The FDA approved Botox for the treatment of chronic migraine because of the two large double-blind and placebo controlled trials which involved close to 1,400 patients (in which we, at the NYHC also participated). These studies showed that Botox reduced the number of days with headaches and it also improved many other related aspects. A study just published in Neurology looked at the effect of Botox on the quality of life of patients that participated in these trials. It is possible to have a treatment that reduces the number and even the severity of migraines without improving patients’ quality of life because of its side effects. This is seen with some patients who take topiramate (Topamax) – their headaches may be much better but the quality of life is not because of memory impairment or fatigue, which makes them unable to function. The same is true with other medications, such as antidepressants. However, the quality of life of patients receiving Botox in these two studies was significantly better than in those receiving placebo injections. This is because their headaches improved dramatically and because Botox rarely caused any side effects. Unfortunately, many insurance companies will pay for Botox only after the patient fails to improve on 2 or 3 prophylactic medications, even though these medications are not approved by the FDA for chronic migraines.
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