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Headline
There is some limited evidence for the clinical and cost-effectiveness of second-line treatments for axillary hyperhidrosis and a RCT of botulinum toxin versus iontophoresis for palmar hyperhidrosis may be warranted.
Abstract
Background:
Hyperhidrosis 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.
Objective:
To establish the expected value of undertaking additional research to determine the most effective interventions for the management of refractory primary hyperhidrosis in secondary care.
Methods:
A 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 conclusions:
Fifty 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.
Limitations:
The 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 work:
Based 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 registration:
This study is registered as PROSPERO CRD42015027803.
Funding:
The National Institute for Health Research Health Technology Assessment programme.
Contents
- Plain English summary
- Scientific summary
- Chapter 1. Background
- Chapter 2. Methods of the clinical effectiveness review
- Chapter 3. Results of the clinical effectiveness review
- Chapter 4. Review of quality-of-life measures/tools
- Chapter 5. Review of cost-effectiveness evidence
- Chapter 6. Development of new cost-effectiveness model
- Overview
- Population, treatment sequences and model structure
- Summary of model data
- Derivation of transition probabilities and reuse of treatments
- Effectiveness evidence
- Utility
- Resource use and unit costs
- Incremental cost-effectiveness analysis, and scenario and sensitivity analyses
- Value-of-information analysis
- Chapter 7. Cost-effectiveness, expected value of perfect information and expected value of partial perfect information results
- Chapter 8. Patient and clinician perspective on research findings
- Chapter 9. Discussion
- Chapter 10. Conclusions
- Acknowledgements
- References
- Appendix 1. Literature search strategies
- Appendix 2. Study details and results tables
- Appendix 3. Studies excluded at full-paper stage with rationale
- Appendix 4. The results of the network meta-analysis
- Appendix 5. Survey of UK dermatologists
- Appendix 6. R code for deriving event ranges for continuously reported outcome measure for the Hyperhidrosis Disease Severity Scale
- Appendix 7. Derivation of the relative risk from the event ranges
- Appendix 8. Network meta-analysis assuming individual surgery effects
- Appendix 9. Between-study variance estimates
- Appendix 10. Methods and graphic plots of the relationships between the Hyperhidrosis Disease Severity Scale level response ratios and the probability of response
- Appendix 11. Sample and sampling distributions for Hyperhidrosis Disease Severity Scale-level EuroQol-5 Dimensions index
- Appendix 12. Summary cost and quality-adjusted life-year estimates for each treatment sequence
- Appendix 13. Economic model
- Appendix 14. End-of-project workshop documents
- List of abbreviations
About the Series
Article history
The research reported in this issue of the journal was funded by the HTA programme as project number 14/211/02. The contractual start date was in December 2015. The draft report began editorial review in December 2016 and was accepted for publication in July 2017. The authors have been wholly responsible for all data collection, analysis and interpretation, and for writing up their work. The HTA editors and publisher have tried to ensure the accuracy of the authors’ report and would like to thank the reviewers for their constructive comments on the draft document. However, they do not accept liability for damages or losses arising from material published in this report.
Declared competing interests of authors
none
Last reviewed: December 2016; Accepted: July 2017.
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