Botulinum toxin type A therapy for cervical dystonia

Cochrane Database of Systematic Reviews

Volumn 2020, Issue 11, 2020, Pages

  Rodrigues, Filipe B ^a,b   Duarte, Gonçalo S ^a,b   Marques, Raquel E ^a,b   Castelão, Mafalda ^a,b   Ferreira, Joaquim ^a,b   Sampaio, Cristina ^c   Moore, Austen P ^d   Costa, João ^a,b  

^a UNIVERSITY OF LISBON   (Portugal)

^b INSTITUTO DE MEDICINA MOLECULAR JOÃO LOBO ANTUNES   (Portugal)

^c CHDI MANAGEMENT CHDI FOUNDATION   (United States)

^d THE WALTON CENTRE NHS FOUNDATION TRUST   (United Kingdom)

Author keywords

[No Author keywords available]

Indexed keywords

BOCOTURE; BOTULINUM TOXIN A; BOTULINUM TOXIN B; LANTOX; MYOBLOC; PLACEBO; MUSCLE RELAXANT AGENT;

AGE DISTRIBUTION; ANALGESIA; CERVICAL DYSTONIA; COMPARATIVE EFFECTIVENESS; DISEASE CLASSIFICATION; DISEASE SEVERITY ASSESSMENT; DOSE RESPONSE; DRUG SAFETY; DRUG TOLERABILITY; DYSPHAGIA; ELECTROMYOGRAPHY; EVIDENCE BASED MEDICINE; FATIGUE; HUMAN; META ANALYSIS; MUSCLE WEAKNESS; PAIN ASSESSMENT; QUALITY OF LIFE; REVIEW; RISK BENEFIT ANALYSIS; SYSTEMATIC REVIEW; TREATMENT OUTCOME; TREATMENT RESPONSE; VISUAL ANALOG SCALE; RANDOMIZED CONTROLLED TRIAL (TOPIC); STATISTICAL BIAS; TORTICOLLIS;

BIAS; BOTULINUM TOXINS, TYPE A; DEGLUTITION DISORDERS; HUMANS; MUSCLE WEAKNESS; NEUROMUSCULAR AGENTS; RANDOMIZED CONTROLLED TRIALS AS TOPIC; TORTICOLLIS;

EID: 85096082515     PISSN: 14651858     EISSN: None     Source Type: Journal    
DOI: 10.1002/14651858.CD003633.pub4     Document Type: Review

References (131)

1. Brashear A, Truong D, Charles D, Comella C, Hauser RA, Tsui J. A randomized double-blind, placebo-controlled study of intramuscular botox for the treatment of cervical dystonia (CD). Movement Disorders 1998;13(Suppl 2):276 (P4.243). x-wiley/crsRef/3291077
2. Charles D, Brashear A, Hauser RA, Li HI, Boo LM, Brin MF, CD 140 Study Group. Efficacy, tolerability, and immunogenicity of onabotulinumtoxinA in a randomized, double-blind, placebo-controlled trial for cervical dystonia. Clinical Neuropharmacology 2012;35(5):208-14. x-wiley/crsRef/3291078
3. Hauser RA, Comella C, Brashear A, Truong D, Charles PD, Tsui J. A randomized, multicenter, placebo-controlled study of original botox (botulinum toxin type A) purified neurotoxin complex for the treatment of cervical dystonia. Movement Disorders 2000;15(Suppl 2):30. x-wiley/crsRef/3291080
4. Comella CL, Jankovic J, Truong DD, Hanschmann A, Grafeon S, on behalf of the US Xeomin Cervical Dystonia Study Group. Efficacy and safety of incobotulinumtoxinA (NT 201, XEOMIN®, botulinumneurotoxin type A, without accessory proteins) in patients with cervical dystonia. Journal of the Neurological Sciences 2011;308(1-2):103-9. x-wiley/crsRef/3291082 [DOI: 10.1016/j.jns.2011.05.041.]
5. Coulonn J-M. Incobotulinumtoxin A (Xeomin) injected with flexible intervals is a well-tolerated long-term treatment of cervical dystonia. Annals of Physical and Rehabilitation Medicine 2013;56:e398. x-wiley/crsRef/3291083
6. Evidente VG, Brashear A, Comella CL, Fernandez H, Grafe S, LeDoux MS, et al. IncobotulinumtoxinA (Xeomin; botulinumneurotoxin type A, free from accessory proteins): flexibility of dosing and injection intervals in cervical dystonia. PM&R 2011;3(10S1):S215 (P131). x-wiley/crsRef/3291084
7. Evidente VG, Truong D, Jankovic J, Comella CL, Grafe S, Hanschmann A. IncobotulinumtoxinA (Xeomin®) injected for blepharospasm or cervical dystonia according to patient needs is well tolerated. Journal of the Neurological Sciences 2014;346(1-2):116-20. x-wiley/crsRef/3291085 [DOI: 10.1016/j.jns.2014.08.004] [MEDLINE: 25186131]
8. Fernandez H, Truong D, Asmus F, Hanschmann A, LeDoux M. IncobotulinumtoxinA (Xeomin®) remains well tolerated across flexible inter-injection intervals of 6-20 weeks in the treatment of cervical dystonia. Neurology 2012;78(Meeting Abstracts 1):P01.219. x-wiley/crsRef/3291086
9. Fernandez HH, Evidente VG, Truong D, Brodsky M, Hanschmann A, Comella CL, et al. Long-term treatment of blepharospasm and cervical dystonia: incobotulinum toxin A is well tolerated when injected at flexible intervals based on patient needs. Journal of the Neurological Sciences 2013;333:109-51 (P1070). x-wiley/crsRef/3291087
10. Fernandez HH, Pappert EJ, Comella CL, Evidente VG, Truong DD, Verma A, et al. Efficacy and safety of incobotulinumtoxinA in subjects previously treated with botulinum toxin versus toxin-naïve subjects with cervical dystonia. Tremor and Other Hyperkinetic Movements 2013;3:1-9. x-wiley/crsRef/3291088
11. Grafe S, Comella C, Hanschmann A, Jankovic J, Truong D. Efficacy and safety of NT 201 (botulinum neurotoxin free from complexing proteins) in cervical dystonia. PM&R 2010;2(9S):S29 (P49). x-wiley/crsRef/3291089
12. Singer C, Pappert E, Hanschmann A, Fernandez H. IncobotulinumtoxinA (NT 201, Xeomin) administered at flexible intervals of 6-20 weeks in subjects with cervical dystonia. Movement Disorders 2012;27(Suppl 1):S365 (P1105). x-wiley/crsRef/3291090
13. Truong D, Fernandez H, Grafe S. IncobotulinumtoxinA (NT-201) injections are safe and effective in adult subjects with cervical dystonia across dosing intervals in a repeated dose-study. Movement Disorders 2011;26(Suppl 2):S211 (P625). x-wiley/crsRef/3291091
14. Greene P, Kang U, Fahn S, Brin M, Moskowitz C, Flaster E. Double-blind, placebo-controlled study of botulinum toxin injection for torticollis. Neurology 1988;38(Suppl 1):244. x-wiley/crsRef/3291093
15. Greene P, Kang U, Fahn S, Brin M, Moskowitz C, Flaster E. Double-blind, placebo-controlled trial of botulinum toxin injections for the treatment of spasmodic torticollis. Neurology 1990;40(8):1213-8. x-wiley/crsRef/3291094
16. Lew MF, Brashear A, Dashtipour K, Isaacson S, Hauser RA, Maisonobe P, et al. A 500 U/2 mL dilution ofabobotulinumtoxinA vs. placebo: randomized study in cervical dystonia. International Journal of Neuroscience 2018;128(7):619-26. x-wiley/crsRef/14738941 [DOI: 10.1080/00207454.2017.1406935]
17. Poewe W, Brans J, Kessler K, Kanovsky P, Odergren T, Aramideh M, et al. Dysport for cervical dystonia. Movement Disorders 2000;15(Suppl 2):7. x-wiley/crsRef/7215410
18. Poewe W, Deuschl G, Nebe A, Feifel E, Wissel J, Benecke R, et al. What is the optimal dose of botulinum toxin A in the treatment of cervical dystonia? Results of a double blind, placebo controlled, dose ranging study using Dysport. German Dystonia Study Group. Journal of Neurology, Neurosurgery and Psychiatry 1998;64(1):13-7. x-wiley/crsRef/7215411
19. Poewe W, Burbaud P, Castelnovo G, Jost WH, Ceballos-Baumann AO, Banach M, et al. Efficacy and safety of abobotulinumtoxinA liquid formulation in cervical dystonia: a randomized-controlled trial. Movement Disorders 21 September 2016 [Epub ahead of print]. x-wiley/crsRef/7215414 [DOI: 10.1002/mds.26760]
20. Coleman CM, Chang SF, Copley-Merriman C, Hubble J, Masaquel C. Health-related quality of life improvements with Dysport in cervical dystonia. PM&R 2011;3 Suppl 1(10):S190 (P41). x-wiley/crsRef/3291103
21. Hauser RA, Truong D, Hubble J, Coleman C, Beffy JL, Chang S, et al. AbobotulinumtoxinA (Dysport) dosing in cervical dystonia: an exploratory analysis of two large open-label extension studies. Journal of Neural Transmission 2013;120(2):299-307. x-wiley/crsRef/3291104 [DOI: 10.1007/s00702-012-0872-1] [PMID: 22878514]
22. Jen M, Kurth H, Iheanacho I, Dinet J, Gabriel S, Wasiak R, et al. Improvement of SF-36 scores in cervical dystonia patients – is there a treatment effect when evaluating subscales? Basal Ganglia 2014;126:1-6. x-wiley/crsRef/3291105
23. Truong D, Duane DD, Jankovic J, Singer C, Seeberger LC, Comella CL, et al. Efficacy and safety of botulinum type A toxin (Dysport) in cervical dystonia: results of the first US randomized, double-blind, placebo-controlled study. Movement Disorders 2005;20(7):783-91. x-wiley/crsRef/3291106
24. Truong DD, Duane DD, Jankovic J, Singer C, Comella CL. The efficacy and safety of Dysport (botulinumtype A toxin) in cervical dystonia: results of the first US study. Movement Disorders 2002;17(Suppl 5):S306 (P1007). x-wiley/crsRef/3291107
25. Mordin M, Masaquel C, Abbott C, Copley-Merriman C. Factors affecting the health-related quality of life of patients with cervical dystonia and impact of treatment with abobotulinumtoxinA (Dysport): results from a randomised, double-blind, placebo-controlled study. BMJ Open 2014;4(10):e005150. x-wiley/crsRef/3291110 [DOI: 10.1136/bmjopen-2014-005150] [PMID: 25324317]
26. Truong D, Brodsky M, Lew M, Brashear A, Jankovic J, Molho E, et al, Global Dysport Cervical Dystonia Study Group. Long-term efficacy and safety of botulinum toxin type A (Dysport) in cervical dystonia. Parkinsonism & Related Disorders 2010;16(5):316-23. x-wiley/crsRef/3291111 [DOI: 10.1016/j.parkreldis.2010.03.002] [MEDLINE: 20359934]
27. Kanovsky P, Ruzicka E, Jech R, Roth J, Schnider P, Auff E, et al. Standardized dose of 500 Mu of Dysport for cervical dystonia: results of a prospective, randomized, double-blind, placebo-controlled study. Movement Disorders 2000;15(Suppl 2):31. x-wiley/crsRef/3291113
28. Poewe W, Brans J, Kessler K, Kanovsky P, Odergren T, Aramideh M, et al. Dysport for cervical dystonia. Movement Disorders 2000;15(Suppl 2):7. x-wiley/crsRef/3291114
29. Wissel J, Kanovsky P, Ruzicka E, Bares M, Hortova H, Streitova H et al. Efficacy and safety of a standardised 500 unit dose of Dysport (clostridium botulinum toxin type A haemaglutinin complex) in a heterogeneous cervical dystonia population: results of a prospective, multicentre, randomised, double-blind, placebo-controlled, parallel group study. Journal of Neurology 2001;248(12):1073-8. x-wiley/crsRef/3291116
30. Blackie JD, Lees AJ. Botulinum toxin treatment in spasmodic torticollis. Journal of Neurology, Neurosurgery and Psychiatry 1990;53(8):640-3. x-wiley/crsRef/3291118
31. Buchman AS, Comella CL, Stebbins GT, Weinstein SL. Determining a dose-effect curve for botulinum toxin in the sternocleidomastoid muscle in cervical dystonia. Clinical Neuropharmacology 1994;17(2):188-95. x-wiley/crsRef/3291121
32. Gelb DJ, Arbor A, Don M, Yoshimura RKO, Lowenstein DH, Aminoff MJ. Change in pattern of muscle activity following botulinum toxin injections for torticollis. Neurology 1989;39(Suppl 1):320. x-wiley/crsRef/3291123
33. Gelb DJ, Lowenstein DH, Aminoff MJ. Botulinum toxin in the treatment of spasmodic torticollis. Neurology 1988;38(Suppl 2):244. x-wiley/crsRef/3291124
34. Gelb DJ, Lowenstein DH, Aminoff MJ. Controlled trial of botulinum toxin injections in the treatment of spasmodic torticollis. Neurology 1989;39(1):80-4. x-wiley/crsRef/3291125
35. Koller W, Vetere-Overfield B, Gray C, Dubinsky R. Failure of fixed-dose, fixed muscle injection of botulinum toxin in torticollis. Clinical Neuropharmacology 1990;13(4):355-8. x-wiley/crsRef/3291127
36. Lange DJ, Rubin M, Greene PE, Kang J, Moskowitz CB, Brin MF, et al. Distant effects of locally injected botulinum toxin: a double-blind study of single fiber EMG changes. Muscle and Nerve 1991;14:672-5. x-wiley/crsRef/3291129
37. Lorentz IT, Subramaniam SS, Yiannikas C. Treatment of idiopathic spasmodic torticollis with botulinum toxin A: a double-blind study on twenty-three patients. Movement Disorders 1991;6(2):145-50. x-wiley/crsRef/3291131
38. Lu CS, Chen RS, Tsai CH. Double-blind, placebo-controlled study of botulinum toxin injections in the treatment of cervical dystonia. Journal of the Formosan Medical Association 1995;94(4):189-92. x-wiley/crsRef/3291133
39. Maurri S, Brogelli S. Botulinum toxin therapy for blepharospasm, hemifacial spasm and spasmodic torticollis: clinical studies with a follow-up of 40 months. Movement Disorders 1990;5(Suppl 1):73 (P262). x-wiley/crsRef/3291135
40. Moore AP, Blumhardt LD. A double blind trial of botulinum toxin 'A' in torticollis, with one year follow-up. Journal of Neurology, Neurosurgery and Psychiatry 1991;54(9):813-6. x-wiley/crsRef/3291137
41. Moore AP, Blumhardt LD. Double blind study of botulinum toxin A in torticollis. Journal of Neurology 1991;54(9):813-6. x-wiley/crsRef/3291138
42. Ostergaard L, Fuglsang-Frederiksen A, Werdelin L, Sjo O, Winkel H. Quantitative EMG in botulinum toxin treatment of cervical dystonia. A double-blind, placebo-controlled study. Electroencephalography and Clinical Neurophysiology 1994;93(6):434-9. x-wiley/crsRef/3291140
43. Perlmutter JS, Tempel LW, Burde R. Double-blind, placebo-controlled, crossover trial of botulinum-A toxin for torticollis. Neurology 1989;39(Suppl 1):352. x-wiley/crsRef/3291142
44. Relja M, Petravic D. Botulinum toxin type A injections for cervical dystonia: a double-blind, placebo controlled study. The Canadian Journal of Neurological Sciences 1993;20(Suppl 4):S185. x-wiley/crsRef/3291144
45. Tsui JK, Eisen A, Stoessl AJ, Calne S, Calne DB. Double-blind study of botulinum toxin in spasmodic torticollis. Lancet 1996;2(2):245-7. x-wiley/crsRef/7215416
46. Tsui J, Eisen A, Calne DB. Botulinum toxin in spasmodic torticollis. In: Stanley Fahn et al, editors(s). Advances in Neurology. New York: Raven Press, 1988:593-7. x-wiley/crsRef/7215418
47. Yoshimura D, Aminoff M, Gelb D. Long term follow-up of patients treated with botulinum toxin for spasmodic torticollis. Movement Disorders 1990;5(Suppl 1):75 (P268). x-wiley/crsRef/3291150
48. Abrams KR, Gillies CL, Lambert PC. Meta-analysis of heterogeneously reported trials assessing change from baseline. Statistics in Medicine 2005;24:3823-44.
49. Albanese A, Asmus F, Bhatia KP, Elia AE, Elibol B, Filippini G, et al. EFNS guidelines on diagnosis and treatment of primary dystonias. European Journal of Neurology 2011;18:5-18.
50. Albanese A, Bhatia K, Bressman SB, Delong MR, Fahn S, Fung VS, et al. Phenomenology and classification of dystonia: a consensus update. Movement Disorders 2013;28(7):863-73.
51. Altman DG, Deeks JJ. Meta-analysis, Simpson's paradox, and the number needed to treat. BMC Medical Research Methodology 2002;2(1):3.
52. Antonucci F, Rossi C, Gianfranceschi L, Rossetto O, Caleo M. Long-distance retrograde effects of botulinum neurotoxin. Journal of Neuroscience 2008;28:3689–96.
53. Balint B, Bhatia KP. Isolated and combined dystonia syndromes – an update on new genes and their phenotypes. European Journal of Neurology 2015;22(4):610-7.
54. Balshem H, Helfand M, Schünemann HJ, Oxman AD, Kunz R, Brozek J, et al. GRADE guidelines: 3. Rating the quality of evidence. Journal of Clinical Epidemiology 2011;64(4):401-6.
55. Boroff DA, Chen GS. On the question of permeability of the blood–brain barrier to botulinum toxin. International Archives of Allergy and Applied Immunology 1975;48:495–504.
56. Brożek JL, Guyatt GH, Schünemann HJ. How a well-grounded minimal important difference can enhance transparency of labelling claims and improve interpretation of a patient reported outcome measure. Health and Quality of Life Outcomes 2006;4:69.
57. Carpenter J, Kenward M. Multiple Imputation and its Application. 1st edition. Chichester: John Wiley & Sons, Lda, 2013.
58. Carrasco-Labra A, Brignardello-Petersen R, Santesso N, Neumann I, Mustafa RA, Mbuagbaw L, et al. Improving GRADE evidence tables part 1: a randomized trial shows improved understanding of content in summary of findings tables with a new format. Journal of clinical epidemiology 2016;74:7-18. [PMID: 26791430]
59. Chan J, Brin MF, Fanh S. Idiopathic cervical dystonia: clinical characteristics. Movement Disorders 1991;6:119-26.
60. Cohen J. Statistical Power Analysis in the Behavioral Sciences. 2nd edition. Hillsdale (NJ): Lawrence Erlbaum Associates, Inc, 1988.
61. Comella CL, Fox SH, Bhatia KP, Perlmutter JS, Jinnah HA, Zurowski M, et al. Development of the comprehensive cervical dystonia rating scale: methodology. Movement Disorders 2015;2(2):135-41.
62. Corbett MS, Higgins JP, Woolacott NF. Assessing baseline imbalance in randomised trials: implications for the Cochrane risk of bias tool. Research Synthesis Methods 2014;5(1):79-85.
63. Deeks JJ, Higgins JPT, Altman DG, editor(s). Chapter 9: Analysing data and undertaking meta-analyses. In: Higgins JPT, Green S, editor(s). Cochrane Handbook for Systematic Reviews of Interventions Version 5.1.0 (updated March 2011). The Cochrane Collaboration, 2011. Available from www.training.cochrane.org/handbooks.
64. Defazio G, Jankovic J, Giel JL, Papapetropoulos S. Descriptive epidemiology of cervical dystonia. Tremor and Other Hyperkinetic Movements 2013;3:tre-03-193-4374-2. [DOI: 10.7916/D80C4TGJ]
65. de Paiva A, Meunier FA, Molgó J, Aoki KR, Dolly JO. Functional repair of motor endplates after botulinum neurotoxin type A poisoning: biphasic switch of synaptic activity between nerve sprouts and their parent terminals. Proceedings of the National Academy of Sciences of the United States of America 1999;96:3200–5.
66. Duarte GS, Castelão M, Rodrigues FB, Marques RE, Ferreira J, Sampaio C, et al. Botulinum toxin type A versus botulinum toxin type B for cervical dystonia. Cochrane Database of Systematic Reviews 2016, Issue 10. Art. No: CD004314. [DOI: 10.1002/14651858.CD004314.pub3]
67. Duarte GD, Rodrigues FB, Ferreira JJ, Costa J. Adverse events with botulinum toxin treatment in cervical dystonia: How much should we blame placebo? Parkinsonism & Related Disorders 2018;56:16-9. [DOI: 10.1016/j.parkreldis.2018.06.017]
68. Duchen LW. An electron microscopic study of the changes induced by botulinum toxin in the motor end-plates of slow and fast skeletal muscle fibres of the mouse. Journal of the Neurological Sciences 1971;14:47-60.
69. Edwards IR, Aronson JK. Adverse drug reactions: definitions, diagnosis, and management. Lancet 2000;356(9237):1255-9.
70. Epidemiological Study of Dystonia in Europe (ESDE) Collaborative Group. A prevalence study of primary dystonia in eight European countries. Journal of Neurology 2000;247:787-92.
71. Espay AJ, Trosch R, Suarez G, Johnson J, Marchese D, Comella C. Minimal clinically important change in the Toronto Western Spasmodic Torticollis Rating Scale. Parkinsonism & Related Disorders 2018;52:94-7. [PMID: 29530726]
72. Filippi GM, Errico P, Santarelli R, Bagolini B, Manni E. Botulinum A toxin effects on rat jaw muscle spindles. Acta Oto-laryngologica 1993;113:400–4.
73. Follmann D, Elliott P, Suh I, Cutler J. Variance imputation for overviews of clinical trials with continuous response. Journal of Clinical Epidemiology 1992;45:769-73.
74. Foltz EL, Knopp LM, Ward AA. Experimental spasmodic torticollis. Journal of Neurosurgery 1959;16:55-72.
75. Frevert J, Dressler D. Complexing proteins in botulinum toxin type A drugs: a help or a hindrance? Biologics: Targets & Therapy 2010;4:325-32.
76. Furukawa TA, Barbui C, Cipriani A, Brambilla P, Watanabe N. Imputing missing standard deviations in meta-analyses can provide accurate results. Journal of Clinical Epidemiology 2006;59(1):7-10.
77. McMaster University (developed by Evidence Prime) GRADEpro GDT. Version assessed 3 January 2017. Hamilton (ON): McMaster University (developed by Evidence Prime). Available at gradepro.org.
78. Guyatt GH, Oxman AD, Kunz R, Brozek J, Alonso-Coello P, Rind D, et al. GRADE guidelines 6. Rating the quality of evidence-imprecision. Journal of Clinical Epidemiology 2011;64(12):1283-93.
79. Hallett M. The neurophysiology of dystonia. Archives of Neurology 1998;55(5):601-3.
80. Hedges LV, Olkin I. Statistical Methods for Meta-Analysis. San Diego, California: Academic Press, Inc, 1985.
81. Higgins JPT, Thompson SG, Deeks JJ, Altman DG. Measuring inconsistency in meta-analyses. BMJ 2003;327(7414):557-60.
82. Higgins JPT, Altman DG, Sterne JAC, editor(s). Chapter 8: Assessing risk of bias in included studies. In: Higgins JPT, Green S, editor(s). Cochrane Handbook for Systematic Reviews of Interventions Version 5.1.0 (updated March 2011). The Cochrane Collaboration, 2011. Available from www.training.cochrane.org/handbooks.
83. Higgins JPT, Deeks JJ, Altman DG, editor(s). Chapter 16: Special topics in statistics. In: Higgins JPT, Green S, editor(s), Cochrane Handbook for Systematic Reviews of Interventions Version 5.1.0 (updated March 2011). The Cochrane Collaboration, 2011. Available from www.training.cochrane.org/handbooks.
84. Higgins JPT, Deeks JJ, editor(s). Chapter 7: Selecting studies and collecting data. In: Higgins JPT, Green S, editor(s), Cochrane Handbook for Systematic Reviews of Interventions Version 5.1.0 (updated March 2011). The Cochrane Collaboration, 2011. Available from www.training.cochrane.org/handbooks.
85. Holland RL, Brown MC. Nerve growth in botulinum toxin poisoned muscles. Neuroscience 1981;6:1167–79.
86. Imberger G, Thorlund K, Gluud C, Wetterslev J. False-positive findings in Cochrane meta-analyses with and without application of Trial Sequential Analysis: an empirical review. BMJ Open 2016;6(8):e011890.
87. Jahnanshani M, Marion M-H, Marsden CD. Natural history of adult-onset idiopathic torticollis. Archives of Neurology 1990;47:548-52.
88. Jakobsen JC, Wetterslev J, Winkel P, Lange T, Gluud C. Thresholds for statistical and clinical significance in systematic reviews with meta-analytic methods. BMC Medical Research Methodology 2014;14(1):120.
89. Jankovic J. Botulinum toxin in clinical practice. Journal of Neurology, Neurosurgery, and Psychiatry 2004;75:951–7.
90. Jankovic J, Tsui J, Bergeron C. Prevalence of cervical dystonia and spasmodic torticollis in the United States general population. Parkinsonism & Related Disorders 2007;13(7):411–6.
91. Juzans P, Comella J, Molgo J, Faille L, Angaut-Petit D. Nerve terminal sprouting in botulinum type-A treated mouse levator auris longus muscle. Neuromuscular Disorders: NMD 1996;6(3):177-85.
92. Liberati A, Altman DG, Tetzlaff J, Mulrow C, Gøtzsche PC, Ioannidis JP, et al. The PRISMA statement for reporting systematic reviews and meta-analyses of studies that evaluate health care interventions: explanation and elaboration. PLoS Medicine 2009;6:e1000100.
93. Lundh A, Lexchin J, Mintzes B, Schroll JB, Bero L. Industry sponsorship and research outcome. Cochrane Database of Systematic Reviews 2017, Issue 2. Art. No: MR000033. [DOI: 10.1002/14651858.MR000033.pub3]
94. Macefield RC, Jacobs M, Korfage IJ, Nicklin J, Whistance RN, Brookes ST, et al. Developing core outcomes sets: methods for identifying and including patient-reported outcomes (PROs). Trials 2014;15:49.
95. Marques RE, Duarte GS, Rodrigues FB, Castelão M, Ferreira J, Sampaio C, et al. Botulinum toxin type B for cervical dystonia. Cochrane Database of Systematic Reviews 2016, Issue 5. Art. No: CD004315. [DOI: 10.1002/14651858.CD004315.pub3] [PMID: 27176573]
96. Matak I, Lacković Z. Botulinum toxin A, brain and pain. Progress in Neurobiology 2014;119-120:39–59.
97. Matak I, Lacković Z. Botulinum neurotoxin type A: actions beyond SNAP-25? Toxicology 2015;335:79-84.
98. O’Brien PC, Fleming TR. A multiple testing procedure for clinical trials. Biometrics 1979;35:549-56.
99. Palomar FJ, Mir P. Neurophysiological changes after intramuscular injection of botulinum toxin. Clinical Neurophysiology 2012;123(23):54–60.
100. Pellizzari R, Rossetto O, Schiavo G, Montecucco C. Tetanus and botulinum neurotoxins: mechanism of action and therapeutic uses. Philosophical Transactions of the Royal Society of London. Series B, Biological Sciences 1999;354:259–68.
101. 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):676-80.
102. Rato ML, Duarte GS, Mestre T, de Carvalho M, Ferreira JJ. Strong nocebo effect in amyotrophic lateral sclerosis trials might mask conclusions. Lancet Neurology 2018;17(10):842. [DOI: 10.1016/S1474-4422(18)30310-7]
103. Rato ML, Duarte GS, Ferreira AN, Alves M, Mainoli B, Teodoro T, et al. Nocebo response in Parkinson's disease: a systematic review and meta-analysis. Parkinsonism & Related Disorders 2019;65:13-9. [DOI: 10.1016/j.parkreldis.2019.04.015]
104. Nordic Centre, The Cochrane Collaboration Review Manager 5 (RevMan 5). Version 5.3. Copenhagen: Nordic Centre, The Cochrane Collaboration, 2014.
105. Rodrigues FB, Duarte GS, Prescott D, Ferreira J, Costa J. Deep brain stimulation for dystonia. Cochrane Database of Systematic Reviews 2019, Issue 1. Art. No: CD012405. [DOI: 10.1002/14651858.CD012405.pub2]
106. Rosales RL, Arimura K, Takenaka S, Osame M. Extrafusal and intrafusal muscle effects in experimental botulinum toxin-A injection. Muscle & Nerve 1996;19:488–96.
107. Rosales RL, Dressler D. On muscle spindles, dystonia and botulinum toxin. European Journal of Neurology 2010;17:71–80.
108. Rubin DB, Schenker N. Multiple imputation in health-care databases: an overview and some applications. Statistics in Medicine 1991;10:585–98.
109. Schünemann HJ, Oxman AD, Higgins JPT, Vist GE, Glasziou P, Guyatt GH. Chapter 11: Presenting results and ‘Summary of findings' tables. In: Higgins JPT, Green S, editor(s), Cochrane Handbook for Systematic Reviews of Interventions Version 5.1.0 (updated March 2011). The Cochrane Collaboration, 2011. Available from www.training.cochrane.org/handbooks.
110. Silva MA, Duarte GS, Camara R, Rodrigues FB, Fernandes RM, Abreu D, et al. Placebo and nocebo responses in restless legs syndrome: a systematic review and meta-analysis. Neurology 2017;88(23):2216-24. [DOI: 10.1212/WNL.0000000000004004]
111. Simpson LL. Identification of the major steps in botulinum toxin action. Annual Review of Pharmacology and Toxicology 2004;44:167-93.
112. Simpson DM, Hallett M, Ashman EJ, Comella CL, Green MW, Gronseth GS, et al. Practice guideline update summary: botulinum neurotoxin for the treatment of blepharospasm, cervical dystonia, adult spasticity, and headache: report of the Guideline Development Subcommittee of the American Academy of Neurology. Neurology 2016;10:1818-26.
113. Smeeth L, Haines A, Ebrahim S. Numbers needed to treat derived from meta-analysis – sometimes informative, usually misleading. BMJ 1999;318(7197):1548-51.
114. Stata Statistical Software: release 14. StataCorp, Version 14. College Station, TX, USA: StataCorp, 2017. Available at www.stata.com.
115. Steeves TD, Day L, Dykeman J, Jette N, Pringsheim T. The prevalence of primary dystonia: a systematic review and meta-analysis. Movement Disorders 2012;27(14):1789-96.
116. Sterne JA, Egger M. Funnel plots for detecting bias in meta-analysis: guidelines on choice of axis. Journal of Clinical Epidemiology 2001;54(10):1046-55.
117. Sterne JAC, Egger M, Moher D, editor(s). Chapter 10: Addressing reporting biases. In: Higgins JPT, Green S, editor(s). Cochrane Handbook for Systematic Reviews of Intervention. Version 5.1.0 (updated March 2011). The Cochrane Collaboration, 2011. Available from www.training.cochrane.org/handbooks.
118. Tarsy D. Comparison of clinical rating scales in treatment of cervical dystonia with botulinum toxin. Movement Disorders 1997;12(1):100-2.
119. Tarsy D, Simon DK. Dystonia. New England Journal of Medicine 2006;355:818-29.
120. Thorlund K, Engstrøm J, Wetterslev J, Brok J, Imberger G, Gluud C. User manual for Trial Sequential Analysis (TSA). ctu.dk/tsa/files/tsa ̇manual.pdf 2011.
121. Copenhagen Trial Unit Trial Sequential Analysis. Version 0.9 Beta. Copenhagen Trial Unit, Version accessed 3 January 2017. Copenhagen: Copenhagen Trial Unit, 2011. Available at www.ctu.dk/tsa/downloads.aspx.
122. Tugwell P, Boers M, Brooks P, Simon L, Strand V, Idzerda L. OMERACT: an international initiative to improve outcome measurement in rheumatology. Trials 2007;8:38.
123. Walker TJ, Dayan SH. Comparison and overview of currently available neurotoxins. Journal of Clinical and Aesthetic Dermatology 2014;7(2):31-9.
124. Wetterslev J, Thorlund K, Brok J, Gluud C. Trial Sequential Analysis may establish when firm evidence is reached in cumulative meta-analysis. Journal of Clinical Epidemiology 2008;61:64-75.
125. Wetterslev J, Thorlund K, Brok J, Gluud C. Estimating required information size by quantifying diversity in random-effects model meta-analyses. BMC Medical Research Methodology 2009;9:86.
126. Wiebe N, Vandermeer B, Platt RW, Klassen TP, Moher D, Barrowman NJ. A systematic review identifies a lack of standardization in methods for handling missing variance data. Journal of Clinical Epidemiology 2006;59(4):342-53.
127. Zoons E, Dijkgraaf MG, Dijk JM, Van Schaik IN, Tijssen MA. Botulinum toxin as treatment for focal dystonia: a systematic review of the pharmaco-therapeutic and pharmaco-economic value. Journal of Neurology 2012;259(12):2519-26.
128. Castelão M, Marques RE, Duarte GS, Rodrigues FB, Ferreira J, Sampaio C, et al. Botulinum toxin type A therapy for cervical dystonia. Cochrane Database of Systematic Reviews 2017, Issue 12. Art. No: CD003633. [DOI: 10.1002/14651858.CD003633.pub3]
129. Costa J, Ferreira JJ, Sampaio C. Botulinum toxin type A for the treatment of cervical dystonia: a systematic review. Movement Disorders 2000;15(Suppl 3):29.
130. Costa J, Espírito-Santo C, Borges A, Ferreira JJ, Coelho M, Moore P, et al. Botulinum toxin type A therapy for cervical dystonia. Cochrane Database of Systematic Reviews 2005, Issue 1. Art. No: CD003633. [DOI: 10.1002/14651858.CD003633.pub2]
131. Ferreira JJ, Costa J, Sampaio C. Botulinum toxin type A for the treatment of cervical dystonia: a systematic review. European Journal of Neurology 1999;6(Suppl 3):76.