For cancer patients dealing with the pain of tumors that have spread to their bones, doctors typically recommend radiation as a palliative therapy. But as in many areas of medicine, more of this treatment isn't actually better. Medical evidence over the past decade has demonstrated that patients with terminal cancer who receive a single session of radiotherapy get just as much pain relief as those who receive multiple treatments. But despite its obvious advantages for patient comfort and convenience -- and the associated cost savings -- this so-called single-fraction treatment has yet to be adopted in routine practice. That's the finding of a new study from researchers in the Perelman School of Medicine at the University of Pennsylvania published in JAMA.
"Increased use of single fraction treatment would achieve the Holy Grail of health reform, which is real improvements in patient care at substantial cost savings," said the new study's lead author, Justin E. Bekelman, MD, an assistant professor of Radiation Oncology in Penn Medicine's Abramson Cancer Center. Yet so far, he notes, "despite the evidence, single fraction treatment is used rarely and it's reserved for patients with the poorest prognosis."
Bekelman and his colleagues examined at a group of 3,050 patients 65 years and older treated with radiotherapy for advanced prostate cancer and bone metastases. In the analysis of patients drawn from the national Surveillance, Epidemiology and End Results (SEER)-Medicare database, they found that only 3 percent of patients studied received just single-fraction treatment, and nearly half the patients had more than 10 treatments. The costs of the excess treatments, the authors found, were substantial: Mean 45-day radiotherapy-related expenditures were 62 percent lower for patients who received one treatment, at $1,873 for single vs. $4,967 for multiple fractions.
Professional societies have recommended single-fraction treatment over multiple fractions for routine pain control, except in cases with complications that require specialized therapy, such as spinal cord compression or broken bones caused by tumors. Bekelman's findings underscore the importance of efforts such as the Choosing Wisely campaign, which seeks to identify and promote medical practices that offer the highest value and best outcome for patients. Bekelman's data shows that patients are routinely receiving extra radiation treatments that drive up health care costs, without conferring additional benefits to patients.
"Whether you get more or less radiation for bone metastases has nothing to do with survival," he says. "When clear and consistent evidence exists that supports single fraction treatment, we should proceed with the treatment that has equivalent pain control, is more convenient, and gets patients out of treatment quicker."
http://www.sciencedaily.com/releases/2013/10/131008165255.htm
Saturday, October 12, 2013
Friday, October 11, 2013
Obesity is not a disease » The Spectator
'Well, what diets have you tried so far?' asked the GP, flicking through the patient's notes. I was an innocent trainee doctor on my general practice placement at the time and watched the interaction carefully, sensing a row was about to ensue. 'Look, I don't want to go on a diet, I want you to prescribe me these,' snapped the patient, bringing out a neatly folded page she had torn out of a magazine. The GP, rolling his eyes at me, took the paper but didn't read it. I suspected he'd read it before. This was yet another example of what's becoming a very British epidemic: obesity being self-diagnosed as disease.
The doctor attempted to explain that tablets really aren't suitable in her case. As well as having some potentially nasty side effects, they're expensive to prescribe, and don't offer a long-term solution. This was clearly not what the woman wanted to hear. 'Fine then, don't help me, see if I care. I'll get my sister to get them off her GP — he gives her whatever she wants'; and she stormed out. It struck me as bizarre that while some people using the NHS are dangerously malnourished, other people are desperate to take tablets to ensure that their food passes through their body unabsorbed, while the taxpayer foots the bill.
It happens all the time. The patients who are not interested in changing their diet in any way, demanding to have their cake, eat it and then pop a pill so that the calories never touch their waistline. And as a result, Britain now combines austerity with obesity. The majority of us are now overweight or obese — a third of children are considered too heavy. It costs an extra £5 billion a year, and 300 hospital admissions a day are directly due to obesity. To pick up the newspapers is to witness a country adjusting itself to losing a national battle of the bulge.
Take the East Midlands Ambulance Service. It emerged this week that it has been picking up so many fat patients — weighing in excess of the 28-stone maximum — that it needs a new fleet. It has, hitherto, been struggling along with just one ambulance for fatties (a 'bariatric' vehicle), but now thinks all 272 of its ambulances need to be upgraded with double-wide stretchers for patients who (it says) can weigh in at 55 stone. The plan will cost £27 million.
Once the obese patient is in hospital, a whole new set of equipment is required: reinforced operating tables, sturdier trollies, longer needles and even wider MRI scanners. There is a great demand for bariatric surgeons. One of them, Sally Norton, recently wrote in the Royal College of Surgeons' house journal that without special equipment for the obese, there may be 'enquiries into the potential use of veterinary or zoological scanners, with resultant loss of dignity for the patient'. There is a cost to all this: in the kit, and in operations like gastric bypass operations, which have increased sevenfold over the last seven years.
Moving obese patients out of their house can be too difficult for the NHS. Recently the fire service had to demolish two walls of a house in south Wales so that a 63-stone teenager could be taken to hospital. This required more than 40 emergency service workers at an estimated cost of £100,000. Over the past five years, fire services have been called to more than 2,700 incidents to assist 'severely obese' people, including some who had got stuck in the bath. Rescuing fatties is now a routine operation, with its own entry in the Fire Brigade incident reporting system (filed under 'bariatric persons').
So what to do? The government spends money asking us to eat 'five a day' fruit and veg, but it seems to have no effect. Nottingham, the fattest region in Britain, recently decided to spend £500,000 on replacing pavements in areas with particularly fat pedestrians, to try and encourage people to walk more. Our landscape is being, quite literally, reshaped in order to accommodate the obese. In the past few years, we have moved from being outraged about the epidemic to just planning around it. Like a middle-aged man deciding to eat what he wants and let himself go, Britain is pulling on a pair of tracksuit bottoms and heading to the fridge.
It need not be this way. For too long, my fellow doctors have pussyfooted around their obese patients, too scared to confront the, er, elephant in the room. They don't want to cause offence. Unbelievably, draft guidelines announced last year by the National Institute of Clinical Excellence and Health (Nice) suggested that doctors should even avoid the use of the term 'obese' for fear that larger patients might be upset. Instead, Nice recommended advising corpulent patients that they should seek a 'healthier weight'.
But nice euphemisms mean that people don't confront reality. I'm not going to stop diagnosing cancer just because people don't like hearing the dreaded word. So why should it be different when informing people that they are obese? Sometimes morbidly so. What Nice is delicately skirting round is what many doctors, nurses and dieticians will confirm: people don't like being told that they are overweight, even if it's objectively clearly the case. And by pretending that this is a disease, the doctors are making it even worse.
There's something comforting about blaming obesity on genes. It enables people to relinquish responsibility for their weight, which can be seen as outside their control. It's nothing new, either. Years ago, fat people blamed their 'glands'. When I started medical school, I patiently waited for us to be taught about these magical 'glands' that made people fat. I'm still waiting. Even when people have problems with an underactive thyroid, which can slow the metabolism and result in weight gain, this can be treated with thyroid replacement tablets and the metabolism returns to normal. As a rule, however, fat people have one thing in common: they eat more than they need to.
Certainly some people metabolise food at a different rate to others, meaning they are more likely to lay down fat stores than other people. But this is a reason to eat less, not to become fat. You cannot get away from the basic biology of the human body — fat is simply stored excess energy, and weight gain is only possible when the total amount of energy consumed exceeds the total amount of energy expended. Even those who have a genetic predisposition to become fat are not slaves to their DNA.
An in-depth study published last year, which looked at the genes of more than 20,000 people and was conducted at the Medical Research Council's epidemiology unit in Cambridge, found some people are predisposed to be overweight. But an active lifestyle and reducing food intake can counteract that. Simple. While some will be annoyed by this research, I find it empowering. The idea that our genes control us is profoundly depressing. After all, there is more to being human than a few strands of DNA.
The rate of people considered clinically obese has risen from around 1 to 2 per cent of the population in the 1960s to over 25 per cent now. Why? A simple answer would be lifestyle, but it's actually a little more complicated. A fascinating survey conducted by the Department of Health compared data collected from 1967 and 2010. It showed that, while people back then were slimmer, they ate fattier foods and had access to far fewer gyms. We eat better now, we work out more. But we live relatively sedentary lives. Only three out of ten households had a car then, compared to seven out of ten now. While 75 per cent of people walked for at least half an hour a day in the 1960s, this is only about 40 per cent now.
What really stands out, more than the lifestyle differences, is the sharp contrast in the attitudes towards obesity between the two different eras. The 1967 survey found that nine out of ten people had attempted to lose weight in the past year, compared with barely half of adults questioned in 2010. Perhaps most tellingly though, 40 years ago only 7 per cent of those people who considered themselves overweight had failed to do anything about it, compared with nearly half now.
It would be easy to blame Britain's fatness on lifestyle changes, but the worst of it is attitude. People just aren't bothering to lose weight any more. Perhaps obesity is viewed as more normal. But this is also down to the attitude that we doctors increasingly encounter in our consulting rooms: the reluctance of patients to accept that ailments can be blamed on their behaviour, for which they are reluctant to take responsibility.
Patients blame obesity on the government, cunning food manufacturers, their parents and their genes. They demand fat-loss pills on the NHS and stomach-stapling surgery as a right. In a world where health care is becoming consumerised, patients see themselves as customers. There's not much demand for hard truths.
America has severe obesity problems, and seems resigned to them. But Britain has a National Health Service, and therefore a far higher capacity to change. It ought to be easy. Doctors should be required to tell patients a blunt truth: if you're fat, eat less, exercise more, or both. And if you keep guzzling the tasty treats, you will die earlier. It's not a disease, it's a mindset — and that means it can be changed. We doctors need to be a little less understanding, a little more judgmental, and realise that our oath — 'do no harm' — must come before our desire to save the feelings of our patients. The truth can be the hardest drug to administer. But holding our tongues, prescribing the fat pills and bankrupting the NHS in the process is the worst solution of all.
http://www.spectator.co.uk/features/9049971/the-battle-of-the-bulge/?
The doctor attempted to explain that tablets really aren't suitable in her case. As well as having some potentially nasty side effects, they're expensive to prescribe, and don't offer a long-term solution. This was clearly not what the woman wanted to hear. 'Fine then, don't help me, see if I care. I'll get my sister to get them off her GP — he gives her whatever she wants'; and she stormed out. It struck me as bizarre that while some people using the NHS are dangerously malnourished, other people are desperate to take tablets to ensure that their food passes through their body unabsorbed, while the taxpayer foots the bill.
It happens all the time. The patients who are not interested in changing their diet in any way, demanding to have their cake, eat it and then pop a pill so that the calories never touch their waistline. And as a result, Britain now combines austerity with obesity. The majority of us are now overweight or obese — a third of children are considered too heavy. It costs an extra £5 billion a year, and 300 hospital admissions a day are directly due to obesity. To pick up the newspapers is to witness a country adjusting itself to losing a national battle of the bulge.
Take the East Midlands Ambulance Service. It emerged this week that it has been picking up so many fat patients — weighing in excess of the 28-stone maximum — that it needs a new fleet. It has, hitherto, been struggling along with just one ambulance for fatties (a 'bariatric' vehicle), but now thinks all 272 of its ambulances need to be upgraded with double-wide stretchers for patients who (it says) can weigh in at 55 stone. The plan will cost £27 million.
Once the obese patient is in hospital, a whole new set of equipment is required: reinforced operating tables, sturdier trollies, longer needles and even wider MRI scanners. There is a great demand for bariatric surgeons. One of them, Sally Norton, recently wrote in the Royal College of Surgeons' house journal that without special equipment for the obese, there may be 'enquiries into the potential use of veterinary or zoological scanners, with resultant loss of dignity for the patient'. There is a cost to all this: in the kit, and in operations like gastric bypass operations, which have increased sevenfold over the last seven years.
Moving obese patients out of their house can be too difficult for the NHS. Recently the fire service had to demolish two walls of a house in south Wales so that a 63-stone teenager could be taken to hospital. This required more than 40 emergency service workers at an estimated cost of £100,000. Over the past five years, fire services have been called to more than 2,700 incidents to assist 'severely obese' people, including some who had got stuck in the bath. Rescuing fatties is now a routine operation, with its own entry in the Fire Brigade incident reporting system (filed under 'bariatric persons').
So what to do? The government spends money asking us to eat 'five a day' fruit and veg, but it seems to have no effect. Nottingham, the fattest region in Britain, recently decided to spend £500,000 on replacing pavements in areas with particularly fat pedestrians, to try and encourage people to walk more. Our landscape is being, quite literally, reshaped in order to accommodate the obese. In the past few years, we have moved from being outraged about the epidemic to just planning around it. Like a middle-aged man deciding to eat what he wants and let himself go, Britain is pulling on a pair of tracksuit bottoms and heading to the fridge.
It need not be this way. For too long, my fellow doctors have pussyfooted around their obese patients, too scared to confront the, er, elephant in the room. They don't want to cause offence. Unbelievably, draft guidelines announced last year by the National Institute of Clinical Excellence and Health (Nice) suggested that doctors should even avoid the use of the term 'obese' for fear that larger patients might be upset. Instead, Nice recommended advising corpulent patients that they should seek a 'healthier weight'.
But nice euphemisms mean that people don't confront reality. I'm not going to stop diagnosing cancer just because people don't like hearing the dreaded word. So why should it be different when informing people that they are obese? Sometimes morbidly so. What Nice is delicately skirting round is what many doctors, nurses and dieticians will confirm: people don't like being told that they are overweight, even if it's objectively clearly the case. And by pretending that this is a disease, the doctors are making it even worse.
There's something comforting about blaming obesity on genes. It enables people to relinquish responsibility for their weight, which can be seen as outside their control. It's nothing new, either. Years ago, fat people blamed their 'glands'. When I started medical school, I patiently waited for us to be taught about these magical 'glands' that made people fat. I'm still waiting. Even when people have problems with an underactive thyroid, which can slow the metabolism and result in weight gain, this can be treated with thyroid replacement tablets and the metabolism returns to normal. As a rule, however, fat people have one thing in common: they eat more than they need to.
Certainly some people metabolise food at a different rate to others, meaning they are more likely to lay down fat stores than other people. But this is a reason to eat less, not to become fat. You cannot get away from the basic biology of the human body — fat is simply stored excess energy, and weight gain is only possible when the total amount of energy consumed exceeds the total amount of energy expended. Even those who have a genetic predisposition to become fat are not slaves to their DNA.
An in-depth study published last year, which looked at the genes of more than 20,000 people and was conducted at the Medical Research Council's epidemiology unit in Cambridge, found some people are predisposed to be overweight. But an active lifestyle and reducing food intake can counteract that. Simple. While some will be annoyed by this research, I find it empowering. The idea that our genes control us is profoundly depressing. After all, there is more to being human than a few strands of DNA.
The rate of people considered clinically obese has risen from around 1 to 2 per cent of the population in the 1960s to over 25 per cent now. Why? A simple answer would be lifestyle, but it's actually a little more complicated. A fascinating survey conducted by the Department of Health compared data collected from 1967 and 2010. It showed that, while people back then were slimmer, they ate fattier foods and had access to far fewer gyms. We eat better now, we work out more. But we live relatively sedentary lives. Only three out of ten households had a car then, compared to seven out of ten now. While 75 per cent of people walked for at least half an hour a day in the 1960s, this is only about 40 per cent now.
What really stands out, more than the lifestyle differences, is the sharp contrast in the attitudes towards obesity between the two different eras. The 1967 survey found that nine out of ten people had attempted to lose weight in the past year, compared with barely half of adults questioned in 2010. Perhaps most tellingly though, 40 years ago only 7 per cent of those people who considered themselves overweight had failed to do anything about it, compared with nearly half now.
It would be easy to blame Britain's fatness on lifestyle changes, but the worst of it is attitude. People just aren't bothering to lose weight any more. Perhaps obesity is viewed as more normal. But this is also down to the attitude that we doctors increasingly encounter in our consulting rooms: the reluctance of patients to accept that ailments can be blamed on their behaviour, for which they are reluctant to take responsibility.
Patients blame obesity on the government, cunning food manufacturers, their parents and their genes. They demand fat-loss pills on the NHS and stomach-stapling surgery as a right. In a world where health care is becoming consumerised, patients see themselves as customers. There's not much demand for hard truths.
America has severe obesity problems, and seems resigned to them. But Britain has a National Health Service, and therefore a far higher capacity to change. It ought to be easy. Doctors should be required to tell patients a blunt truth: if you're fat, eat less, exercise more, or both. And if you keep guzzling the tasty treats, you will die earlier. It's not a disease, it's a mindset — and that means it can be changed. We doctors need to be a little less understanding, a little more judgmental, and realise that our oath — 'do no harm' — must come before our desire to save the feelings of our patients. The truth can be the hardest drug to administer. But holding our tongues, prescribing the fat pills and bankrupting the NHS in the process is the worst solution of all.
http://www.spectator.co.uk/features/9049971/the-battle-of-the-bulge/?
Wednesday, October 9, 2013
Blocked vein theory of MS debunked again | Metro
TORONTO – A long-awaited Canadian study has found that narrowed neck veins are as common in healthy people as those with multiple sclerosis, sounding what's being called the "death knell" of the theory that blocked blood vessels may cause the debilitating neurological disease.
The study, published Tuesday in The Lancet, is the latest to question the validity of a controversial theory put forth in 2009 by Dr. Paolo Zamboni that MS is related to narrowed neck veins, which prevent blood from properly draining from the brain.
The Italian vascular surgeon named the condition "chronic cerebrospinal venous insufficiency," or CCSVI. He suggested iron deposits from backed-up blood cause the lesions in the brain that are the hallmarks of MS. The disease causes inflammation that destroys the myelin sheath around nerves, leading to widespread disability.
Zamboni said patients treated with a procedure to open up their neck veins — called balloon venoplasty — saw a significant reduction in symptoms.
News of Zamboni's "liberation therapy," generated through traditional and social media, sent thousands of MS patients from Canada and elsewhere to private clinics around the world, where they spent thousands of dollars each for the unproven treatment.
In the Lancet study, researchers at the universities of British Columbia and Saskatchewan found CCSVI was a rare phenomenon: out of 177 MS patients, unaffected siblings and healthy volunteers, only one in each group was found to have CCSVI as defined by Zamboni.
"And this was a big surprise to all of us," said Dr. Anthony Traboulsee, medical director of the UBC Hospital MS Clinic, who headed the study. "We were really expecting to find many more people with this feature."
What they did find, however, was that at least two-thirds in each group — so both those with MS and those without MS — had a 50 per cent or greater narrowing in a jugular or other neck vein.
Among 79 subjects with MS, 74 per cent had neck vein narrowing, while the same was true for 66 per cent of 55 unaffected siblings and 70 per cent of the 43 healthy volunteers.
"So there weren't really any significant differences between the three groups," said Traboulsee, noting that the study was done with catheter venography, considered the gold standard for radiologists to view the inside of veins — and the one Zamboni used, along with ultrasound imaging.
"So using the best method available, we were unable to confirm Dr. Zamboni's theory that MS is caused by CCSVI," he said. "And our conclusion is that the narrowing of the neck veins is common and a normal finding in most people.
"We recognize that for many people with MS, this will be a great disappointment. Many people were hoping that this was really a breakthrough in terms of knowledge of MS."
In an accompanying commentary, Dr. Friedemann Paul of NeuroCure Clinical Research Center in Berlin and radiologist Mike Wattjes of the MS Center Amsterdam said the Canadian study "sounds a death knell for the hypothesis of chronic cerebrospinal venous insufficiency as a disease entity."
"Chronic cerebrospinal venous insufficiency is not highly prevalent in multiple sclerosis," they write. "The disorder is neither specific to the disease nor does it have a causative role."
Paul and Wattjes also said the findings should put an end to discussions about whether millions of dollars spent on researching CCSVI in relation to MS has been a waste of valuable time and intellectual energy.
The study should be viewed as "the definitive conclusion to this discussion … now it is absolutely clear that no reason exists to allocate any further resources to chronic cerebrospinal venous insufficiency research, be they financial or intellectual."
However, the MS Society of Canada, which primarily funded the $450,000 study, said in a statement that it "remains committed to funding research that will answer the questions of those who live with the disease."
And Traboulsee said a federally supported clinical trial of the so-called liberation therapy is going ahead as planned.
The cross-Canada study will enrol 100 MS patients with evidence of narrowed veins to receive either the venoplasty treatment — in which a tiny balloon is fed into the neck veins to widen them — or a sham treatment. Neither patients nor the doctors who assess them will know which treatment they received.
Researchers will follow patients for two years to assess whether they experience sustained improvement in symptoms and whether tests, such as MRI brain imaging, show evidence of a reduction or halt in the progression of lesions.
Traboulsee said it is critical that researchers determine whether many of the MS patients who have sought the treatment — including at least an estimated 3,000 Canadians — truly had improvement or experienced a placebo effect, as some critics of the procedure contend.
"People might want to discount this as a placebo effect," he said. "I think that's being a bit patronizing to people and we need to do the proper research to fully address if there is any treatment benefit. And if we determine treatment benefit, then we have to figure out why."
Yet Traboulsee admits he has struggled with the issue, given that Zamboni's theoretical basis for the therapy appears after many studies to have no validity. "If the original theory is now faulty, why continue down this pathway?"
"Sometimes these things can become separated, and what we've found is that although CCSVI as defined by Zamboni doesn't really exist … we still have the situation where thousands of Canadians have gone abroad and have had a treatment … (and many have) reported significant improvement."
Other underlying theories in medicine have been proven wrong but have still led to benefit for patients, he said. "I think it justifies going forward.
"But I'll be honest — I don't fully understand how they're feeling better," admitted Traboulsee, suggesting that opening up veins may set off a process in the nerves or cause the release of substances that reduce symptoms like fatigue and brain fog.
A spokeswoman for the Canadian Institutes of Health Research, which has earmarked $6 million for the clinical trial, said the study will continue "because we still need to determine the safety of venous angioplasty and better evidence on patient outcomes."
So far, seven MS patients have been randomized to receive either the treatment or the sham procedure. All 100 patients should be recruited by next summer and preliminary results should be ready by fall 2015, Traboulsee said.
His message to MS patients is the same as it's been from the beginning: "Please do not rush out and spend your hard-earned money, mortgage your house, (spend) your life savings to get this procedure done out of country at private clinics.
"Research is the way to answer this," he said. "We're doing the research. We're doing it as rapidly as possible. We will have answers to these questions, but hang tight."
http://metronews.ca/news/canada/818901/blocked-vein-theory-of-ms-debunked-again/
The study, published Tuesday in The Lancet, is the latest to question the validity of a controversial theory put forth in 2009 by Dr. Paolo Zamboni that MS is related to narrowed neck veins, which prevent blood from properly draining from the brain.
The Italian vascular surgeon named the condition "chronic cerebrospinal venous insufficiency," or CCSVI. He suggested iron deposits from backed-up blood cause the lesions in the brain that are the hallmarks of MS. The disease causes inflammation that destroys the myelin sheath around nerves, leading to widespread disability.
Zamboni said patients treated with a procedure to open up their neck veins — called balloon venoplasty — saw a significant reduction in symptoms.
News of Zamboni's "liberation therapy," generated through traditional and social media, sent thousands of MS patients from Canada and elsewhere to private clinics around the world, where they spent thousands of dollars each for the unproven treatment.
In the Lancet study, researchers at the universities of British Columbia and Saskatchewan found CCSVI was a rare phenomenon: out of 177 MS patients, unaffected siblings and healthy volunteers, only one in each group was found to have CCSVI as defined by Zamboni.
"And this was a big surprise to all of us," said Dr. Anthony Traboulsee, medical director of the UBC Hospital MS Clinic, who headed the study. "We were really expecting to find many more people with this feature."
What they did find, however, was that at least two-thirds in each group — so both those with MS and those without MS — had a 50 per cent or greater narrowing in a jugular or other neck vein.
Among 79 subjects with MS, 74 per cent had neck vein narrowing, while the same was true for 66 per cent of 55 unaffected siblings and 70 per cent of the 43 healthy volunteers.
"So there weren't really any significant differences between the three groups," said Traboulsee, noting that the study was done with catheter venography, considered the gold standard for radiologists to view the inside of veins — and the one Zamboni used, along with ultrasound imaging.
"So using the best method available, we were unable to confirm Dr. Zamboni's theory that MS is caused by CCSVI," he said. "And our conclusion is that the narrowing of the neck veins is common and a normal finding in most people.
"We recognize that for many people with MS, this will be a great disappointment. Many people were hoping that this was really a breakthrough in terms of knowledge of MS."
In an accompanying commentary, Dr. Friedemann Paul of NeuroCure Clinical Research Center in Berlin and radiologist Mike Wattjes of the MS Center Amsterdam said the Canadian study "sounds a death knell for the hypothesis of chronic cerebrospinal venous insufficiency as a disease entity."
"Chronic cerebrospinal venous insufficiency is not highly prevalent in multiple sclerosis," they write. "The disorder is neither specific to the disease nor does it have a causative role."
Paul and Wattjes also said the findings should put an end to discussions about whether millions of dollars spent on researching CCSVI in relation to MS has been a waste of valuable time and intellectual energy.
The study should be viewed as "the definitive conclusion to this discussion … now it is absolutely clear that no reason exists to allocate any further resources to chronic cerebrospinal venous insufficiency research, be they financial or intellectual."
However, the MS Society of Canada, which primarily funded the $450,000 study, said in a statement that it "remains committed to funding research that will answer the questions of those who live with the disease."
And Traboulsee said a federally supported clinical trial of the so-called liberation therapy is going ahead as planned.
The cross-Canada study will enrol 100 MS patients with evidence of narrowed veins to receive either the venoplasty treatment — in which a tiny balloon is fed into the neck veins to widen them — or a sham treatment. Neither patients nor the doctors who assess them will know which treatment they received.
Researchers will follow patients for two years to assess whether they experience sustained improvement in symptoms and whether tests, such as MRI brain imaging, show evidence of a reduction or halt in the progression of lesions.
Traboulsee said it is critical that researchers determine whether many of the MS patients who have sought the treatment — including at least an estimated 3,000 Canadians — truly had improvement or experienced a placebo effect, as some critics of the procedure contend.
"People might want to discount this as a placebo effect," he said. "I think that's being a bit patronizing to people and we need to do the proper research to fully address if there is any treatment benefit. And if we determine treatment benefit, then we have to figure out why."
Yet Traboulsee admits he has struggled with the issue, given that Zamboni's theoretical basis for the therapy appears after many studies to have no validity. "If the original theory is now faulty, why continue down this pathway?"
"Sometimes these things can become separated, and what we've found is that although CCSVI as defined by Zamboni doesn't really exist … we still have the situation where thousands of Canadians have gone abroad and have had a treatment … (and many have) reported significant improvement."
Other underlying theories in medicine have been proven wrong but have still led to benefit for patients, he said. "I think it justifies going forward.
"But I'll be honest — I don't fully understand how they're feeling better," admitted Traboulsee, suggesting that opening up veins may set off a process in the nerves or cause the release of substances that reduce symptoms like fatigue and brain fog.
A spokeswoman for the Canadian Institutes of Health Research, which has earmarked $6 million for the clinical trial, said the study will continue "because we still need to determine the safety of venous angioplasty and better evidence on patient outcomes."
So far, seven MS patients have been randomized to receive either the treatment or the sham procedure. All 100 patients should be recruited by next summer and preliminary results should be ready by fall 2015, Traboulsee said.
His message to MS patients is the same as it's been from the beginning: "Please do not rush out and spend your hard-earned money, mortgage your house, (spend) your life savings to get this procedure done out of country at private clinics.
"Research is the way to answer this," he said. "We're doing the research. We're doing it as rapidly as possible. We will have answers to these questions, but hang tight."
http://metronews.ca/news/canada/818901/blocked-vein-theory-of-ms-debunked-again/
Tuesday, October 8, 2013
Treating Cancer that Has Spread to the Brain Locally with Neurosurgical Resection and Chemotherapeutic Wafers Can Improve Cognitive Function - Penn Medicine
A new approach to treating cancer that has spread to the brain is able to preserve and, in some cases, improve cognitive function in patients, while achieving local control of tumor progression. A study led by researchers with the Perelman School of Medicine at the University of Pennsylvania found that 98 percent of patients who deferred whole brain radiation therapy and had chemotherapeutic wafers placed around the areas where metastatic tumors in the brain had been surgically removed showed preserved cognitive function in one or more of three domains; 65 percent showed preservation in all areas tested: memory, executive function, and fine motor skills. The study, published online in Cancer, demonstrated improvements in cognitive function, particularly in executive function and memory, which were observed in more than 40 percent of patients. In the fine motor movement category, 50 percent of patients showed improvements.
Brain metastases affect between 25 and 45 percent of all cancer patients. Whole brain radiation therapy is often used to control recurrence and spreading of metastases in the brain, but it causes cognitive decline in more than a third of patients and fails to improve independent function or prolong overall survival. Newer treatments, such as stereotactic radiation (e.g. Cyberknife or Gamma knife) and chemotherapeutic wafers (Gliadel® wafers) aim to treat metastases or recurrences locally while preserving cognitive function. These new approaches preserve white matter integrity; previous studies have looked at current surgical approaches using advanced neuroimaging, such as diffusion tensor imaging (DTI or diffusion tractography), that enable surgeons to remove the tumor while sparing the fiber tracts that mediate language, motor skills, and other key functions.
"While not denying the value of whole brain radiation therapy for select patients, the current study supports the growing trend for some patients to have surgery and local therapy to the tumor bed, via stereotactic radiosurgery or chemowafers," said lead author Steven Brem, MD, professor of Neurosurgery at the Perelman School of Medicine. "We know that about half of patients with metastatic brain cancer go on to develop a new, separate brain metastasis, which can be detected by using surveillance MRI every 2 to 3 months. Some patients can go for years with normal brain function without risking the toxicity of whole brain radiation."
The study – by a team of researchers from Perelman School of Medicine at the University of Pennsylvania, the University of North Carolina, MD Anderson Cancer Center, and Moffitt Cancer Center – followed 59 patients with up to three metastatic tumors who had received surgery and chemowafers wafers lining the tumor cavity. Of the 54 patients who followed the post-surgical protocol, 63 percent of patients had preserved fine motor coordination (34 of 54 patients), 72 percent had preserved executive function (39 of 54), and 69 percent had preserved memory (37 of 54), including 48 percent that saw an improvement in memory function (26 of 54). Only one patient (2 percent) had a decrease in all three cognition domains. Local tumor recurrences occurred in 28 percent of patients evaluated at the end of the one-year study. Distant recurrences were found in 48 percent of patients, with more than half of recurrences happening within four months of the treatment.
"We will continue to try to find interventions that preserve function while preserving or increasing the quality life for patients with cancer that spreads to their brain," said Dr. Brem, noting that further studies comparing treatment options are needed to determine the optimal treatment strategy.
The toxicity profile was that expected for a patient population with advanced cancer metastatic to the brain. Serious adverse events were reported in 40 of 59 patients; complications related to the chemowafers were resolved with medical or surgical intervention. Nine patients died during the study, one from a neurologic cause and eight as a result of their primary cancers.
Subscribe to:
Posts (Atom)