Botulinum Toxin Versus Placebo: A Meta-Analysis of Treatment and Quality-of-life Outcomes for Hyperhidrosis

Abstract

Aims: This study aims at assessing the treatment effect, disease severity and quality-of-life outcomes of botulinum toxin (BTX) injections for focal hyperhidrosis.

Methods: We included randomized controlled trials of BTX injections compared with placebo for patients with primary or secondary focal hyperhidrosis. PubMed, Embase and the Cochrane Library were searched to August 2020. Gravimetric sweat rate reduction, disease severity measured by Hyperhidrosis Disease Severity Scale and quality-of-life assessment measured by Dermatology Life Quality Index were the outcomes of interest. Cochrane risk-of-bias tools were employed for quality assessment of given randomized controlled trials.

Results: Eight studies met our inclusion criteria (n=937). Overall, risk bias was mixed and mostly moderate. BTX injections showed reduced risk in comparison with placebo for the gravimetric quantitative sweat reduction of > 50 % from baseline (risk difference: 0.63, 95% CI 0.51 to 0.74). Additionally, improvements were seen for disease severity and quality-of-life assessments evaluated by Hyperhidrosis Disease Severity Score reduction of ≥ 2 points (risk difference: 0.56, 95% CI 0.42 to 0.69) and mean change in Dermatology Life Quality Index (mean difference: - 5.55, 95% CI - 7.11 to - 3.98). The acquired data were insufficient to assess for long-term outcomes and limited to an eight-week follow-up period.

Conclusions: In focal axillary hyperhidrosis, BTX significantly reduces sweat production and yields superior outcomes in assessments of disease severity and quality-of-life. However, the quality-of-evidence is overall moderate and included studies account for short-term trial periods only. Further studies assessing BTX in comparison with first-line treatments for hyperhidrosis are warranted.

Level of evidence iii: This journal requires that authors assign a level of evidence to each article. For a full description of these evidence-based medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .

Keywords: Botox; Botulinum toxin; Hyperhidrosis; Meta-analysis; Randomized controlled trial.

Fig. 1

PRISMA flow diagram of the study selection process

Fig. 2

Risk of bias graph presented as percentages across all included studies

Fig. 3

Risk of bias summary with detailed assessment of all included studies

Fig. 4

Comparison of botulinum toxin vs. placebo: gravimetric sweat reduction of ≥ 50% from baseline at weeks 2–6

Fig. 5

Comparison of botulinum toxin vs. placebo: reduction of ≥ 2 points in Hyperhidrosis Disease Severity Scale at weeks 2–8

Fig. 6

Comparison of botulinum toxin vs. placebo: mean change from baseline in Dermatology Life Quality Index score at weeks 2–8