M K Naumann1, H Hamm, N J Lowe. 1. Department of Neurology, University of Würzburg, Josef-Schneider-Str. 11, D-97080 Würzburg, Germany.
Abstract
BACKGROUND:Botulinum toxin type A (BTX-A) has been shown to be a safe and effective treatment for primary focal hyperhidrosis. However, the effect of BTX-A therapy on quality of life (QOL) in patients with this condition has only recently begun to be studied in controlled clinical trials. OBJECTIVES: To assess the impact on QOL of BTX-A treatment in patients with bilateral primary axillary hyperhidrosis. METHODS: A multicentre, randomized, double-blind, placebo-controlled trial enrolled 320 patients who exhibited persistent, bilateral, primary axillary hyperhidrosis sufficient to interfere with daily activities. These patients were treated with either 50 U BTX-A (Botox, Allergan, Inc., Irvine, CA, U.S.A.) or placebo in each axilla. QOL was assessed using the Hyperhidrosis Impact Questionnaire (HHIQ) at baseline and 1, 4, 8, 12 and 16 weeks post-treatment, as well as the Medical Outcomes Trust Short Form-12 Health Survey(SF-12) at baseline and 16 weeks post-treatment. RESULTS: At baseline, participants reported a marked negative impact of hyperhidrosis on various measures, including emotional status, ability to participate in daily and social activities, productivity at work and number of clothing changes per day. During the post-treatment period, statistically and clinically significantly greater improvements in all of these parameters were observed for the BTX-A group compared with the placebo group (P < 0.01). The BTX-A group improvements were observed within 1 week of treatment, and were sustained with little or no decline throughout the 16-week follow-up period. Compared with the baseline HHIQ responses regarding treatment history, BTX-A treatment resulted in a greater level of overall treatment satisfaction than did many other hyperhidrosis treatments. In addition, patients treated with BTX-A exhibited statistically significantly greater improvement in the physical component summary score of the SF-12 at 16 weeks than did placebo-treated patients (P < or = 0.019). CONCLUSIONS: Hyperhidrosis is associated with a substantial QOL burden; however, QOL is markedly improved with BTX-A treatment.
RCT Entities:
BACKGROUND: Botulinum toxin type A (BTX-A) has been shown to be a safe and effective treatment for primary focal hyperhidrosis. However, the effect of BTX-A therapy on quality of life (QOL) in patients with this condition has only recently begun to be studied in controlled clinical trials. OBJECTIVES: To assess the impact on QOL of BTX-A treatment in patients with bilateral primary axillary hyperhidrosis. METHODS: A multicentre, randomized, double-blind, placebo-controlled trial enrolled 320 patients who exhibited persistent, bilateral, primary axillary hyperhidrosis sufficient to interfere with daily activities. These patients were treated with either 50 U BTX-A (Botox, Allergan, Inc., Irvine, CA, U.S.A.) or placebo in each axilla. QOL was assessed using the Hyperhidrosis Impact Questionnaire (HHIQ) at baseline and 1, 4, 8, 12 and 16 weeks post-treatment, as well as the Medical Outcomes Trust Short Form-12 Health Survey(SF-12) at baseline and 16 weeks post-treatment. RESULTS: At baseline, participants reported a marked negative impact of hyperhidrosis on various measures, including emotional status, ability to participate in daily and social activities, productivity at work and number of clothing changes per day. During the post-treatment period, statistically and clinically significantly greater improvements in all of these parameters were observed for the BTX-A group compared with the placebo group (P < 0.01). The BTX-A group improvements were observed within 1 week of treatment, and were sustained with little or no decline throughout the 16-week follow-up period. Compared with the baseline HHIQ responses regarding treatment history, BTX-A treatment resulted in a greater level of overall treatment satisfaction than did many other hyperhidrosis treatments. In addition, patients treated with BTX-A exhibited statistically significantly greater improvement in the physical component summary score of the SF-12 at 16 weeks than did placebo-treated patients (P < or = 0.019). CONCLUSIONS:Hyperhidrosis is associated with a substantial QOL burden; however, QOL is markedly improved with BTX-A treatment.