Oxybutynin as a Treatment for Generalized Hyperhidrosis: A Randomized, Placebo-controlled Trial

M. Schollhammer; E. Brenaut; N. Menard-Andivot; M. Pillette-Delarue; A. Zagnoli; M. Chassain-Le Lay; B. Sassolas; N. Jouan; Y. Le Ru; C. Abasq-Thomas; M. Greco; K. Penven; A.M. Roguedas-Contios; D. Dupré-Goetghebeur; C. Gouedard; L. Misery; G. Le Gal

Disclosures

The British Journal of Dermatology. 2015;173(5):1163-1168. 

In This Article

Abstract and Introduction

Abstract

Background Hyperhidrosis is a disorder that can impair quality of life. Localized treatments may be cumbersome and ineffective, and no systemic treatments have proven to be significantly beneficial.

Objectives To evaluate the effectiveness and tolerance of low-dose oxybutynin for hyperhidrosis.

Methods We conducted a prospective, randomized, placebo-controlled trial. From June 2013 to January 2014, 62 patients with localized or generalized hyperhidrosis were enrolled. Oxybutynin was started at a dose of 2·5 mg per day and increased gradually to 7·5 mg per day. The primary outcome was defined as improvement of at least one point on the Hyperhidrosis Disease Severity Scale (HDSS). Dermatology Life Quality Index (DLQI) and tolerance were also reported.

Results Most patients (83%) in our study had generalized hyperhidrosis. Oxybutynin was superior to placebo in improving the HDSS: 60% of patients treated with oxybutynin, compared with 27% of patients treated with placebo, improved at least one point on the HDSS (P = 0·009). The mean improvement in quality of life measured by DLQI was significantly better in the oxybutynin arm (6·9) than in the placebo arm (2·3). The most frequent side-effect was dry mouth, which was observed in 43% of the patients in the oxybutynin arm, compared with 11% in the placebo arm.

Conclusions Treatment with low-dose oxybutynin is effective in reducing symptoms of hyperhidrosis in generalized or localized forms. Side-effects were frequent but minor and mainly involved dry mouth.

Introduction

Hyperhidrosis is frequently observed in dermatological practice. The prevalence of hyperhidrosis is estimated to be between 1% and 2·9% in the general population.[1,2] The most frequent form is primary hyperhidrosis, which is localized to the palms, soles, axillae, trunk and face, and is exacerbated by intense emotion or stress. Secondary hyperhidrosis can be localized or generalized and is associated with other systemic disorders such as malignancy and infectious, endocrine or neurological disorders. Quality-of-life impairment (i.e. occupational, emotional, psychological, social and physical) can be severe. This negative impact on health-related quality of life has been reported by validated questionnaires to be similar to or greater than that reported for other dermatological (e.g. psoriasis) and nondermatological chronic diseases.[3] Despite an impaired quality of life, patients do not show increased symptoms of anxiety, depression or social phobia.[3] Some treatments are available for localized hyperhidrosis. These include topical aluminium chloride hexahydrate, tap water iontophoresis or intradermal injection of botulinum toxin, but they are not always efficient. No treatment has been validated for generalized hyperhidrosis.

Oxybutynin is a cholinergic antagonist that is used to treat pollakiuria and hyper-reflectory urine bladder, and it is generally used at a dose of 10–15 mg per day. In 1988 a case report described a patient with hyperhidrosis who began taking oxybutynin for urinary urgency; his episodes of severe sweating were abolished within a few hours.[4] Subsequently, four other cases have been reported.[5–7] Several series of patients treated with oxybutynin have been published,[8–10] including from specific populations such as postmenopausal patients,[10] children[11] and obese patients,[12] and from specific locations, such as plantar,[13] palmar[14] or facial[15] hyperhidrosis. Two randomized trials evaluated its use in patients with localized palmar or axillar hyperhidrosis,[16] and in women with persistent plantar hyperhidrosis despite sympathectomy.[17]

To date, no study has evaluated the efficacy and tolerance of oxybutynin in generalized hyperhidrosis. To fill this knowledge gap, we designed a placebo-controlled trial of low-dose oxybutynin in patients with primary generalized or localized hyperhidrosis.

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