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Assessment: Botulinum neurotoxin in the treatment of autonomic disorders and pain (an evidence-based review)

Report of the Therapeutics and Technology Assessment Subcommittee of the American Academy of Neurology

From the Department of Neurology (M.N.), Klinikum Augsburg, Germany; Stanford University (Y.S.), CA; Department of Neurology (H.C.K.), New York University School of Medicine (C.E.A.), New York; Wake Forest University Health Sciences (M.K.C.), Winston-Salem, NC; Department of Physical Medicine and Rehabilitation (D.D.D.), University of Minnesota, Minneapolis; University of Kansas (G.S.G.), Kansas City; Department of Neurology (B.J.), Yale University School of Medicine, New Haven, CT; Balgrist University Hospital (B.S.), Zurich, Switzerland; Jefferson Headache Center (S.D.S.), Thomas Jefferson University Hospital, Philadelphia, PA; and Department of Neurology (D.M.S.), Mount Sinai Medical Center, New York, NY.

Addresses correspondence and reprint requests to the American Academy of Neurology, 1080 Montreal Ave., St. Paul, MN 55116 guidelines{at}aan.com

Objective: To perform an evidence-based review of the safety and efficacy of botulinum neurotoxin (BoNT) in the treatment of autonomic and urologic disorders and low back and head pain.

Methods: A literature search was performed including MEDLINE and Current Contents for therapeutic articles relevant to BoNT and the selected indications. Authors reviewed, abstracted, and classified articles based on the quality of the study (Class I–IV). Conclusions and recommendations were developed based on the highest level of evidence and put into current clinical context.

Results: The highest quality literature available for the respective indications was as follows: axillary hyperhidrosis (two Class I studies); palmar hyperhidrosis (two Class II studies); drooling (four Class II studies); gustatory sweating (five Class III studies); neurogenic detrusor overactivity (two Class I studies); sphincter detrusor dyssynergia in spinal cord injury (two Class II studies); chronic low back pain (one Class II study); episodic migraine (two Class I and two Class II studies); chronic daily headache (four Class II studies); and chronic tension-type headache (two Class I studies).

Recommendations: Botulinum neurotoxin (BoNT) should be offered as a treatment option for the treatment of axillary hyperhidrosis and detrusor overactivity (Level A), should be considered for palmar hyperhidrosis, drooling, and detrusor sphincter dyssynergia after spinal cord injury (Level B), and may be considered for gustatory sweating and low back pain (Level C). BoNT is probably ineffective in episodic migraine and chronic tension-type headache (Level B). There is presently no consistent or strong evidence to permit drawing conclusions on the efficacy of BoNT in chronic daily headache (mainly transformed migraine) (Level U). While clinicians’ practice may suggest stronger recommendations in some of these indications, evidence-based conclusions are limited by the availability of data.

Abbreviations: BoNT = botulinum neurotoxin; CDH = chronic daily headache; DSD = detrusor sphincter dyssynergia; LBP = low back pain; MS = multiple sclerosis; NNT = number needed to treat; OLBPQ = Oswestry Low Back Pain Questionnaire; VAS = visual analog scale.

Supplemental data at www.neurology.org

See pages 1691 and 1699

Approved by the Therapeutics and Technology Assessment Subcommittee on March 31, 2007; by the Practice Committee on July 12, 2007; and by the AAN Board of Directors on January 30, 2008.

The Mission Statement, Conflict of Interest Statement, Subcommittee and Panel members, AAN classification of evidence, and Classification of recommendations are available as supplemental data on the Neurology® Web site at www.neurology.org.

Endorsed by the American Academy of Physical Medicine and Rehabilitation on March 14, 2008.

Disclosure: Author disclosures are provided at the end of the article.

Received September 29, 2007. Accepted in final form January 30, 2008.

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