Robert Badgett, MD; Andrew Massey, MD
Does prophylactic botulinum toxin A reduce frequency of migraine or tension headaches, or chronic daily headaches in adults?
Included studies compared botulinum toxin A, alone or combined with other prophylactic or analgesic treatments, with placebo or other treatments in adults who had headaches; were ≥ 4 weeks in duration; and reported headache frequency or severity. Exclusion criteria were headaches associated with other disorders (e.g., cervical dystonia) or secondary headaches (e.g., postlumbar puncture headaches). Outcomes were patient-reported headache frequency or severity, indices that included patient-reported headache frequency and severity, and adverse events.
MEDLINE, EMBASE/Excerpta Medica, Cochrane Library, and reference lists were searched to March 2012 for randomized controlled trials (RCTs). 31 RCTs met inclusion criteria: 27 used placebo controls (n = 5423, mean age 42 y, 76% women) and 4 used active controls (n = 210, mean age range 30 to 42 y, 89% women), including topiramate, amitriptyline, methylprednisolone, and valproate. 10 placebo-controlled trials evaluated treatment for episodic migraine headaches (< 15 headaches/mo), 8 for chronic tension-type headaches (≥ 15 headaches/mo), 5 for chronic migraine headaches, 3 for chronic daily migraine or tension-type headaches, and 1 for a mixed population; 2 active-controlled trials evaluated treatment for chronic migraine headaches and 2 for a mixed population. 17 placebo-controlled RCTs and 1 active-controlled RCT scored ≥ 6 out of 8 on the Jadad scale for methodological quality.
Botulinum toxin A reduced frequency of chronic migraine and chronic daily headaches more than placebo; groups did not differ for reducing frequency of episodic migraine or chronic tension-type headaches (Table). In single RCTs, botulinum toxin A reduced the severity of chronic tension-type headaches more than methylprednisolone; botulinum toxin A did not differ from topiramate, valproate, or amitriptyline for reducing headache frequency. Botulinum toxin A increased adverse events more than placebo (25 RCTs; 57% vs 46%; relative risk increase 25%, 95% CI 14 to 36; number needed to harm 9, CI 7 to 16*).
In adults, prophylactic botulinum toxin A reduces frequency of chronic migraine headaches and chronic daily headaches but increases adverse events.
Prophylactic botulinum toxin A vs placebo in adults with headaches†
†CI defined in Glossary.
‡Episodic headache, < 15 headaches/mo; chronic headache, ≥ 15 headaches/mo.
§Negative values favor treatment.
Badgett R, Massey A. Review: Prophylactic botulinum toxin A reduces frequency of chronic migraine headaches in adults. Ann Intern Med. ;157:JC2–10. doi: 10.7326/0003-4819-157-4-201208210-02010
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Published: Ann Intern Med. 2012;157(4):JC2-10.
Headache, Neurology, Prevention/Screening.
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Print ISSN: 0003-4819 | Online ISSN: 1539-3704
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