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Toronto (June 12, 2006) - Use of the antidepressant Fluoxetine did not help patients with anorexia nervosa who had restored their body weight maintain that weight or reduce their risk of relapse, according to a study in the June 14 issue of JAMA.
Anorexia nervosa is an eating disorder primarily affecting young women and marked by an extreme fear of becoming overweight that leads to excessive dieting and extreme weight loss to the point of serious ill-health and sometimes death. It is a serious psychiatric illness with a lifetime death rate arguably as high as that associated with any psychiatric illness, according to background information in the article. A major contributor to the poor prognosis of this illness is the high rate of relapse, with 30 to 50 percent of patients requiring re-hospitalization within 1 year of discharge after successful weight restoration. This has prompted interest in interventions aimed at preventing relapse following weight restoration. A substantial number of patients with anorexia nervosa receive antidepressant medications. Fluoxetine was initially marketed under the brand name of Prozac.
Co-Principal Investigators Dr. Allan S. Kaplan, Loretta Anne Rogers Chair and Head of the Eating Disorders Program at Toronto General Hospital, University Health Network and Professor of Psychiatry at the University of Toronto and Dr. Timothy Walsh at the New York State Psychiatric Institute and Professor of Psychiatry at Columbia University Medical Centre, and colleagues compared fluoxetine with placebo to determine the rate of relapse over one year following initial weight restoration treatment for anorexia nervosa. The trial included 93 patients with anorexia nervosa who had received intensive inpatient or day-program treatment and regained weight to a minimum body mass index (BMI) of 19.0. Participants were then randomly assigned to receive fluoxetine (n = 49) or placebo (n = 44) and were treated for up to 1 year as outpatients. All patients also received manualized cognitive behavioral therapy over the one year period in addition to drug or placebo.
The researchers found that similar percentages of patients assigned to fluoxetine and to placebo maintained a BMI of at least 18.5 and remained in the study for 52 weeks (fluoxetine: 26.5 percent; placebo: 31.5 percent). The most conservative analysis of time-to-relapse found no significant difference between the fluoxetine and placebo groups in time-to-relapse. At 52 weeks, 45 percent of the placebo group and 43 percent of the fluoxetine group had not relapsed.
"The current study has implications for both clinical practice and research. The present findings, coupled with those of previously published studies, indicate that the common practice of prescribing antidepressant medication is unlikely to provide substantial benefit for most patients with anorexia nervosa, either when they are underweight or immediately upon weight restoration. These data imply that therapeutic efforts would be better devoted to psychological and behavioral interventions for which there is some, albeit modest, evidence of efficacy," the authors write. "Future research on the utility of novel psychological treatments and innovative psychotropic and nonpsychotropic medications is obviously needed."
Toronto General Hospital is a partner in the University Health Network, along with the Toronto Western Hospital and the Princess Margaret Hospital. These teaching hospitals are affiliated with the University of Toronto. The scope of research at Toronto General Hospital has made this institution a national and international source for cardiovascular discovery, education and patient care, as well as for its innovations in transplantation, surgical innovation, infectious diseases, diabetes and genomic medicine.
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