Lidocaine for systemic sclerosis: a double-blind randomized clinical trial
Rachel Riera1, Luís E C Andrade, Alexandre W S Souza
1The 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
Lidocaine did not prove effective in treating systemic sclerosis (scleroderma) in this clinical trial. While safe, it showed no significant benefit over placebo for skin, esophageal, or microvascular improvements.
Area of Science:
- Rheumatology
- Dermatology
- Pharmacology
Background:
- Systemic sclerosis (SSc) is a severe connective tissue disease characterized by excessive collagen deposition.
- Lidocaine's potential to inhibit prolyl hydroxylase, an enzyme crucial for collagen synthesis, suggested a possible therapeutic role.
- This study investigated lidocaine's efficacy for SSc, a condition with high mortality.
Purpose of the Study:
- To evaluate the efficacy and safety of lidocaine in treating systemic sclerosis (SSc).
- To assess lidocaine's impact on skin, esophageal, and microvascular manifestations of SSc.
- To compare lidocaine's effects against a placebo in SSc patients.
Main Methods:
- A randomized, double-blind clinical trial involving 24 SSc patients.
- Patients received intravenous lidocaine or placebo across three cycles.
- Outcomes included modified Rodnan skin score, esophageal manometry, nailfold capillaroscopy, and quality of life assessments.
Main Results:
- No statistically significant differences were observed between lidocaine and placebo groups for any outcome.
- Skin improvement (modified Rodnan score) was seen in 66.7% of placebo and 50% of lidocaine recipients.
- Subjective self-assessment improved similarly in both groups, with no significant difference.
Conclusions:
- Lidocaine, at the tested dosage and administration method, demonstrated a lack of efficacy in treating systemic sclerosis.
- The treatment was found to be safe, with no significant adverse effects reported.
- Further research with different dosages and administration routes is warranted to fully explore lidocaine's potential in SSc.
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