Skip to main content
Erschienen in: Journal of Neural Transmission 5/2016

31.03.2016 | Neurology and Preclinical Neurological Studies - Original Article

Long-term treatment of chronic migraine with OnabotulinumtoxinA: efficacy, quality of life and tolerability in a real-life setting

verfasst von: Katja Kollewe, Claus M. Escher, Dirk U. Wulff, Davood Fathi, Lejla Paracka, Bahram Mohammadi, Matthias Karst, Dirk Dressler

Erschienen in: Journal of Neural Transmission | Ausgabe 5/2016

Einloggen, um Zugang zu erhalten

Abstract

Botulinum toxin was shown to be effective in treatment of chronic migraine. We wanted to explore its efficacy and tolerability in chronic application under real-life conditions. For this, 27 consecutive patients (age 45.6 ± 10.8 years, 25 females, 2 males) received altogether 176 injection series (IS) with 189.7 ± 45.8MU onabotulinumtoxinA (Botox®) according to the PREEMPT scheme. During the study period altogether 6.5 ± 2.9 (min 4, max 13) IS were applied per patient (total treatment time of 73.1 ± 36.9 weeks). 96 % of the patients reported benefit. Monthly headache days were reduced from 18.9 ± 3.9 to 8.7 ± 4.5 (p < 0.001, −53.7 %), migraine days from 16.8 ± 4.9 to 7.4 ± 4.6 (p < 0.001, −55.1 %), autonomic days from 8.6 ± 7.5 to 2.7 ± 4.2 (p < 0.001, −71.9 %) and medication days from 14.2 ± 4.6 to 8.3 ± 4.2 (p < 0.001, −71.1 %). Health-related quality of life improved by 0.6–1.5 standard deviations (SD) (Short Form Health Survey), migraine-related quality of life by 1.4–2.0 SD (Migraine-Specific Quality of Life Questionnaire) and by 1.9 SD (Headache Impact Test), depression by 1.1 SD (Beck Depression Inventory). Subjective global clinical improvement was 2.6 ± 0.6 (Global Clinical Improvement Scale). All improvements were stable throughout the entire study period. Adverse effects were infrequent, mild and transient. Botulinum toxin provides highly effective and safe long-term treatment of chronic migraine.
Literatur
Zurück zum Zitat Aoki KR (2003) Evidence for antinociceptive activity of botulinum toxin type A in pain management. Headache 43(Suppl 1):S9–S15CrossRefPubMed Aoki KR (2003) Evidence for antinociceptive activity of botulinum toxin type A in pain management. Headache 43(Suppl 1):S9–S15CrossRefPubMed
Zurück zum Zitat Aurora SK, Dodick DW, Diener HC, DeGryse RE, Turkel CC, Lipton RB, Silberstein SD (2014) OnabotulinumtoxinA for chronic migraine: efficacy, safety, and tolerability in patients who received all five treatment cycles in the PREEMPT clinical program. Acta Neurol Scand 129:61–70. doi:10.1111/ane.12171 CrossRefPubMedPubMedCentral Aurora SK, Dodick DW, Diener HC, DeGryse RE, Turkel CC, Lipton RB, Silberstein SD (2014) OnabotulinumtoxinA for chronic migraine: efficacy, safety, and tolerability in patients who received all five treatment cycles in the PREEMPT clinical program. Acta Neurol Scand 129:61–70. doi:10.​1111/​ane.​12171 CrossRefPubMedPubMedCentral
Zurück zum Zitat Bigal ME, Rapoport AM, Sheftell FD, Tepper SJ, Lipton RB (2004) Transformed migraine and medication overuse in a tertiary headache centre–clinical characteristics and treatment outcomes. Cephalalgia 24:483–490CrossRefPubMed Bigal ME, Rapoport AM, Sheftell FD, Tepper SJ, Lipton RB (2004) Transformed migraine and medication overuse in a tertiary headache centre–clinical characteristics and treatment outcomes. Cephalalgia 24:483–490CrossRefPubMed
Zurück zum Zitat Blumenfeld A, Silberstein SD, Dodick DW, Aurora SK, Turkel CC, Binder WJ (2010) Method of injection of OnabotulinumtoxinA for chronic migraine: a safe, well-tolerated, and effective treatment paradigm based on the PREEMPT clinical program: October 2010. Headache J Head Face Pain 50:1406–1418. doi:10.1111/j.1526-4610.2010.01766.x CrossRef Blumenfeld A, Silberstein SD, Dodick DW, Aurora SK, Turkel CC, Binder WJ (2010) Method of injection of OnabotulinumtoxinA for chronic migraine: a safe, well-tolerated, and effective treatment paradigm based on the PREEMPT clinical program: October 2010. Headache J Head Face Pain 50:1406–1418. doi:10.​1111/​j.​1526-4610.​2010.​01766.​x CrossRef
Zurück zum Zitat Cady RK, Schreiber CP, Porter JAH, Blumenfeld AM, Farmer KU (2011) A multi-center double-blind pilot comparison of OnabotulinumtoxinA and topiramate for the prophylactic treatment of chronic migraine. Headache J Head Face Pain 51:21–32. doi:10.1111/j.1526-4610.2010.01796.x CrossRef Cady RK, Schreiber CP, Porter JAH, Blumenfeld AM, Farmer KU (2011) A multi-center double-blind pilot comparison of OnabotulinumtoxinA and topiramate for the prophylactic treatment of chronic migraine. Headache J Head Face Pain 51:21–32. doi:10.​1111/​j.​1526-4610.​2010.​01796.​x CrossRef
Zurück zum Zitat Castillo J, Muñoz P, Guitera V, Pascual J (1999) Epidemiology of chronic daily headache in the general population. Headache J Head Face Pain 39:190–196CrossRef Castillo J, Muñoz P, Guitera V, Pascual J (1999) Epidemiology of chronic daily headache in the general population. Headache J Head Face Pain 39:190–196CrossRef
Zurück zum Zitat Cernuda-Morollon E, Ramon C, Larrosa D, Alvarez R, Riesco N, Pascual J (2014) Long-term experience with onabotulinumtoxinA in the treatment of chronic migraine: what happens after 1 year? Cephalalgia. doi:10.1177/0333102414561873 Cernuda-Morollon E, Ramon C, Larrosa D, Alvarez R, Riesco N, Pascual J (2014) Long-term experience with onabotulinumtoxinA in the treatment of chronic migraine: what happens after 1 year? Cephalalgia. doi:10.​1177/​0333102414561873​
Zurück zum Zitat Conway S, Delplanche C, Crowder J, Rothrock J (2005) Botox therapy for refractory chronic migraine. Headache 45:355–357CrossRefPubMed Conway S, Delplanche C, Crowder J, Rothrock J (2005) Botox therapy for refractory chronic migraine. Headache 45:355–357CrossRefPubMed
Zurück zum Zitat Cui M, Khanijou S, Rubino J, Aoki KR (2004) Subcutaneous administration of botulinum toxin a reduces formalin-induced pain. Pain 107:125–133CrossRefPubMed Cui M, Khanijou S, Rubino J, Aoki KR (2004) Subcutaneous administration of botulinum toxin a reduces formalin-induced pain. Pain 107:125–133CrossRefPubMed
Zurück zum Zitat Diener HC, Weimar C (2012) Therapie der Migräne. In: Leitlinien für Diagnostik und Therapie in der Neurologie. Thieme Verlag, Stuttgart Diener HC, Weimar C (2012) Therapie der Migräne. In: Leitlinien für Diagnostik und Therapie in der Neurologie. Thieme Verlag, Stuttgart
Zurück zum Zitat Dodick D, Mauskop A, Elkind A, DeGryse R, Brin M, Silberstein S (2005) 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. Headache 45:315–324CrossRefPubMed Dodick D, Mauskop A, Elkind A, DeGryse R, Brin M, Silberstein S (2005) 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. Headache 45:315–324CrossRefPubMed
Zurück zum Zitat Evers S, Rahmann A, Vollmer-Haase J, Husstedt IW (2002) Treatment of headache with botulinum toxin A—a review according to evidence-based medicine criteria. Cephalalgia 22:699–710CrossRefPubMed Evers S, Rahmann A, Vollmer-Haase J, Husstedt IW (2002) Treatment of headache with botulinum toxin A—a review according to evidence-based medicine criteria. Cephalalgia 22:699–710CrossRefPubMed
Zurück zum Zitat Headache Classification Committee of the International Headache S (2013) The international classification of headache disorders, 3rd edition (beta version). Cephalalgia 33:629–808. doi:10.1177/0333102413485658 CrossRef Headache Classification Committee of the International Headache S (2013) The international classification of headache disorders, 3rd edition (beta version). Cephalalgia 33:629–808. doi:10.​1177/​0333102413485658​ CrossRef
Zurück zum Zitat Jackson JL, Kuriyama A, Hayashino Y (2012) Botulinum toxin A for prophylactic treatment of migraine and tension headaches in adults: a meta-analysis. Jama 307:1736–1745CrossRefPubMed Jackson JL, Kuriyama A, Hayashino Y (2012) Botulinum toxin A for prophylactic treatment of migraine and tension headaches in adults: a meta-analysis. Jama 307:1736–1745CrossRefPubMed
Zurück zum Zitat Jhingran P, Osterhaus JT, Miller DW, Lee JT, Kirchdoerfer L (1998) Development and validation of the migraine-specific quality of life questionnaire. Headache J Head Face Pain 38:295–302CrossRef Jhingran P, Osterhaus JT, Miller DW, Lee JT, Kirchdoerfer L (1998) Development and validation of the migraine-specific quality of life questionnaire. Headache J Head Face Pain 38:295–302CrossRef
Zurück zum Zitat Kosinski M et al (2003) A six-item short-form survey for measuring headache impact: the HIT-6. Qual Life Res Int J Qual Life Asp Treat Care Rehabil 12:963–974CrossRef Kosinski M et al (2003) A six-item short-form survey for measuring headache impact: the HIT-6. Qual Life Res Int J Qual Life Asp Treat Care Rehabil 12:963–974CrossRef
Zurück zum Zitat Kühner C, Bürger C, Keller F, Hautzinger M (2007) Reliabilität und Validität des revidierten Beck-Depressionsinventars (BDI-II): befunde aus deutschsprachigen Stichproben. Der Nervenarzt 78:651–656. doi:10.1007/s00115-006-2098-7 CrossRefPubMed Kühner C, Bürger C, Keller F, Hautzinger M (2007) Reliabilität und Validität des revidierten Beck-Depressionsinventars (BDI-II): befunde aus deutschsprachigen Stichproben. Der Nervenarzt 78:651–656. doi:10.​1007/​s00115-006-2098-7 CrossRefPubMed
Zurück zum Zitat Magid M, Reichenberg JS, Poth PE, Robertson HT, LaViolette AK, Kruger TH, Wollmer MA (2014) Treatment of major depressive disorder using botulinum toxin A: a 24-week randomized, double-blind, placebo-controlled study. J Clin Psychiatry 75:837–844CrossRefPubMed Magid M, Reichenberg JS, Poth PE, Robertson HT, LaViolette AK, Kruger TH, Wollmer MA (2014) Treatment of major depressive disorder using botulinum toxin A: a 24-week randomized, double-blind, placebo-controlled study. J Clin Psychiatry 75:837–844CrossRefPubMed
Zurück zum Zitat Petri S, Tölle TT, Straube A, Pfaffenrath V, Stefenelli U, Ceballos-Baumann A (2009) Botulinum toxin as preventive treatment for migraine: a randomized double-blind study. Eur Neurol 62:204–211. doi:10.1159/000228987 CrossRefPubMed Petri S, Tölle TT, Straube A, Pfaffenrath V, Stefenelli U, Ceballos-Baumann A (2009) Botulinum toxin as preventive treatment for migraine: a randomized double-blind study. Eur Neurol 62:204–211. doi:10.​1159/​000228987 CrossRefPubMed
Zurück zum Zitat Rollnik JD, Tanneberger O, Schubert M, Schneider U, Dengler R (2000) Treatment of tension-type headache with botulinum toxin type A: a double-blind Placebo-Controlled Study. Headache J Head Face Pain 40:300–305CrossRef Rollnik JD, Tanneberger O, Schubert M, Schneider U, Dengler R (2000) Treatment of tension-type headache with botulinum toxin type A: a double-blind Placebo-Controlled Study. Headache J Head Face Pain 40:300–305CrossRef
Zurück zum Zitat Sandrini G, Perrotta A, Tassorelli C, Torelli P, Brighina F, Sances G, Nappi G (2011) Botulinum toxin type-A in the prophylactic treatment of medication-overuse headache: a multicenter, double-blind, randomized, placebo-controlled, parallel group study. J Headache Pain 12:427–433. doi:10.1007/s10194-011-0339-z CrossRefPubMedPubMedCentral Sandrini G, Perrotta A, Tassorelli C, Torelli P, Brighina F, Sances G, Nappi G (2011) Botulinum toxin type-A in the prophylactic treatment of medication-overuse headache: a multicenter, double-blind, randomized, placebo-controlled, parallel group study. J Headache Pain 12:427–433. doi:10.​1007/​s10194-011-0339-z CrossRefPubMedPubMedCentral
Zurück zum Zitat Silberstein et al (2000) Botulinum toxin type A as a migraine preventive treatment. Headache 40:445–450CrossRefPubMed Silberstein et al (2000) Botulinum toxin type A as a migraine preventive treatment. Headache 40:445–450CrossRefPubMed
Zurück zum Zitat Welch MJ, Purkiss JR, Foster KA (2000) Sensitivity of embryonic rat dorsal root ganglia neurons to Clostridium botulinum neurotoxins. Toxicon 38:245–258CrossRefPubMed Welch MJ, Purkiss JR, Foster KA (2000) Sensitivity of embryonic rat dorsal root ganglia neurons to Clostridium botulinum neurotoxins. Toxicon 38:245–258CrossRefPubMed
Metadaten
Titel
Long-term treatment of chronic migraine with OnabotulinumtoxinA: efficacy, quality of life and tolerability in a real-life setting
verfasst von
Katja Kollewe
Claus M. Escher
Dirk U. Wulff
Davood Fathi
Lejla Paracka
Bahram Mohammadi
Matthias Karst
Dirk Dressler
Publikationsdatum
31.03.2016
Verlag
Springer Vienna
Erschienen in
Journal of Neural Transmission / Ausgabe 5/2016
Print ISSN: 0300-9564
Elektronische ISSN: 1435-1463
DOI
https://doi.org/10.1007/s00702-016-1539-0

Weitere Artikel der Ausgabe 5/2016

Journal of Neural Transmission 5/2016 Zur Ausgabe

Neurology and Preclinical Neurological Studies - Original Article

Botulinum toxin therapy: reduction of injection site pain by pH normalisation

Neurology and Preclinical Neurological Studies - Short communication

Nigral involvement in atypical parkinsonisms: evidence from a pilot study with ultra-high field MRI

Leitlinien kompakt für die Neurologie

Mit medbee Pocketcards sicher entscheiden.

Seit 2022 gehört die medbee GmbH zum Springer Medizin Verlag

Update Neurologie

Bestellen Sie unseren Fach-Newsletter und bleiben Sie gut informiert.