title: Lidocaine for systemic sclerosis: a double-blind randomized clinical trial.
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.
  
  
  RESULTS
  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.
authors.affiliation: The Brazilian Cochrane Center and Discipline of Emergency Medicine and Evidence-Based Medicine, Universidade Federal de São Paulo-Escola Paulista de Medicina (UNIFESP-EPM), São Paulo, Brazil. rachelriera@hotmail.com
authors.forename: Rachel
authors.initials: R
authors.lastname: Riera
authors.forename: Luís E C
authors.initials: LE
authors.lastname: Andrade
authors.forename: Alexandre W S
authors.initials: AW
authors.lastname: Souza
authors.forename: Cristiane
authors.initials: C
authors.lastname: Kayser
authors.forename: Edison T
authors.initials: ET
authors.lastname: Yanagita
authors.forename: Virgínia F M
authors.initials: VF
authors.lastname: Trevisani
mesh_terms: D000328:Adult; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008012:Lidocaine / Q000008:administration & dosage / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D012595:Scleroderma, Systemic / Q000188:drug therapy*; D016896:Treatment Outcome
chemical_list: D008012:Lidocaine