This version first published online:
January 26. 1998
Abstract
Background
Scleroderma is a connective tissue disease causing fibrosis and commonly affects the skin and internal organs such as the GI tract, lungs, kidney and heart. Cyclofenil is a drug which is well tolerated and may have efficacy in the treatment of primary and secondary RP.
Objectives
To assess the effects and toxicity of Cyclofenil versus placebo for the treatment of Raynaud's phenomenon (RP) in scleroderma.
Search strategy
We searched the Cochrane Controlled Trials Register, and MEDLINE up to 1996 using the Cochrane Collaboration search strategy developed by Dickersin et al.(1994). Key words included: Raynaud's or Vasospasm, Scleroderma or Progressive Systematic Sclerosis or Connective Tissue Disease or Autoimmune Disease. Current Contents were searched up to and including April 7, 1997. All bibliographies of articles retrieved were searched and key experts in the area were contacted for additional and unpublished data. The initial search strategy included all languages.
Selection criteria
All randomized trials comparing cyclofenil versus placebo were eligible if they reported any clinical outcomes within the trial.
Data collection and analysis
Data were abstracted independently by two reviewers (DF, AT). Peto's odds ratio (OR) was calculated for all dichotomous outcomes, and a weighted mean difference was calculated for all continuous outcomes. A fixed effects or random effects model was used if the data were homogeneous or heterogeneous respectively.
Main results
One trial with 38 patients was included. There was a trend for Cyclofenil to demonstrate more improvement and more dropouts compared to placebo, but there were no statistically significant differences.
Authors' conclusions
There is insufficient evidence either to support or to refute the use of Cyclofenil in the treatment of Raynaud's phenomenon secondary to scleroderma.