Botulinum Toxin Type A in the Prophylactic Treatment of Chronic Tension-Type Headache: A Multicentre, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Study

Abstract

We studied the safety and efficacy of 0 U, 50 U, 100 U, 150 U (five sites), 86 Usub and 100 Usub (three sites) botulinum toxin type A (BoNTA; BOTOX®; Allergan, Inc., Irvine, CA, USA) for the prophylaxis of chronic tension-type headache (CTTH). Three hundred patients (62.3± female; mean age 42.6 years) enrolled. For the primary endpoint, the mean change from baseline in the number of TTH-free days per month, there was no statistically significant difference between placebo and four BoNTA groups, but a significant difference favouring placebo vs. BoNTA 150 was observed (4.5 vs. 2.8 tension headache-free days/month; P = 0.007). All treatment groups improved at day 60. Although efficacy was not demonstrated for the primary endpoint, at day 90, more patients in three BoNTA groups had ≥50± decrease in tension headache days than did placebo ( P ≤ 0.024). Most treatment-related adverse events were mild or moderate, and transient. BoNTA was safe and well-tolerated in the study.

Botulinum toxin type A in refractory chronic migraine: an open-label trial

“…As migraine has peripheral and central mechanisms, it is possible that BT-A can influence pain perception in different levels of the peripheral and central nervous system in a way not yet established. Results of all studies published up to now have shown BT-A to be safe and well tolerated, and it its action was observed up to four months 12,13 , making it an alternative to patients in whom other therapeutic options to migraine have failed. Both of them had better response than the placebo group 23 .…”

“…Although many open trials have demonstrated improvement in patients with chronic tension type headache 10,11 , the controlled double blind trials did not support these results [12][13][14] .…”

Long-term benefits of botulinum toxin type A (BOTOX) in chronic daily headache: a five-year long experience

“…For tension headache-free days per month, all groups improved at the day 60 primary endpoint, while after 90 days a 50% decrease in terms of headache days was observed in BoNT-A patients. This suggests the necessity of a longer evaluation period [27].…”

Assessment: Botulinum neurotoxin in the treatment of autonomic disorders and pain (an evidence-based review) [RETIRED]

“…Thus, a clinically meaningful effect of BoNT was excluded. The other Class I study 34 used as primary outcome the mean change from baseline in number of headache-free days from day 30 to 60 after injection. Both BoNT and placebo groups improved after injection, but BoNT was not more beneficial.…”