Lidocaine for systemic sclerosis: a double-blind randomized clinical trial

Lidocaine for systemic sclerosis: a double-blind randomized clinical trial

Author Riera, Rachel Autor UNIFESP Google Scholar
Andrade, Luis E. C. Autor UNIFESP Google Scholar
Souza, Alexandre W. S. Autor UNIFESP Google Scholar
Kayser, Cristiane Autor UNIFESP Google Scholar
Yanagita, Edison T. Google Scholar
Trevisani, Virginia F. M. Autor UNIFESP Google Scholar
Institution Universidade Federal de São Paulo (UNIFESP)
Univ Santo Amaro
Abstract Background: Systemic sclerosis (scleroderma; SSc) is an orphan disease with the highest case-specific mortality of any connective-tissue disease. Excessive collagen deposit in affected tissues is a key for the disease's pathogenesis and comprises most of the clinical manifestations. Lidocaine seems to be an alternative treatment for scleroderma considering that: a) the patient's having excessive collagen deposits in tissues affected by scleroderma; b) the patient's demonstrating increased activity of the enzyme prolyl hydroxylase, an essential enzyme for the biosynthesis of collagen; and c) lidocaine's reducing the activity of prolyl hydroxylase. the aim of this study was to evaluate the efficacy and safety of lidocaine in treating scleroderma.Methods: A randomized double-blind clinical trial included 24 patients with scleroderma randomized to receive lidocaine or placebo intravenously in three cycles of ten days each, with a one-month interval between them. Outcomes: cutaneous (modified Rodnan skin score), oesophageal (manometry) and microvascular improvement (nailfold capillaroscopy); improvement in subjective self-assessment and in quality of life (HAQ).Results: There was no statistically significant difference between the groups for any outcome after the treatment and after 6-months follow-up. Improvement in modified Rodnan skin score occurred in 66.7% and 50% of placebo and lidocaine group, respectively (p = 0.408). Both groups showed an improvement in subjective self-assessment, with no difference between them.Conclusions: Despite the findings of a previous cohort study favouring the use of lidocaine, this study demonstrated that lidocaine at this dosage and means of administration showed a lack of efficacy for treating scleroderma despite the absence of significant adverse effects. However, further similar clinical trials are needed to evaluate the efficacy of lidocaine when administered in different dosages and by other means.
Language English
Sponsor Fundação de Amparo à Pesquisa do Estado de São Paulo (FAPESP)
Grant number FAPESP: 01-13895-9
Date 2011-02-07
Published in Orphanet Journal of Rare Diseases. London: Biomed Central Ltd, v. 6, 7 p., 2011.
ISSN 1750-1172 (Sherpa/Romeo, impact factor)
Publisher Biomed Central Ltd
Extent 7
Access rights Open access Open Access
Type Article
Web of Science ID WOS:000287522000001

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