ESPASTICIDAD: tratamiento mediante neurotoxina botulítica

Brief Summary
GUIDELINE TITLE
Assessment: botulinum neurotoxin for the treatment of spasticity (an evidence-based review). Report of the Therapeutics and Technology Assessment Subcommittee of the American Academy of Neurology.

BIBLIOGRAPHIC SOURCE(S)
Simpson DM, Gracies JM, Graham HK, Miyasaki JM, Naumann M, Russman B, Simpson LL, So Y, Therapeutics and Technology Assessment Subcommittee of the American Academy of Neurology. Assessment: Botulinum neurotoxin for the treatment of spasticity (an evidence-based review): report of the Therapeutics and Technology Assessment Subcommittee of the American Academy of Neurology. Neurology 2008 May 6;70(19):1691-8. [48 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.

Upper Extremity Spasticity and Lower Extremity Spasticity in Adults

Conclusions

Botulinum neurotoxin (BoNT) is established as effective in the treatment of adult spasticity in the upper and lower limb in reducing muscle tone and improving passive function (14 Class I studies). While relatively few studies examined active function, recent data suggest that BoNT is probably effective in improving active function (one Class I study). There are inadequate data to determine if electrical stimulation or electromyography (EMG) techniques for optimal muscle localization improves outcome.

Recommendations

BoNT should be offered as a treatment option to reduce muscle tone and improve passive function in adults with spasticity (Level A), and should be considered to improve active function (Level B).
There is insufficient evidence to recommend an optimum technique for muscle localization at the time of injection (Level U).
Spasticity Due to Cerebral Palsy in Children

Conclusions

BoNT injection of the gastrocnemius-soleus muscles is established as effective in the treatment of spastic equinus in patients with cerebral palsy (CP) (four Class I studies). There is insufficient evidence to support or refute the benefit of additional casting to BoNT injection of the gastrocnemius-soleus muscles (inconsistent Class II and III studies) and the injection of BoNT into the hamstrings (only Class IV studies). In patients with adductor spasticity, BoNT injection is probably effective in improving adductor spasticity and range of motion (one Class I study), as well as postoperative pain in children undergoing adductor muscle lengthening surgery (one Class I study). In patients with upper extremity symptoms, BoNT injection is probably effective in improving spasticity and range of motion (two Class II studies and one Class III study).

Recommendations

BoNT injection of the calf muscles should be offered as a treatment option for equinus varus deformity in children with cerebral palsy (Level A).
BoNT injection should be considered as a treatment option for treatment of adductor spasticity and for pain control in children undergoing adductor-lengthening surgery (Level B).
BoNT injection should be considered as a treatment option in children with upper extremity spasticity (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 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–III.)

*In exceptional cases, one convincing Class I study may suffice for an "A" recommendation if 1) all criteria are met, 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, Gracies JM, Graham HK, Miyasaki JM, Naumann M, Russman B, Simpson LL, So Y, Therapeutics and Technology Assessment Subcommittee of the American Academy of Neurology. Assessment: Botulinum neurotoxin for the treatment of spasticity (an evidence-based review): report of the Therapeutics and Technology Assessment Subcommittee of the American Academy of Neurology. Neurology 2008 May 6;70(19):1691-8. [48 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; J-M. Gracies, MD, PhD; H.K. Graham, MD; J.M. Miyasaki, MD, Med; M. Naumann, MD; B. Russman, MD; L.L. Simpson, PhD; 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. Gracies has received speaker honoraria and research support from Allergan, Merz, and Solstice, Inc. Dr. Graham has received speaker honoraria and research support from Allergan and performs botulinum toxin injections. 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. Russman has received research support from Allergan and performs botulinum toxin injections. Dr. L. Simpson has received research support from Allergan. 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 spasticity. 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 American Academy of Neurology 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.
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 spasticity. 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 October 31, 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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Assessment: botulinum neurotoxin for the treatment of spasticity (an evidence-based review). Report of the Therapeutics