BMJ 2001;323:596 ( 15 September )

Papers

Botulinum toxin type A in treatment of bilateral primary axillary hyperhidrosis: randomised, parallel group, double blind, placebo controlled trial

M Naumann, assistant professor of neurology, ^a N J Lowe, consultant dermatologist, ^b on behalf of the Hyperhidrosis Clinical Study Group.

^a Department of Neurology, Bayerische Julius-Maximilians-Universität Würzburg, Josef-Schneider Strasse 11, 97080 Würzberg, Germany, ^b Cranley Clinic for Dermatology, London W1M 9AD

Correspondence to: M Naumann naumann{at}mail.uni-wuerzburg.de

Objectives: To evaluate the safety and efficacy of botulinum toxin type A in the treatment of bilateral primary axillary hyperhidrosis.
Design: Multicentre, randomised, parallel group, placebo controlled trial.
Setting: 17 dermatology and neurology clinics in Belgium, Germany, Switzerland, and the United Kingdom.
Participants: Patients aged 18-75 years with bilateral primary axillary hyperhidrosis sufficient to interfere with daily living. 465 were screened, 320 randomised, and 307 completed the study.
Interventions: Patients received either botulinum toxin type A (Botox) 50 U per axilla or placebo by 10-15 intradermal injections evenly distributed within the hyperhidrotic area of each axilla, defined by Minor's iodine starch test.
Main outcome measures: Percentage of responders (patients with 50% reduction from baseline of spontaneous axillary sweat production) at four weeks, patients' global assessment of treatment satisfaction score, and adverse events.
Results: At four weeks, 94% (227) of the botulinum toxin type A group had responded compared with 36% (28) of the placebo group. By week 16, response rates were 82% (198) and 21% (16), respectively. The results for all other measures of efficacy were significantly better in the botulinum toxin group than the placebo group. Significantly higher patient satisfaction was reported in the botulinum toxin type A group than the placebo group (3.3 v 0.8, P<0.001 at 4 weeks). Adverse events were reported by only 27 patients (11%) in the botulinum toxin group and four (5%) in the placebo group (P>0.05).
Conclusion: Botulinum toxin type A is a safe and effective treatment for primary axillary hyperhidrosis and produces high levels of patient satisfaction.

What is already known on this topic Primary hyperhidrosis is a chronic disorder that can affect any part of the body, especially the axillas, palms, feet, and face Current treatments are often ineffective, short acting, or poorly tolerated What this study adds Botulinum toxin type A was significantly better than placebo on all measures of sweating Patient satisfaction was high and few adverse events were reported Effects of treatment remained apparent at 16 weeks

---

© BMJ 2001
CiteULike    Complore    Connotea    Del.icio.us    Digg    Reddit    StumbleUpon    Technorati    What's this?

Relevant Article

Botulinum toxin type A can control excessive sweating
BMJ 2001 323: 0. [Full Text]

This article has been cited by other articles:

• Naumann, M., So, Y., Argoff, C. E., Childers, M. K., Dykstra, D. D., Gronseth, G. S., Jabbari, B., Kaufmann, H. C., Schurch, B., Silberstein, S. D., Simpson, D. M. (2008). 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. Neurology 70: 1707-1714 [Abstract] [Full text]  
• Vlahovic, T. C., Dunn, S. P., Blau, J. C., Gauthier, C. (2008). Injectable Botulinum Toxin as a Treatment for Plantar Hyperhidrosis: A Case Study. J. Am. Podiatr. Med. Assoc. 98: 156-159 [Abstract] [Full text]  
• (2005). Treatments for excessive armpit sweating. DTB 43: 77-80 [Abstract] [Full text]  
• Heckmann, M., Plewig, G., for the Hyperhidrosis Study Group, (2005). Low-Dose Efficacy of Botulinum Toxin A for Axillary Hyperhidrosis: A Randomized, Side-By-Side, Open-Label Study. Arch Dermatol 141: 1255-1259 [Abstract] [Full text]  
• Eisenach, J. H., Atkinson, J. L. D., Fealey, R. D. (2005). Hyperhidrosis: Evolving Therapies for a Well-Established Phenomenon. Mayo Clin Proc. 80: 657-666 [Abstract]  
• Hayton, M.J., Santini, A.J.A., Hughes, P.J., Frostick, S.P., Trail, I.A., Stanley, J.K. (2005). Botulinum Toxin Injection in the Treatment of Tennis Elbow. A Double-Blind, Randomized, Controlled, Pilot Study. JBJS 87: 503-507 [Abstract] [Full text]  
• Haider, A., Solish, N. (2005). Focal hyperhidrosis: diagnosis and management. CMAJ 172: 69-75 [Abstract] [Full text]  
• Jongerius, P. H., Hoogen, F. J.A. v. d., Limbeek, J. v., Gabreels, F. J., Hulst, K. v., Rotteveel, J. J. (2004). Effect of Botulinum Toxin in the Treatment of Drooling: A Controlled Clinical Trial. Pediatrics 114: 620-627 [Abstract] [Full text]  
• Naumann, M., Lowe, N. J., Kumar, C. R., Hamm, H. (2003). Botulinum Toxin Type A Is a Safe and Effective Treatment for Axillary Hyperhidrosis Over 16 Months: A Prospective Study. Arch Dermatol 139: 731-736 [Abstract] [Full text]  
• Gossot, D., Galetta, D., Pascal, A., Debrosse, D., Caliandro, R., Girard, P., Stern, J.-B., Grunenwald, D. (2003). Long-term results of endoscopic thoracic sympathectomy for upper limb hyperhidrosis. Ann. Thorac. Surg. 75: 1075-1079 [Abstract] [Full text]  
• Heckmann, M., Teichmann, B., Pause, B. M., Plewig, G. (2003). Amelioration of Body Odor After Intracutaneous Axillary Injection of Botulinum Toxin A. Arch Dermatol 139: 57-59 [Abstract] [Full text]  
• (2001). Botulinum Toxin Helps Hyperhidrosis. JWatch General 2001: 5-5 [Full text]  

Rapid Responses:

Read all Rapid Responses

Long-term treatment of axillary hyperhidrosis with botulinium toxin type A

Markus Naumann, et al.
bmj.com, 5 Mar 2002 [Full text]

Online poll

Find out more here>> and here>>