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Economic Evaluation of Botulinum Toxin Versus Thoracic Sympathectomy for Palmar Hyperhidrosis: Data from a Real-World Scenario

Introduction Local botulinum toxin injections and endoscopic thoracic sympathectomy (ETS) have shown clinical effectiveness for the treatment of palmar hyperhidrosis in several studies. Although both strategies cause considerable costs for health-care systems, at the moment there are no studies examining directly their cost-effectiveness performance. The aim of the study was to assess the incremental cost-effectiveness of botulinum toxin when compared with ETS for palmar hyperhidrosis. Materials and Methods Costs, effectiveness, and incremental cost-effectiveness ratio (ICER) were calculated. Costs were assessed from a Spanish National Health System perspective in a historical cohort of patients with palmar hyperhidrosis attending a tertiary referral hospital. Effectiveness was evaluated by using the Hyperhidrosis Disease Severity Scale (HDSS). A responder was defined as a patient who reported at least a two-grade improvement on the HDSS scale with respect to the baseline value. The horizon of time was 1 year. Results Effectiveness was greater for ETS (n = 128) when compared with botulinum toxin (n = 100) for the treatment of palmar hyperhidrosis (92% vs. 68%; odds ratio (OR) = 6.22 [2.80, 13.80]; absolute risk ratio (ARR) = −0.24 [−0.45, −0.14]; number-needed-to-treat (NNT) = −4 [−2, −11]). Botulinum toxin had an ICER of 125 € when compared with ETS during the first year of treatment. Conclusions In this retrospective real-world observational sample of patients with palmar hyperhidrosis, treatment with ETS appears to be more effective and less costly when compared with botulinum toxin during the first year of treatment. Analyses such as this give decision makers the tools to choose a better treatment option which is both highly effective and yet has a low cost.


INTRODUCTION
Primary palmar hyperhidrosis can cause occupational, social, and emotional problems that affect physical and mental well-being and usually lead to diminished quality of life [1].
Two of the treatment options currently considered as being most effective for this condition are periodical local injections of botulinum toxin and endoscopic thoracic sympathectomy (ETS) [2,3]. At present, there are no guidelines for the clinical use of these treatment modalities for palmar hyperhidrosis. In most cases, botulinum toxin and ETS are contemplated only when the less invasive medical treatments, such as topical or systemic medications (including glycopyrrolate and clonidine) and iontophoresis, have failed to provide adequate control of hyperhidrosis [4][5][6][7][8].
Studies directly comparing the effectiveness of botulinum toxin and ETS for palmar hyperhidrosis are scarce [9]. Recently, our group has observed that ETS is superior to botulinum toxin in the treatment of palmar hyperhidrosis in terms of efficacy and patient satisfaction, particularly in subjects with baseline severe palmar hyperhidrosis [10]. However, as yet there are no published studies that analyze the economic impact of both treatments. We believe that such an analysis is necessary, particularly because of the high cost associated with both treatments. Regardless of perspective, the objective of such an evaluation would be to provide information on the clinical and economic consequences related to these therapeutic alternatives faced by patient/ physician. From an economic standpoint, an outcomes analysis may provide general evidence that could guide future research efforts by identifying decision-critical parameters that help to indicate the best way to treat palmar hyperhidrosis. Therefore, the aim of this study was to evaluate the cost (expressed in monetary terms), with regard to efficiency and patientreported outcomes, between botulinum toxin and ETS in the treatment of palmar hyperhidrosis in a real-world scenario.

Population and Design
Following a retrospective and observational design, an economic evaluation was performed

Evaluation of Effectiveness and Patient Satisfaction
Effectiveness was evaluated by estimating hyperhidrosis severity at baseline and after treatment using the Hyperhidrosis Disease Severity Scale (HDSS) [11]. The patient is asked to select the statement that best reflects his or her experience with sweating of the specified body area ( An improvement of 1 or 2 points on the HDSS scale represents a reduction in sweat production

Statistical Analysis
The normality of the data was assessed using the Shapiro-Wilk test; logarithmic transformation was used when variables did not have a normal distribution. To check for differences between the two treatment groups, the Chi-square test was used for qualitative variables and the Student's t test for quantitative variables. All the data presented in the text, tables, and graphs are expressed as mean and standard deviation (SD), unless otherwise specified. We considered a 95% confidence interval for the mean and a P value of less than 0.05 as statistically significant. All tests were performed with different packages of the R statistical programming environment (GNU) [12].
All procedures were performed in accordance with the ethical standards of the responsible committee on human experimentation and with the Declaration of Helsinki of 1975.
Informed consent was obtained from all the patients included in the study.

Descriptive Temporal Analysis
The temporal analysis of efficacy, satisfaction,   My sweating is intolerable and always interferes with my daily activities this moment, an overlapping effect is observed between ETS cost/HDSSdif ratio and botulinum toxin cost/satisfaction ratio (Fig. 1).

Incremental Cost-effectiveness Analysis
In the course of the 5-year study period, total costs associated with palmar hyperhidrosis treatment at Reina Sofia University Hospital were € 178,704.00 for botulinum toxin and € 144,896.00 for ETS (Tables 5, 6). There are statistically significant differences in the reduction of HDSS and degree of satisfaction when botulinum toxin is compared with ETS (all P\0.05) ( Table 4). The incremental cost per additional responder following treatment with botulinum toxin was € 125 higher than after ETS during the first year ( Table 7). As the number-needed-to-treat (NNT) value shows, four patients have to be treated with botulinum toxin to obtain the same rate of effectiveness that is achieved with ETS (Table 8).     and reproduction in any medium, provided the original author(s) and the source are credited.