Abstract
BackgroundSystemic 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.MethodsA 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).ResultsThere 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.ConclusionsDespite 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.
Highlights
Systemic sclerosis is an orphan disease with the highest case-specific mortality of any connective-tissue disease
A double-blind randomized clinical trial conducted in accordance with the Declaration of Helsinki and the CONSORT Statement (Consolidated Standards of Reporting Trials) [8], following approval by the Local Ethics Committee and trial registered in the Clinical Trials Database (NCT00740285)
Patients Eligible for participation were those patients with diffuse or limited SSc according to the American College of Rheumatology (ACR) criteria [9]
Summary
Systemic sclerosis (scleroderma; SSc) is an orphan disease with the highest case-specific mortality of any connective-tissue disease. A cohort study, published in 1977, demonstrated that lidocaine appears to be an alternative treatment for patients with scleroderma - associated with an improvement in the cutaneous disorders and oesophageal manifestations and with no adverse effects [5]. This experimental cohort study included 15 patients with SSc and one patient with localized scleroderma. There was no change in the radiographic and electrocardiographic patterns and no occurrence of moderate or severe adverse effects during and after the infusions as well
Sign-in/Register to view highlights & summary Sign-in/Register to access full text options 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a callDisclaimer: All third-party content on this website/platform is and will remain the property of their respective owners and is provided on "as is" basis without any warranties, express or implied. Use of third-party content does not indicate any affiliation, sponsorship with or endorsement by them. Any references to third-party content is to identify the corresponding services and shall be considered fair use under The CopyrightLaw.
