Trotting Out STAMPEDE
Wednesday, April 2, 2014
In the obesity world, this week’s big news is the publication of the three year results of the STAMPEDE trial in the New England Journal of Medicine.
As a regular reader, you may recall my previous post on this randomised controlled trial of bariatric surgery for the treatment of type 2 diabetes.
STAMPEDE involved the randomisation of 150 obese patients with uncontrolled type 2 diabetes to either intensive medical therapy alone or intensive medical therapy plus Roux-en-Y gastric bypass or sleeve gastrectomy.
Rather than weight loss, the primary end point of STAMPEDE was a glycated hemoglobin (HbA1C) level of 6.0% or less (from a mean baseline of 9.3%).
For the 91% of the patients who completed 36 months of follow-up at three years, 5% of the patients in the medical-therapy group achieved an HbA1c of 6.0% compared to 38% of those in the gastric-bypass group and 24% of those in the sleeve-gastrectomy group.
In addition, surgically treated subjects overall had far lesser need for glucose-lowering medications, including insulin than those receiving medical treatment.
Weight was reduced by 20-25% in the surgical groups compared to a 4% weight loss in the medical arm of the study.
Quality-of-life was also significantly better in the two surgical groups than in the medical-therapy group.
There were no major late surgical complications.
By any reasonable standard, there cannot be any remaining doubt in anyone’s mind that surgical treatment for type 2 diabetes is vastly superior to anything that medical treatment has to offer.
Diabetologists and, in fact, all physicians, diabetes educators, dietitians and other health professionals, who fail to inform and counsel their type 2 patients with regard to surgical treatment options for their condition, risk being accused of malpractice.
Whether patients want surgery for diabetes or not is ultimately their choice – being informed of the potential benefits of surgery should not be a matter of choice – it should be good clinical practice.
@DrSharma
Edmonton, AB
Disclaimer: I am NOT a surgeon!
Schauer PR, Bhatt DL, Kirwan JP, Wolski K, Brethauer SA, Navaneethan SD, Aminian A, Pothier CE, Kim ES, Nissen SE, Kashyap SR, & the STAMPEDE Investigators (2014). Bariatric Surgery versus Intensive Medical Therapy for Diabetes – 3-Year Outcomes. The New England journal of medicine PMID: 24679060
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Wednesday, April 2, 2014
Arya, your blog is so valuable!! I really get information here first!! Thanks for bringing the STAMPEDE paper to my attention. I like your insights also.
Wednesday, April 2, 2014
And what of the waitlist for these surgeries?
Wednesday, April 2, 2014
Good question – access to surgery varies widely from province to province and can be anywhere between 12 months and 5 years.
A
Wednesday, April 2, 2014
It can also be difficult to qualify for the surgery. Mental health needs to be stable, you need to be able to attend multiple pre-surgery appointments and prove you are able to make sustained lifestyle changes.
Thursday, April 3, 2014
Hi Dr. Sharma
I think your conclusion that:
“By any reasonable standard, there cannot be any remaining doubt in anyone’s mind that surgical treatment for type 2 diabetes is vastly superior to anything that medical treatment has to offer”
Is justified only in comparison to the standard treatment, with the standard diet regimen, since the trial only compared surgery to the standard treatment and all subject were advised the standard ADA nutritional “wisdom”.
It might be that the surgery itself is only circumstantially related to the benefits .
For example, it might be that the difference in outcomes is caused by the fact that after surgery and due to the physically smaller stomach, patients are advised (in contradiction to the standard advice) that they have to drop nutrition-poor-carbs and eat instead meat, eggs and vegtables etc… in order to satisfy min requirements of proteins and vitamins while consuming a much diminished portion sizes.
for example it seems that when compared to a ketogenic diet results are similar and are remarkably consistent:
Surgery:
1.
http://www.nejm.org/doi/full/10.1056/NEJMoa1200111
7.69% – non surgery group (medical therapy)
6.35% – bariatric surgery group.
2.
http://www.nejm.org/doi/full/10.1056/NEJMoa1200225
7.5±1.8% in the medical-therapy group
6.4±0.9% in the gastric-bypass group
Ketogenic diet:
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1325029/
7.5 ± 1.4% – prior to diet (on medications i.e. medical therapy)
6.3 ± 1.0% – Ketogenic diet
Thursday, April 3, 2014
I may not have been clear – but medical treatment included all anti-diabetic medications including insulin. Also, I am not aware of any randomised controlled trial that has studied ketogenic diets for three years. My guess is that attrition rates on ketogenic diets would be so high that such a trial would in fact be impossible.
Thursday, April 3, 2014
Dr Sharma, thank-you for this blog, as always you presented the information in a clear and respectful fashion. That said, my experiment of one has conclusively proven to me that diet is absolutely the best way for me to manage T2, your mileage may vary. I was on two different diabetes med, then 3 years ago I started eating a lchf diet. Within two weeks I was able to drop one med. I continued with 500mg of metformen for some months, then decided to see what would happen if I dropped it. I now have fasting BG ranging from 83 to 106. My A1C has been normal (under 6) for a year now. I had these results as I also lost weight. I have dropped 50 pounds. As for attrition, not likely as I have lost friends to the horrors of T2 I can’t even imagine going back to the ADA recommended diet. By the way, I am still fat, just no longer REALLY fat, and I don’t actually care if I lose more or not. For me it was all about health. I have only used my asthma inhaler a few time in the past 6 months and my IBS has improved. However, the pain issues have not improved. So this way eating has helped me a lot, but is not the panacea it is sometimes claimed to be, still, “By any reasonable standard” for me, it is the best option.
Friday, April 4, 2014
Vic – sounds like you are doing just great!
Friday, April 4, 2014
So if this is a treatment for uncontrolled diabetes, I am curious if you would offer it to ‘normal’ weight patients as well?
Friday, April 4, 2014
Sandra – great quesion. This is something currenly being explored in studies and we’ll have to see how they turn out.
Friday, April 4, 2014
While I agree that bariatric surgery will always show more significant weight loss than lifestyle/medical management, I think it is important to note that for the Stampede study, the lifestyle management used is not one that has ever been shown to be effective at facilitating long-term weight loss, albeit in compliance with ADA guidelines. Pts were given an intial 2 hr session with a CDE/nurse to discuss meds and nutrition (carb counting) and were encouraged to be active. They then met every 3 months with the CDE for follow-up on nutrition issues. Not only is the frequency of the lifestyle intervention inadequate, it appears that there was no attempt to modify behaviours. In many ways it is remarkable they achieved the weight loss they did on the medical management side of this study.