Evidence strengths and limitations

Evidence strengths and limitations

No randomised controlled trials were identified comparing oral glycopyrronium bromide with placebo or with alternative treatment for hyperhidrosis (primary or secondary) in adults, young people or children.

This evidence summary was limited to a retrospective review of case series of people who had been treated with oral glycopyrronium bromide tablets. This included 3 case series of mainly adults with primary hyperhidrosis (Bajaj and Langtry 2007; Lee et al. 2012; Walling 2012; reporting results for a total of 100 adults), 1 of children or young people with primary hyperhidrosis (Paller et al. 2012, n=31), and 1 of adults or young people with compensatory hyperhidrosis following sympathectomy (Gong and Kim 2013, n=19).

Dosages of oral glycopyrronium bromide in case series ranged from 1 mg to a maximum 8 mg (in divided doses) daily, and treatment duration was variable or unreported. In all but 1 case series, participants had tried previous treatments and either the condition had not responded, or they had been intolerant to the treatment.

These case series provide weak evidence on the efficacy and safety of oral glycopyrronium bromide for treating hyperhidrosis in children, young people and adults. Response rates were based on absolute responses to therapy as recorded in patient records, or on patient questionnaires, which could be subjective and do not appear to be validated. Randomised controlled trials comparing oral glycopyrronium bromide with placebo or alternative treatments on validated measures of hyperhidrosis are needed.

A Cochrane review protocol on interventions for excessive sweating of unknown cause (Shams et al. 2011) states that, 'Quantifying hyperhidrosis remains challenging in the absence of a widely acceptable definition of the condition. Attempts at finding a quantitative cut-off for hyperhidrosis are marred by a high degree of variability of sweating in the same individual that depends on their level of physical activity, the ambient temperature, their emotional state, and even the type of food consumed, amongst other factors. As a result, a diagnosis of hyperhidrosis is often made subjectively by the physician depending on the individual circumstances, aided sometimes by different means of quantification of sweating. The main modes of quantification are objective (e.g. gravimetry, starch-iodine testing, vaporimetry), subjective (e.g. visual analogue scales), and the overall impact on the person affected (e.g. by the Hyperhidrosis Disease Severity Scale).

The validated Dermatology Life Quality Index (DLQI) is frequently used in dermatology and in clinical trials to assess the impact of skin conditions on the participant. It is also used when assessing hyperhidrosis. The Hyperhidrosis Disease Severity Scale and Hyperhidrosis Impact Questionnaire specifically measure the impact of hyperhidrosis on those affected. There is a high degree of variation in terms of the level of sweating which causes problems for an individual, and, thus, purely quantitative methods of measuring hyperhidrosis fail to adequately record the impact the condition has on the individual affected. Therefore, it has been suggested that the inclusion of a functional assessment of hyperhidrosis, i.e. the impact it has on the sufferer, may more accurately reflect the condition's severity rather than isolated quantitative measurements of sweat production.