Raynaud's phenomenon is a disease that causes decreased blood flow and circulation to patients' extremeties. Symptoms include discolouration, pain, and in some severe cases ulceration of the hands and feet. It is most often triggered by cold, stress, and emotional discomfort. Primary Raynaud's phenomenon has no underlying disease associated with it. Secondary Raynaud's phenomenon is most often associated with scleroderma, but may also be related to systemic lupus erythematosus, mixed connective tissue disease, Sjorgen's syndrome, dermatomyositis or rheumatoid arthritis.
Scleroderma is a connective tissue disease causing hardening and commonly affects the skin and internal organs such as the GI tract, lungs, kidney and heart.
One trial which investigated the effect of cyclofenil on 38 patients was included (Blom-Bulow 1981). In general patients treated with Cyclofenil improved more than those treated with placebo, however, these improvements were not statistically significant. Patients treated with cyclofenil reported numerous side effects which in some cases were severe and included an allergic reaction and complications associated with underlying heart conditions.
This review assessed a limited number of studies and therefore the conclusions reached need to be investigated further.
阅读完整摘要
Raynaud's is a vasodilatory phenomenon characterised by digital pallor, cyanosis and pain of the extremities. Primary Raynaud's phenomenon has no underlying disease associated with it, while secondary Raynaud's phenomenon is associated with conective tissue disorders such as scleroderma. 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 RP secondary to scleroderma.
研究目的
To assess the effects and toxicity of Cyclofenil versus placebo for the treatment of Raynaud's phenomenon (RP) in scleroderma.
检索策略
We searched the Cochrane Central Register of Controlled Trials (The Cochrane Library 2007, Issue 3), Medline (January 1966 to August 2007), and Embase (1974 to August 2007) using the Cochrane Collaboration search strategy developed by Dickersin et al.(1994). Current Contents were searched up to and including August 1, 2007. All bibliographies of articles retrieved were searched and key experts in the area were contacted for additional and unpublished data.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.
纳入排除标准
All randomized controlled trials comparing cyclofenil versus placebo were eligible if they reported clinical outcomes of interest. Trials with dropout rates greater than 30% were excluded.
资料收集与分析
All data were abstracted by two independent and trained reviewers (SH, PT), and verified by a third reviewer (JP). Each trial was assessed independently by the same two reviewers for its quality using a validated quality assessment tool (Altman 2001).
Peto's odds ratios were calculated for all dichotomous outcomes and a weighted mean difference was carried out on all continuous outcomes. Fixed effects and random effects model were used if the data was homogeneous or heterogeneous, respectively.
主要结果
One trial with 38 patients was included. There was a trend for Cyclofenil to demonstrate more improvement [OR 1.26 (95% CI 0.33, 4.73)] and more dropouts [OR 1.58 (95% CI 0.42, 5.91)] compared to placebo, but there were no statistically significant differences. The quality score of the one included study was 4 of 5.
作者结论
There is insufficient evidence either to support or to refute the use of Cyclofenil in the treatment of Raynaud's phenomenon secondary to scleroderma.
