Side-controlled intradermal injection of botulinum toxin A in recalcitrant axillary hyperhidrosis

Heckmann, Marc; Breit, Susanne; Ceballos-Baumann, Andrés; Schaller, Martin; Plewig, Gerd

doi:10.1016/s0190-9622(99)70258-6

Cited by 89 publications

(95 citation statements)

References 22 publications

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“…Studies were conducted in a range of different countries: 23 studies were conducted in European countries [Germany (n = 9 25,68,69,75,89,148,150,154,155 ), the UK (n = 2 91,184 ), Denmark (n = 2 37,149 ), Austria (n = 2 84,85 ), Poland (n = 1 ) and multiple European countries (n = 3 24,79,80 )], 15 studies were conducted in the Americas [USA (n = 13 21,26,27,29,42,53,71,73,74,76,77,82 ) and Brazil (n = 2 57,60 )], 11 studies were conducted in Asian countries [Japan (n = 4 41,83,90,185 ), South Korea (n = 3 43,44,51 ), Turkey (n = 2 39,40 ), India (n = 1 88 ) and Iran (n = 1 28 )] and one study was conducted in Australia. 38 Therefore, many of the study populations may not be representative of hyperhidrosis patients in the UK, because of the differences in climate.…”

Section: Characteristics Of Studies Included In the Review Of Effectimentioning

confidence: 99%

“…It was clear that the allocation sequence was adequately generated in only eight RCTs; 21,51,59,69,75,76,79,83 methods of sequence generation were unclear in the other 24 RCTs. [24][25][26][27]29,37,41,42,53,57,60,68,[71][72][73][74]77,82,84,85,88,147,150 Seventeen studies were non-RCTs; 28,38,40,43,44,80,81,[89][90][91][92]148,149,154,155,184,185 therefore, there was no randomised sequence generation. Concealment of allocation was also poorly reported; only two RCTs reported adequate methods, and methods were unclear in the remaining 30 RCTs.…”

Section: Quality Of Studies Included In the Reviewmentioning

confidence: 99%

“…Twenty-four studies reported blinding of participants to treatment group, [27][28][29]37,38,40,51,53,57,59,60,69,71,[73][74][75][76][77]79,[82][83][84][85] in 17 studies participants were not blinded, 21,[24][25][26]43,80,81,89,90,92,[148][149][150]155,184,185 and in eight studies it was unclear whether or not participants were blinded. 41,42,68,72,88,91,147,154 It is not always feasible to blind patients in studies comparing minor surgical interventions with non-surgical interventions, or minor surgical interventions with more major surgery; such studies were considered to have a high overall risk of bias, owing to the potential effect on outcomes, many of which are subjective.…”

Section: Quality Of Studies Included In the Reviewmentioning

confidence: 99%

“…41,42,68,72,88,91,147,154 It is not always feasible to blind patients in studies comparing minor surgical interventions with non-surgical interventions, or minor surgical interventions with more major surgery; such studies were considered to have a high overall risk of bias, owing to the potential effect on outcomes, many of which are subjective. Blinding of care providers was reported in only 12 studies; 37,57,69,[73][74][75][76][77][82][83][84][85] in 21 studies it was clear that care providers were not blinded, 21,[25][26][27][28]38,40,43,44,72,80,81,[88][89][90]92,[147][148][149][150]154 and in 16 studies it was unclear whether or not care providers were blinded. 24,29,41,42,51,53,59,60,68,71,…”

Section: Quality Of Studies Included In the Reviewmentioning

confidence: 99%

“…Blinding of care providers was reported in only 12 studies; 37,57,69,[73][74][75][76][77][82][83][84][85] in 21 studies it was clear that care providers were not blinded, 21,[25][26][27][28]38,40,43,44,72,80,81,[88][89][90]92,[147][148][149][150]154 and in 16 studies it was unclear whether or not care providers were blinded. 24,29,41,42,51,53,59,60,68,71,79,91,155,184,185 Blinding of outcome assessors, for at least one outcome, was reported in 21 studies (for subjective outcomes, the patient was considered to be the outcome assessor), [27][28][29]38,51,…”

Section: Quality Of Studies Included In the Reviewmentioning

confidence: 99%

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Interventions for hyperhidrosis in secondary care: a systematic review and value-of-information analysis

Wade

Rice

Llewellyn

et al. 2017

Health Technol Assess

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BackgroundHyperhidrosis is uncontrollable excessive sweating that occurs at rest, regardless of temperature. The symptoms of hyperhidrosis can significantly affect quality of life. The management of hyperhidrosis is uncertain and variable.ObjectiveTo establish the expected value of undertaking additional research to determine the most effective interventions for the management of refractory primary hyperhidrosis in secondary care.MethodsA systematic review and economic model, including a value-of-information (VOI) analysis. Treatments to be prescribed by dermatologists and minor surgical treatments for hyperhidrosis of the hands, feet and axillae were reviewed; as endoscopic thoracic sympathectomy (ETS) is incontestably an end-of-line treatment, it was not reviewed further. Fifteen databases (e.g. CENTRAL, PubMed and PsycINFO), conference proceedings and trial registers were searched from inception to July 2016. Systematic review methods were followed. Pairwise meta-analyses were conducted for comparisons between botulinum toxin (BTX) injections and placebo for axillary hyperhidrosis, but otherwise, owing to evidence limitations, data were synthesised narratively. A decision-analytic model assessed the cost-effectiveness and VOI of five treatments (iontophoresis, medication, BTX, curettage, ETS) in 64 different sequences for axillary hyperhidrosis only.Results and conclusionsFifty studies were included in the effectiveness review: 32 randomised controlled trials (RCTs), 17 non-RCTs and one large prospective case series. Most studies were small, rated as having a high risk of bias and poorly reported. The interventions assessed in the review were iontophoresis, BTX, anticholinergic medications, curettage and newer energy-based technologies that damage the sweat gland (e.g. laser, microwave). There is moderate-quality evidence of a large statistically significant effect of BTX on axillary hyperhidrosis symptoms, compared with placebo. There was weak but consistent evidence for iontophoresis for palmar hyperhidrosis. Evidence for other interventions was of low or very low quality. For axillary hyperhidrosis cost-effectiveness results indicated that iontophoresis, BTX, medication, curettage and ETS was the most cost-effective sequence (probability 0.8), with an incremental cost-effectiveness ratio of £9304 per quality-adjusted life-year. Uncertainty associated with study bias was not reflected in the economic results. Patients and clinicians attending an end-of-project workshop were satisfied with the sequence of treatments for axillary hyperhidrosis identified as being cost-effective. All patient advisors considered that the Hyperhidrosis Quality of Life Index was superior to other tools commonly used in hyperhidrosis research for assessing quality of life.LimitationsThe evidence for the clinical effectiveness and safety of second-line treatments for primary hyperhidrosis is limited. This meant that there was insufficient evidence to draw conclusions for most interventions assessed and the cost-effectiveness analysis was restricted to hyperhidrosis of the axilla.Future workBased on anecdotal evidence and inference from evidence for the axillae, participants agreed that a trial of BTX (with anaesthesia) compared with iontophoresis for palmar hyperhidrosis would be most useful. The VOI analysis indicates that further research into the effectiveness of existing medications might be worthwhile, but it is unclear that such trials are of clinical importance. Research that established a robust estimate of the annual incidence of axillary hyperhidrosis in the UK population would reduce the uncertainty in future VOI analyses.Study registrationThis study is registered as PROSPERO CRD42015027803.FundingThe National Institute for Health Research Health Technology Assessment programme.

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