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A double-blind, randomized, placebo-controlled comparison of botulinum toxin type a injection sites and doses in the prevention of episodic migraine.
Pain Med 2007; 8(6):478-85PM

Abstract

BACKGROUND

Several randomized, controlled studies have reported benefits of botulinum toxin type A (BoNTA; Allergan Inc., Irvine, CA, USA) over placebo in the treatment of migraine. Some studies reported significant benefits at dosages as low as 16 U, while other studies reported safety, tolerability, and efficacy at dosages up to 260 U. However, the optimal treatment paradigm and patient population have yet to be defined.

OBJECTIVE

To compare different injection sites and doses of BoNTA in the prevention of episodic migraine.

DESIGN AND METHODS

This was a randomized, double-blind, placebo-controlled study of 232 patients with a history of four to eight moderate to severe migraines per month, with or without aura. Patients were randomized to placebo or one of four BoNTA groups that received injections into different muscle regions: frontal (10 U), temporal (6 U), glabellar (9 U), or all three areas (total dose 25 U). For 3 months following a single treatment, patients recorded migraine-related variables in a daily diary.

RESULTS

BoNTA and placebo produced comparable decreases from baseline in the frequency of migraines (P > or = 0.411). In general, no statistically significant differences were observed for any efficacy variable. The overall rates of adverse events (any type) or treatment-related adverse events were similar among the groups.

CONCLUSIONS

In this exploratory study of episodic migraine patients, low-dose injections of BoNTA into the frontal, temporal, and/or glabellar muscle regions were not more effective than placebo. BoNTA was safe and well tolerated. Future studies may examine higher BoNTA doses, flexible injection sites, multiple treatments, and disallow concomitant prophylactic medications.

Authors+Show Affiliations

Michigan Head Pain & Neurological Institute, Ann Arbor, Michigan, USA. jrsaper@aol.comNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

17716321

Citation

Saper, Joel R., et al. "A Double-blind, Randomized, Placebo-controlled Comparison of Botulinum Toxin Type a Injection Sites and Doses in the Prevention of Episodic Migraine." Pain Medicine (Malden, Mass.), vol. 8, no. 6, 2007, pp. 478-85.
Saper JR, Mathew NT, Loder EW, et al. A double-blind, randomized, placebo-controlled comparison of botulinum toxin type a injection sites and doses in the prevention of episodic migraine. Pain Med. 2007;8(6):478-85.
Saper, J. R., Mathew, N. T., Loder, E. W., DeGryse, R., & VanDenburgh, A. M. (2007). A double-blind, randomized, placebo-controlled comparison of botulinum toxin type a injection sites and doses in the prevention of episodic migraine. Pain Medicine (Malden, Mass.), 8(6), pp. 478-85.
Saper JR, et al. A Double-blind, Randomized, Placebo-controlled Comparison of Botulinum Toxin Type a Injection Sites and Doses in the Prevention of Episodic Migraine. Pain Med. 2007;8(6):478-85. PubMed PMID: 17716321.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - A double-blind, randomized, placebo-controlled comparison of botulinum toxin type a injection sites and doses in the prevention of episodic migraine. AU - Saper,Joel R, AU - Mathew,Ninan T, AU - Loder,Elizabeth W, AU - DeGryse,Ronald, AU - VanDenburgh,Amanda M, AU - ,, PY - 2007/8/25/pubmed PY - 2007/11/14/medline PY - 2007/8/25/entrez SP - 478 EP - 85 JF - Pain medicine (Malden, Mass.) JO - Pain Med VL - 8 IS - 6 N2 - BACKGROUND: Several randomized, controlled studies have reported benefits of botulinum toxin type A (BoNTA; Allergan Inc., Irvine, CA, USA) over placebo in the treatment of migraine. Some studies reported significant benefits at dosages as low as 16 U, while other studies reported safety, tolerability, and efficacy at dosages up to 260 U. However, the optimal treatment paradigm and patient population have yet to be defined. OBJECTIVE: To compare different injection sites and doses of BoNTA in the prevention of episodic migraine. DESIGN AND METHODS: This was a randomized, double-blind, placebo-controlled study of 232 patients with a history of four to eight moderate to severe migraines per month, with or without aura. Patients were randomized to placebo or one of four BoNTA groups that received injections into different muscle regions: frontal (10 U), temporal (6 U), glabellar (9 U), or all three areas (total dose 25 U). For 3 months following a single treatment, patients recorded migraine-related variables in a daily diary. RESULTS: BoNTA and placebo produced comparable decreases from baseline in the frequency of migraines (P > or = 0.411). In general, no statistically significant differences were observed for any efficacy variable. The overall rates of adverse events (any type) or treatment-related adverse events were similar among the groups. CONCLUSIONS: In this exploratory study of episodic migraine patients, low-dose injections of BoNTA into the frontal, temporal, and/or glabellar muscle regions were not more effective than placebo. BoNTA was safe and well tolerated. Future studies may examine higher BoNTA doses, flexible injection sites, multiple treatments, and disallow concomitant prophylactic medications. SN - 1526-2375 UR - https://www.unboundmedicine.com/medline/citation/17716321/A_double_blind_randomized_placebo_controlled_comparison_of_botulinum_toxin_type_a_injection_sites_and_doses_in_the_prevention_of_episodic_migraine_ L2 - https://academic.oup.com/painmedicine/article-lookup/doi/10.1111/j.1526-4637.2006.00168.x DB - PRIME DP - Unbound Medicine ER -