Review of botulinum toxin type A for the prophylactic treatment of chronic daily headache

Figures & data

Table 1 Randomized, double-blind, placebo-controlled studies on botulinum toxin in the prophylactic treatment of tension-type headache

Reference	Indication to treatment	Number of patients	Results compared with placebo
Göbel et al 1999	chronic tension-type headache	10	No significant reduction of pain intensity, headache hours, or use of analgesics
Smuts et al 1999	chronic tension-type headache	41	Significant reduction of headache intensity and pain-free days in month 3 compared with baseline data in group with botulinum toxin but not in placebo group
Rollnik et al 2000	chronic tension-type headache	21	No significant differences between botulinum toxin and placebo in all headache parameters
Burch et al 2001	episodic and chronic tension- type headache	41	No significant difference in headache frequency
Schmitt et al 2001	chronic tension-type headache	59	No significant differences between botulinum toxin and placebo in all headache parameters
Schulte-Mattler and Krack 2004	chronic tension-type headache	113	No significant reduction in all efficacy endpoints
Ka et al 2004	chronic tension-type headache	40	No significant reduction of headache frequency; significant reduction of pain intensity
Padberg et al 2004	chronic tension-type headache	40	No significant results
Empl et al 2005	chronic tension-type headache	125	No significant results
Silberstein et al 2006	chronic tension-type headache	300	No significant difference in headache frequency (primary endpoint) for all treatment groups (treatment with 150 U was significantly inferior to placebo); significant increase in percentage of responders for three treatment groups

Table 2 Randomized, double-blind, placebo-controlled studies on botulinum toxin in the prophylactic treatment of chronic daily headache

Reference	Indication to treatment	Number of patients	Results compared with placebo
Ondo et al 2004	chronic daily headache	60	No significant reduction but trend (p = 0.07) in primary endpoint (days with headache)
Silberstein et al 2005	chronic daily headache	702	No significant reduction of headache frequency
Mathew et al 2005	chronic daily headache	355	Primary endpoint (reduction of headache free days) negative; secondary endpoint(percentage of patients with reduction >50%) positive
Dodick et al 2005	chronic daily headache	228	Significant reduction of headache frequency in patients not receiving other prophylactic drugs (subanalysis of Mathew et al 2005)
Elkind and Turkel 2005	chronic migraine	355	Significant reduction of migraine frequency for all treatment arms (105–260 U Botox®) as compared to placebo (subanalysis of Mathew et al 2005)
Freitag et al 2006	chronic migraine	60	No significant reduction in migraine days (p=0.18)

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