Abstract
Medication-overuse headache (MOH) represents a severely disabling condition, with a low response to prophylactic treatments. Recently, consistent evidences have emerged in favor of botulinum toxin type-A (onabotulinum toxin A) as prophylactic treatment in chronic migraine. In a 12-week double-blind, parallel group, placebo-controlled study, we tested the efficacy and safety of onabotulinum toxin A as prophylactic treatment for MOH. A total of 68 patients were randomized (1:1) to onabotulinum toxin A (n = 33) or placebo (n = 35) treatment and received 16 intramuscular injections. The primary efficacy end point was mean change from baseline in the frequency of headache days for the 28-day period ending with week 12. No significant differences between onabotulinum toxin A and placebo treatment were detected in the primary (headache days) end point (12.0 vs. 15.9; p = 0.81). A significant reduction was recorded in the secondary end point, mean acute pain drug consumption at 12 weeks in onabotulinum toxin A-treated patients when compared with those with placebo (12.1 vs. 18.0; p = 0.03). When we considered the subgroup of patients with pericranial muscle tenderness, we recorded a significant improvement in those treated with onabotulinum toxin A compared to placebo treated in both primary (headache days) and secondary end points (acute pain drug consumption, days with drug consumption), as well as in pain intensity and disability measures (HIT-6 and MIDAS) at 12 weeks. Onabotulinum toxin A was safe and well tolerated, with few treatment-related adverse events. Few subjects discontinued due to adverse events. Our data identified the presence of pericranial muscle tenderness as predictor of response to onabotulinum toxin A in patients with complicated form of migraine such as MOH, the presence of pericranial muscle tenderness and support it as prophylactic treatment in these patients.Electronic supplementary materialThe online version of this article (doi:10.1007/s10194-011-0339-z) contains supplementary material, which is available to authorized users.
Highlights
The 2nd edition of the International Headache Society’s International Classification of Headache Disorders (ICHDII, IHS 2004) [1] introduced the term medication-overuse headache (MOH: code 8.2, ICHD-II) to indicate a chronic daily headache condition in which an excessive intake of symptomatic drugs has played a role in the chronification,J Headache Pain (2011) 12:427–433 and in which a clear relationship between increased drug intake and worsening of the headache is detectable [2]
When we considered the subgroup of patients with pericranial muscle tenderness, we recorded a significant improvement in those treated with onabotulinum toxin A compared to placebo treated in both primary and secondary end points, as well as in pain intensity and disability measures (HIT-6 and Migraine Disability Assessment Scale (MIDAS)) at 12 weeks
Intramuscular injections of botulinum toxin type-A has been employed to treat headache pain including episodic migraine [9, 10] and chronic tension-type headache [11,12,13] without univocal results as prophylactic treatment and chronic daily headaches not responding to previous prophylactic treatments with encouraging results [14]
Summary
The 2nd edition of the International Headache Society’s International Classification of Headache Disorders (ICHDII, IHS 2004) [1] introduced the term medication-overuse headache (MOH: code 8.2, ICHD-II) to indicate a chronic daily headache condition in which an excessive intake of symptomatic drugs has played a role in the chronification,. As in chronic daily headache, including MOH patients with migraine as primary headache, both pericranial muscle tenderness [22] and sensitization of the pain pathways at the trigeminal [23] and spinal levels [24] has been demonstrated, one would predict that in these patients onabotulinum toxin A would further improve the benefit of the withdrawal treatment and so facilitate the reversion to an episodic form of headache. Our study was aimed to evaluate in a multicenter, doubleblind placebo-controlled study the efficacy and safety of onabotulinum toxin A as prophylactic treatment for patients with MOH with migraine as primary headache, as well as to address if specific features such as cephalic allodynia, pericranial muscle tenderness, type of headache pain or of drug overuse may influence the response to onabotulinum toxin A
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