Botulinum Toxin Type A for the Prophylaxis of Chronic Daily Headache: Subgroup Analysis of Patients Not Receiving Other Prophylactic Medications: A Randomized Double‐Blind, Placebo‐Controlled Study

Abstract

Objective.-To assess the efficacy and safety of botulinum toxin type A (BoNT-A; BOTOX ® , Allergan, Inc., Irvine, CA) for the prophylaxis of headaches in patients with chronic daily headache (CDH) without the confounding factor of concurrent prophylactic medications.Background.-Several open-label studies and an 11-month, randomized, double-blind, placebo-controlled study suggest that BoNT-A may be an effective therapy for the prophylaxis of headaches in patients with CDH.Design and Methods.-This was a subgroup analysis of an 11-month, randomized double-blind, placebocontrolled study of BoNT-A for the treatment of adult patients with 16 or more headache days per 30-day periods conducted at 13 North American study centers. All patients had a history of migraine or probable migraine. This analysis involved data for patients who were not receiving concomitant prophylactic headache medication and who constituted 64% of the full study population. Following a 30-day screening period and a 30-day single-blind, placebo injection, eligible patients were injected with BoNT-A or placebo and assessed every 30 days for 9 months The following efficacy measures were analyzed per 30-day periods: change from baseline in number of headache-free days; change from baseline in headache frequency; proportion of patients with at least 30% or at least 50% decrease from baseline in headache frequency; and change from baseline in mean headache severity. Acute medication use was assessed, and adverse events were recorded at each study visit.Results.-Of the 355 patients randomized in the study, 228 (64%) were not taking prophylactic medication and were included in this analysis (117 received BoNT-A, 111 received placebo injections). Mean age was 42.4 ± 10.90 years; the mean frequency of headaches per 30 days at baseline was 14.1 for the BoNT-A group and 12.9 for the placebo group (P = .205). After two injection sessions, the maximum change in the mean frequency of headaches per 30 days was −7.8 in the BoNT-A group compared with only −4.5 in the placebo group (P = .032), a statistically significant between-group difference of 3.3 headaches. The between-group difference favoring BoNT-A treatment continued to improve to 4.2 headaches after a third injection session (P = .023). In addition, BoNT-A treatment at least halved the frequency of baseline headaches in over 50% of patients after three injection sessions compared to baseline. Statistically significant differences between BoNT-A and placebo were evident for the change from baseline in headache frequency and headache severity for most time points from day 180 through day 270. Only 5 patients (4 patients receiving BoNT-A treatment; 1 patient receiving placebo) discontinued the study due to adverse events and most treatment-related events were transient and mild to moderate in severity.Conclusions.-BoNT-A is an effective and well-tolerated prophylactic treatment in migraine patients with CDH who are not using other prophylactic medications.

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

“…Headache frequency diminished in over 50% of patients after two BoNT-A injection sessions, and the mean number of headache-free days per month was almost tripled (from 6 to 16 days). Furthermore, drug consumption decreased remarkably [22]. Similar results were shown by Mathew et al [23].…”

“…As recorded in the literature the percentage of adverse events is extremely low, BoNT-A appearing to be therefore safe and well tolerated [20][21][22][23]. In our data, only 1.6% of patients reported side effects.…”

Preventive treatment of migraine

“…BTNA treatment was well tolerated but high-dose BTN-A produced significantly more treatment-related AEs than did placebo. Recent studies indicate that BTN-A is no more effective than placebo at preventing infrequent migraine but is effective at preventing very frequent migraine [64].…”

The Efficacy of Botulinum Toxin in Patients with Cervicogenic Headache: a Placebo-Controlled Clinical Trial

“…According to the present results (similar to other published results), BoNTA can be an effective treatment method in patients with CH. The results of controlled studies on patients with chronic daily headache show that BoNTA is well tolerated and effective in reducing the frequency of painful episodes and the number of painful days (36,37 Neck muscle weakness 1 0 Table 4. Side effects…”