Low-dosed Botulinum Toxin A in the Prophylactic Management of Unilateral Migraine: A Randomized Double-blind Placebo-Controlled Crossover Study

Abstract

Botulinum toxin is a therapeutic option in chronic migraine. No dose-finding studies have been conducted so far. Some authors maintain that one injection into the corrugator muscle will do.Objective: We studied the effect of Botulinum toxin (BTX) injections in patients with strictly unilateral migraine. Methods:We treated 22 patients (ITT) in a crossover design for 4 months with 2 x 5 units Onabotulinum toxin (in the corrugator and occipitalis muscle ipsilaterally). Aside from patient data, we also gathered information on undesired drug effects, besides IQOLA SF36, SF-MPQ SADP, OLBPDQ, VAS (pain intensity and daily living skills), PPI, frequency of attacks and application of medication. The statistical evaluation was guided by SPSS (V.13).Results: Assessed were 19 patients (PP) aged 45.2 ± 11.1 years, thereof 17 women. In both injection intervals there were no clinically relevant and/or statistically significant differences as to the target parameters (for example: VAS pain intensity p=0.702), with a notably evident placebo effect (VAS in placebo prior to the injection was 61.4, after 6 weeks 45.1; good or excellent improvement (TOQ) was quoted by 36.8% after 6 weeks in the placebo group). BTX merely proved superior in two aspects: Regarding the pain quality "throbbing" (SF-MPQ SADP), 11 patients initially indicated a pronounced intensity; after BTX only 4 of them did. As to the severity of the pain felt, (PPI) 42.2 of the subjects described "limiting" or "horrible" pain prior to the injection versus 26.3% six weeks after the injection and 21.1% 4 months later. The placebo group started out with 31.6%, that figure remaining the same (31.6%) 6 weeks later, rising to 42.2% after 4 months. 84.2% of the BTX-group and 63.2% in the placebo group requested a reinjection when the study was completed. Conclusion:The injection of low-dosed Botulinumtoxin A did not show any relevant or significant effects in patients with unilateral migraine without aura. One injection into the corrugator muscle alone must be considered as ineffective. The place-value of the two injection sites remains in the open.

Botulinumtoxin A bei der Migräne

“…Andere Sponsoren sind bei dem erheblichen Aufwand aber leider auch nicht zu erwarten. Eine kleine Studie die von der AG Botulinumtoxin der DGN gefördert wurde, untersuchte die Wirkung einer geringen Dosis an nur zwei Stellen und fand keinen signifikanten Effekt (11).…”