Nov. 10, 2003 -- At first glance, the study findings may seem anything but surprising: The popular "antiobesity" drug Meridia used by millions to lose weight appears to help obese binge eaters shed excess pounds, but this new report shows that the drug can also help binge eaters control their eating behavior.
Specifically, Brazilian researchers find that obese patients with binge eating disorder given a daily 15 mg dose of Meridia reported fewer days of binge eating and lost an average of 16 pounds during the three-month study. By comparison, a group of similarly obese binge eaters getting a placebo had no change in the frequency of their binge-eating days and gained an average of 3 pounds during the study.
But this new research, published in the latest issue of Archives of General Psychiatry, may provide yet another piece to a puzzle that has long baffled experts: Exactly what causes binge eating disorder, which affects at least one of every 100 Americans, and how can it successfully be treated?
"We have all these hints that there may be some abnormal brain chemistry that gives risk to this irresistible urge to eat, and many different drugs that alter brain chemistry have been investigated," says Susan L. McElroy, MD, professor of psychiatry and psychopharmacology at the University of Cincinnati College of Medicine and director of its weight management program.
"But what's interesting is that all of these drugs have slightly different mechanisms, so we really don't know the exact mechanism involved in binge eating disorder," she tells WebMD. "So when a drug seems safe and effective, it really helps us. This is a great study because it was well done. And it's exciting because it provides another alternative for people with binge eating disorder."
In recent years, several studies have looked at various antidepressants and other drugs that alter brain chemistry as possible treatments for binge eating disorder -- including two by McElroy published this year. She was not involved in the Brazilians' study.
She found that both Topamax, an epilepsy drug sometimes used to treat depression and other illness, and Celexa, an antidepressant in the same class of drugs as Prozac, Zoloft, and Paxil, helped patients lose weight and reduce bingeing episodes compared with those getting a placebo.
Currently, only one drug, Prozac, is specifically approved to treat an eating disorder, bulimia, in conjunction with counseling. However, many antidepressants and other drugs are used "off-label" in conjunction with therapy for various eating disorders.
But Meridia has produced some of the most impressive results to date, says lead researcher of the new study, Jose C. Appolinario, MD, DSc, of Federal University of Rio de Janeiro.
"We were surprised at the substantial amount of weight loss observed," he tells WebMD. "This amount of weight loss was (rarely) observed in clinical trials of binge eating disorder with other agents."
In fact, the weight loss he observed is better than the 1 pound per week expectation from using Meridia for its intended and FDA-approved purpose -- to help those with clinical obesity lose weight. The drug was approved in 1997 and has since been prescribed to at least 9 million Americans with a body mass index of 30 or higher who have failed lifestyle changes alone in the management of obesity.
But Meridia has its share of controversy. Last year, Italy's Health Ministry briefly suspended the sale of products containing sibutramine, the primary ingredient in Meridia; that ban was lifted months later. And this year, the consumer interest group Public Citizen continued its push to have Meridia banned, with an August letter to the FDA saying that it documented nearly 50 cases of deaths from cardiovascular problems among people using the drug.
However, Appolinario tells WebMD that his Meridia patients also had fewer depressive episodes than those on placebo, with no measured side effects. That's significant because major depression affects between 30% and 50% of those with binge eating disorder -- characterized in this study by at least two episodes per week of uncontrollable eating, even when they feel full or don't want to eat.
His study, funded by the Brazilian branch of Abbott Laboratories, which manufactures Meridia, is believed to be the first published trial examining Meridia as a binge-eating treatment. But American researchers completed a similar study that hasn't been published.
"As I recall, our findings were pretty consistent with this one -- the drug seems to be very effective for those with binge eating disorder," says Lisa Lilenfeld, PhD, of Georgia State University, one of the investigators in that 20-site study.
Meanwhile, eating disorders specialist Marsha D. Marcus, PhD, says that Appolinario's results are encouraging but his study was too short to imply a long-range solution. She runs the Behavioral Medicine and Eating Disorders Program at the University of Pittsburgh Medical Center and is a spokeswoman for the Academy for Eating Disorders.
"It yielded results that one might expect," she tells WebMD. "The $64 million question remains: Once the drug is withdrawn, in the absence of other interventions, what will happen? It's likely the weight would be regained."