psychosomatic medicine fluoxetine offers no benefit for ......twice a week. at 50 weeks, 27% of the...

Au g u s t 2 0 0 6 • w w w. c l i n i c a l p s yc h i a t r y n ew s . c o m Psychosomatic Medicine 67

Fluoxetine Offers No Benefit for Anorexia PatientsB Y T I M O T H Y F. K I R N

Sacramento Bureau

T O R O N T O — Fluoxetine failed to pre-vent relapse of anorexia nervosa in thelargest controlled medication trial to dateexploring the issue, Dr. B. Timothy Walshreported at the annual meeting of theAmerican Psychiatric Association.

“Antidepressants don’t offer patientswith anorexia nervosa very much,” saidDr. Walsh, director of the eating disorders

research unit of the New York State Psy-chiatric Institute, New York City. “Wecan’t say for sure that an antidepressantother than fluoxetine wouldn’t have an ef-fect, but it would surprise me.”

The study represents yet another failureto find an efficacious medical treatmentfor anorexia. These failures imply thatanorexia is unlike any other psychiatriccondition, Dr. Walsh said.

“Interventions that are useful for othersorts of possibly related disorders don’t

work terribly well for anorexia nervosa,”he said. The only evidence-based treat-ment for anorexia is cognitive-behavioraltherapy (CBT), which helps, but “not alot,” he added.

The investigators, whose results werelater published, compared fluoxetine withplacebo in a clinical trial involving 93 pa-tients who had completed intensive treat-ment and maintained a body mass index(BMI) of at least 19 kg/m2 for at least 2weeks. The patients, all female, were aged

16-45 years and were treated at two med-ical centers that had extensive experiencetreating the disorder. The mean age of thepatients was 23 years, and the averageBMI of the subjects at the start of the tri-al was 20 ( JAMA 2006;295:2605-12).

Subjects were randomly assigned to re-ceive 20 mg daily of fluoxetine (49 pa-tients), with a goal of increasing to 60 mg,or placebo (44 patients). They were mon-itored by a psychiatrist for dosing, adverseeffects, and general medical status. Theyalso received CBT.

The subjects underwent assessments ofdepression, anxiety, self-esteem, and quali-ty of life every month. They were followedfor 50 weeks, or until they either relapsed,

defined as falling back to a BMI of 16.5 for2 weeks, or dropped out of the study.

At 25 weeks, 48% of the 49 fluoxetine-treated subjects had either dropped out orrelapsed, versus 39% of the placebo con-trols. At 50 weeks, 58% of the fluoxetine-treated subjects and 55% of the controlshad either dropped out or relapsed.

To pick up on any possible benefit of thedrug, Dr. Walsh and his colleagues alsoconsidered just those who relapsed, andthose who relapsed plus those who clini-cally appeared to be in trouble when theydropped out—either because their BMIhad dropped to 17 or because they had be-gun binging and purging again, at leasttwice a week.

At 50 weeks, 27% of the fluoxetine-treated patients and 29% of the placebocontrols were documented relapsers.

Considering as failures both those withdocumented relapse and those who clini-cally appeared to be not doing well whenthey dropped out, the percentages were49% fluoxetine and 51% placebo.

Dr. Walsh said he also looked only atthose with depression, and at those whopurged or restricted food only, and treat-ment still made no difference in thoseparticular patients. “However we cut it, wecan find no evidence that fluoxetine pro-longs time to relapse following successfulinitial treatment, and we’ve looked prettyhard,” Dr. Walsh said.

In an editorial comment accompanyingthe published report, Dr. Scott J. Crow ofthe University of Minnesota, Minneapolis,said, “While the results of previous relapseprevention trials have been mixed, the re-port by Walsh and colleagues has manystrengths and appears convincingly nega-tive” ( JAMA 2006;295:2659-60).

The study amply demonstrates that an-tidepressant therapy, “a fairly commontreatment practice for this illness,” pro-vides no benefit, Dr. Crow noted. ■

Additional reporting was done by

contributing writer Mary Ann Moon.

‘We can find noevidence thatfluoxetineprolongs time torelapse … andwe’ve lookedpretty hard.’

DR. WALSH