Radical doctors throw away rule book to beat diabetes and obesity

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.

 

Jerome Burne

Jerome Burne

Jerome Burne is the editor of HealthInsightUK. He is an award-winning journalist who has been specialising in medicine and health for the last 10 years and now works mainly for the Daily Mail. His most recent book “10 Secrets of Healthy Ageing” was written with nutritionist Patrick Holford. He blogs at “Body of Evidence” – jeromeburne.com. 2015: Finalist for 'Blogger of the Year' award from Medical Journalists' Association.

11 Comments

  • The Prime Minister is a type 1 diabetic and might be the only person with the power to overturn the current disgraceful treatment of diabetics. There could be enormous financial savings for the NHS and huge health benefits for diabetics.

    RCTs will never be done to show a dietary solution is far superior to drugs. The pharmaceutical industry are the only people with the money to do RCTs, but have a vested interest in perpetuating the curent idiocy. The result is 130 diabetes-related amputations a week carried out by the NHS. The scale of needless harm is jaw dropping.

  • Surely it’s a false dichotomy to oppose these methods to RCTs; in medicine you can decide the worth of a therapy from RCTs and other experimental evidence, but you still need to know how to roll it out to patients. This is especially true of diet and lifestyle interventions, but even drugs often need more detail than RCTs supply.
    Will it work better, and be more cost-effective, with one-on-one coaching, a support group, an app, an in-patient training period?
    The practitioners will choose the option they are best placed to provide, apply it, and document their results.
    Then other practitioners can read these papers and decide if they are able to provide something similar, with a reasonable idea of how effective it will be.
    There are hundreds of these cost-and-efficacy trials in the literature. So this a

    • Editorial

      That is all true in an ideal world but at the moment nearly all doctors are following official guidelines, patients are getting fatter and intake of diabetes medication is soaring. Meanwhile those who come out strongly for a low carb approach are told it has no evidence and in some cases are struck off official registers or hauled in front of hearings. This brave band of brothers are trying to come up with an approach that begins to offer options ASAP rather than waiting for the RCT engine to leisurely produce narrowly framed results.

  • New thinking and new approaches must be welcome in Diabetes. The real problem is that no-one really knows what diabetes is! Is it one disease or several. Redefinition has occurred recently and as a result many more people now have “it” – or is “it” a group of different diseases? Definition based on blood glucose or HbA1c is based on the end result. The disease of the small arteries/arterioles is the important thing, but then how to define it becomes the problem. We seem to be stuck with an inappropriate name. It would be better defined as ???? syndrome, as a syndrome is merely descriptive and acknowledges ignorance.

    • We measure fasting glucose, HbA1c, and OGTT glucose response because these are easy and cheap to measure, but if we could measure the insulin response as easily and cheaply we would have a better guide to risk and to the type and stage of diabetes.
      This is because most of the pathologies of type 2 diabetes – cardiovascular disease and vascular disease in particular, but also, probably, the progression of beta-cell failure – are driven by the elevated insulin levels. Retinopathy, on the other hand, is driven by high glucose and is the only pathology of type 2 diabetes reduced by the administration of insulin or sulfonyureas.
      On the other hand, drugs that reduce both glucose and insulin (secretion or requirement) by restricting uptake or increasing excretion of glucose – i.e. acarbose (STOP-NIDDM trial) or SGLT2 inhibitors (EMPA-REG ttrial) – significantly reduce the risk of cardiovascular disease and vascular pathologies.
      What of statins? These have some lesser effect on the incidence of cardiovascular and vascular disease, despite the potential for increased blood glucose.
      Statins inhibit the synthesis of cholesterol in cells, and the synthesis of excessive cholesterol, which disrupts mitochondrial function, is driven by excessive insulin concentrations.
      What therapy lowers the secretion of or requirement for insulin, but does not increase and will usually lower blood glucose?
      A low carbohydrate, high fat diet.
      Q.E.D.

      • My wife, a diabetic of many years, in Feb 2014 went on a LCHF diet (Thanks Prof Noakes). In 18 months she lost 30kg, stopped insulin totally (fasting blood glucose <6.2%), stopped blood pressure meds (=normal), stopped statins. HUGE health improvement which continues to today.
        Q.E.D.

  • For many sufferers I believe we could rename diabetes T2 “insulin intolerance”. It seems to me at least that high insulin production, to counter diets full of sugar and carbohydrates, is the trigger to developing so many ‘modern’ diseases, including T2, gout, high blood pressure and possibly even Alzheimer’s and dementia. Kudos to these brave band of brothers and sisters for not towing the corporate/ government line. We all need brave mavericks in our lives to challenge the status quo. Without them change would never come.

  • “How did you do it” is the question I’m asked when people see my weight loss. What they don’t see is the blood work and the sharply enhanced lipid profiles that I am now dealing with. They don’t know about the diabetes reversal nor the elimination of arthritic pain until I tell them. It is also amazing to see their open mouthed incredulity at my description of the Way of Eating that resulted in the transformation. Then I show them a picture of my beer bottle burger – low carb, high fat, wrapped in bacon and topped with smoked cheddar. This is not deprivation but a wonderful way to live.

  • Treatment of Diabetes
    Diet is the only treatment needed by many adults diabetics,particularly those who are obese when they develop the disease,provide they can lose and not regain their excess weight Since obese people are more likely to developed diabetes.
    We know combinations of diet habits acquired in youth conditioning during early years to react to emotional stress by eating,the absence of appropriate exercise patterns of genetic inheritance Simply put ,they do not know when to stop eating.Others particularly girls may eat less .
    Obesity is a health hazard.My concern is a young child lack of exercise and eating rubbish .Reversal of the accumulation process is your best chance of preventing far worse diseases doctors understand little and treat poorly.
    There are no miracle cures …except the miracle cure that nature performs.No one can cure you.Health building requires individual discipline.Your mind and brain must take over the operation of your body.Only a clear intelligent and reasoning mind will carefully supervise what to put in the stomach .The human body is the most powerful instrument and can take years of the cruellest punishment.Misleading research is determined to produce sound statistical work that they choose problems easy to analyse,but a profound triviality .Your health the length of time you are going to remain on top of this earth is strictly up to you and you alone.

  • No one who uses the construct that is ‘obesity’ has thrown away any rule book. ‘Obesity’ is the rule book. It has achieved nothing of any value and likely never will.

    • Editorial

      The phrase ‘rule book’ refers not to obesity or diabetes (why on earth would it) but to the official advice given to treating them. Don’t know where ‘obesity is the rule book’ but it is nowhere I have ever been

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