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. Most people with scleroderma also have Raynaud's phenomenon (RP). One of the possible treatment options for RP in scleroderma is ketanserin.
To assess the effects and toxicity of ketanserin versus placebo for the treatment of Raynaud's phenomenon (RP) in scleroderma.
We searched the Cochrane Controlled Trials Register, and Medline up to August 1, 2007 using the Cochrane Collaboration search strategy developed by Dickersin et al.(1994). Key words included: Raynaud's or vasospasm, scleroderma or progressive systemic sclerosis or connective tissue disease or autoimmune disease. 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 All bibliographies of articles retrieved were searched and key experts in the area were contacted for additional and unpublished data.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.
All randomized controlled trials comparing ketanserin 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.
Six trials and 146 patients were included. The proportion improved was significantly better in the group on ketanserin with a Peto's odds ratio (OR) of 2.74 (95% CI 1.42, 5.11) (Cadranel 1986; Dormandy 1988; Kirch 1987; Lukac 1985; van de Wal 1987). When comparing ketanserin to placebo, the decrease in frequency of RP attacks favoured placebo and was statistically significant [WMD (fixed) 25.20 (95% CI 22.55,27.85)] (Kirch 1987). Side effects were significantly more common in the group using active treatment [Peto's OR 2.63 (95% CI 1.42, 4.88)] (Cadranel 1986; Kirch 1987; Lukac 1985; Ortonne 1989; van de Wal 1987). Duration of attacks significantly favoured the placebo group over the active treatment [WMD (fixed) 4.10 (95% CI 3.57, 4.63)] (Kirch 1987).
Ketanserin may have some efficacy in the treatment of Raynaud's phenomenon secondary to scleroderma. Overall, ketanserin is not significantly different from placebo for the treatment of Raynaud's phenomenon except for some decrease in the duration of attacks and more subjects improved on ketanserin compared to placebo. However, there were more side effects, and the frequency of attacks actually favored placebo. It can be concluded that ketanserin treatment in Raynaud's phenomenon secondary to scleroderma is not clinically beneficial.
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。
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(fixedeffects model)或隨機效應模型(randomeffects model)分別來檢定分析同質或異質性的資料。
3篇研究，共有66例病患包含於分析中。在ketanserin治療組進步比率較多OR 4.80 (95% CI 1.33, 17.37)。但在發作發作嚴重度減少方面，安慰劑組減少比ketanserin組多，但未達顯著上差異。副作用在治療組較多OR 5.96 (95% CI 1.61, 22.06)，ketanserin組發作頻率未改變，但發作時間顯著減少。
此翻譯計畫由臺灣國家衛生研究院(National Health Research Institutes, Taiwan)統籌。