Monday, September 18, 2006

Diabetes Prevention - What's the Bottomline?

Imagine for a moment you are at your doctors' office for a check-up.

While reviewing the various tests, your doctor's face shows his concern as he tells you your blood sugars worry him, they show you are "pre-diabetic;" when he factors in your weight, blood pressure and cholesterol levels, he's even more concerned for your long term health, especially your risk for diabetes and cardiovascular disease.

This scenario is one millions face each year in the United States.

Now imagine you're faced with the decision about what to do to reduce your risk for progressing to diabetes. Your doctor presents you with the following information:
  • Dietary modification to reduce fat, especially trans and saturated fat; basic calorie restriction within the recommendations
  • Lifestyle modification to start an exercise program;
  • Pharmaceutical intervention with a medication, rosiglitazone, shown to reduce the risk of progressing to diabetes in a recent study.

Your doctor tells you quickly about some of the side effects of the drug, but says that the latest trial using the medication showed it reduced the risk of developing diabetes in the study by 66%.

Do you do it?

Most people in such a situation would; without knowing that there are other, clinically effective interventions they might want to consider as their first line defense.

While the media is hot on reporting the recent study, Effect of Rosiglitazone on the frequency of diabetes in patients with impaired glucose tolerance or impaired fasting glucose: a randomized controlled trial, that found a reduction in the risk of progression to diabetes in those treated with rosiglitazone, much of the important data is being lost in the hype.

Lost in the frenzy to report the results of the study is the side effects of rosiglitazone:

  • upper respiratory tract infection
  • headache
  • back pain
  • hyperglycemia
  • fatigue
  • sinusitis
  • diarrhea
  • hypoglycemia
  • mild to moderate accumulation of fluid (edema); can lead to heart failure
  • weight gain
  • potential for liver injury
  • elevated total and low-density cholesterol (LDL)

Also lost is the number of people who would have to follow the course of treatment for three years to prevent one case of diabetes.

Bottom line from the study - for every seven people compliant with treatment for three years, one case of diabetes may be prevented.

In other words, the treatment will not prevent diabetes in six out of seven people of those who modify their lifestyle, diet and take the prescribed rosiglitazone for three years when compared with those who only modified their diet.

Now that doesn't sound quite as impressive as the first statistic - a 66% reduction of risk of developing diabetes in those treated - does it?

That's because it's not.

The current hype also doesn't tell you that those taking the rosiglitazone - those without cardiovascular disease in this trial - also had an "excess" of 4 to 5 cases of congestive heart failure compared with those not taking the drug.

But, when you want to promote a pharmaceutical intervention, it's a very effective way to present findings in a positive light.

Really, who would take the time to hype an intervention that works for only one in seven who follow it or come right out and say the risk for congestive heart failure increases?

No one.

So, instead of taking such an honest approach, the tact is to hype the risk reduction compared to the control group, then take it a step further and compare it to other miserable trial results!

Within the published study, the researchers compare their results with those found in trials in the US and Finland. In those trials, both reported a 58% reduction of risk when subjects followed a lifestyle intervention; in both that translated to the intervention working for one in five, or 20% of those who made the changes recommended. Stated another way, a failure rate of 80% that is easily glossed over when one highlights the reduction in risk rather than absolute numbers of prevention.

So what we have here are three trials being promoted as evidence that one can reduce their risk of developing diabetes if they follow the recommendations for diet, lifestyle and/or include medications too. It will only work 14% to 20% of the time over a period of three to five years, but hey it sounds so much better if stated as a risk reduction of 58% to 66%!

This is nothing more than doublespeak - failure is being hyped as success; failure is being hyped as prevention.

Let's also not forget the side effects reported by those who follow the lifestyle intervention promoted - weight loss, hunger, fatigue, strict calorie counting, strictly limiting many foods like eggs, headache, increased triglycerides, reduced HDL, reduced LDL, and loss of lean body mass with fat loss. Add to this, if you take this new course - the lifetyle, diet and rosiglitazone intervention, you also have to remember to take your medication as prescribed in addition to any other medications you're already taking.

Now take a look again at the side effects listed above if you follow the intervention to include rosiglitazone too. Consider those together with the lifestyle consider you're presented with an alternative with these side effects:

  • Weight loss
  • Loss of body fat, sparing lean body mass
  • High satiety (loss of hunger)
  • Headache
  • Normalized triglycerides
  • Increased HDL
  • LDL change uncertain
  • Total:HDL improvement
  • Improved glycemic control
  • Fatigue
  • Improved HbA1c
  • Bad breath
  • Constipation
  • Reduced blood pressure
  • Reduction in inflammatory markers
  • Reduction in use of medications

Would you rather try the drugs with the recommended diet, or the dietary intervention above, alone without additions to any medications you are already taking?

No matter which you would choose, don't you think you should be told about both options so you can decide which one may be easier for you to follow, stay compliant with longer? The one that may work better for you and your lifestyle and eating preferences?

1 comment:

  1. I was put on Avandia (amongst other things)- at age 18. It was expensive and made me gain weight. I read up on what it was about, then stopped taking it.

    A little off topic, but sometimes I wonder- not so much that the doctor didn't care about me (because I know he does/did) but that he talks to so many patients each day about lifestyle change until he's blue in the face, and the majority of people don't change their lifestyle, and then he gets discouraged, and just starts to throw pills at the problem, thinking that it's not going to matter anyway.

    Not that it's an excuse...but I really wonder...