http://annals.org/ en-us Tue, 21 Aug 2012 00:00:00 GMT Tue, 09 Apr 2013 13:47:12 GMT Silverchair editor@annals.org webmaster@annals.org http://annals.org/article.aspx?articleID=1351389 Tue, 21 Aug 2012 00:00:00 GMT Badgett R, Massey A. <span class="paragraphSection"><div class="boxTitle">Question</div>Does prophylactic botulinum toxin A reduce frequency of migraine or tension headaches, or chronic daily headaches in adults?<div class="boxTitle">Review scope</div>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.<div class="boxTitle">Review methods</div>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 (<span style="font-style:italic;">n</span> = 5423, mean age 42 y, 76% women) and 4 used active controls (<span style="font-style:italic;">n</span> = 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.<div class="boxTitle">Main results</div>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*).<div class="boxTitle">Conclusion</div>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†OutcomeHeadache type‡Number of trials (<span style="font-style:italic;">n</span>)Weighted mean difference (95% CI)§Headaches/moEpisodic migraine9 (1838)0.05 (−0.26 to 0.36)Chronic migraine5 (1508)−2.30 (−3.66 to −0.94)Chronic tension-type7 (675)−1.43 (−3.13 to 0.27)Chronic daily3 (1115)−2.06 (−3.56 to −0.56)†CI defined in Glossary.‡Episodic headache, < 15 headaches/mo; chronic headache, ≥ 15 headaches/mo.§Negative values favor treatment.</span> http://annals.org/article.aspx?articleID=1351389