Prazosin for Raynaud's phenomenon in progressive systemic sclerosis

  • Harding S
  • Tingey P
  • Pope J
  • et al.
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Abstract

BackgroundBackgroundScleroderma 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.ObjectivesObjectivesTo assess the effects and toxicity of ketanserin versus placebo for the treatment of Raynaud's phenomenon (RP) in scleroderma.Search methodsSearch methodsWe 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 All bibliographies of articles retrieved were searched and key experts in the area were contacted for additional and unpublished data.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.Selection criteriaSelection criteriaAll 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 analysisData collection and analysisAll 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 resultsMain resultsSix 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).Authors' conclusionsAuthors' conclusionsKetanserin 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.

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Harding, S. E., Tingey, P. C., Pope, J., Fenlon, D., Furst, D., Shea, B., … Wells, G. A. (1998). Prazosin for Raynaud’s phenomenon in progressive systemic sclerosis. Cochrane Database of Systematic Reviews. https://doi.org/10.1002/14651858.cd000956

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