Medicine Section - Treatment of Hyperhidrosis

IMPORTANT REMINDER

This Medical Policy has been developed through consideration of medical necessity, generally accepted standards of medical practice, and review of medical literature and government approval status.

Benefit determinations should be based in all cases on the applicable contract language. To the extent there are any conflicts between these guidelines and the contract language, the contract language will control.

The purpose of medical policy is to provide a guide to coverage. Medical Policy is not intended to dictate to providers how to practice medicine. Providers are expected to exercise their medical judgment in providing the most appropriate care.

Description

Hyperhidrosis may be defined as excessive sweating, beyond a level required to maintain normal body temperature in response to heat exposure or exercise. Hyperhidrosis can be classified as either primary or secondary. Primary hyperhidrosis is idiopathic in nature, typically involving the hands (palmar), feet (plantar), or axillae. Secondary hyperhidrosis can result from a variety of drugs, such as tricyclic antidepressants, selective serotonin reuptake inhibitors (SSRIs), or underlying diseases/conditions, such as febrile diseases, diabetes mellitus, anxiety or menopause. Gustatory hyperhidrosis is an unusual iatrogenic cause of facial hyperhidrosis in response to hot or spicy foods, resulting from surgery to the parotid gland and subsequent aberrant regenerating parasympathetic fibers.

The consequences of hyperhidrosis are primarily psychosocial in nature. Excessive sweating may be socially embarrassing or may interfere with certain professions. For example, palmar hyperhidrosis may preclude art work, working with electrical components, or playing certain musical instruments. In addition, hyperhidrosis may lead to a need for several changes of clothing a day; excessive sweating may also result in staining of clothing or shoes.

Treatment of secondary hyperhidrosis naturally focuses on treatment of the underlying cause. A variety of therapies have been investigated for treating primary hyperhidrosis, including topical therapy with aluminum chloride or tanning agents, iontophoresis, botulinum toxin endoscopic transthoracic sympathectomy and surgical excision of axillary sweat glands. Botulinum toxin has also been investigated as a treatment of secondary gustatory hyperhidrosis. Note: Indications for botulinum toxin other than the treatment of hyperhidrosis are discussed in a separate policy (see Cross Reference).

Policy/Criteria

Scientific Background

Aluminum chloride

Aluminum chloride is a common component of over-the-counter antiperspirants, although a prescription product is available (Drysol). Although the mechanism is unclear, aluminum chloride is associated with atrophy of the secretory cells seen in eccrine sweat glands. Aluminum chloride is predominantly used to treat axillary hyperhidrosis and not palmar or volar hyperhidrosis.

Botulinum toxin

Botulinum toxin is a potent neurotoxin that blocks cholinergic nerve terminals; symptoms of botulism include cessation of sweating. Therefore, intracutaneous injections have been investigated as a treatment of gustatory hyperhidrosis and focal primary hyperhidrosis, most frequently involving the axillae or palms. Laskawi and colleagues reported on the outcomes of 19 patients with gustatory hyperhidrosis treated with botulinum toxin injected into every 4 cm2 of involved skin. (2) In all cases, gustatory sweating ceased within two days, with a mean duration of effect of 17 months. There is a considerable body of published literature regarding botulinum toxin injection for the treatment of axillary hyperhidrosis, all of which substantiates its effectiveness. (3-12) Two of these were double-blind, randomized trials that demonstrated that botulinum toxin was more effective than placebo in patients with palmar hyperhidrosis. (3,9) The drawback of this approach is the need for repeated injections, which has led some to consider surgical approaches to treatment.

Endoscopic Transthoracic Sympathectomy

Eccrine sweat glands produce an aqueous secretion, the overproduction of which is primarily responsible for hyperhidrosis. These glands are innervated by the sympathetic nervous system. Therefore, various surgical techniques of thoracic sympathectomy have been investigated as a curative procedure, primarily for combined palmar and axillary hyperhidrosis. Large case series have reported success rates of up to 98%. (13-19) A variety of approaches have been reported but endoscopic techniques have emerged as minimally invasive alternatives to transaxillary, supraclavicular, or anterior thoracic approaches. While accepted as an effective treatment, sympathectomy is not without complications. In addition to the immediate surgical complications of pneumothorax or temporary Horner's syndrome, compensatory sweating on the trunk can occur in up to 55% of patients, reducing patient satisfaction with the procedure. Gustatory sweating may also occur. Sympathectomy also results in cardiac sympathetic denervation, which in turn can lead to a 10% reduction in the heart rate.

Iontophoresis

Iontophoresis is a technique that involves the use of an electric current to introduce various ions through the skin. The mechanism of action is not precisely known but is thought to be related to plugging of the sweat gland pores. The typical device consists of trays containing electrodes. Prior to using, the trays are filled with tap water, the patient inserts the hands or feet or positions the device in the axilla, and the current is turned on. Patients are treated for approximately 20 minutes, with treatments every 2 or 3 days for 5 to 10 sessions before an effect is observed. Maintenance therapy may be required every 2 weeks after initial therapy.

Iontophoresis in conjunction with tap water or anticholinergic agents is a long-standing treatment of palmar or plantar, and more recently, axillary idiopathic hyperhidrosis, with a reported success rate of up to 85%. (20) However, the published literature regarding iontophoresis as a treatment of hyperhidrosis is sparse. A 2003 BlueCross BlueShield Association Technology Evaluation Center (TEC) Assessment on iontophoresis concluded that the evidence was insufficient to determine whether the effects of iontophoresis for the treatment of hyperhidrosis exceed those of placebo. (21) The TEC Assessment also concluded that in the treatment of hyperhidrosis, there is insufficient evidence to show that tap water iontophoresis is as beneficial as topical drug administration.

Surgical Removal of Axillary Sweat Glands (including Liposuction)

Both eccrine and apocrine axillary sweat glands are predominantly located in the superficial subcutis and dermal subcutaneous interface, with scattered eccrine glands located completely in the dermis. Surgical removal has been performed in patients with severe isolated axillary hyperhidrosis. Removal may involve removal of the subcutaneous sweat glands without removal of any skin, limited excision of skin and removal of surrounding subcutaneous sweat glands or a more radical excision of skin and subcutaneous tissue en bloc. (22) Depending on the completeness of surgical excision, the treatment is effective in 50-95% of patients. Liposuction has also been investigated as a minimally invasive technique to surgical excision. In some cases, the procedure has been performed to remove the apocrine sweat glands, located deeper in the dermis. These sweat glands are responsible for axillary malodor, which may be referred to as osmidrosis or bromidrosis if the malodor is also associated with hyperhidrosis. Although this procedure has been performed for several decades, only scattered reports regarding its effectiveness were identified in a MEDLINE literature search. (23-27)

An updated search of the MEDLINE database through April 19, 2007 identified no additional data that alters the conclusions reached above.

References

1. BlueCross BlueShield Association Medical Policy Reference Manual, Policy No. 8.01.19
2. Laskawi R, Drobik C, Schonebeck. Up-to-date report of botulinum toxin Type A treatment in patients with gustatory sweating. Laryngoscope 1998;108(3):3811-4
3. Schnider P, Binder M, Auff E et al. Double-blind trial of botulinum A toxin for the treatment of focal hyperhidrosis of the palms. Br J Dermatol 1997;136(4):548-52
4. Shelley WB, Talanin NY, Shelley ED. Botulinum toxin therapy for palmar hyperhidrosis. J Am Acad Dermatol 1998;38(2 pt 1):227-9
5. Naumann M, Hofmann U, Bergman I et al. Focal hyperhidrosis. Effective treatment with intracutaneous botulinum toxin. Arch Dermatol 1998;134(3):301-04
6. Naumann MK, Hamm H, Lowe NJ. Effect of botulinum toxin type A on quality of life measures in patients with excessive axillary sweating: a randomized controlled trial. Br J Dermatol 2002;147(6):1218-26
7. Nauman M, Lowe NJ, Kumar CR et al. Botulinum toxin type A is a safe and effective treatment for axillary hyperhidrosis over 16 months: a prospective study. Arch Dermatol 2003;139(6):731-6
8. Campanati A, Penna L, Guzzo T et al. Quality-of-life assessment in patients with hyperhidrosis before and after treatment with botulinum toxin: results of an open-label study. Clin Ther 2003;25(1):298-308
9. Lowe NJ, Yamauchi PS, Lask GP et al. Efficacy and safety of botulinum toxin type A in the treatmnet of palmar hyperhidrosis: a double-blind, randomized, placebo-controlled study. Dermatol Surg 2002;28(9):822-7
10. Saadia D, Voustianiouk A, Wang AK et al. Botulinum toxin type A in primary palmar hyperhidrosis: randomized, single-blind, two-dose study. Neurology 2001;57(11):2095-9
11. Nauman M, Lowe NJ. Botulinum toxin type A in treatment of bilateral primary axillary hyperhidrosis: randomised, parallel group, double blind, placebo controlled trial. BJM 2001;323(7313):596-9
12. Heckmann M, Ceballos-Baumann AO, Plewig G. Botulinum toxin A for axillary hyperhidrosis (excessive sweating). N Engl J Med 2001;344(7):488-93
13. Drott C, Gothberg G, Claes G. Endoscopic transthoracic sympathectomy: An efficient and safe method for the treatment of hyperhidrosis. J Am Acad Dermatol 1995;33(1):78-81
14. Shachor D, Jedeikin R, Olsfanger D et al. Endoscopic transthoracic sympathectomy in the treatment of primary hyperhidrosis. A review of 290 sympathectomies. Arch Surg 1994;129(3):241-4
15. Gossot D, Galetta D, Pascal A et al. Long-term results of endoscopic thoracic sympathectomy for upper limb hyperhidrosis. Ann Thorac Surg 2003;75(4):1075-9
16. Leseche G, Castier Y, Thabut G et al. Endoscopic transthoracic sympathectomy for upper limb hyperhidrosis: limited sympathectomy does not reduce postoperative compensatory sweating. J Vasc Surg 2003;37(1):124-8
17. Atkinson JL, Fealey RD. Sympathotomy instead of sympathectomy for palmar hyperhidrosis: minimizing postoperative compensatory hyperhidrosis. Mayo Clin Proc 2003;78(2):167-72
18. Lin TS, Kuo SJ, Chou MC. Uniportal endoscopic thoracic sympathectomy for treatment of palmar and axillary hyperhidrosis: analysis of 2000 cases. Neurosurgery 2002;51(5 suppl):84-7
19. Han PP, Gottfried ON, Kenny KJ et al. Biportal thoracoscopic sympathectomy: surgical techniques and clinical results for the treatment of hyperhidrosis. Neurosurgery 2002;50(2):306-12
20. Levit F. Treatment of hyperhidrosis by tap water iontophoresis. Cutis 1980;26(2):192-4
21. TEC Assessment: Iontophoresis for Medical Indications. 2003; BlueCross and BlueShield Association Technology Evaluation Center, Vol 18, Tab 3
22. Hafner J, Beer GM. Axillary sweat gland excision. Curr Probl Dermatol 2002;30:57-63
23. Park S. Very superficial ultrasound-assisted lipoplasty for the treatment of axillary osmidrosis. Anesthetic Plast Surg 2000;24(4):275-9
24. Tsai RY, Lin JY. Experience of tumescent liposuction in the treatment of osmidrosis. Dermatol Surg 2001;27(5):446-8
25. Swinehart JM. Treatment of axillary hyperhidrosis: combination of the starch-iodine test with the tumescent liposuction technique. Dermatol Surg 2000;26(4):392-6
26. Shenaq SM, Spira M, Christ J. Treatment of bilateral axillary hyperhidrosis by suction-assisted lipolysis technique. Ann Plast Surg 1987;19(6):548-51
27. Ong WC, Lim TC, Lim J et al. Suction-curettage: treatment for axillary hyperhidrosis and hidradentitis. Plast Reconstr Surg 2003;111(2):958-9

Cross References

Botox® botulinum toxin Type A injection, Regence Medication Policy Manual, Drugs, Policy No. 006

Medicine Section Table of Contents