Licence for Botox in so-called chronic migraine.

摘要

As experts in headache classification and in the methodology of clinical trials in migraine and other headaches, we were su rprised to read that the UK's Medicines and Healthcare Products Regulatory Agency had extended the licence for botulinum A toxin (Botox) to include prophylactic treatment for headache in adults who have chronic migraine. Botulinum A toxin has been studied in numerous randomised controlled trials in episodic migraine and in tension-type headache with negative results. After these indications were given up, two large trials (n=1384) were done in so-called chronic migraine. However, the diagnosis was not correct since 65% had medication overuse, which precludes the diagnosis of chronic migraine according to the international headache classification.