LAS VEGAS — Laparoscopic gastric band bypass produced significantly better outcomes for weight loss, health, and quality of life without sacrificing safety in a randomized, controlled trial comparing surgery with medical treatment for mild to moderate obesity.
At 2 years of follow-up, surgical patients had lost more excess weight (68%) than patients given individualized medical care (17%), Paul E. O'Brien, M.D., reported at the annual meeting of the North American Association for the Study of Obesity.
The trial included 80 patients, mean age 41 years, of whom 40 were randomized to surgery and 40 to medical care. At the outset, 38% of each group had metabolic syndrome. At 2 years' follow-up, all surgical patients but one were free of metabolic syndrome, while 24% of the medical patients still met criteria for the constellation of disorders.
Medical and surgical patients alike lost 45% of their excess weight in the first 6 months of the study. Over time, however, the medical patients began to gain weight, while the surgical patients continued to lose throughout the 2-years of follow-up.
Despite the disparity in results, Dr. O'Brien characterized the medical group's average loss of 17% of their excess weight over 2 years as “still quite a reasonable outcome for this group of patients.”
The surgical patients reported better quality-of-life outcomes on the SF-36 questionnaire. They showed significant improvement in all eight subscales, whereas the medical patients did so in three: physical functioning, vitality, and mental health.
The medical treatment was primarily a very-low-calorie diet, with counseling, exercise, and a behavioral therapy program. Although orlistat (Xenical) was prescribed, Dr. O'Brien minimized its role, characterizing compliance as “touchy.”
“We feel it's time that health administrators, insurers, physicians, and surgeons recognize the effectiveness of bariatric surgery for this most common and most lethal of our health problems,” said Dr. O'Brien, a surgeon at Monash University in Victoria, Australia, where the study was conducted.
The investigators found no difference in adverse events between the medical and surgical patients. Eight medical patients could not tolerate orlistat or another medication prescribed as part of their regimen, Dr. O'Brien said.
No major surgical complications occurred, but one surgical patient had a transient port infection, and four had to have their bands adjusted because of posterior prolapse. Four medical patients and one surgical patient underwent cholecystectomy for acute cholecystitis.
Participants had to agree to accept randomization before entering the trial; Dr. O'Brien said that none were allowed to choose between medical and surgical care. One man in the surgical group backed out on the eve of surgery, and five medical patients withdrew during the study.
In each case, Dr. O'Brien said the patient's last clinical measures were carried forward in the intent-to-treat analysis presented at the meeting, cosponsored by the American Diabetes Association.
None of the patients met National Institutes of Health criteria for gastric bypass surgery, which specify that the surgery can be considered in motivated patients with severe obesity (body mass index [BMI] greater than 40 kg/m2) or in patients with less severe obesity (BMI greater than 35 kg/m2) who have high-risk comorbid conditions. The average BMI of the study patients was 33 kg/m2, with a range of 30 to 35 kg/m2.
A randomized trial would not have been ethical had the patients been more obese, Dr. O'Brien said. “Ethically, I couldn't look someone in the eye with a BMI of 36 and say medical therapy might just work as well as surgery,” he said, “whereas 30 to 35 is a gray zone in our thinking.”
In an interview, Dr. O'Brien predicted that the laparoscopic gastric band procedure would be standard for patients with mild to moderate obesity in 5-10 years. First, he said, advocates must balance the costs of surgery against the costs of continuing to treat diabetes and the other conditions of metabolic syndrome.