May 2, 2013
Study Suggests Dropping Comorbidity Requirements For Some Weight Loss Surgery Patients
Alan McStravick for redOrbit.com — Your Universe Online
It seems you can´t drive more than five miles down a highway without passing by a billboard extolling the virtues of the LAP-BAND® weight loss procedure. Most of these roadside advertisements show before and after photos of the now svelte and happy person. Guidelines were put in place to ensure, in this image-obsessed culture in which we live, only individuals who truly required this medical procedure would be covered by both their private insurer and/or Medicare. A new study is challenging the original guidelines by showing this surgery is effective for an expanded group of patients above and beyond those classified as morbidly obese. Their findings are published in the scientific journal Obesity.
Some twelve years ago, the procedure received approval from the US Food and Drug Administration (FDA) as a weight loss procedure for patients whose body mass index (BMI) was 40kg/m2 or higher. Additionally, individuals presenting a BMI of 35 paired with an obesity-related condition, like diabetes or hypertension, were also eligible for this surgery. The procedure consists of a surgeon making small incisions in the patient´s abdomen and then placing an adjustable band around the upper part of the stomach. This forms a new “upper pouch,” allowing the patient to drastically limit the amount of food consumed. The patient also experiences periods of prolonged appetite suppression as a result.
This latest study was conducted by Robert Michaelson, MD, PhD, FACS, of Northwest Weight Loss Surgery in Everett, Washington, and his colleagues. They sought out 149 individuals who presented a BMI between 35 and 39.9 with no additional co-morbidity conditions, as well as individuals with a BMI between 30 to 34.9 with at least one obesity-related condition.
According to Michaelson, “Patients in our study had been obese for an average of 17 years. They tried numerous other weight loss methods and finally reached out for surgical treatment when they were weary of the repetitive failures at maintaining weight loss.”
Results of the study found after one year, nearly 85 percent of patients who underwent the procedure achieved at least a 30 percent loss in excess body weight. Additionally, 66.4 percent of the study subjects were no longer considered obese. Those subjects who presented obesity-related conditions at the start of the study were experiencing significant improvement, whether the condition was elevated cholesterol, hypertension or even diabetes. Study subjects reported their overall quality of life had improved as a result of the surgical procedure.
The research team also states the one-year results could be maintained and even improved through the second year of the study. For each subject who reported an additional ten percent weight loss at the year two mark, decreases were noted in important health markers like triglyceride counts, blood sugar levels and the subject´s systolic blood pressure.
“The results of this study convinced the FDA that early intervention in the continuum of obesity is the right thing to do: treat before people go on to develop serious comorbid conditions of obesity,” claims Michaelson. He also pointed out other, similar studies, in combination with his own study, have prompted the American Society for Metabolic and Bariatric Surgery to issue a position statement endorsing the expansion of weight loss surgery to include patients with moderate obesity that have tried and failed with non-surgical methods of weight loss. “The next step,” according to Michaelson, “is to get the private insurers and Medicare, who continue to rely on guidelines established in 1991, to review incontrovertible literature, take down the barriers to the necessary treatment for this disease, and offer the hope of a cure to 27 million Americans.”
Michaelson and his findings are not without their detractors, however. David Arterburn, MD, MPH, of the Group Health Research Institute in Seattle, along with Melinda Maggard, MD, MSH, of the University of California — Los Angeles, submitted an accompanying editorial to this current study. In it, they caution the long-term benefits and risks of the procedure in individuals with a lower BMI still require study. They also note previous studies of higher weight individuals show a progressive weight regain starting after the two year mark. “There are also concerns that serious adverse events are common; including reports of removal rates as high as 50 percent. As the prevalence of severe comorbidities is less in this patient population, the benefits of preventing comorbidities is not known, which will require larger sample sizes to determine,” the pair wrote. “Until longer-term data on the benefits and harms are available, the use of LAGB in patients with BMI of 30 to 35 kg/m2 should be primarily reserved for clinical research studies.”