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October 17, 2008

Page history last edited by PBworks 14 years, 1 month ago


 

Reference(s):

  1. Reference: Bissada, H., Tasca, G. A., Barber, A. M., & Bradwejn, J. (2008). Olanzapine in the treatment of low body weight and obsessive thinking in women with anorexia nervosa: a randomized, double-blind, placebo-controlled trial. Am J Psychiatry, 165(10), 1281-1288.

 

Article(s):

  1. Bissada Olanzapine in the treatment of low body weight and obsessive thinking in women with AN - an RCT.pdf

     

 

Discussion:

 

We had a good discussion at this journal club. The authors' primary goal was to assess the efficacy of olanzapine in promoting weight gain, and the secondary endpoint was to assess its efficacy in reducing obsessive symptoms.

 

Introduction: the authors make a good case for why they are doing the study: case reports and open label trials have suggested olanzapine might be effective at assisting with weight gain, and obsessional thinking is a concommittant of AN. There have been no blinded trials of olanzapine to date.

 

Methods: the authors took nearly six years to recruit the 28 participants in this study, who were all partial hospital patients in Ottowa. The CONSORT diagram (for the CONSORT statement's website, see http://consort-statement.org/, and for a reference, see Rennie, D. (2001). "CONSORT revised--improving the reporting of randomized trials." Jama 285(15): 2006-7.) shows the difficulties with recruitment. Most patients who did not participate in the study (n=63) did not want day hospital treatment, but a substantial fraction of those who accepted day hospital treatment declined to participate in the study (n=42). What is encouraging is that of those who agreed to participate, most completed the study (14/16 patients, 14/18 controls), which is unusual in AN trials.

 

The authors measured BMI, anxiety and depression via the PAI, and obsessions and compulsions with the YBOCS. The PAI and YBOCS are widely used. The authors stratified their randomization scheme by diagnostic subtype, that is, they made sure that the same numbers of AN-R and AN-P subjects were in the control and treatment arms of the study. The study took place over 13 weeks; there was a two-week run-in when patients had to be off medicines; and then the patients began receiving drug or placebo, with the drug titrated up from 2.5 mg/day to a mean of 6.6 mg/day. The authors analyzed weight gain using hierarchical linear modeling, which allows comparisons of multiple measurements over time, without the same requirements as other methods, like repeated-measures ANOVAs.

 

Results: both groups gained a significant amount of weight during the trial, statistically speaking. Patients taking olanzapine gained weight faster, but the actual differences between groups were small, with drug+DH patients gaining from 16.39-20.30 kg/m2 and placebo+DH patients gaining from 15.93-19.66 kg/m2. On average, drug patients reached a BMI of 18.5 two weeks earlier than placebo patients, but the difficult with this analysis is that it was done using the "target" BMI of 18.5, which, while it is often the BMI at which a patient might be required to step-down to a lower level of care, it is nevertheless not the actual target BMI clinically, so it would be more useful to have seen the survival curves to the actualy target BMI. There were no differences in levels of depression or anxiety, or in self-reports of compulsions, but there was an improvement in obessiveness as measured by the YBOCS.

 

In many ways this study reinforces our clinical experience with AN patients, viz., though who are agreeable will take medicine, but most, because of concerns about weight gain or ambivalence about treatment in general as a consequence of their illness, will not be willing to take the medicine. Benefits in terms of differential weight gain will be modest, and there may be some benefit in easing the burden of AN conferred by the intrusive nature of ED cognitions. One thing the authors don't mention is that their article may actually make the problem worse, in that our patients are willing and able, generally speaking, to find the extant literature on weight gain and pharma, so by publishing a study that finds a weight-gain effect, however modest, it may be that patients will be even less willing to take the medicine in the future! Still, the study needed to have been done, and will need to be replicated.

 

As always, please forward the link to these pages to others who may be interested in attending.

 

Thanks, and I look forward to continuing the discussion.

 

 

Graham

 

 

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