Prozac Fails to Prevent Anorexia Relapse

NEW YORK, June 13 ? Prozac (fluoxetine) does not prevent relapse in anorexia nervosa, according to researchers in two cities.

A two-site, randomized, placebo-controlled trial of nearly 100 patients who had passed through the acute phase of the disease and were attempting to avoid relapse, showed no significant differences between Prozac and placebo, found Timothy Walsh, M.D., of the New York State Psychiatric Institute at Columbia.

"The common practice of prescribing antidepressant medication is unlikely to provide substantial benefit for most patients with anorexia nervosa," Dr. Walsh and colleagues in Toronto concluded in the June 14 issue of the Journal of the American Medical Association.

Earlier studies had shown no benefit for patients in the acute phase of the disease, they noted, but one small randomized study had shown the medication reduced the rate of relapse, compared with placebo, for patients who had regained significant amounts of weight.

Despite the limited evidence, the researchers said, about 60% of patients at the New York State Psychiatric Institute and at the Toronto General Hospital - centers highly experienced in treating anorexia - reported being prescribed a selective serotonin re-uptake inhibitor, such as Prozac.

Over a five-year period, ending in May 2005, the researchers enrolled 93 patients who received intensive treatment for anorexia - either in hospital or as part of a day program - and had regained enough weight to have a body mass index of at least 19.

The patients were randomized to Prozac (starting at 20 mg/day and rising to 60 mg/day) or placebo for 12 months in a double-blind fashion.

The results, however, were disappointing:

• 26.5% of Prozac patients maintained a body mass index of at least 18.5 and remained in the study for 52 weeks, compared with 31.5% of the placebo patients. The difference was not statistically significant (P=0.57).
• In a Cox proportional hazards analysis, there was no significant difference between Prozac and placebo in time-to-relapse. The hazard ratio was 1.12, with a 95% confidence interval ranging from 0.65 to 2.01.

"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," Dr. Walsh and colleagues said.

The study "is an important contribution that addresses a major gap in research on anorexia nervosa and provides vital information about a fairly common treatment practice for this illness," said Scott Crow, M.D., of the University of Minnesota in Minneapolis, writing in an accompanying editorial.

"Unfortunately, it appears that fluoxetine provides no benefit in the relapse prevention treatment of anorexia nervosa," Dr. Crow said.

Dr. Crow said anorexia nervosa has a prevalence rate similar to that of many other psychiatric illnesses and a high mortality rate, but "there is a serious under-representation of anorexia nervosa in biomedical research."

He called for more research on treating anorexia patients while they are at low weight, as well as new strategies to help prevent relapses.

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