Brief Summary
GUIDELINE TITLE
Assessment: botulinum neurotoxin for the treatment of movement disorders (an evidence-based review). Report of the Therapeutics and Technology Assessment Subcommittee of the American Academy of Neurology.
BIBLIOGRAPHIC SOURCE(S)
Simpson DM, Blitzer A, Brashear A, Comella C, Dubinsky R, Hallett M, Jankovic J, Karp B, Ludlow CL, Miyasaki JM, Naumann M, So Y, Therapeutics and Technology Assessment Subcommittee of the American Academy of Neurology. Assessment: Botulinum neurotoxin for the treatment of movement disorders (an evidence-based review): report of the Therapeutics and Technology Assessment Subcommittee of the American Academy of Neurology. Neurology 2008 May 6;70(19):1699-706. [35 references] PubMed
GUIDELINE STATUS
This is the current release of the guideline.
BRIEF SUMMARY CONTENT
RECOMMENDATIONS
EVIDENCE SUPPORTING THE RECOMMENDATIONS
IDENTIFYING INFORMATION AND AVAILABILITY
DISCLAIMER
RECOMMENDATIONS
MAJOR RECOMMENDATIONS
Definitions of the levels of the recommendations (A, B, C, U) and classification of the evidence (Class I through Class IV) are provided at the end of the "Major Recommendations" field.
Blepharospasm
Conclusions
For patients with blepharospasm, botulinum neurotoxin (BoNT) injection is probably effective with minimal side effects (two Class II studies). After dosage adjustment, Botox® and Xeomin® are probably equivalent (one Class I study), and Botox® and Dysport® are possibly equivalent (one Class II and one Class III study).
Recommendation
BoNT injection should be considered as a treatment option for blepharospasm (Level B).
Hemifacial Spasm
Conclusions
BoNT is possibly effective with minimal side effects for the treatment of hemifacial spasm (one Class II and one Class III study). Botox® and Dysport®, after dosage adjustment, are possibly equivalent in efficacy (one Class II study).
Recommendation
BoNT injection may be considered as a treatment option for hemifacial spasm (Level C).
Cervical Dystonia
Conclusion
BoNT is established as safe and effective for the treatment of CD (seven Class I studies).
Recommendations
BoNT injection should be offered as a treatment option to patients with cervical dystonia (Level A).
BoNT is probably more efficacious and better tolerated in patients with CD than treatment with trihexyphenidyl (Level B).
Focal Limb Dystonia
Conclusions
BoNT is probably effective for the treatment of focal upper extremity limb dystonia (one Class I and three Class II studies). While a few patients in one Class II study suggest that BoNT may be effective for lower extremity dystonia, the data are inadequate to provide a recommendation.
Recommendation
BoNT should be considered as a treatment option for focal upper extremity dystonia (Level B).
Laryngeal Dystonia
Conclusions
BoNT is probably effective for the treatment of adductor type spasmodic dysphonia (ADSD) (one Class I study). There is insufficient evidence to support a conclusion of effectiveness for BoNT in abductor type spasmodic dysphonia (ABSD).
Recommendations
BoNT should be considered as a treatment option for adductor spasmodic dysphonia (Level B).
There is insufficient evidence to support or refute the use of BoNT in abductor spasmodic dysphonia (Level U).
Tics
Conclusions
BoNT is possibly effective for the treatment of motor tics (one Class II study). There are insufficient data to determine the effectiveness of BoNT in phonic tics (one Class IV study).
Recommendation
BoNT may be considered as a treatment option for motor tics (Level C).
Tremor
Conclusions
BoNT injection of forearm muscles is probably effective in reducing the tremor amplitude in patients with essential hand tremor (two Class II studies). The benefits must be considered in conjunction with the common adverse effect of muscle weakness associated with BoNT injection. Existing data are insufficient to draw a conclusion on the use of BoNT in the treatment of head and voice tremor.
Recommendation
BoNT should be considered as a treatment option for essential hand tremor in those patients who fail treatment with oral agents (Level B).
Definitions:
Classification of Recommendations
Level A = Established as effective, ineffective or harmful (or established as useful/predictive or not useful/predictive) for the given condition in the specified population. (Level A rating requires at least two consistent Class I studies.*)
Level B = Probably effective, ineffective or harmful (or probably useful/predictive or not useful/predictive) for the given condition in the specified population. (Level B rating requires at least one Class I study or at least two consistent Class II studies.)
Level C = Possibly effective, ineffective or harmful (or possibly useful/predictive or not useful/predictive) for the given condition in the specified population. (Level C rating requires at least one Class II study or two consistent Class III studies)
Level U = Data inadequate or conflicting; given current knowledge, treatment (test, predictor) is unproven. (Studies not meeting criteria for Class I–Class III).
* In exceptional cases, one convincing Class I study may suffice for an "A" recommendation if 1) all criteria are met and/or 2) the magnitude of effect is large (relative rate improved outcome >5 and the lower limit of the confidence interval is >2.
Classification of Evidence for Therapeutic Intervention
Class I: Randomized, controlled clinical trial with masked or objective outcome assessment in a representative population. Relevant baseline characteristics are presented and substantially equivalent among treatment groups or there is appropriate statistical adjustment for differences. The following are required: a) concealed allocation, b) primary outcome(s) clearly defined, c) exclusion/inclusion criteria clearly defined, and d) adequate accounting for drop-outs (with at least 80%of enrolled subjects completing the study) and cross-overs with numbers sufficiently low to have minimal potential for bias.
Class II: Prospective matched group cohort study in a representative population with masked outcome assessment that meets b-d above OR a randomized controlled trial in a representative population that lacks one criteria a-d.
Class III: All other controlled trials (including well-defined natural history controls or patients serving as own controls) in a representative population, where outcome is independently assessed, or independently derived by objective outcome measurement.*
Class IV: Studies not meeting Class I, II, or III criteria, including consensus, expert opinion, or a case report.
*Objective outcome measurement: An outcome measure that is unlikely to be affected by an observer's (patient, treating physician, investigator) expectation or bias (e.g., blood tests, administrative outcome data).
CLINICAL ALGORITHM(S)
None provided
EVIDENCE SUPPORTING THE RECOMMENDATIONS
TYPE OF EVIDENCE SUPPORTING THE RECOMMENDATIONS
The type of supporting evidence is identified and graded for each recommendation (see "Major Recommendations").
IDENTIFYING INFORMATION AND AVAILABILITY
BIBLIOGRAPHIC SOURCE(S)
Simpson DM, Blitzer A, Brashear A, Comella C, Dubinsky R, Hallett M, Jankovic J, Karp B, Ludlow CL, Miyasaki JM, Naumann M, So Y, Therapeutics and Technology Assessment Subcommittee of the American Academy of Neurology. Assessment: Botulinum neurotoxin for the treatment of movement disorders (an evidence-based review): report of the Therapeutics and Technology Assessment Subcommittee of the American Academy of Neurology. Neurology 2008 May 6;70(19):1699-706. [35 references] PubMed
ADAPTATION
Not applicable: The guideline was not adapted from another source.
DATE RELEASED
2008 May 6
GUIDELINE DEVELOPER(S)
American Academy of Neurology - Medical Specialty Society
SOURCE(S) OF FUNDING
American Academy of Neurology (AAN)
GUIDELINE COMMITTEE
Therapeutics and Technology Assessment Subcommittee
COMPOSITION OF GROUP THAT AUTHORED THE GUIDELINE
Primary Authors: D.M. Simpson, MD; A. Blitzer, MD, DDS; A. Brashear, MD; C. Comella, MD; R. Dubinsky, MD, MPH; M. Hallett, MD; J. Jankovic, MD; B. Karp, MD; C.L. Ludlow, PhD; J.M. Miyasaki, MD, MEd; M. Naumann, MD; Y. So, MD, PhD
FINANCIAL DISCLOSURES/CONFLICTS OF INTEREST
The American Academy of Neurology (AAN) is committed to producing independent, critical and truthful clinical practice guidelines (CPGs). Significant efforts are made to minimize the potential for conflicts of interest to influence the recommendations of this CPG. To the extent possible, the AAN keeps separate those who have a financial stake in the success or failure of the products appraised in the CPGs and the developers of the guidelines. Conflict of interest forms were obtained from all authors and reviewed by an oversight committee prior to project initiation. AAN limits the participation of authors with substantial conflicts of interest. The AAN forbids commercial participation in, or funding of, guideline projects. Drafts of the guidelines have been reviewed by at least three AAN committees, a network of neurologists, Neurology® peer reviewers, and representatives from related fields. The AAN Guideline Author Conflict of Interest Policy can be viewed at www.aan.com.
The authors report the following conflicts: Dr. Simpson has received speaker honoraria and research support from Allergan, Merz, and Solstice, Inc., and performs botulinum toxin injections. Dr. Blitzer has received speaker honoraria from Allergan, Solstice, and Merz; research support from Allergan; and performs botulinum toxin injections. Dr. Brashear has received speaker honoraria from Allergan, Solstice, and Merz; research support from Allergan, Ipsen, Merz, and Oviation; performs botulinum toxin injections and has received payment for expert testimony. Dr. Comella has received speaker honoraria from Jazz Pharmaceutical, Merz Pharmaceutical, and UCB Pharmaceutical; research support from Allergan, Dystonia Study Group, and Solstice; and performs botulinum toxin injections. Dr. Dubinsky has received speaker honoraria from Allergan and research support from Allergan, MERZ-INC, and Solstice Neurosciences. Dr. Dubinsky holds financial interest in Abbott Laboratories (spouse), performs botulinum toxin injections, and presents annual courses at AANEM on chemodenervation. Dr. Hallett holds financial interest in Amylin Pharmaceuticals, Eli Lilly, Genetech, Genzyme, Healthsouth Corp., Medtronic, Pfizer, St. Jude Medical, Triad Hospitals, United Healthcare, and Valeant Pharmaceuticals International and performs botulinum toxin injections. Dr. Jankovic has received speaker honoraria from Allergan and Merz Pharmaceutical, research support from Allergan, Ipsen, and Merz Pharmaceutical, and performs botulinum toxin injections. Dr. Karp performs botulinum toxin injections. Dr. Ludlow holds financial interest in Fidelity Biotechnology (family member). Dr. Miyasaki has received research support from Boehringer Ingelheim, Huntington Study Group, NIH, Solvay, Solstice, and Teva. Dr. Naumann has received speaker honoraria from Ipsen and Allergan and performs botulinum toxin injections. Dr. So holds financial interest in Satoris Inc., and has received research support from NIH, Pfizer, Inc., and NeurogesX, Inc.
ENDORSER(S)
American Academy of Physical Medicine and Rehabilitation - Medical Specialty Society
GUIDELINE STATUS
This is the current release of the guideline.
GUIDELINE AVAILABILITY
Electronic copies: A list of American Academy of Neurology (AAN) guidelines, along with a link to a Portable Document Format (PDF) file for this guideline, is available at the AAN Web site.
Print copies: Available from the AAN Member Services Center, (800) 879-1960, or from AAN, 1080 Montreal Avenue, St. Paul, MN 55116.
AVAILABILITY OF COMPANION DOCUMENTS
The following are available:
Use of botulinum neurotoxin for the treatment of movement disorders. AAN summary of evidence-based guidelines for clinicians. St. Paul (MN): American Academy of Neurology. 2008. 2 p. Available in Portable Document Format (PDF) from the AAN Web site.
Assessment: botulinum neurotoxin for the treatment of autonomic disorders and pain, movement disorders, and spasticity (an evidence-based review). Slide presentation. St. Paul (MN): American Academy of Neurology. 2008. 146 p. Available from the AAN Web site.
Assessment: botulinum neurotoxin for the treatment of autonomic disorders and pain, movement disorders, and spasticity (an evidence-based review). Case study and coding. St. Paul (MN): American Academy of Neurology. 2008. 3 p. Available from the AAN Web site.
Assessment: botulinum neurotoxin for the treatment of autonomic disorders and pain, movement disorders, and spasticity (an evidence-based review). Case study in Neurology Today®. St. Paul (MN): American Academy of Neurology. 2008. 1 p. Available from the AAN Web site.
AAN guideline development process [online]. St. Paul (MN): American Academy of Neurology. Available from the AAN Web site.
PATIENT RESOURCES
The following is available:
Use of botulinum neurotoxin injections to treat movement disorders. AAN summary of evidence-based guideline for patients and their families. St. Paul (MN): American Academy of Neurology (AAN). 2008. 2 p.
Electronic copies: Available in Portable Document Format (PDF) from the AAN Web site.
Please note: This patient information is intended to provide health professionals with information to share with their patients to help them better understand their health and their diagnosed disorders. By providing access to this patient information, it is not the intention of NGC to provide specific medical advice for particular patients. Rather we urge patients and their representatives to review this material and then to consult with a licensed health professional for evaluation of treatment options suitable for them as well as for diagnosis and answers to their personal medical questions. This patient information has been derived and prepared from a guideline for health care professionals included on NGC by the authors or publishers of that original guideline. The patient information is not reviewed by NGC to establish whether or not it accurately reflects the original guideline's content.
NGC STATUS
This summary was completed by ECRI Institute on November 3, 2008. The information was verified by the guideline developer on December 30, 2008.
COPYRIGHT STATEMENT
This NGC summary is based on the original guideline, which is copyrighted by the American Academy of Neurology.
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