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All Behavioural Interventions Carry Risks

sharma-obesity-kids-scale1Following the recent release of the Canadian Task Force on Preventive Health Care guidelines for prevention and management of adult obesity in primary care, the Task Force yesterday issued guidelines on the prevention and management of childhood obesity in the Canadian Medical Association Journal (CMAJ).

Key recommendations include:

  • For children and youth of all ages the Task Force recommends growth monitoring at appropriate primary care visits using the World Health Organization Growth Charts for Canada.
  • For children and youth who are overweight or obese, the Task Force recommends that primary health care practitioners offer or refer to formal, structured behavioural interventions aimed at weight loss.
  • For children who are overweight or obese, the Task Force recommends that primary health care practitioners not routinely offer Orlistat or refer to surgical interventions aimed at weight loss.

The lack of enthusiasm for the prevention of childhood obesity is perhaps understandable as the authors note that,

“The quality of evidence for obesity prevention in primary care settings is weak, with interventions showing only modest benefits to BMI in studies of mixed-weight populations, with no evidence of long-term effectiveness.”

leading the Task Force to the following statement,

“We recommend that primary care practitioners not routinely offer structured interventions aimed at preventing overweight and obesity in healthy-weight children and youth aged 17 years and younger. (Weak recommendation; very low-quality evidence)”

Be that as it may, the Task Force does recommend structured behavioural interventions for kids who already carry excess weight based on the finding that,

“Behavioural interventions have shown short-term effectiveness in reducing BMI in overweight or obese children and youth, and are the preferred option, because the benefit-to-harm ratio appears more favourable than for pharmacologic interventions.”

What caught my eye however, was the statement in the accompanying press release which says that,

“Unlike pharmacological treatments that can have adverse effects, such as gastrointestinal problems, behavioural interventions carry no identifiable risks.” (emphasis mine) 

While I would certainly not argue for the routine use of orlistat (the only currently available prescription drug for obesity in Canada) in children (or anyone else), I do take exception to the notion that behavioural interventions carry no identifiable risks – they very much do.

As readers may be well aware, a large proportion of the adverse effects of medications is attributable to the wrong use of these medications – problems often occur when they are taken for the wrong indication, at the wrong dose (too high or too low), the wrong frequency (too often or too seldom), and/or when patients are not regularly monitored. In a perfect world,  many medications that often lead to problems would be far less problematic than they are in the real world.

Interestingly, the same applies to behavioural interventions.

Take for example diets – simply asking a patient to “eat less” can potentially lead to all kinds of health problems from patients drastically reducing protein, vitamin and mineral intake as a result of going on the next “fad” or “do-it-yourself” diet. Without ensuring that the patient actually follows a prudent diet and does not “overdo” it, which may well require ongoing monitoring, there is very real potential of patients harming themselves. There is also the real danger of promoting an eating disorder or having patients face the negative psychological consequences of yet another “failed” weight-loss diet. Exactly how many patients are harmed by well-meant dietary recommendations is unknown, as I am not aware of any studies that have actually looked at this.

The same can be said for exercise – simply asking a patient to “move more” can result in injury (both short and long-term) and coronary events (in high-risk patients).  Again, ongoing guidance and monitoring can do much to reduce this potential harm.

In short when patient apply behavioural recommendations at the wrong dose (too much or too less), wrong frequency (too often or too seldom), and/or are not regularly monitored, there is indeed potential for harm – I would imagine that this potential for harm is of particular concern in kids.

This is not to say that we should not use behavioural interventions – we should – but we must always consider the potential for harm, which is never zero.

I’d certainly be interested in hearing from anyone who has seen harm resulting from a behavioural intervention.

@DrSharma
Edmonton, AB

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Weight Gain With Methadone Treatment For Opioid Addiction

scaleWeight gain is not an uncommon phenomenon with addiction treatment. This has been reported both in smokers and in those with alcohol addiction.

Now a study by Jennifer Fenn and colleagues from the University of Vermont report significant weight gain with methadone treatment for opioid addiction in a paper published in the Journal of Substance Abuse Treatment.

The retrospective chart review included 96 patients enrolled in an outpatient methadone clinic for ≥ 6 months.

Overall mean BMIs increased by about 3 units (from 27.2 to 30.1), which corresponds roughly to an 18 lb or 10% increase in body weight.

Interestingly, the weight gain was predominantly seen in women, who gained about 28 lbs or 17.5% body weight compared to men, who only increased their weight by about 12 lbs or 6.4%.

As the study did not have access to food records, one can only speculate as to the causes. While better nutrition may well play a role, one could also speculate that there may be some addiction transfer from opioids to calorie-dense foods.

Whatever the cause, clinicians should probably be aware of this potential impact of methadone treatment on body weight, as prevention of excess weight gain may be easier than treating obesity once it is established.

@DrSharma
Edmonton, AB

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MetAP2 Inhibitor Beloranib Produces Weight Loss in “Simple” Obesity

sharma-obesity-insulin-injectionReaders may recall a previous post on the remarkable efficacy of beloranib, a methionine aminopeptidase 2 (MetAP2 ) inhibitor, in patients with hypothalamic obesity.

Now, a paper by Dennis Kim and colleagues present the results of a phase II study in individuals with “simple” obesity, published in Diabetes, Obesity and Metabolism.

The study included 147 participants with moderate obesity, who were randomised to 0.6, 1.2, and 2.4 mg beloranib or placebo for 12 weeks, with no specific diet or exercise recommendations.

At 12 weeks, participants had on average lost between 5.5 and 10.9 Kg in a dose-dependent fashion.

This reduction in body weight was associated with relevant improvements in waist circumference, lipids and blood pressure.

Adverse effects included dose-dependent increase in sleep latency and mild to moderate gastrointestinal symptoms.

Beloranib is an investigational weight loss therapy with a novel mechanism of action. This study assessed the efficacy, safety, and tolerability of beloranib treatment for obesity.

This is certainly a most remarkable degree of weight loss seen at 12 weeks and it will be interesting to see the results of the longer-term studies that are currently underway.

@DrSharma
Edmonton, AB

Disclaimer: I have received consulting honararia from Zafgen, the maker of belanorib.

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Obesity Management Belongs In Primary Care

sharma-obesity-doctor-kidNo matter if and when obesity prevention efforts bear fruit, there are currently well over 6,000,000 Canadian adults and children, who could benefit from obesity management today.

Even, if one were to limit more intense obesity management (such as behavioral, pharmacological and/or surgical treatments) to those with more severe obesity (Edmonton Obesity Staging System 2+), this would still overwhelm the capacity of existing tertiary care systems.

Thus, as William Dietz and colleagues point out in their recent article in the 2015 Lancet Obesity Series, even the majority of severe (or complicated) obesity will still need to be managed in primary care.

“Care for adults with severe obesity has generally been delivered in tertiary-care centres. Although such programmes are efficacious, they are poorly suited to address the number of patients with severe obesity. Alternative approaches for the management of adults with severe obesity include primary-care settings or community settings to deliver care.”

However,

“Transition from efficacy to effectiveness will require substantial and challenging changes in how primary care is delivered. Practices often lack the organisational structure, such as patient registries and methods for systematic tracking to assess clinical interventions, care teams to manage patients with chronic illnesses, or health information systems that support the use of evidence-based practices at the point-of-care to provide longitudinal care for chronic illnesses.”

Where they exist, these structures are already at capacity dealing with other chronic diseases including diabetes, hypertension, COPD and other lifelong disorders.

Even if many of these problems are directly related to excess weight (or would at least substantially improve with weight loss), most primary care practitioners have yet to take on the challenge of managing obesity (not just the obese patient).

Surely enthusiasm for obesity management will increase in primary care settings as more effective obesity treatments become available – making these available to those who stand to benefit, needs to be a key priority of health care system planners and payers.

The fact that many payers chose not to cover obesity treatments by delegating this to the category of “lifestyle”, shows that they have yet to take obesity seriously as a chronic disease in its own right.

It may also demonstrates their biases and discrimination of people living obesity – after all the same payers have no problem shelling out billions of dollars to treat other “lifestyle” disorders like strokes, heart attacks, type 2 diabetes or COPD.

This is where health policies can and should make a difference to people living with obesity – the sooner, the better.

@DrSharma
Edmonton, AB

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First New Anti-Obesity Drug in Canada in Two Decades

saxendaOn Friday, Health Canada approved the first new anti-obesity drug for Canadian in nearly two decades.

Thus, soon, Canadians looking for medical treatment for obesity will soon have two prescription drugs available to them – the almost two decades old orlistat (Xenical®) and the soon to be launched liraglutide 3 mg (Saxenda®).

The differences between the two drugs could not be bigger. While orlistat works by inhibiting fat digestion and therefore reduces the number of calories absorbed from fat in the gut, liraglutide is a close analogue to human glucagon-like peptide 1, a gut hormone known to play a key role in insulin secretion and appetite regulation.

Because liraglutide is a peptide, it comes as a once daily injection, not unlike insulin. As an injectable prescription drug, Saxenda is not meant to be taken by anyone, who wants to quickly lose a few pounds. In fact, it takes several weeks of careful uptitration before you even reach the recommended dose for treating obesity – and, as with any obesity medication, you have to stay on it to keep the weight off.

According to Health Canada,

Saxenda® s indicated as an adjunct to a reduced calorie diet and increased physical activity for chronic weight management in adult patients with an initial body mass index (BMI) of:

-      30 kg/m2 or greater (obese), or;

-      27 kg/m2 or greater (overweight) in the presence of at least one weight-related comorbidity (e.g., hypertension, type 2 diabetes, or dyslipidemia);

and who have failed a previous weight management intervention. 

While seeing this approval is certainly a major step forward in our ability to medically treat obesity, liraglutide is neither effective for everyone nor will everyone tolerate it (the most common adverse effect is nausea). So, hopefully, this is only the first of several new anti-obesity drugs that we can expect to see in Canada in the coming years.

After all, there is no reason why we should not one day have as many drugs to treat obesity, as we have to treat other chronic diseases (e.g. hypertension, diabetes, etc.).

@DrSharma
Edmonton, AB

Disclaimer: I have received honoraria as a speaker and consultant from Novo Nordisk, the maker of Saxenda®.

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