Is gastric by-pass surgery a recommended course of action in the treatment of uncontrolled diabetes? Two studies, the COSMID study published at this year’s annual conference of the American Diabetes Association (ADA) and the STAMPEDE study published at the same conference last year, seem to suggest so. A number of physicians however hold a contrary opinion.
COSMID stands for Comparison of Surgery Vs Medicines in Indian Diabetes, and is making waves in this country for two reasons. Firstly, it was conducted entirely on Indian patients, mostly Mumbai and Pune, and secondly, the lead author of the study, Dr Shashank Shah, a Pune-based surgeon, was awarded the prestigious Vivian Fonseca Scholar Award at the 2016 ADA conference held in New Orleans less than two weeks ago.
The study results are the outcome of five-year international scientific collaboration between Dr. Shah, David Cummings, MD from the University of Washington, and Keith Kim, MD, Celebration Health, Florida.
STAMPEDE (Surgical Therapy and Medications Potentially Eradicate Diabetes Efficiently) was another similar study conducted by Dr Philip Schauer, a top notch bariatric surgeon with Cleveland Clinic. It covered 150 patients, of which 50 had undergone a Roux-en-Y gastric bypass, 50 others had been given a sleeve gastrectomy and the last one-third were given conservative therapy. After this, all the patients were followed up for five years, at the end of which their results were published.
“We had a total of 80 patients in our study, of which 40 were subjected to a Roux-en-Y operation while the remaining 40 in the control group were managed with medicines alone,” says Dr Shashank Shah. The patients in the Indian study were followed up for two years. Considering that several thousand people in India have undergone bariatric surgery in the past decade, a study of a mere 80 patients is perhaps too small to be of lasting value!
Interestingly, both studies were funded by Ethicon, which is a part of the multinational company Johnson and Johnson, and what is more, Dr Schauer, the lead investigator of the STAMPEDE study is a paid consultant for Ethicon (the latter is mentioned in the Cleveland Clinic news release announcing the STAMPEDE study results).
But an interesting point, which is almost glossed over in the STAMPEDE news release and not mentioned at all in the COSMID study announcement, is that the surgical option is at best a mixed blessing!
“The superior benefits of surgery to attain diabetes treatment goals must be carefully balanced with the long-term risks associated with surgery for individual patients,” said Sangeeta Kashyap, MD, co-investigator involved with the trial and an endocrinologist at Cleveland Clinic’s Endocrinology & Metabolism Institute.
Likewise, the last point in the summary of benefits of the STAMPEDE trial reads, “The effects of both surgical procedures to normalize glucose levels did however diminish over time and some late complications were noted with surgery.”
“We have also seen this in our regular practice,” says Dr Shashank Joshi, one of the most senior physicians in India to have specialized in diabetes mellitus and a co-author of several research studies published in international journals. He explained that he and his colleagues often noted that patients who underwent gastric bypass for other reasons including morbid obesity were able to keep their blood sugar levels under some control for about four-five years. Thereafter, he said, the diabetes aspect came back to pre-surgery levels.
Quite clearly, the surgical option is not meant for each and every patient who happens to face difficulties of glycemic control, but only for those in whom all other alternative approaches have failed.
Dr Sumit Ghoshal is a professional journalist with an MBBS qualification and almost three decades of experience. He has been writing all along on health issues in various mainstream publications and is currently a Contributing Editor with Business India magazine.