Cyclofenil for Raynaud's phenomenon in progressive systemic sclerosis.

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 All bibliographies of articles retrieved were searched and key experts in the area were contacted for additional and unpublished data.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.

REVIEWER'S CONCLUSIONS: Cyclofenil is not effective in the treatment of Raynaud's phenomenon secondary to scleroderma.