Ketanserin for Raynaud's phenomenon in progressive systemic sclerosis.
OBJECTIVE
To assess the effects and toxicity of the following agent: ketanserin versus placebo proposed for the treatment of Raynaud's phenomenon (RP) in scleroderma.


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 All bibliographies of articles retrieved were searched and key experts in the area were contacted for additional and unpublished data.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


METHODS
All randomized controlled trials comparing ketanserin versus placebo were eligible if they reported clinical outcomes of interest. Trials with dropout rates greater than 35% were excluded.


METHODS
Data were abstracted independently by two reviewers (DF, AT). Peto's odds ratios (OR) were calculated for all dichotomous outcomes, and a weighted mean difference (WMD) was carried out on all continuous outcomes. A fixed effects or random effects model were used if the data was homogeneous or heterogeneous, respectively.


RESULTS
Three trials and 66 patients were included. The proportion improved was significantly better in the group on ketanserin with an odds ratio (OR) of 4.80 (95% CI 1.33, 17.37). However, when comparing ketanserin to placebo, the decrease in severity of RP attacks favoured placebo but this was not statistically significant. Side effects were significantly more common in the group using active treatment with an OR of 5.96 (95% CI 1.61, 22.06). Frequency of attacks did not change, but the duration of attacks decreased significantly in the ketanserin group.


CONCLUSIONS
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. It can be concluded that ketanserin treatment in Raynaud's phenomenon secondary to scleroderma is not clinically beneficial.
Pope
J
J
Medicine (Division of Rheumatology), University of Western Ontario, LHSC-South Campus, 375 South Street Room 309;Colborne Bldg., London, Ontario, Canada, N6A 4G5. jpope@julian.uwo.ca
Fenlon
D
D
Thompson
A
A
Shea
B
B
Furst
D
D
Wells
G
G
Silman
A
A
D006801:Humans; D007650:Ketanserin / Q000627:therapeutic use*; D011928:Raynaud Disease / Q000188:drug therapy* / Q000209:etiology*; D012595:Scleroderma, Systemic / Q000150:complications*; D012702:Serotonin Antagonists / Q000627:therapeutic use*
D012702:Serotonin Antagonists; D007650:Ketanserin