By Jerome Burne
A small but remarkable trial of the effects that a change of lifestyle can have on diabetes and obesity has just been published in the relatively obscure SAMJ (South African Medical Journal).
The results are impressive and the implications ground breaking. The starting point is that the official ‘evidence based’, low fat, calories-in equals calories-out approach isn’t working.
This initiative comes from a self-styled ‘rag-tag ‘band of clinicians and data geeks in Northern Canada who have thrown away the rule book and started from scratch. Questioning the official guidelines they have begun gathering evidence on what does work in the real world. The trial is the first report of what they have found.
Their approach is right at the other end of the spectrum from conventional evidence based medicine (EBM) which relies on a hierarchy of methods with the RCT (randomised controlled trials) at the top. These are the research equivalent of dreadnought battleships or nuclear submarines – massive, hugely expensive and taking years to build.
In theory, their statistical fire power allows them authoritatively to distinguish between what works and what doesn’t, but when it comes to providing a reliable guide for doctors on how best to deal with the diabesity epidemic, there’s little evidence to show this system has worked. By contrast these research mavericks are more like small and highly mobile Special Forces units operating behind enemy lines.
Dramatic improvements in health markers
They have jettisoned the idea of a formal hypothesis, rely on fairly simple statistics and make limited use of control groups. Most heretical is that the number of variables they include can’t possibly all be controlled for.
The trial involved 372 patients in rural Canada who first followed a low calorie and low carbohydrate diet; unusually they were asked not to do any vigorous exercise. When they had lost an agreed amount of weight, calorie counting was abandoned but they continued with low carbs and started exercising, as well as attending meetings with their clinician and other patients.
The results were very encouraging. Most had ‘unusually large improvements in their health’ and lost over 12% of their body weight. Among those who had had various risk biomarkers measured, 58% had unhealthy levels at the beginning of the trial compared to 19% at the end. Their average BMI at the start was 37 dropping to a borderline overweight classification of 30.
Other health indicators also got better. Blood pressure went from 136/85 to a healthy 122/77 and even though they had been on a high fat diet, their LDL cholesterol fell from 3.3 to 2.9. As a result of these changes, many were able to cut their drug intake. Inevitably the first report of this lighter, faster approach can’t answer the question of how long the weight stays off.
Frustrated by failure of official guidelines
What it does give us, and more importantly, other doctors, is a place to start a life-style treatment for obesity and diabetes rather than depending on the mixed messages in the scientific literature. The urgency of the situation means that this is a work in progress. The idea is that doctors can integrate new findings about what works into their treatment package as they come out.
The physician that kicked it off was one of the authors, Dr Stefan du Toit of the Valemount Health Centre in British Columbia.’ I was getting frustrated, giving the approved prescriptions every month for chronic conditions and watching as my patients generally got worse. So I wanted to know why the evidence-based medicine we are supposed to rely on isn’t working.’
About six years ago Dr du Toit began doing a number of non-randomized trials with groups of fifteen to twenty of his patients. He looked at things affecting weight loss such as drinking water, physical activity, and whether calorie restriction initially worked better with low carb or low fat.
‘The results of these “trials” were incorporated into patient care at the first intervention site – and with the success there, the intervention started spreading to other communities,’ says lead author and Canadian epidemiologist Dr Sean Mark. Counselling patients to avoid strenuous exercise during weight loss, for instance, meant people didn’t get so hungry and later the low carb diet keeps the blood glucose down. Actually you don’t need quick and dirty trials to establish that. There’s a study dating back to 1994 by Professor Gerry Reaven showing that insulin resistance is fundamentally a disorder of carbohydrate metabolism.
Gathering real world data with phone apps
Building on the foundation of this grass-roots science, Mark and his colleagues plan to make use of mobile phones to gather data from practitioner led “pragmatic trials”. ‘We are working on an app that allows doctors to experiment with and optimize lifestyle interventions in their respective practices,’ says Mark.
‘To start things off, we plan to better document the impact of physical activity on weight loss and weight maintenance. This is fluid, “real-world science” not the ivory tower stuff. An appreciation of how little we know about lifestyle medicine is the key’ (For more details see nutrition2p0.com).
But the new protocol is not just based on non-randomised trials in a corner of rural Canada. At least two of the other authors are high profile advocates of the low carb diet with not only extensive clinical experience but who also eat scientific literature for breakfast.
One is Dr Jay Wortman a Canadian physician and clinical assistant professor at the University of British Columbia’s faculty of medicine who “cured” his own type 2 diabetes 12 years ago by cutting sugars and starches from his diet. He went on to study the diets of Canadian aboriginal groups, who were eating a regular western diet and had high rates of diabetes. ‘I discovered that their traditional diets were low in carbohydrates and virtually every traditional diet had a centrally important fat.’
Changes also improve auto-immune disorders
The other is Tim Noakes emeritus professor in the Division of Exercise Science and Sports Medicine at the University of Cape Town who is also an enthusiastic supporter of the low carb diet after it helped him avoid diabetes. He tells the story in his book The Real Meal Revolution. Currently he is embroiled in an ongoing hearing before the Health Professions Council of SA for his ‘unconventional’ views on butter, eggs, bacon and broccoli’.
The benefits of the recent trial weren’t limited to markers for obesity and diabetes either. ‘One of the really interesting and unexpected results of the therapeutic diet was the huge improvement in the symptoms of autoimmune conditions that showed up,’ says Dr Mark.
However the idea of rethinking the best ways to implement lifestyle change with a series of investigatory trials has not been well received by the dietary establishment. The fullest account of the trial and of the negative reaction to it comes from South African journalist and blogger Marika Sboros in this source and here.
Top South African endocrinologist Dr Tessa van der Merwe is reported as having been particularly dismissive, describing the trial as ‘nonsense based on … (personal) … assumptions.’ Like others she also pointed out the lack of a control group who received no treatment. She also claims the trial gives no evidence for the benefits of high fat diet, apparently ignoring the extensive literature supporting its use that both Noakes and Wortman would have relied on.
RCT results not repeated in real world
The trial certainly failed to tick a number of evidence based medicine boxes but it also had advantages that overcome a major shortcoming of RCTs. The fact that the trial was open to anyone meant that those involved had all sorts of other medical problems – hypertension, alcoholism, inflammatory bowel. Just like the people who seek help in clinics all over the western world in fact. Yet because of the financial and career pressures to report favourable results, such patients are regularly excluded from those ‘gold standard’ RCTs.
This makes the RCT results unreliable when the treatment (usually a drug) is rolled out in the real world. The patients in RCTs are invariably younger and fitter than most of those who will be prescribed the treatment. They also only suffer from the disorder the drug is designed treat. In the Canadian real world trial the protocol was run on patients who often had three, four or more conditions. They would have been getting drugs to treat them and yet they still benefited.
But the most jaw dropping element of van der Merwe’s critique was her agreement that a shift in the treatment of diabesity and obesity was certainly needed – perform more bariatric surgery operations. Not only is this an acknowledgement that the low fat approach has failed but it is a counsel of despair as far patients are concerned. You have to be seriously ignorant of the potential of life-style change to consider bariatric surgery as a superior option.
Saggy skin, blood clots, pain and nausea
The NHS website lists of some of the side effects. These include infection, clots in the legs and lungs and internal bleeding. Then there is ‘saggy skin’ – excess rolls around the breasts, tummy, hips and limbs which ‘look ugly and are difficult to keep clean’. Ten months after surgery one in 12 patients develop gall stones which can cause sudden intense pain, nausea and vomiting and jaundice.
However the iron logic of the current EBM approach is that RCTs and complex meta-analyses of existing trials trump patient anecdotes and clinical experience. There are reasons for this but as a way to dealing with diabesity this approach has manifestly failed.
Details of why EBM needs a radical overhaul if it is to become a tool for benefiting patients is set out in a recent article entitled ‘Evidence based medicine has been hijacked’ by John Ioannides, Professor of Medicine and of Health Research and Policy at Stanford University School of Medicine.
An early and enthusiastic advocate of EBM, Ioannides’ presents a long list of charges including; being used to buttress ‘eminence based medicine claims’; that the industry ‘runs a large share of the most influential randomised trials’ and that ‘vested interests dictate pre-emptively large segments of the research agenda and its evidence-based aura.’
We don’t have time to wait for RCT results
Rather than being a way of ‘integrating individual clinical expertise with the best external evidence’ he writes, EBM has succumbed to ‘pressure to deliver services (and) capture the largest possible market share.’
This is the dreadnought that the rag-tag band has had the temerity to challenge. ‘Relying on the RCT model to generate an optimal lifestyle prescription and then having that trickle down to patient care would take 25 years.’ says Mark. ‘With the diabetes and obesity pandemics already having a crushing impact on budgets, health systems around the world don’t have that long.’
It’s a brave and quixotic venture. The firepower and finances of an industry uninterested in life-style options is formidable. Research published in the BMJ this week reveals that in one year companies making diabetes drugs paid an astonishing 100 million dollars to the doctors who prescribe diabetes medications in just 306 American hospitals. The money was for hospitality, speaking and consulting fees. The payments correlated with a much higher prescribing rate of the paying company’s drug. This, the article stressed, did not prove causation.
Still, poorly equipped guerrillas have defeated imperial armies in the past. In his article Professor Ioannides hopes they will again. ‘I am still fantasising of some place where the practice of medicine can still be undeniably helpful to human beings and society at large. Does it have to be in a very remote place in northern Canada close to the Arctic?’ Just maybe.