Botulinum toxin A for prophylactic treatment of migraine and tension headaches in adults: A meta-analysis

JAMA

Volumn 307, Issue 16, 2012, Pages 1736-1745

  Jackson, Jeffrey L ^a,b   Kuriyama, Akira ^c   Hayashino, Yasuaki ^d  

^a CLEMENT J ZABLOCKI VETERANS AFFAIRS MEDICAL CENTER   (United States)

^b MEDICAL COLLEGE OF WISCONSIN   (United States)

^c RAKUWAKAI OTOWA HOSPITAL   (Japan)

^d KYOTO UNIVERSITY GRADUATE SCHOOL OF MEDICINE   (Japan)

Author keywords

[No Author keywords available]

Indexed keywords

AMITRIPTYLINE; BOTULINUM TOXIN A; PLACEBO; TOPIRAMATE; VALPROIC ACID;

ADULT; CHRONIC TENSION HEADACHE; CLINICAL EFFECTIVENESS; COMPARATIVE EFFECTIVENESS; CONTROLLED STUDY; DIZZINESS; DRUG DOSE COMPARISON; DRUG EFFICACY; DRUG RESPONSE; DRUG SAFETY; DRUG USE; DRUG WITHDRAWAL; EPISODIC TENSION HEADACHE; FEMALE; HUMAN; INJECTION SITE PAIN; MAJOR CLINICAL STUDY; MALE; META ANALYSIS; MIGRAINE; MUSCLE WEAKNESS; NAUSEA; NECK PAIN; OUTCOME ASSESSMENT; PARESTHESIA; PRIORITY JOURNAL; PTOSIS; QUALITY CONTROL; RANDOMIZED CONTROLLED TRIAL; REVIEW; SENSITIVITY ANALYSIS; SKIN BRUISING; SKIN TIGHTNESS; SYSTEMATIC REVIEW; TREATMENT DURATION;

EID: 84860116612     PISSN: 00987484     EISSN: 15383598     Source Type: Journal    
DOI: 10.1001/jama.2012.505     Document Type: Review

References (85)

1. Lipton RB, Bigal ME, Kolodner K, Stewart WF, Liberman JN, Steiner TJ. The family impact of migraine: population-based studies in the USA and UK. Cephalalgia. 2003;23(6):429-440. (Pubitemid 36776059)
2. Radtke A, Neuhauser H. Prevalence and burden of headache and migraine in Germany. Headache. 2009; 49(1):79-89.
3. Wang SJ. Epidemiology of migraine and other types of headache in Asia. Curr Neurol Neurosci Rep. 2003; 3(2):104-108.
4. Blumenfeld AM, Varon SF, Wilcox TK, et al. Disability, HRQoL and resource use among chronic and episodic migraineurs: results from the International Burden of Migraine Study (IBMS). Cephalalgia. 2011; 31(3):301-315.
5. Freitag FG. The cycle of migraine: patients' quality of life during and between migraine attacks. Clin Ther. 2007;29(5):939-949. (Pubitemid 47223427)
6. Goldberg LD. The cost of migraine and its treatment. Am J Manag Care. 2005;11(2)(suppl):S62-S67. (Pubitemid 40875301)
7. Pringsheim T, Davenport WJ, Becker WJ. Prophylaxis of migraine headache. CMAJ. 2010;182(7): E269-E276.
8. Binder WJ, Brin MF, Blitzer A, Schoenrock LD, Pogoda JM. Botulinum toxin type A (BOTOX) for treatment of migraine headaches: an open-label study. Otolaryngol Head Neck Surg. 2000;123(6):669-676.
9. Evans RW, Blumenfeld A. Botulinum toxin injections for headache. Headache. 2003;43(6):682-685. (Pubitemid 36828808)
10. Pascual J. Influence of botulinum toxin treatment on previous primary headaches in patients with cranio-cervical dystonia. Neurologia. 2004;19(5): 260-263. (Pubitemid 38843378)
11. Aurora SK, Dodick DW, Turkel CC, et al; PREEMPT 1 Chronic Migraine Study Group. Onabotulinum-toxinA for treatment of chronic migraine: results from the double-blind, randomized, placebo-controlled phase of the PREEMPT 1 trial. Cephalalgia. 2010; 30(7):793-803.
12. Diener HC, Dodick DW, Aurora SK, et al; PREEMPT 2 Chronic Migraine Study Group. Onabotulinum-toxinA for treatment of chronic migraine: results from the double-blind, randomized, placebo-controlled phase of the PREEMPT 2 trial. Cephalalgia. 2010; 30(7):804-814.
13. Moher D, Liberati A, Tetzlaff J, Altman DG; PRISMA Group. Preferred reporting items for systematic reviews and meta-analyses: the PRISMA statement. PLoS Med. 2009;6(7):e1000097. doi:10.1371/journal .pmed.1000097.
14. Siberstein SD, Lipton RB, Solomon S, Mathew NT. Classification of daily and near-daily headaches: proposed revisions to the IHS criteria. Headache. 1994; 34(1):1-7. (Pubitemid 24038967)
15. Bendtsen L, Bigal ME, Cerbo R, et al International Headache Society Clinical Trials Subcommittee. Guidelines for controlled trials of drugs in tension-type headache: second edition. Cephalalgia. 2010; 30(1):1-16.
16. Silberstein S, Tfelt-Hansen P, Dodick DW, et al Task Force of the International Headache Society Clinical Trials Subcommittee. Guidelines for controlled trials of prophylactic treatment of chronicmigraine in adults. Cephalalgia. 2008;28(5):484-495. (Pubitemid 351502554)
17. Follmann D, Elliott P, Suh I, Cutler J. Variance imputation for overviews of clinical trials with continuous response. J Clin Epidemiol. 1992;45(7):769- 773.
18. Higgins JPT, Altman DG, Sterne JAC, eds. Chapter 8: assessing risk of bias in included studies. In: Higgins JPT, Green S, eds. Cochrane Handbook for Systematic Reviews of Interventions Version 5.1.0 (updated March 2011). The Cochrane Collaboration; 2011. http://www.cochrane-handbook.org/.
19. Jadad AR, Moore RA, Carroll D, et al. Assessing the quality of reports of randomized clinical trials: is blinding necessary? Control Clin Trials. 1996;17 (1):1-12. (Pubitemid 26120810)
20. Higgins JPT, Green S. Cochrane Handbook for Systematic Reviews of Interventions, version 5.1.0, updated March 2011. Chichester, England: John Wiley & Sons, Ltd; 2011.
21. DerSimonian R, Laird N. Meta-analysis in clinical trials. Control Clin Trials. 1986;7(3):177-188. (Pubitemid 17189972)
22. Galbraith RF. A note on graphical presentation of estimated odds ratios from several clinical trials. Stat Med. 1988;7(8):889-894.
23. Higgins JP, Thompson SG, Deeks JJ, Altman DG. Measuring inconsistency in meta-analyses. BMJ. 2003; 327(7414):557-560. (Pubitemid 37088507)
24. Kazis LE, Anderson JJ, Meenan RF. Effect sizes for interpreting changes in health status. Med Care. 1989; 27(3)(suppl):S178-S189.
25. Riley RD, Higgins JP, Deeks JJ. Interpretation of random effects meta-analyses. BMJ. 2011;342: d549.
26. Higgins JP, Thompson SG, Spiegelhalter DJ. A re-evaluation of random-effects meta-analysis. J R Stat Soc Ser A Stat Soc. 2009;172(1):137-159.
27. Peters JL, Sutton AJ, Jones DR, Abrams KR, Rushton L. Comparison of two methods to detect publication bias in meta-analysis. JAMA. 2006;295(6):676- 680.
28. Egger M, Davey Smith G, Schneider M, Minder C. Bias in meta-analysis detected by a simple, graphical test. BMJ. 1997;315(7109):629-634. (Pubitemid 27387172)
29. Sharp S. Meta-analysis regression. Stata Tech Bull. 1998;42:16-22.
30. Anand KS, Prasad A, Singh MM, Sharma S, Bala K. Botulinum toxin type A in prophylactic treatment of migraine. Am J Ther. 2006;13(3):183-187. (Pubitemid 44026183)
31. Aurora SK, Gawel M, Brandes JL, Pokta S, Vandenburgh AM; BOTOX North American Episodic Migraine Study Group. Botulinum toxin type a prophylactic treatment of episodic migraine: a randomized, double-blind, placebo-controlled exploratory study. Headache. 2007;47(4):486-499. (Pubitemid 46625251)
32. Cady R, Schreiber C. Botulinum toxin type A as migraine preventive treatment in patients previously failing oral prophylactic treatment due to compliance issues. Headache. 2008;48(6):900-913. (Pubitemid 351795552)
33. Chankrachang S, Arayawichanont A, Poungvarin N, et al. Prophylactic botulinum type A toxin complex (Dysport) for migraine without aura. Headache. 2011;51(1):52-63.
34. Elkind AH, O'Carroll P, Blumenfeld A, DeGryse R, Dimitrova R; BoNTA-024-026-036 Study Group. A series of three sequential, randomized, controlled studies of repeated treatments with botulinum toxin type A for migraine prophylaxis. J Pain. 2006;7 (10):688-696. (Pubitemid 44466688)
35. Evers S, Vollmer-Haase J, Schwaag S, Rahmann A, Husstedt IW, Frese A. Botulinum toxin A in the prophylactic treatment of migraine: a randomized, doubleblind, placebo-controlled study. Cephalalgia. 2004; 24(10):838-843. (Pubitemid 39319180)
36. Freitag FG, Diamond S, Diamond M, Urban G. Botulinum toxin type A in the treatment of chronic migraine without medication overuse. Headache. 2008; 48(2):201-209. (Pubitemid 351192876)
37. Hamdy SM, Samir H, El-Sayed M, Adel N, Hasan R. Botulinum toxin: could it be an effective treatment for chronic tension-type headache? J Headache Pain. 2009;10(1):27-34.
38. Harden RN, Cottrill J, Gagnon CM, et al. Botulinum toxin A in the treatment of chronic tension-type headache with cervicalmyofascial trigger points: a randomized, double-blind, placebo-controlled pilot study. Headache. 2009;49(5):732-743.
39. Mathew NT, Frishberg BM, Gawel M, Dimitrova R, Gibson J, Turkel C; BOTOX CDH Study Group. Botulinum toxin type A (BOTOX) for the prophylactic treatment of chronic daily headache: a randomized, doubleblind, placebo-controlled trial. Headache. 2005; 45(4):293-307. (Pubitemid 40530193)
40. Ondo WG, Vuong KD, Derman HS. Botulinum toxin A for chronic daily headache: a randomized, placebo-controlled, parallel design study. Cephalalgia. 2004;24(1):60-65. (Pubitemid 38085196)
41. Padberg M, de Bruijn SF, de Haan RJ, Tavy DL. Treatment of chronic tension-type headachewith botulinum toxin: a double-blind, placebo-controlled clinical trial. Cephalalgia. 2004;24(8):675-680. (Pubitemid 39061258)
42. Petri S, Tölle T, Straube A, Pfaffenrath V, Stefenelli U, Ceballos-Baumann A; Dysport Migraine Study Group. Botulinum toxin as preventive treatment for migraine: a randomized double-blind study. Eur Neurol. 2009;62(4):204-211.
43. Relja M, Poole AC, Schoenen J, Pascual J, Lei X, Thompson C; European BoNTA Headache Study Group. A multicentre, double-blind, randomized, placebo-controlled, parallel group study of multiple treatments of botulinum toxin type A (BoNTA) for the prophylaxis of episodic migraine headaches. Cephalalgia. 2007;27(6):492-503. (Pubitemid 46848913)
44. Rollnik JD, Tanneberger O, Schubert M, Schneider U, Dengler R. Treatment of tension-type headache with botulinum toxin type A: a double-blind, placebocontrolled study. Headache. 2000;40(4):300-305. (Pubitemid 30220572)
45. Rollnik JD, Karst M, Fink M, Dengler R. Botulinum toxin type A and EMG: a key to the understanding of chronic tension-type headaches? Headache. 2001;41(10):985-989. (Pubitemid 34008135)
46. Sandrini G, Perrotta A, Tassorelli C, et al. 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. 2011;12(4): 427-433.
47. Saper JR, Mathew NT, Loder EW, DeGryse R, VanDenburgh AM; BoNTA-009 Study Group. 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):478-485. (Pubitemid 47316329)
48. Schmitt WJ, Slowey E, Fravi N, Weber S, Burgunder JM. Effect of botulinum toxin A injections in the treatment of chronic tension-type headache: a doubleblind, placebo-controlled trial. Headache. 2001; 41(7):658-664. (Pubitemid 32777748)
49. Schulte-Mattler WJ, Krack P; BoNTTH Study Group. Treatment of chronic tension-type headache with botulinum toxin A: a randomized, double-blind, placebo-controlled multicenter study. Pain. 2004; 109(1-2):110-114. (Pubitemid 38479776)
50. Silberstein S, Mathew N, Saper J, Jenkins S; For the BOTOX Migraine Clinical Research Group. Botulinum toxin type A as amigraine preventive treatment. Headache. 2000;40(6):445-450. (Pubitemid 30421875)
51. Silberstein SD, Stark SR, Lucas SM, Christie SN, Degryse RE, Turkel CC; BoNTA-039 StudyGroup. Botulinum toxin type A for the prophylactic treatment of chronic daily headache: a randomized, double-blind, placebo-controlled trial. Mayo Clin Proc. 2005; 80(9):1126-1137. (Pubitemid 41233350)
52. Silberstein SD, Göbel H, Jensen R, et al. Botulinum toxin type A in the prophylactic treatment of chronic tension-type headache: a multicentre, double-blind, randomized, placebo-controlled, parallel-group study. Cephalalgia. 2006;26(7): 790-800. (Pubitemid 43882987)
53. Straube A, Empl M, Ceballos-Baumann A, Tölle T, Stefenelli U, Pfaffenrath V; Dysport Tension-Type Headache Study Group. Pericranial injection of botulinum toxin type A (Dysport) for tension-type headache: a multicentre, double-blind, randomized, placebo-controlled study. Eur J Neurol. 2008;15 (3):205-213. (Pubitemid 351257926)
54. Vo AH, Satori R, Jabbari B, et al. Botulinum toxin type-A in the prevention of migraine: a double-blind controlled trial. Aviat Space Environ Med. 2007; 78(5)(suppl):B113-B118. (Pubitemid 46717215)
55. Magalhães E, Menezes C, Cardeal M, Melo A. Botulinum toxin type A versus amitriptyline for the treatment of chronic daily migraine. Clin Neurol Neurosurg. 2010;112(6):463-466.
56. Porta M. A comparative trial of botulinum toxin type A and methylprednisolone for the treatment of tension-type headache. Curr Rev Pain. 2000;4 (1):31-35.
57. Cady RK, Schreiber CP, Porter JA, Blumenfeld AM, Farmer KU. A multi-center double-blind pilot comparison of onabotulinumtoxinA and topiramate for the prophylactic treatment of chronic migraine. Headache. 2011;51(1):21-32.
58. Blumenfeld AM, Schim JD, Chippendale TJ. Botulinum toxin type A and divalproex sodium for prophylactic treatment of episodic or chronic migraine. Headache. 2008;48(2):210-220. (Pubitemid 351178286)
59. Mathew NT, Kailasam J, Meadors L. Predictors of response to botulinum toxin type A (BoNTA) in chronic daily headache. Headache. 2008;48(2): 194-200. (Pubitemid 351178284)
60. Behmand RA, Tucker T, Guyuron B. Single-site botulinum toxin type A injection for elimination of migraine trigger points. Headache. 2003;43(10):1085- 1089.
61. Binder WJ, Brin MF, Blitzer A, Pogoda JM. Botulinum toxin type A (BOTOX) for treatment of migraine. Dis Mon. 2002;48(5):323-335. (Pubitemid 35007058)
62. Blumenfeld A. Botulinum toxin type A as an effective prophylactic treatment in primary headache disorders. Headache. 2003;43(8):853-860. (Pubitemid 37108342)
63. Burstein R, Dodick D, Silberstein S. Migraine prophylaxis with botulinum toxin A is associated with perception of headache. Toxicon. 2009;54(5):624- 627.
64. Calandre EP, Hidalgo J, García-Leiva JM, Rico-Villademoros F. Trigger point evaluation in migraine patients: an indication of peripheral sensitization linked to migraine predisposition? Eur J Neurol. 2006;13(3):244-249.
65. Chan VW, McCabe EJ, MacGregor DL. Botox treatment for migraine and chronic daily headache in adolescents. J Neurosci Nurs. 2009;41(5):235- 243.
66. Christie SN, Giammarco R, Gawel M, Mackie G, Gladstone J, Becker WJ. Botulinum toxin type A and acute drug costs in migraine with triptan overuse. Can J Neurol Sci. 2010;37(5):588-594.
67. Dowson AJ, Kilminster SG, Salt R. Clinical profileof botulinum toxin A in patients with chronic headaches and cervical dystonia: a prospective, open-label, longitudinal study conducted in a naturalistic clinical practice setting. Drugs R D. 2008;9(3):147- 158.
68. Erdemoglu AK, Varlibas A. The long-term efficacy and safety of botulinum toxin in refractory chronic tension-type headache. J Headache Pain. 2007; 8(5):294-300. (Pubitemid 350214728)
69. Eross EJ, Gladstone JP, Lewis S, Rogers R, Dodick DW. Duration of migraine is a predictor for response to botulinum toxin type A. Headache. 2005;45 (4):308-314. (Pubitemid 40530194)
70. Harrison AR, Erickson JP, Anderson JS, Lee MS. Pain relief in patients receiving periocular botulinum toxin A. Ophthal Plast Reconstr Surg. 2008;24 (2):113-116. (Pubitemid 351450706)
71. Kapural L, Stillman M, Kapural M, McIntyre P, Guirgius M, Mekhail N. Botulinum toxin occipital nerve block for the treatment of severe occipital neuralgia: a case series. Pain Pract. 2007;7(4):337-340. (Pubitemid 350142303)
72. Liu YC, Fuh JL, Chen RC, Lin KP, Wang SJ. Botulinum toxin type A in the prophylactic treatment of transformed migraine in Taiwanese patients: a review of 30 consecutive cases. J Chin Med Assoc. 2007; 70(12):535-540.
73. Menezes C, Rodrigues B, Magalhães E, Melo A. Botulinum toxin type A in refractory chronic migraine: an open-label trial. Arq Neuropsiquiatr. 2007; 65(3A):596-598. (Pubitemid 47451081)
74. Smuts JA, Schultz D, Barnard A. Mechanism of action of botulinum toxin type A in migraine prevention: a pilot study. Headache. 2004;44(8):801-805. (Pubitemid 39310965)
75. Sostak P, Krause P, Förderreuther S, Reinisch V, Straube A. Botulinum toxin type-A therapy in cluster headache: an open study. J Headache Pain. 2007; 8(4):236-241. (Pubitemid 350020777)
76. Suzuki K, Iizuka T, Sakai F. Botulinum toxin type A for migraine prophylaxis in the Japanese population: an open-label prospective trial. Intern Med. 2007; 46(13):959-963. (Pubitemid 47261638)
77. Taylor M, Silva S, Cottrell C. Botulinum toxin type-A (BOTOX) in the treatment of occipital neuralgia: a pilot study. Headache. 2008;48(10):1476- 1481.
78. Tepper SJ, Bigal ME, Sheftell FD, Rapoport AM. Botulinum neurotoxin type A in the preventive treatment of refractory headache: a review of 100 consecutive cases. Headache. 2004;44(8): 794-800. (Pubitemid 39310964)
79. Türk U, Ilhan S, Alp R, Sur H. Botulinum toxin and intractable trigeminal neuralgia. Clin Neuropharmacol. 2005;28(4):161-162. (Pubitemid 41134241)
80. Solomon S. Botulinum toxin for the treatment of chronic migraine: the placebo effect. Headache. 2011; 51(6):980-984.
81. Lu CL, Chang FY. Placebo effect in patients with irritable bowel syndrome. J Gastroenterol Hepatol. 2011;26(suppl 3):116-118.
82. Mangera A, Chapple CR, Kopp ZS, Plested M. The placebo effect in overactive bladder syndrome. Nat Rev Urol. 2011;8(9):495-503.
83. Puhl AA, Reinhart CJ, Rok ER, Injeyan HS. An examination of the observed placebo effect associated with the treatment of low back pain: a systematic review. Pain Res Manag. 2011;16(1):45-52.
84. Gallahan WC, Case D, Bloomfeld RS. An analysis of the placebo effect in Crohn's disease over time. Aliment Pharmacol Ther. 2010;31(1):102-107.
85. Jackson JL, Shimeall W, Sessums L, et al. Tricyclic antidepressants and headaches: systematic review and meta-analysis. BMJ. 2010;341:c5222.