Treating morbid obesity without surgery: Studies aim for primary care alternatives

Researchers are examining behavioral approaches for those with severe excess weight.

By — Posted April 3, 2006

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Todd M. Sheperd, MD, a family physician in Petoskey, Mich., has a couple of morbidly obese patients contemplating bariatric surgery and a couple more who have lost a significant amount of weight as a result of undergoing this procedure. But he'd love to have something else he could offer.

"We would all prefer to find something that worked better than surgery, with no surgical risks," he said.

More doctors are recognizing that more interventions are needed to treat the swelling ranks of people who have body mass indexes higher than 40. Until recently, though, research in this area -- and, therefore, treatment innovations -- was lacking.

To fill the gap, two targeted projects have been launched within the past year.

In March, the University at Buffalo School of Public Health and Health Professions kicked off a $5 million, five-year study that will randomize morbidly obese patients to various combinations of behavioral therapy, weight-loss medications and low-calorie diets. The groups will be compared with each other and with a group of bariatric surgery patients.

"Surgery is not a magic bullet for this problem by any means," said Michael F. Noe, MD, MPH, principal investigator and clinical professor of social and preventive medicine at the University at Buffalo. "It's essential that alternative nonsurgical approaches to help people who are severely overweight be evaluated."

Also, last July the Pennington Biomedical Research Center at Louisiana State University in Baton Rouge began the Louisiana Obese Subjects Study. It randomized several hundred patients to either usual primary care treatment or a more intensive intervention, which is also conducted in the primary care setting.

"We need to evaluate a program in the primary care setting, because this population really needs physician direction in order to be successful in weight loss," said Donna Ryan, MD, the principal investigator of that project and Pennington's associate executive director for clinical research.

Responding to a need

These endeavors are a response to the alarming reality that obesity, including morbid obesity, continues to become more widespread. The Centers for Disease Control and Prevention's latest obesity and overweight rates are to be published in the Journal of the American Medical Association this month. According to current data, which track incidence from 1999 to 2000 and appeared in the Oct. 9, 2002 JAMA, 4.7% of the U.S. population was severely obese. This amount represented a significant jump from the 2.9% noted from 1988 to 1994.

This trend also has been accompanied by a boost in bariatric surgery rates. But with only an estimated 0.6% of those medically eligible for the procedure actually having it, it is becoming clear bariatric surgery is not for everyone.

"Some people don't want the surgery or cannot have the surgery or cannot afford the surgery," said Laura Rogers, MD, MPH, medical research director of the Comprehensive Obesity Management Program at Southern Illinois University School of Medicine in Springfield.

Many patients are reluctant because they fear the procedure itself. It's also very expensive, creating a need for less-pricey options.

These studies, both sponsored by insurance companies, will include cost effectiveness as part of their analyses. Researchers hope to determine the gold standard treatment. And, depending on which intervention proves to be the most cost-effective, these studies also might make insurance reimbursement easier for weight-loss assistance, surgical or otherwise.

"We will be able to evaluate the cost of treatment," Dr. Ryan said. "Does it pay off in less hospitalizations? Less physician visits? Reductions in their medications? If we are able to show an intervention produced meaningful health benefits to people, our health insurance companies would reimburse."

Observers praised these attempts to answer key research questions.

"There's a national movement to treat obesity like any other chronic disease, and there are a lot of resources being spent," said David Flum, MD, MPH, director of the Surgical Outcomes Research Center at the University of Washington in Seattle. "But the science of sustaining weight loss has had less consideration than other things."

Still, skepticism is significant. Some feel the issue had been studied enough and doubted nonsurgical interventions would work at such high weights when similar steps failed for these patients when they were not as heavy. Also, many experts questioned whether any weight lost will stay lost, perhaps an even bigger challenge and more important for long-term health.

"A number of studies have been done with currently available modalities, none of which have shown the significant long-term effective weight loss seen with bariatric surgery," said Harvey Sugerman, MD, past president of the American Society for Bariatric Surgery. "The critical question is: What is the recidivism rate?"

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Study details: University at Buffalo

Goal: Determine the effectiveness of nonsurgical interventions for severe obesity.

Institution: The University at Buffalo School of Public Health and Health Professions.

Participants: 280 severely obese enrollees of BlueCross BlueShield of Western New York.

Methods: Patients will be randomized to four interventions. All groups will receive behavioral therapy. Two groups will receive an 800-calorie-a-day diet, one with and one without medication such as orlistat or sibutramine. The two other groups will follow a 1,200- to 1,500-calorie diet, also with or without medication.

Measurements: Changes in blood pressure, blood sugar, lipids and quality of life will be assessed throughout the study. The outcomes and health care costs of the different groups will be compared with each other as well as with a population of patients who had gastric bypass surgery.

Expected outcome: Researchers believe that those who stay on 800 calories per day, take medication and receive behavioral treatment will have the best results.

Source: University at Buffalo School of Public Health and Health Professions

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Study details: Pennington Biomedical Research Center

Goal: To determine if a nonsurgical intervention can achieve a 25% weight loss in people who are severely obese and to study whether a loss of at least 20% can be maintained for five years.

Institution: Pennington Biomedical Research Center at Louisiana State University in Baton Rouge.

Participants: 480 enrollees in the state health insurance plan.

Methods: Patients have been randomized to receive either an intensive intervention involving group behavioral therapy, medication and a low-calorie diet or usual medical care and access to a weight-loss Web site. Both occur in the primary care setting.

Measurements: Changes in weight, blood pressure, fasting glucose, lipids, quality of life, stress, depression and socioeconomic status will be assessed throughout the study. The cost-effectiveness of the interventions also will be determined.

Expected outcome: Researchers believe patients in the intensive medical management arm will exceed the 20% weight-loss goal and lose more than those in the usual care arm. These patients also will experience other health gains and a reduction in medical costs, researchers predict.

Source: Pennington Biomedical Research Center

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External links

AMA Roadmap for Clinical Practice: "Assessment and Management of Adult Obesity" (link)

Recommendations for Physician and Community Collaboration on the Management of Obesity, American Medical Association's Council on Scientific Affairs, 2005 (link)

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