Page 85 - The clinical aspects and management of chronic migraine Judith Anne Pijpers
P. 85

Withdrawal and botulinum toxin A: a double blind RCT
each (155 units).20–24 If the low dose treatment protocol was indeed effective, the high dose treatment protocol could easily be simplified by drastically reducing the doses and number of injection sites.
Finally, unlike in the PREEMPT and other studies,21–24 we did not exclude patients with moderate to severe depression or who had no headache-free days as these characteristics are common in chronic migraine.1,6,48 This, combined with the fact that many patients included in the study were directly referred from general practitioners or general neurologists throughout the country, makes us believe that our study population is more representative for the average patient with chronic migraine and medication overuse.
In conclusion, withdrawal is an efficacious and well-tolerated treatment for patients with chronic migraine and medication overuse. Add-on therapy with BTA did not afford any additional benefit whatsoever, neither on headache frequency nor on quality of life, disability or a range of other outcome measures. The therapeutic gain in previous BTA trials was only modest and likely positively influenced by unblinding. In the present study, low masking doses of BTA in the forehead successfully prevented unblinding. Before prescribing medications such as BTA, withdrawal should be tried first in patients with chronic migraine and medication overuse. Similarly, emerging and likely expensive new antimigraine medications such as antibodies against CGRP or its receptor38,41,49 should also first be compared against withdrawal. As traditional designs are impossible, a similar add-on design as the one used in the present study might prove useful.
Acknowledgements
We thank all participants for their time and effort. We thank Mrs. J. Trouerbach, headache nurse, for supporting patients during withdrawal, and Mrs. G. Hendriks, research nurse, for preparing randomised medication. Furthermore, we would like to thank the neurologists, who participated in the CHARM study by referring chronic migraine patients. Lastly, we thank prof. dr. F. Dekker and prof. dr. T. Stijnen for their statistical advice.
4
83
 


























































































   83   84   85   86   87