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Let's Give Botox a Break

As with certain other hot button topics (the West Bank settlements, Obamacare, Mitt’s car elevator), onabotulinumtoxinA (Botox A) therapy for chronic migraine (CM) provokes expressions of dissent. For Botox A and CM, perhaps the most public example of this antipathy, albeit wellmodulated and wearing the respectable cloak of scientific discourse, was a recent review and metaanalysis in JAMA heralded as indicating that Botox A is, well, not all it was cracked up to be. Although JAMA’s publicized advance notice arguably may have oversold the article’s purported devaluation of Botox A as a therapy for migraine, the authors did conclude that their analysis of existing data indicated that “. . . [for CM] the association of botulinum toxin A with clinical benefit was small.” Really? While all the tedious, expensive, and time-consuming research undertaken by those dedicated to relieving the burden of headache sufferers did indeed indicate no clear benefit from Botox A for tension-type headache or episodic migraine (EM), why did these authors appear to extrapolate those frustrating results to the arena of CM? It’s been well less than a decade since CM entered the official lexicon (ie, the ICHD classification system). The pharmaceutical industry traditionally has been the primary source of funding for the development of migraine therapeutics, and hardly surprising was the disinclination of that industry to invest millions of dollars to develop new therapies for a disease/disorder that remained undefined, excluded from that lexicon . . . and even, at least as perceived by many at the time, possibly not even a distinct headache disorder at all. Equally unsurprising, then, is the relative dearth of effective evidence-based therapies for this nascent diagnosis. Examination of the primary endpoint in the placebo-controlled PREEMPT studies – frequency of headache days – demonstrated a statistically significant benefit in favor of Botox A. The authors of the JAMA article are correct; by this endpoint, the reduction in headache burden relative to placebo was modest and of questionable clinical relevance . . . but also evident was the emergence of a signal clearly indicating therapeutic efficacy. Surveying the secondary endpoints, one finds that after only 2 treatments with Botox A almost 50% of subjects experienced a 50% or greater reduction in headache frequency . . . a response rising to involve just under 70% of subjects by week 56 of therapy. This result – implying remission of CM to EM – is of tremendous clinical relevance to both those who suffer from CM and those who endeavor to treat them, and the response rates compare quite favorably to what has been recorded from studies involving administration of oral agents for the prophylaxis of EM or CM. Studies involving open-label administration of Botox A for CM have yielded a similar incidence of remission to EM, and that result has been accompanied by a notable reduction in migrainerelated healthcare resource utilization. CM is more disabling and exacts higher direct and indirect medical costs than EM. Administration of Botox A for CM reduces migraine-related direct medical costs and improves quality of life. What precisely is it, then, that JAMA and the authors of the index article desire? Sure, all of us yearn for a “full glass” therapy – cheap and invariably effective – ISSN 0017-8748 doi: 10.1111/j.1526-4610.2012.02193.x Published by Wiley Periodicals, Inc. Headache © 2012 American Headache Society