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London 2012: Future of Obesity Treatment

What clinical evidence do we need?

Surgeons need to improve the evidence base
New studies should examine the cost of operation and the cost not intervening
Philip Schauer

Dr Philip R Schauer, Cleveland Clinic, USA, discussed ‘What clinical evidence do we need to move bariatric and metabolic surgery forward?’ He began by stating bariatric and metabolic surgery has evolved and so the evidence gathered from these procedures is less than the gold standard randomised controlled trial. Despite this, the guidelines across the national organisations (NICE, NIH etc) show a large consensus and organisations with an interest also agree about the benefits of bariatric surgery (such as national diabetes organisations).

“However, despite this recognition of bariatric surgery, the adoption of surgery remains low,” explained Schauer. “In the US, although there are 200,000 procedures each year that is only 1-2% of the patients who are eligible.”

Evidence

In order to increase the number of procedures, Schauer said that it was necessary improve the evidence such a case studies, registries and clinical trials. Such studies should examine operative morality and complications, short and long term outcomes, weight loss, the effect on co-morbidities, cost of operation and the cost the natural progression of the disease (of not intervening). 

For surgery the evidence is minimal and there are only three randomised clinical studies that have examined the outcomes of surgery compared with non-surgical treatment such as medial therapy, lifestyle changes or modifications (diet, exercise). He added that the evidence so far from medical therapy based studies (such as the Look Ahead study) have shown a decrease in weight loss of some 4%, which has a modest impact on type 2 diabetes.

“There are challenges of creating and running these trials, particularly costs,” he stated. “And there are also challenges of recruiting patients to an arm that we know is not effective (medical therapy).” The case for the safety and efficacy of bariatric surgery is already proven, said Schauer, with hundreds of thousands of cases over 20 years demonstrating a very low mortality rate and a serious complication rate of 4-5%. 

Stampede trial

He added that much needed data will come from numerous clinical trials currently underway examining the effectiveness of bariatric surgery to reduce type 2 diabetes. One such randomized study is the Surgical Therapy And Medications Potentially Eradicate Diabetes Efficiently (Stampede) trial at the Cleveland Clinic's Bariatric and Metabolic Institute. The Principal Investigators are Drs Philip Schauer, Sangeeta Kashyap (an endocrinologist) and Deepak Bhatt (a cardiologist). The study will compare the effectiveness of advanced medical therapy alone versus bariatric surgery and therapy combined, for the treatment of type 2 diabetes during a five year study period. 

Patients with a BMI of 27-43 will be recruited and the primary end point is the rate of biochemical resolution of type 2 diabetes at one year, as measured by HbA1c<6%. The safety and adverse event rates will also be compared between the three arms of the study. Interestingly, Schauer reported that they screened thousands of patients as many refused to be considered for both treatments strategies. 

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