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Since the 1980s, botulinum toxins (BTX) have been used for many putative conditions that cause pain. The U.S. Food and Drug Administration (FDA) has not yet approved their use for any specific pain disorders, although two forms of BTX (A and B) have been approved by the FDA for other medical conditions associated with pain and discomfort. However, BTX continues to be used successfully by a range of specialists to address pain control.

Although there are many case reports and open-label studies on the effectiveness of BTX in treating painful conditions, a dearth of double-blind, placebo-controlled, randomized clinical trials exist that directly addresses its use for pain management. Some double-blind, placebo-controlled, randomized clinical studies show that botulinum toxin type A (BTX-A) injections are effective in treating various headache disorders (Table 23-1). However, there are no published clinical trials showing its effectiveness in cluster headaches.

Table 23-1 Summary of Results from Clinical Trials

All of the data presented in this chapter, and most of the published experience in headache management is from BTX-A studies, but botulinum toxin type B (BTX-B) also may be effective, given the similarity of the two serotypes.

Headache is one of the most common types of pain disorder, responsible for more than 10 million physician visits annually in the United States. Although the terminology of various types of headaches may be confusing, we limit our discussion here to primary headaches, for which BTX data is available to make preliminary recommendations until more information is available from ongoing large, multi-center, double-blind, randomized, placebo-controlled trials.

Migraine is a neurologic disorder that features recurrent attacks of headache, most often occurring unilaterally. It accompanies various combinations of symptoms, such as nausea, vomiting, and sensitivity to light, sound, and other stimuli. Migraine attacks can occur at any time of day or ...

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