mindfulness in Medicine, Health Care and Society at the University of Massachusetts Medical School.

However, you don't need a formal program to incorporate mindfulness into your day. Here are some ideas:

• When you start a task, imagine you're doing it for the first time. Be curious. Feel sensations like you've never experienced them before.
• Focus on your breathing. Take notice as you breathe in and as you breathe out. Follow your breath. It's a reminder that you're alive.
• When you're overcome with emotion, take a step back and trace the emotion's origin and duration. Mindfulness teaches recognition that emotions are fleeting, which helps to reduce fear and anxiety.
• Embrace imperfection. Once you understand that the world is filled with it, it becomes less upsetting.
• Always try to immerse yourself in your surroundings; this helps you be present and connect with the world around you.

More information: The U.S. National Center for Complementary and Integrative Health has more on the positive brain changes from mindfulness and on meditation itself.

Seven body organs you can live without

The human body is incredibly resilient. When you donate a pint of blood, you lose about 3.5 trillion red blood cells, but your body quickly replaces them. You can even lose large chunks of vital organs and live. For example, people can live relatively normal lives with just half a brain). Other organs can be removed in their entirety without having too much impact on your life. Here are some of the "non-vital organs".

Spleen

07 oct 2017--This organ sits on the left side of the abdomen, towards the back under the ribs. It is most commonly removed as a result of injury. Because it sits close the ribs, it is vulnerable to abdominal trauma. It is enclosed by a tissue paper-like capsule, which easily tears, allowing blood to leak from the damaged spleen. If not diagnosed and treated, it will result in death.
When you look inside the spleen, it has two notable colours. A dark red colour and small pockets of white. These link to the functions. The red is involved in storing and recycling red blood cells, while the white is linked to storage of white cells and platelets.
You can comfortably live without a spleen. This is because the liver plays a role in recycling red blood cells and their components. Similarly, other lymphoidtissues in the body help with the immune function of the spleen.

Stomach

The stomach performs four main functions: mechanical digestion by contracting to smash up food, chemical digestion by releasing acid to help chemically break up food, and then absorption and secretion. The stomach is sometimes surgically removed as a result of cancer or trauma. In 2012, a British woman had to have her stomach removed after ingesting a cocktail that contained liquid nitrogen.
When the stomach is removed, surgeons attach the oesophagus (gullet) directly to the small intestines. With a good recovery, people can eat a normal diet alongside vitamin supplements.

Reproductive organs

The primary reproductive organs in the male and female are the testes and ovaries, respectively. These structures are paired and people can still have children with only one functioning.
The removal of one or both are usually the result of cancer, or in males, trauma, often as a result of violence, sports or road traffic accidents. In females, the uterus (womb) may also be removed. This procedure (hysterectomy) stops women from having children and also halts the menstrual cycle in pre-menopausal women. Research suggests that women who have their ovaries removed do not have a reduced life expectancy. Interestingly, in some male populations, removal of both testicles may lead to an increase in life expectancy
.
Colon

The colon (or large intestine) is a tube that is about six-feet in length and has four named parts: ascending, transverse, descending and sigmoid. The primary functions are to resorb water and prepare faeces by compacting it together. The presence of cancer or other diseases can result in the need to remove some or all of the colon. Most people recover well after this surgery, although they notice a change in bowel habits. A diet of soft foods is initially recommended to aid the healing process

Gallbladder

The gallbladder sits under the liver on the upper-right side of the abdomen, just under the ribs. It stores something called bile. Bile is constantly produced by the liver to help break down fats, but when not needed in digestion, it is stored in the gallbladder.
When the intestines detect fats, a hormone is released causing the gallbladder to contract, forcing bile into the intestines to help digest fat. However, excess cholesterol in bile can form gallstones, which can block the tiny pipes that move bile around. When this happens, people may need their gallbladder removed. The surgery is known as (cholecystectomy. Every year, about 70,000 people have this procedure in the UK.
Many people have gallstones that don't cause any symptoms, others are not so fortunate. In 2015, an Indian woman had 12,000 gallstones removed – a world record.

Appendix

The appendix is a small blind-ended worm-like structure at the junction of the large and the small bowel. Initially thought to be vestigial, it is now believed to be involved in being a "safe-house" for the good bacteria of the bowel, enabling them to repopulate when needed.
Due to the blind-ended nature of the appendix, when intestinal contents enter it, it can be difficult for them to escape and so it becomes inflamed. This is called appendicitis. In severe cases, the appendix needs to be surgically removed.
A word of warning though: just because you've had your appendix out, doesn't mean it can't come back and cause you pain again. There are some cases where the stump of the appendix might not be fully removed, and this can become inflamed again, causing "stumpitis". People who have had their appendix removed notice no difference to their life.

Kidneys

Most people have two kidneys, but you can survive with just one – or even none (with the aid of dialysis). The role of the kidneys is to filter the blood to maintain water and electrolyte balance, as well as the acid-base balance. It does this by acting like a sieve, using a variety of processes to hold onto the useful things, such as proteins, cells and nutrients that the body needs. More importantly, it gets rid of many things we don't need, letting them pass through the sieve to leave the kidneys as urine.
There are many reasons people have to have a kidney – or both kidneys – removed: inherited conditions, damage from drugs and alcohol, or even infection. If a person has both kidneys fail, they are placed onto dialysis. This comes in two forms: haemodialysis and peritoneal dialysis. The first uses a machine containing dextrose solution to clean the blood, the other uses a special catheter inserted into the abdomen to allow dextrose solution to be passed in and out manually. Both methods draw waste out of the body.
If a person is placed on dialysis, their life expectancy depends on many things, including the type of dialysis, sex, other diseases the person may have and their age. Recent research has shown someone placed on dialysis at age 20 can expect to live for 16-18 years, whereas someone in their 60s may only live for five years.

Orthorexia: When 'healthy eating' ends up making you sick

07 oct 2017--People, it seems, have never been so afraid of their food—and, say some experts, an obsession with healthy eating may paradoxically be endangering lives.
Twenty-nine-year-old Frenchwoman Sabrina Debusquat recounts how, over 18 months, she became a vegetarian, then a vegan—eschewing eggs, dairy products and even honey—before becoming a "raw foodist" who avoided all cooked foods, and ultimately decided to eat just fruit.
It was only when her deeply worried boyfriend found clumps of her hair in the bathroom sink and confronted her with the evidence that she realised that she was on a downward path.
"I thought I held the truth to food and health, which would allow me to live as long as possible," said Debusquat.
"I wanted to get to some kind of pure state. In the end my body overruled my mind."
For some specialists, the problem is a modern eating disorder called orthorexia nervosa.
Someone suffering from orthorexia is "imprisoned by a range of rules which they impose on themselves," said Patrick Denoux, a professor in intercultural psychology at the University of Toulouse-Jean Jaures.
These very strict self-enforced laws isolate the individual from social food gatherings and in extreme cases, can also endanger health.
Paris nutritionist Sophie Ortega said she had one patient who was going blind due to deficiency of vitamin B12, which is needed to make red-blood cells.
B12 is not made by the body, and most people get what they need from animal-derived foods such as eggs, dairy products, meat or fish or from supplements.
"A pure, unbending vegan," her patient even refused to take the supplements, said Ortega. "It was as if she preferred to lose her sight... rather than betray her commitment to animals."

'Disease disguised as virtue'

The term orthorexia nervosa was coined in the 1990s by the then alternative medicine practitioner Steven Bratman, a San Francisco-based physician.
To be clear, orthorexia is not an interest in healthy eating—it's when enthusiasm becomes a pathological obsession, which leads to social isolation, psychological disturbance and even physical harm. In other words, as Bratman said in a co-authored book in 2000, it's "a disease disguised as a virtue."
But as is often the case in disorders that may have complex psychological causes, there is a strong debate as to whether the condition really exists.
The term is trending in western societies, prompting some experts to wonder whether it is being fanned by "cyber-chondria"—self-diagnosis on the internet.

'Not medically recognised'

Orthorexia is not part of the Diagnostic and Statistical Manual of Mental Disorders, set down by mental health professionals in the United States that is also widely used as a benchmark elsewhere. The fifth edition of this "bible," published in 2013, includes anorexia nervosa and bulimia nervosa, but not orthorexia.
"The term orthorexia was proposed as a commonly used term but it is not medically recognised," said Pierre Dechelotte, head of nutrition at Rouen University Hospital in northern France and head of a research unit investigating the link between the brain and the intestines in food behaviour.
Even so, says Dechelotte, it has a home in the family of "restrictive food-related disorders—but it's not on the radar screen."
Alain Perroud, a psychiatrist who has worked in France and Switzerland over the course of a 30-year career, says orthorexia "is much closer to a phobia" than to a food disorder.
As with other phobias, the problem may be tackled by cognitive behavioural therapy—talking about incorrect or excessive beliefs, dealing with anxiety-provoking situations and using relaxation techniques and other methods to tackle anxiety, he suggested.
Denoux contends that between two and three percent of the French population suffer from orthorexia, but stresses that there is a lack of reliable data as the condition has not been officially recognised.
Denoux's figure seems coherent to Dechelotte, who says that women seem to be more than twice as susceptible to the problem as men.

'Bubble of restriction'

Outside the world of clinicians, orthorexia seems to be creeping into wider usage.
American blogger Jordan Younger has helped to popularise the term, documenting her own painful downward spiral—since reversed—into unhealthy living.
On her blog, she describes it as "a bubble of restriction," obsessing over a diet that was "entirely vegan, entirely plant-based, entirely gluten-free, oil-free, refined sugar-free, flour-free, dressing/sauce-free, etc."
Those who seem to be most worried about healthy food are often concerned about food scandals in the West, Pascale Hebel from the Paris-based CREDOC research centre told AFP.
Over nearly three decades, Europe has experienced a string of food safety scandals—beginning with mad-cow disease and continuing recently with insecticide-contaminated eggs—as well as mounting opposition to the use of antibiotics, genetically modified foods and corporate farming practices.
The disorder reflects a craving for control, suggested Denoux: food is seen as a form of medicine to fix a western lifestyle that may be seen as polluting or toxic.
"We are living through a time of change in our food culture, which has led us to fundamentally doubt what we are eating," said Denoux.
Among believers, this "suspicion of being poisoned is deemed proof of insight."

No clear evidence that most new cancer drugs extend or improve life

Even where drugs did show survival gains over existing treatments, these were often marginal, the results show.

Many of the drugs were approved on the basis of indirect ('surrogate') measures that do not always reliably predict whether a patient will live longer or feel better, raising serious questions about the current standards of drug regulation.

05 oct 2017--The researchers, based at King's College London and the London School of Economics say: "When expensive drugs that lack clinically meaningful benefits are approved and paid for within publicly funded healthcare systems, individual patients can be harmed, important societal resources wasted, and the delivery of equitable and affordable care undermined."
The research team analysed reports on cancer approvals by the European Medicines Agency (EMA) from 2009 to 2013.
Of 68 cancer indications approved during this period, 57% (39) came onto the market on the basis of a surrogate endpoint and without evidence that they extended survival or improved the quality of patients' lives.
After a median of 5 years on the market, only an additional 8 drug indications had shown survival or quality of life gains.
Thus, out of 68 cancer indications approved by the EMA, and with a median 5 years follow-up, only 35 (51%) had shown a survival or quality of life gain over existing treatments or placebo. For the remaining 33 (49%), uncertainty remains over whether the drugs extend survival or improve quality of life.
The researchers outline some study limitations which could have affected their results, but say their findings raise the possibility that regulatory evidence standards "are failing to incentivise drug development that best meets the needs of patients, clinicians, and healthcare systems."
Taken together, these facts paint a sobering picture, says Vinay Prasad, Assistant Professor at Oregon Health & Science University in a linked editorial.
He calls for "rigorous testing against the best standard of care in randomized trials powered to rule in or rule out a clinically meaningful difference in patient centered outcomes in a representative population" and says "the use of uncontrolled study designs or surrogate endpoints should be the exception not the rule."
He adds: "The expense and toxicity of cancer drugs means we have an obligation to expose patients to treatment only when they can reasonably expect an improvement in survival or quality of life." These findings suggest "we may be falling far short of this important benchmark."
This study comes at a time when European governments are starting to seriously challenge the high cost of drugs, says Dr Deborah Cohen, Associate Editor at The BMJ, in an accompanying feature.
She points to examples of methodological problems with trials that EMA has either failed to identify or overlooked, including trial design, conduct, analysis and reporting.
"The fact that so many of the new drugs on the market lack good evidence that they improve patient outcomes puts governments in a difficult position when it comes to deciding which treatments to fund," she writes. "But regulatory sanctioning of a comparator that lacks robust evidence of efficacy, means the cycle of weak evidence and uncertainty continues."
In a patient commentary, Emma Robertson says: "It's clear to me and thousands of other patients like me that our current research and development model has failed."
Emma is leader of Just Treatment, a patient led campaign with no ties to the pharmaceutical industry, which is calling for a new system that rewards and promotes innovation, so that more effective and accessible cancer medicines are brought within reach.

More information: Availability of evidence on overall survival and quality of life benefits of cancer drugs approved by the European Medicines Agency: A retrospective cohort study of drug approvals from 2009-2013,www.bmj.com/content/359/bmj.j4530

Editorial: Do cancer drugs improve survival or quality of life? www.bmj.com/content/359/bmj.j4528

Patient commentary: the current model has failed, www.bmj.com/content/359/bmj.j4568

Feature: Cancer drugs: high price, uncertain value, www.bmj.com/content/359/bmj.j4543


Provided by British Medical Journal

One hour of exercise a week can prevent depression

A landmark study led by the Black Dog Institute has revealed that regular exercise of any intensity can prevent future depression - and just one hour can help.
Published today in the American Journal of Psychiatry, the results show even small amounts of exercise can protect against depression, with mental health benefits seen regardless of age or gender.

04 oct 2017--In the largest and most extensive study of its kind, the analysis involved 33,908 Norwegian adults who had their levels of exercise and symptoms of depression and anxiety monitored over 11 years.
The international research team found that 12 percent of cases of depression could have been prevented if participants undertook just one hour of physical activity each week.
"We've known for some time that exercise has a role to play in treating symptoms of depression, but this is the first time we have been able to quantify the preventative potential of physical activity in terms of reducing future levels of depression," said lead author Associate Professor Samuel Harvey from Black Dog Institute and UNSW.
"These findings are exciting because they show that even relatively small amounts of exercise - from one hour per week - can deliver significant protection against depression.
"We are still trying to determine exactly why exercise can have this protective effect, but we believe it is from the combined impact of the various physical and social benefits of physical activity.
"These results highlight the great potential to integrate exercise into individual mental health plans and broader public health campaigns. If we can find ways to increase the population's level of physical activity even by a small amount, then this is likely to bring substantial physical and mental health benefits."
The findings follow the Black Dog Institute's recent Exercise Your Mood campaign, which ran throughout September and encouraged Australians to improve their physical and mental wellbeing through exercise.
Researchers used data from the Health Study of Nord-Trøndelag County (HUNT study) - one of the largest and most comprehensive population-based health surveys ever undertaken - which was conducted between January 1984 and June 1997.
A healthy cohort of participants was asked at baseline to report the frequency of exercise they participated in and at what intensity: without becoming breathless or sweating, becoming breathless and sweating, or exhausting themselves. At follow-up stage, they completed a self-report questionnaire (the Hospital Anxiety and Depression Scale) to indicate any emerging anxiety or depression.
The research team also accounted for variables which might impact the association between exercise and common mental illness. These include socio-economic and demographic factors, substance use, body mass index, new onset physical illness and perceived social support.
Results showed that people who reported doing no exercise at all at baseline had a 44% increased chance of developing depression compared to those who were exercising one to two hours a week.
However, these benefits did not carry through to protecting against anxiety, with no association identified between level and intensity of exercise and the chances of developing the disorder.
According to the Australian Health Survey, 20 percent of Australian adults do not undertake any regular physical activity, and more than a third spend less than 1.5 hours per week being physically active. At the same time, around 1 million Australians have depression, with one in five Australians aged 16-85 experiencing a mental illness in any year.
"Most of the mental health benefits of exercise are realised within the first hour undertaken each week," said Associate Professor Harvey.
"With sedentary lifestyles becoming the norm worldwide, and rates of depression growing, these results are particularly pertinent as they highlight that even small lifestyle changes can reap significant mental health benefits."


Provided by University of New South Wales

Biological clock discoveries by three Americans earn Nobel prize 

Winners of the 2017 Nobel Prize for Medicine are displayed, from left, Jeffrey C. Hall, Michael Rosbash and Michael W. Young, during a press conference in Stockholm, Monday Oct. 2, 2017. The Nobel Prize for Medicine has been awarded to the three Americans for discoveries about the body's daily rhythms.

03 oct 2017--Three Americans won a Nobel Prize on Monday for discovering key genetic "gears" of the body's 24-hour biological clock, the mechanism best known for causing jet lag when it falls out of sync.
Problems with our body clock also been linked to such disorders as sleep problems, depression, heart disease, diabetes and obesity. Researchers are now trying to find ways to tinker with the clock to improve human health, the Nobel committee said in Stockholm.
It awarded the $1.1 million (9 million kronor) Nobel Prize in Physiology or Medicine to Jeffrey C. Hall and Michael Rosbash, who worked together at Brandeis University in Massachusetts, and Michael W. Young of Rockefeller University in New York.
They "were able to peek inside our biological clock" and discover details of its inner workings, the Nobel citation said.
The work, done in fruit flies and dating back to 1984, identified genes and proteins that work together in people and other animals to synchronize internal activities throughout the day and night. Various clocks in the brain and elsewhere in the body, working together, regulate things like sleep patterns, eating habits and the release of hormones and blood pressure. Such 24-hour patterns are called circadian rhythms.
At age 72, the retired Hall wryly noted that he was already awake when the call about the prize came around 5 a.m., because of age-related changes in his own circadian rhythms.
"I said 'Is this a prank'?" he told The Associated Press by telephone from his home in Cambridge, Maine.
Rosbash, a 73-year-old professor at Brandeis, told the AP that he and his two colleagues worked to understand "the watch ... that keeps time in our brains."
"You recognize circadian rhythms by the fact that you get sleepy at 10 or 11 at night, you wake up automatically at 7 in the morning, you have a dip in your alertness in the midday, maybe at 3 or 4 in the afternoon when you need a cup of coffee, so that is the clock," he explained.
"The fact that you go to the bathroom at a particular time of day, the fact if you travel over multiple time zones your body is screwed up for several days until you readjust—all that is a manifestation of your circadian clock."

This undated photo provided by The Rockefeller University shows Michael W. Young, who was one of three Americans awarded the Nobel Prize in Physiology or Medicine on Monday, Oct. 2, 2017, for discoveries about the body's daily rhythms. The other winners are are Jeffrey C. Hall and Michael Rosbash. 

Jay Dunlap, who studies biological clocks in bread mold at Dartmouth College's medical school, called the Nobel-winning work "beautiful." It helped expose the molecular details behind daily rhythms, he said. Such knowledge can be important in telling when to deliver drugs for maximum effect, and perhaps for developing new ones, he said.
Michael Hastings, a scientist at the U.K. Medical Research Council, said the field of body clock study "has exploded massively, propelled by the discoveries by these guys." Nobel committee member Carlos Ibanez said the work helped in understanding how people adapt to shiftwork.

Michael Rosbash takes a phone call at his home, Monday, Oct. 2, 2017, in Newton, Mass. Rosbach is one of the Americans awarded this year's Nobel Prize in physiology or medicine for discovering the molecular mechanisms that control humans' circadian rhythm. 

Young, 68, said genes that control our body clock were revealed "just like puzzle pieces." The research showed "the way they worked together to provide this beautiful mechanism."
Hall said that once scientists understand how the clock normally works, "that gives you a chance, not an inevitability, but a chance to influence the internal workings of the clock and possibly to improve a patient's well-being."

Thomas Perlmann, Chariman of the Nobel Committee of Medicine, announces the winners of the 2017 Nobel Prize for Medicine during a press conference at the Nobel Forum in Stockholm, Monday Oct. 2, 2017. The Nobel Prize for Medicine has been awarded to three Americans for discoveries about the body's daily rhythms. The laureates are Jeffrey Hall, Michael Rosbash and Michal Young. 

Rosbash said he thinks most of the practical applications of the work lie in the future.
A genetic mutation has already been found in some people who have a chronic sleeping problem, Young said.
"This gives us a target to work on (and) ways of thinking we didn't have before," he said. "I think we're going to run into this over and over."

Anna Wedell, chairman of the Nobel committee, center, and members of the committee Juleen Zierath, left, and Carlos Ibanez, announce the winners of the 2017 Nobel Prize for Medicine during a press conference at the Nobel Forum in Stockholm, Monday Oct. 2, 2017. The Nobel Prize for Medicine has been awarded to three Americans for discoveries about the body's daily rhythms. The laureates are Jeffrey c. Hall, Michael Rosbash and Michael W. Young. 

Monday's award was the first of this year's Nobel Prizes to be announced. The physics prize will be given Tuesday, followed by the chemistry prize on Wednesday. The prizes were established by the will of Swedish industrialist Alfred Nobel, who died in 1896.

In this Thursday, Oct. 13, 2016 file photo, permanent Secretary of the Swedish Academy Sara Danius announces that Bob Dylan is awarded the 2016 Nobel Prize in Literature during a presser at the Old Stockholm Stock Exchange Building in Stockholm, Sweden. The panel that awards the Nobel Prize in literature says this year's winner will be announced Thursday, Oct. 5, 2017. In 2015 and 2016, the award went to writers outside the conventional conception of "literature" as novels and poetry. Svetlana Alexievich's books are artistic sociopolitical reportage, and Bob Dylan's lyrics arguably have more power as song than on the page. 

In this Jan. 12, 2012, file photo, Bob Dylan performs in Los Angeles. The panel that awards the Nobel Prize in literature says this year's winner will be announced Thursday, Oct. 5, 2017. In 2015 and 2016, the award went to writers outside the conventional conception of "literature" as novels and poetry. Svetlana Alexievich's books are artistic sociopolitical reportage, and Bob Dylan's lyrics arguably have more power as song than on the page. 

Michael Rosbash smiles during an interview at his home, Monday, Oct. 2, 2017, in Newton, Mass. Rosbach is one of the Americans awarded this year's Nobel Prize in physiology or medicine for discovering the molecular mechanisms that control humans' circadian rhythm. 

Michael Rosbash smiles during an interview at his home, Monday, Oct. 2, 2017, in Newton, Mass. Rosbach is one of the Americans awarded this year's Nobel Prize in physiology or medicine for discovering the molecular mechanisms that control humans' circadian rhythm. 

Michael Rosbash takes a phone call at his home, Monday, Oct. 2, 2017, in Newton, Mass. Rosbach is one of the Americans awarded this year's Nobel Prize in physiology or medicine for discovering the molecular mechanisms that control humans' circadian rhythm. 

Recent winners of the Nobel Medicine Prize
Here is a list of the winners of the Nobel Medicine Prize in the past 10 years, awarded on Monday to US geneticists Jeffrey Hall, Michael Rosbash and Michael Young for their work on internal biological clocks:
2017: US geneticists Jeffrey Hall, Michael Rosbash and Michael Young for their discoveries on the internal biological clock that governs the wake-sleep cycles of most living things.
2016: Yoshinori Ohsumi of Japan for his work on autophagy—a process whereby cells "eat themselves"—which when disrupted can cause Parkinson's and diabetes.
2015: William Campbell (US citizen born in Ireland) and Satoshi Omura (Japan), Tu Youyou (China) for unlocking treatments for malaria and roundworm.
2014: John O'Keefe (Britain, US), Edvard I. Moser and May-Britt Moser (Norway) for discovering how the brain navigates with an "inner GPS".
2013: Thomas C. Suedhof (US citizen born in Germany), James E. Rothman and Randy W. Schekman (US) for work on how the cell organises its transport system.
2012: Shinya Yamanaka (Japan) and John B. Gurdon (Britain) for discoveries showing how adult cells can be transformed back into stem cells.
2011: Bruce Beutler (US), Jules Hoffmann (French citizen born in Luxembourg) and Ralph Steinman (Canada) for work on the body's immune system.
2010: Robert G. Edwards (Britain) for the development of in-vitro fertilisation.
2009: Elizabeth Blackburn (Australia-US), Carol Greider and Jack Szostak (US) for discovering how chromosomes are protected by telomeres, a key factor in the ageing process.
2008: Harald zur Hausen (Germany), Francoise Barre-Sinoussi and Luc Montagnier (France) for work on the viruses causing cervical cancer and AIDS.

More information: www.nobelprize.org/nobel_prize … ates/2017/press.html