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Botulinum toxin Time to call it quits.

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DOI: 10.1002/ana.21672
Botulinum Toxin: Time to Call It Quits?
Josh Torgovnick, MD,1 Nitin K. Sethi, MD,2
Edward Arsura, MD,3 and Audrey C. Pendleton4
We read Ranoux and colleagues’1 article with interest but
have some comments. First, though it appears to be a welldesigned study, the sample size is small (N ⫽ 29), with 7
patients withdrawing from the study before 24 weeks. Some
patients who received placebo did remarkably well, suggesting that spontaneous improvement can occur at unexpected
distance from the time of injury. Moreover, some patients
who received botulinum toxin A (BTX-A) did not respond at
all, raising the question why?
Our experience with BTX-A is in migraine where our personal experience concurs with the current literature that
BTX-A is ineffective in migraine despite anecdotal reports of
its effectiveness. A central role for the effectiveness of BTX-A
has been postulated here as well. One may ask why despite
multiple class I studies assessing BTX-A in conditions such
as migraine and chronic neuropathic pain is the evidence for
efficacy still not infallible. If a drug works for a condition,
one rarely needs studies to prove it. There are no class I
Annals of Neurology
Vol 65
No 3
March 2009
studies with level A evidence establishing the efficacy of penicillin for syphilis or ethosuximide for absence seizures, yet
we can all vouch for their effectiveness. It is only when the
evidence is insufficient to support a recommendation that
studies are needed. Maybe the time has come to bury the
hatchet. We know the conditions for which botulinum toxin
works, therefore expensive studies, some funded by the drug
manufacturer to discover novel indications for BTX-A, are
Lastly, we believe that the lead author, Daniel Ranoux, is
the second author on another article2 that discusses clinical
differences between botulinum toxin formulations where in
the declaration of interests she admits to receiving honorarium payments from Allergan and educational grants from
Ipsen. If this is indeed true, the potential for bias cannot be
excluded, further weakening the findings of this study.
Department of Neurology, Saint Vincent’s Hospital and
Medical Centers, 2Department of Neurology, New York
Presbyterian, Weill Cornell Medical Center, 3Department of
Medicine, Saint Vincent’s Hospital and Medical Centers, and
Stony Brook School of Medicine, New York, NY
1. Ranoux D, Attal N, Morain F, Bouhassira D. Botulinum toxin
type A induces direct analgesic effects in chronic neuropathic
pain. Ann Neurol 2008;64:274 –284.
2. Aoki KR, Ranoux D, Wissel J. Using translational medicine to
understand the clinical differences between botulinum toxin formulations. Eur J Neurol 2006;13(suppl 4):10 –19.
DOI: 10.1002/ana.21646
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