Abstract
Dear Sir, The two PREEMPT articles published in the July 2010 issue enrolled a large number of patients comparing active medication (Botox) and placebo. The studies were well designed and run in parallel. The total number of patients treated with Botox was about 700, yet only a small statistical difference was found between active treatment and placebo. What is striking is that the authors do not report even one patient with a complete response in their headaches, and apparently no one was able to stop rescue medication because their headaches became mild enough to do so. The number needed to treat to get one complete response is unknown, and the number needed to treat to get a small response seems very large. With doses of Botox required of nearly 200 units at times, at a medication cost alone of nearly 1100 US dollars, one would hope for more useful information on how to select patients for treatment. It shouldn’t be necessary to remind the community that there are no statistical studies on the treatment of syphilis with penicillin because it works. For everything else there are statistics, and here the statistics do not make the point for the usefulness of Botox outside specialized headache centers where clinician researchers can continue to look for the headache population that can benefit from this treatment. The cost seems to be prohibitive for general practice until this population is better defined.