July 9, 2006

STAR*D Augmentation Trial: WRONG!

This is what a $150 subscription to the NEJM gets you: 

From the abstract:

Conclusions Augmentation of citalopram with either sustained-release bupropion or buspirone appears to be useful in actual clinical settings.


I can't be the only person who actually reads the articles and not just the titles, can I?  There has to be at least one other person?


565 Celexa failures (i.e. did not achieve remission) from the previous STAR*D trial were then randomized to  Celexa (avg dose 54mg) + Wellbutrin or Celexa + Buspar.  30 percent of the augmented patients (either Wellbutrin or Buspar) achieved remission. 

From this it is concluded "These findings show that augmentation of SSRIs with either agent will result in symptom remission."

How the hell do you conclude that?  Is it a mere coincidence that the remission rates of Celexa+Wellbutrin in this group were the same as Celexa alone in the other study (30%)-- and the same as almost every other monotherapy trial for every other antidepressant?

In other words, how can you be sure it was the combination of Celexa+Wellbutrin that got the patients better, and not the Wellbutrin alone?  What would have happened if you had given these patients Wellbutrin but taken them off Celexa?  They would have done half as well?  Are you sure?

I'm not saying that it might not be true that two drugs are better than one, I'm saying that this study doesn't show that.  If anything, this study actually supports switching as a strategy (i.e. fail Celexa, so switch to Wellbutrin)-- because two drugs are not proven here to be twice as good as one alone, but I can certainly prove they carry twice as many side effects and are twice as expensive. 

Here we have a massive expenditure of tax dollars that will undoubtedly lead to treatment guidelines that will be clinically misleading and economically wasteful.  How much did the NIMH pay for this?  And for CATIE?  I'm not a Pharma apologist, but what  was wrong with forcing Pharma to pay for their own studies which we get to pick apart?  These government sponsored studies are no better.  Gee-- the generic came out on top?