Botulinum toxin treatment of adult spasticity: A benefit-risk assessment

Drug Safety

Volumn 29, Issue 1, 2006, Pages 31-48

  Sheean, Geoffrey ^a  

^a UNIVERSITY OF CALIFORNIA   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

BACLOFEN; BOTULINUM TOXIN A; BOTULINUM TOXIN B; DANTROLENE; DIAZEPAM; PHENOL; TIZANIDINE;

ARM MUSCLE; AUTONOMIC DYSFUNCTION; BLEEDING; BOTULISM; BRACHIAL PLEXUS NEUROPATHY; BRAIN HYPOXIA; CLINICAL TRIAL; DISEASE EXACERBATION; DORSAL RHIZOTOMY; DRUG CONTRAINDICATION; DRUG ERUPTION; DRUG FEVER; DRUG SAFETY; DRY EYE; DYSTONIA; FATIGUE; FLU LIKE SYNDROME; GAIT; HEART MUSCLE CONDUCTION DISTURBANCE; HEART RATE VARIABILITY; HUMAN; IMMUNOGENICITY; INFECTION; INJECTION SITE PAIN; LACRIMATION DISORDER; LEG MUSCLE; META ANALYSIS; MOTOR NEURON DISEASE; MULTIPLE SCLEROSIS; MUSCLE CONTRACTURE; MUSCLE HYPERTONIA; MUSCLE TONE; MUSCLE WEAKNESS; NEUROLOGIC DISEASE; PASSIVE MOVEMENT; PRIORITY JOURNAL; RANGE OF MOTION; REFLEX DISORDER; REVIEW; SENSORY DYSFUNCTION; SIDE EFFECT; SKIN BRUISING; SOMNOLENCE; SPASTIC PARAPLEGIA; SPASTICITY; STROKE; SYSTEMATIC REVIEW; TRAUMATIC BRAIN INJURY; TREATMENT OUTCOME; UNITED STATES; XEROSTOMIA;

ADULT; BOTULINUM TOXIN TYPE A; BOTULINUM TOXINS; HUMANS; MOTOR NEURON DISEASE; MUSCLE SPASTICITY; NEUROMUSCULAR AGENTS; RANDOMIZED CONTROLLED TRIALS; RISK ASSESSMENT;

EID: 32244432601     PISSN: 01145916     EISSN: None     Source Type: Journal    
DOI: 10.2165/00002018-200629010-00003     Document Type: Review

References (108)

1. Naumann M, Toyka KV, Moore P. History and current applications of botulinum toxin: from poison to remedy. In: Naumann P, Moore P, editors. Handbook of botulinum toxin treatment. 2nd ed. Cambridge (MA), Blackwell Science, 2003: 3-8
2. Brin MF, Aoki KR. Botulinum toxin type A: pharmacology. In: Mayer NH, Simpson DM, editors. Spasticity: etiology, evaluation, management and the role of botulinum toxin. New York (NY): WeMove Organization, 2002: 110-24
3. Aoki KR. Evidence for antinociceptive activity of botulinum toxin type A in pain management. Headache 2003 Jul-Aug; 43 Suppl 1: S9-15
4. Berweck S, Heinen F. Use of botulinum toxin in pediatric spasticity (cerebral palsy). Mov Disord 2004 Mar; 19 Suppl. 8: S162-7
5. Wong V. Evidence-based approach of the use of Botulinum toxin type A (BTX) in cerebral palsy. Pediatr Rehabil 2003 Apr-Jun; 6 (2): 85-96
6. Sheean G. Use of botulinum toxin for spasticity. Expert Rev Neurother 2003; 3 (6): 773-85
7. Sheean G. The treatment of musculoskeletal pain and spasm with botulinum toxin. Curr Pain Headache Rep 2002; 6: 460-9
8. Sheean G. Neurophysiology of Spasticity. In Barnes MP, Johnson G, editors. Clinical management of spasticity and the upper motor neurone syndrome. Cambridge: Cambridge University Press, 2001: 12-78
9. Lance JW. Symposium synopsis. In: Feldman RG, Young RR, Koella WP, editors. Spasticity: disordered motor control. Chicago: Year Book Medical Publishers, 1980: 485-94
10. Mayer NH, Simpson DM. Preface. In: Mayer NH, Simpson DM, editors. Spasticity: etiology, evaluation, management and the role of botulinum toxin. New York (NY): We Move Organization, 2002
11. Bhakta BB, Cozens JA, Chamberlain MA, et al. Impact of botulinum toxin type A on disability and carer burden due to arm spasticity after stroke: a randomised double blind placebo controlled trial. J Neurol Neurosurg Psychiatry 2000; 69: 217-21
12. Landau WM. Spasticity: the fable of a neurological demon and the emperor's new therapy. Arch Neurol 1974; 31: 217-9
13. Landau WM. Tizanidine and spasticity: neuromythology XIV. Neurology 1995; 45: 2295-6
14. Landau WM. Botulinum toxin for spasticity after stroke. N Engl J Med 2003 Jan 16; 348 (3): 258-9
15. Dietz V. Spastic movement disorder: what is the impact of research on clinical practice? J Neurol Neurosurg Psychiatry 2003 Jun; 74 (6): 820-1
16. Snow BJ, Tsui JK, Bhatt MH, et al. Treatment of spasticity with botulinum toxin: a double-blind study. Ann Neurol 1990; 28: 512-5
17. Simpson DM, Alexander DN, O'Brien CF, et al. Botulinum toxin type A in the treatment of upper extremity spasticity: a randomized, double-blind, placebo-controlled trial. Neurology 1996; 46: 1306-10
18. Burbaud P, Wiart L, Dubos JL, et al. A randomised, double blind, placebo controlled trial of botulinum toxin in the treatment of spastic foot in hemiparetic patients. J Neurol Neurosurg Psychiatry 1996; 61: 265-9
19. Bakheit AM, Thilmann AF, Ward AB, et al. A randomized, double-blind, placebo-controlled, dose-ranging study to compare the efficacy and safety of three doses of botulinum toxin type A (Dysport) with placebo in upper limb spasticity after stroke. Stroke 2000; 31: 2402-6
20. Richardson D, Sheean G, Werring D, et al. Evaluating the role of botulinum toxin in the management of focal hypertonia in adults. J Neurol Neurosurg Psychiatry 2000; 69: 499-506
21. Hyman N, Barnes M, Bhakta B, et al. Botulinum toxin (Dysport) treatment of hip adductor spasticity in multiple sclerosis: a prospective, randomised, double blind, placebo controlled, dose ranging study. J Neurol Neurosurg Psychiatry 2000; 8: 707-12
22. Smith SJ, Ellis E, White S, et al. A double-blind placebo-controlled study of botulinum toxin in upper limb spasticity after stroke or head injury. Clin Rehabil 2000; 14: 5-13
23. Bakheit AM, Pittock S, Moore AP, et al. A randomized, double-blind, placebo-controlled study of the efficacy and safety of botulinum toxin type A in upper limb spasticity in patients with stroke. Eur J Neurol 2001; 8 (6): 559-65
24. Brashear A, Gordon MF, Elovic E, et al. Intramuscular injection of botulinum toxin for the treatment of wrist and finger spasticity after a stroke. N Engl J Med 2002, 400
25. Pittock SJ, Moore AP, Hardiman O, et al. A double-blind randomised placebo-controlled evaluation of three doses of plabotulinum toxin type A (Dysport®) in the treatment of spastic equinovarus deformity after stroke. Cerebrovasc Dis 2003; 15 (4): 289-300
26. Brashear A, McAfee AL, Kuhn ER, et al. Botulinum toxin type B in upper-limb poststroke spasticity: a double-blind, placebo-controlled trial. Arch Phys Med Rehabil 2004 May; 85 (5): 705-9
27. Ashworth B. Preliminary trial of carisoprodol in multiple sclerosis. Practitioner 1964 Apr; 192: 540-2
28. Bohannon RW, Smith MB. Interrater reliability of a modified Ashworth scale of muscle spasticity. Phys Ther 1987 Feb; 67 (2): 206-7
29. Sheean GL. Botulinum treatment of spasticity: why is it so difficult to show a functional benefit? Curr Opin Neurol 2001 Dec; 14 (6): 771-6
30. Bakheit AM. Optimising the methods of evaluation of the effectiveness of botulinum toxin treatment of post-stroke muscle spasticity. J Neurol Neurosurg Psychiatry 2004 May; 75 (5): 665-6
31. Satila H, Iisalo T, Pietikainen T, et al. Botulinum toxin treatment of spastic equinus in cerebral palsy: a randomized trial comparing two injection sites. Am J Phys Med Rehabil 2005; 84: 355-65
32. Steenbeek D, Meester-Delver A, Becher JG, et al. The effect of botulinum toxin type A treatment of the lower extremity on the level of functional abilities in children with cerebral palsy: evaluation with goal attainment scaling. Clin Rehabil 2005; 19: 274-82
33. Fehlings D, Rang M, Glazier J, et al. An evaluation of botulinum-A toxin injections to improve upper extremity function in children with hemiplegic cerebral palsy. J Pediatr 2000; 137: 331-7
34. Koman LA, Mooney III JF, Smith BP, et al. Botulinum toxin type A neuromuscular blockade in the treatment of lower extremity spasticity in cerebral palsy: a randomized, double-blind, placebo-controlled trial. BOTOX Study Group. J Pediatr Orthop 2000; 20: 108-15
35. Brashear A, McAfee AL, Kuhn ER, et al. Treatment with botulinum toxin type B for upper-limb spasticity. Arch Phys Med Rehabil 2003 Jan; 84 (1): 103-7
36. Francis HP, Wade DT, Turner-Stokes L, et al. Does reducing spasticity translate into functional benefit? An exploratory meta-analysis. J Neurol Neurosurg Psychiatry 2004 Nov; 75 (11): 1547-51
37. Bhakta BB, Cozens JA, Bamford JM, et al. Use of botulinum toxin in stroke patients with severe upper limb spasticity. J Neurol Neurosurg Psychiatry 1996 Jul; 61 (1): 30-5
38. Dengler R, Neyer U, Wohlfarth K, et al. Local botulinum toxin in the treatment of spastic drop foot. J Neurol 1992 Aug; 239 (7): 375-8
39. Dunne JW, Heye N, Dunne SL. Treatment of chronic limb spasticity with botulinum toxin A. J Neurol Neurosurg Psychiatry 1995 Feb; 58 (2): 232-5
40. Fock J, Galea MP, Stillman BC, et al. Functional outcome following Botulinum toxin A injection to reduce spastic equinus in adults with traumatic brain injury. Brain Inj 2004 Jan; 18 (1): 57-63
41. Hesse S, Lucke D, Malezic M, et al. Botulinum toxin treatment for lower limb extensor spasticity in chronic hemiparetic patients. J Neurol Neurosurg Psychiatry 1994 Nov; 57 (11): 1321-4
42. Hesse S, Krajnik J, Luecke D, et al. Ankle muscle activity before and after botulinum toxin therapy for lower limb extensor spasticity in chronic hemiparetic patients. Stroke 1996; 27: 455-60
43. Hesse S, Reiter F, Konrad M, et al. Botulinum toxin type A and short-term electrical stimulation in the treatment of upper limb flexor spasticity after stroke: a randomized, double-blind, placebo-controlled trial. Clin Rehabil 1998 Oct; 12 (5): 381-8
44. Konstanzer A, Ceballos-Baumann AO, Dressnandt J, et al. Local injection treatment with botulinum toxin A in severe arm and leg spasticity. Nervenarzt 1993 Aug; 64 (8): 517-23
45. Lagalla G, Danni M, Reiter F, et al. Post-stroke spasticity management with repeated botulinum toxin injections in the upper limb. Am J Phys Med Rehabil 2000 Jul-Aug; 79 (4): 377-84
46. Memin B, Pollak P, Hommel M, et al. Treatment of spasticity with botulinum toxin. Rev Neurol (Paris) 1992; 148 (3): 212-4
47. Panizza M, Castagna M, di Summa A, et al. Functional and clinical changes in upper limb spastic patients treated with botulinum toxin (BTX). Funct Neurol 2000 Jul-Sep; 15 (3): 147-55
48. Pierson SH, Katz DI, Tarsy D. Botulinum toxin A in the treatment of spasticity: functional implications and patient selection Arch Phys Med Rehabil 1996 Jul; 77 (7): 717-21
49. Reiter F, Danni M, Lagalla G, et al. Low-dose botulinum toxin with ankle taping for the treatment of spastic equinovarus foot after stroke. Arch Phys Med Rehabil 1998 May; 79 (5): 532-5
50. Rodriquez AA, McGinn M, Chappell R. Botulinum toxin injection of spastic finger flexors in hemiplegic patients. Am J Phys Med Rehabil 2000 Jan-Feb; 79 (1): 44-7
51. Rousseaux M, Kozlowski O, Froger J. Efficacy of botulinum toxin A in upper limb function of hemiplegic patients. J Neurol 2002 Jan; 249 (1): 76-84
52. Sampaio C, Ferreira JJ, Pinto AA, et al. Botulinum toxin type A for the treatment of arm and hand spasticity in stroke patients. Clin Rehabil 1997 Feb; 11 (1): 3-7
53. Viriyavejakul A, Vachalathiti R, Poungvarin N. Botulinum treatment for post-stroke spasticity: low dose regime. J Med Assoc Thai 1998 Jun; 81 (6): 413-22
54. Wang HC, Hsieh LF, Chi WC, et al. Effect of intramuscular botulinum toxin injection on upper limb spasticity in stroke patients. Am J Phys Med Rehabil 2002 Apr; 81 (4): 272-8
55. Woldag H, Hummelsheim H. Is the reduction of spasticity by botulinum toxin a beneficial for the recovery of motor function of arm and hand in stroke patients? Eur Neurol 2003; 50 (3): 165-71
56. Slawek J, Bogucki A, Reclawowicz D. Botulinum toxin type A for upper limb spasticity following stroke: an open-label study with individualised, flexible injection regimens. Neurol Sci 2005; 26: 32-9
57. Suputtitada A. Local botulinum toxin type A injections in the treatment of spastic toes. Am J Phys Med Rehabil 2002; 81: 770-5
58. Miscio G, Del Conte C, Pianca D, et al. Botulinum toxin in post-stroke patients: stiffness modifications and clinical implications. J Neurol 2004; 251: 189-96
59. Finsterer J, Fuchs I, Mamoli B. Automatic EMG-guided botulinum toxin treatment of spasticity. Clin Neuropharmacol 1997 Jun; 20 (3): 195-203
60. Oechsner M. Treatment of hip adductor spasticity with botulinum toxin type B. Nervenarzt 2002; 73: 1179-82
61. Sheean G. Neurophysiology of spasticity. In: Barnes MP, Johnson G, editors. Clinical management of spasticity and the upper motor neurone syndrome. Cambridge: Cambridge University Press, 2001: 12-78
62. Graven-Nielsen T, Mense S. The peripheral apparatus of muscle pain: evidence from animal and human studies. Clin J Pain 2001; 17: 2-10
63. Francis J, You S, Satorius A, et al. Analgesic properties and mechanism of action of botulinum toxin type A (Botox) [abstract]. 5th International Conference on Basic and Therapeutic Aspects of Botulinum and Tetanus Toxins; Denver (CO); 2005 Jun
64. Verplancke D, Snape S, Salisbury CF, et al. A randomized controlled trial of botulinum toxin on lower limb spasticity following acute acquired severe brain injury. Clin Rehabil 2005; 19: 117-25
65. Reiter F, Danni M, Lagalla G, et al. Low-dose botulinum toxin with ankle taping for the treatment of spastic equinovarus foot after stroke. Arch Phys Med Rehabil 1998; 79: 532-5
66. Hesse S, Jahnke MT, Luecke D, et al. Short-term electrical stimulation enhances the effectiveness of Botulinum toxin in the treatment of lower limb spasticity in hemiparetic patients. Neurosci Lett 1995; 201: 37-40
67. Page SJ, Elovic E, Levine P, et al. Modified constraint-induced therapy and botulinum toxin A: a promising combination. Am J Phys Med Rehabil 2003; 82: 76-80
68. Johnson CA, Wood DE, Swain ID, et al. A pilot study to investigate the combined use of botulinum neurotoxin type a and functional electrical stimulation, with physiotherapy, in the treatment of spastic dropped foot in subacute stroke. Artif Organs 2002; 26: 263-6
69. Shaari CM, George E, Wu BL, et al. Quantifying the spread of botulinum toxin through muscle fascia. Laryngoscope 1991; 101 (9): 960-4
70. Cote TR, Mohan AK, Polder JA, et al. Botulinum toxin type A injections: adverse events reported to the US Food and Drug Administration in therapeutic and cosmetic cases. J Am Acad Dermatol 2005; 53 (3): 407-15
71. Bhatia KP, Munchau A, Thompson PD, et al. Generalised muscular weakness after botulinum toxin injections for dystonia: a report of three cases. J Neurol Neurosurg Psychiatry 1999; 67 (1): 90-3
72. Sheean GL, Murray NM, Marsden CD. Pain and remote weakness in limbs injected with botulinum toxin A for writer's cramp. Lancet 1995; 346 (8968): 154-6
73. Andrade LA, Borges V, Ferraz HB, et al. Botulinum toxin A: experience in the treatment of 115 patients. Arq Neuropsiquiatr 1997; 55: 553-7
74. Holzer SE, Ludlow CL The swallowing side effects of botulinum toxin type A injection in spasmodic dysphonia. Laryngoscope 1996; 106: 86-92
75. Tuite PJ, Lang AE. Severe and prolonged dysphagia complicating botulinum toxin A injections for dystonia in Machado-Joseph disease. Neurology 1996; 46: 846
76. Comella CL, Tanner CM, DeFoor-Hill L, et al. Dysphagia after botulinum toxin injections for spasmodic torticollis: clinical and radiological findings. Neurology 1992; 42: 1307-10
77. Mezaki T, Kaji R, Kohara N, et al. Development of general weakness in a patient with amyotrophic lateral sclerosis after focal botulinum toxin injection. Neurology 1996; 46: 845-6
78. Brashear A, Lew MF, Dykstra DD, et al. Safety and efficacy of NeuroBloc (botulinum toxin type B) in type A-responsive cervical dystonia. Neurology 1999 Oct 22; 53 (7): 1439-46
79. Bakheit AM, Ward CD, McLellan DL. Generalised botulism-like syndrome after intramuscular injections of botulinum toxin type A: a report of two cases [letter]. J Neurol Neurosurg Psychiatry 1997 Feb; 62 (2): 198
80. Bakheit AM. Botulinum toxin in the management of childhood muscle spasticity: comparison of clinical practice of 17 treatment centres. Eur J Neurol 2003; 10: 415-9
81. Borodic G. Myasthenic crisis after botulinum toxin [letter]. Lancet 1998; 352: 1832
82. Tarsy D, Bhattacharyya N, Borodic G. Myasthenia gravis after botulinum toxin A for Meige syndrome. Mov Disord 2000; 15: 736-8
83. Erbguth F, Claus D, Engelhardt A, et al. Systemic effect of local botulinum toxin injections unmasks subclinical Lambert-Eaton myasthenic syndrome. J Neurol Neurosurg Psychiatry 1993; 56: 1235-6
84. Fasano A, Bentivoglio AR, Ialongo T, et al. Treatment with botulinum toxin in a patient with myasthenia gravis and cervical dystonia. Neurology 2005; 64: 2155-6
85. Lange DJ, Rubin M, Greene PE, et al. Distant effects of locally injected botulinum toxin: a double-blind study of single fiber EMG changes. Muscle Nerve 1991; 14: 672-5
86. Costa J, Espirito-Santo C, Borges A. Botulinum toxin type A therapy for cervical dystonia. Cochrane Database Syst Rev 2005; Jan 25 (1): CD003633
87. Costa J, Espirito-Santo C, Borges A. Botulinum toxin type B for cervical dystonia. Cochrane Database Syst Rev 2005; Jan 25 (1): CD004315
88. Nebe A, Schelosky L, Wissel J, et al. No effects on heart-rate variability and cardiovascular reflex tests after botulinum toxin treatment of cervical dystonia. Mov Disord 1996; 11: 337-9
89. Claus D, Druschky A, Erbguth F. Botulinum toxin: influence on respiratory heart rate variation. Mov Disord 1995; 10: 574-9
90. Girlanda P, Vita G, Nicolosi C, et al. Botulinum toxin therapy: distant effects on neuromuscular transmission and autonomic nervous system. J Neurol Neurosurg Psychiatry 1992; 55: 844-5
91. Dressler D, Benecke R. Autonomic side effects of botulinum toxin type B treatment of cervical dystonia and hyperhidrosis. Eur Neurol 2003; 49: 34-8
92. Molgo J, Lemeignan M, Thesleff S. Aminoglycosides and 3,4-diaminopyridine on neuromuscular block caused by botulinum type A toxin. Muscle Nerve 1987; 10: 464-70
93. Santos JI, Swensen P, Glasgow LA. Potentiation of Clostridium botulinum toxin aminoglycoside antibiotics: clinical and laboratory observations. Pediatrics 1981; 68: 50-4
94. Newman WJ, Davis TL, Padaliya BB, et al. Botulinum toxin type A therapy during pregnancy. Mov Disord 2004; 19: 1384-5
95. Jankovic J, Schwartz K. Response and immunoresistance to botulinum toxin injections. Neurology 1995 Sep; 45 (9): 1743-6
96. Kessler KR, Skutta M, Benecke R, et al. Long-term treatment of cervical dystonia with botulinum toxin A: efficacy, safety, and antibody frequency. J Neurol 1999; 246: 265-74.
97. Jankovic J, Vuong KD, Ahsan J. Comparison of efficacy and immunogenicity of original versus current botulinum toxin in cervical dystonia. Neurology 2003; 60: 1186-8
98. Comella CL, Jankovic J, Daggett S, et al. Interim results of an observational study of neutralizing antibody formation with the current preparation of botulinum toxin type a treatment for cervical dystonia [abstract]. Presented at the 56 Annual Meeting of the AAN, San Francisco (CA), 2004. Neurology 2004; 62 Suppl. 5: A511
99. Pistolesi D, Selli C, Rossi B, et al. Botulinum toxin type B for type A resistant bladder spasticity. J Urol 2004; 171: 802-3
100. Khalili AA, Harmel MH, Forster S, et al. Management of spasticity by selective peripheral nerve block with dilute phenol solutions in clinical rehabilitation. Arch Phys Med Rehabil 1964; 45: 513-9
101. Halpern D, Meelhuysen FE. Phenol motor point block in the management of muscular hypertonia. Arch Phys Med Rehabil 1966 Oct; 47 (10): 659-64
102. Garland DE, Lilling M, Keenan MA. Percutaneous phenol blocks to motor points of spastic forearm muscles in head-injured adults. Arch Phys Med Rehabil 1984 May; 65 (5): 243-5
103. Nathan PW, Sears TA, Smith MC. Effects of phenol solutions on the nerve roots of the cat: an electrophysiological and histological study. J Neurol Sci 1965; 2 (1): 7-29
104. Gracies J-M, Elovic E, McGuire JR, et al. Traditional pharmacologic treatments for spasticity. Part 1: local treatments. In: Mayer NH, Simpson DM, editors. Spasticity: etiology, evaluation, management and the role of botulinum toxin. New York: We Move Organization, 2002: 44-65
105. Trigaux JP, Deceone B, Van Beers B. Focal necrosis of the ureter following CT-guided chemical sympathectomy. Cardiovasc Intervent Radiol 1992; 15 (3): 180-2
106. The Wemove Spasticity Study Group. Dosing, administration and a treatment algorithm for the use of botulinum toxin type A for adult-onset muscle overactivity in patients with an upper motorneuron lesion. In: Mayer NH, Simpson DM, editors. Spasticity: etiology, evaluation, management and the role of botulinum toxin. New York (NY): WeMove Organization, 2002: 154-65
107. Kirazli Y, On AY, Kismali B, et al. Comparison of phenol block and botulinus toxin type A in the treatment of spastic foot after stroke: a randomized, double-blind trial. Am J Phys Med Rehabil 1998 Nov-Dec; 77 (6): 510-15
108. Sheean G. Botulinum toxin treatment of spasticity: why is it so hard to show a functional benefit? Curr Opin Neurol 2002; 14: 771-6