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Cyclofenil for Raynaud's phenomenon in progressive systemic sclerosis

  • Review
  • Intervention

Authors


Abstract

Background

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.

Objectives

To assess the effects and toxicity of Cyclofenil versus placebo for the treatment of Raynaud's phenomenon (RP) in scleroderma.

Search methods

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 All bibliographies of articles retrieved were searched and key experts in the area were contacted for additional and unpublished data.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

Selection criteria

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.

Data collection and analysis

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.

Main results

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.

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.

摘要

背景

Cyclofenil用於治療全身性硬化症之雷諾氏症現象

硬皮症是結締組織纖維化,常影響皮膚及內臟器官,如胃腸、肺、腎、心臟。Cyclofenil可能可以治療原發性及次發性雷諾氏症現象。

目標

評估Cyclofenil與安慰劑用於治療硬皮症之雷諾氏症的效果與毒性比較

搜尋策略

搜尋包括the Cochrane Controlled Trials Register, MEDLINE (直到1996年)。關鍵字包括Raynaud's or vasospasm, scleroderma or progressive systematic sclerosis or connective tissue disease or autoimmune disease,Current Contents搜尋到1997年4月7日。同時手動搜尋文章之參考文獻,及詢問專家其它發表及未發表文獻。初步搜尋包括所有語言。

選擇標準

所有比較Cyclofenil與安慰劑且報告有任何臨床結果之隨機對照試驗研究。

資料收集與分析

兩位作者獨立進行資料摘錄。本文使用Peto's odds ratios來計算二分法的資料,使用加權平均差異(weighted mean difference:WMD)來分析連續性資料。並用固定效應模型(fixedeffects model)或隨機效應模型(randomeffects model)分別來檢定分析同質或異質性的資料。

主要結論

1篇研究,共有38例病患包含於分析中。在Cyclofenil治療組顯示進步比安慰劑組多趨勢,而比安慰劑組病患流失多,但未達統計上顯著差異。

作者結論

目前證據不足以支持或排除使用Cyclofenil用於治療全身性硬化症之雷諾氏症。

翻譯人

本摘要由林口長庚醫院余光輝翻譯。

此翻譯計畫由臺灣國家衛生研究院(National Health Research Institutes, Taiwan)統籌。

總結

無總結

Plain language summary

Cyclofenil is a drug that has been studied in the treatment for Raynaud's phenomenon and associated conditions. It is not used for RP and is an anabolic steroid. See also Cochrane review on Stanazol which is also an anabolic steroid.

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.

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