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. 2000;1998(2):CD000954.
doi: 10.1002/14651858.CD000954.

Ketanserin for Raynaud's phenomenon in progressive systemic sclerosis

J Pope  1 , D Fenlon, A Thompson, B Shea, D Furst, G Wells, A Silman
Affiliations

Ketanserin for Raynaud's phenomenon in progressive systemic sclerosis

J Pope et al. Cochrane Database Syst Rev. 2000.

Abstract

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

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 All bibliographies of articles retrieved were searched and key experts in the area were contacted for additional and unpublished data.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

Selection criteria: 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.

Data collection and analysis: 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.

Main 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.

Reviewer's 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.

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Conflict of interest statement

None known

Figures

1.1
1.1. Analysis
Comparison 1 Ketanserin vs. Placebo, Outcome 1 Number of patients who improved.
1.2
1.2. Analysis
Comparison 1 Ketanserin vs. Placebo, Outcome 2 side effects.
1.3
1.3. Analysis
Comparison 1 Ketanserin vs. Placebo, Outcome 3 Change in duration of attacks over the course of the study (min).
1.4
1.4. Analysis
Comparison 1 Ketanserin vs. Placebo, Outcome 4 Change in frequency of attacks over a 2 week period.
1.5
1.5. Analysis
Comparison 1 Ketanserin vs. Placebo, Outcome 5 Change in severity (10 point scale).
1.6
1.6. Analysis
Comparison 1 Ketanserin vs. Placebo, Outcome 6 Mean Functional Index.
See this image and copyright information in PMC

References

References to studies included in this review

Cadranel 1986 {published data only}
    1. Cadranel J, Bletry O, Guillevin L, Lacombe C, Fraitag B, Duloroy J, Mouthon JM, Godeau P. [Treatment of systemic scleroderma with ketanserin. Randomized, double‐blind 6‐months study of 27 cases]. [French] [Traitment de la sclerodermie systemique par la ketanserine]. Annales de Medecine Interne 1986;137(3):260‐3. - PubMed
Kirch 1987 {published data only}
    1. Kirch W, Linder HR, Hutt HJ, Ohnhaus EE, Mahler F. Ketanserin versus nifedipine in secondary Raynaud's phenomenon. VASA 1987;16(1):77‐80. - PubMed
Lukac 1985 {published data only}
    1. Lukac J, Rovensky J. Tauchmannova H.Zitnan D. Effect of ketanserin on Raynaud's phenomenon in progressive systemic sclerosis: a double‐blind trial. Drugs Under Experimental & Clinical Research 1985;11(9):659‐63. - PubMed
Ortonne 1989 {published data only}
    1. Ortonne JP, Torzuoli C. Dujardin P.Fraitag B. Ketanserin in the treatment of systemic sclerosis: a double‐blind controlled trial. British Journal of Dermatology 1989;120(2):261‐6. - PubMed
van de Wal 1987 {published data only}
    1. Wal HJCM, Wijn PFF, Leer HJJ, Skotnicki SH. The effectiveness of ketanserin in patients with primary Raynaud's phenomenon. A randomized, double blind, placebo controlled study. International Angiology 1987;6(3):313‐22. - PubMed

References to studies excluded from this review

Arneklo‐Nobin 1988 {published data only}
    1. Arneklo‐Nobin B, Elmer O, Akesson A. Effect of long‐term ketanserin treatment on 5‐HT levels, platelet aggregation and peripheral circulation in patients with Raynaud's phenomenon. A double‐blind, placebo‐controlled cross‐over study. International Angiology 1988;7(1):19‐25. - PubMed
Arosio 1989 {published data only}
    1. Arosio E, Montesi G, Zannoni M, Paluani F, Lechi A. Comparative efficacy of ketanserin and pentoxiphylline in treatment of Raynaud's phenomenon. Angiology 1989;40(7):633‐8. - PubMed
Arosio 1991 {published data only}
    1. Arosio E, Montesi G, Zannoni M, Perbellini L, Paluani F, Lechi A. Efficacy of ketanserin in the therapy of Raynaud's phenomenon: thermometric data. Angiology ‐ The Journal of Vascular Diseases 1991;42(5):408‐13. - PubMed
Baart 1986 {published data only}
    1. Baart de la Faille H, Weelden H, Banga JD, Kesteren RG. Cold‐induced Raynaud's phenomenon ameliorated by intravenous administration of ketanserin: a double‐blind cross‐over study. Archives of Dermatological Research 1986;279(1):3‐7. - PubMed
Brouwer 1987 {published data only}
    1. Brouwer RML, Wenting GJ, Man in't Veld AJ, Schalekamp MADH. Role of alpha‐adrenergic blockade in the cardiovascular actions of ketanserin: studies in patients with essential hypertension, autonomic insufficiency, and Raynaud's disease. Journal of Cardiovascular Pharmacology 1987;10(Supplement 3):S26‐31. - PubMed
Caputi 1991 {published data only}
    1. Caputi CA, Carolis G, Tomasetti C. Regional intravenous ketanserin and guanethidine therapy in Raynaud's phenomenon. Angiology 1991;42(6):473‐80. - PubMed
Codella 1989 {published data only}
    1. Codella O, Caramaschi P, Olivieri O, Perbellini L, Perbellini A, Bambara LM, Corrocher R, Sandre G. Controlled comparison of ketanserin and nifedipine in Raynaud's phenomenon. Angiology 1989;40(2):114‐21. - PubMed
Coffman 1989 {published data only}
    1. Coffman JD, Clement DL, Creager MA, Dormandy JA, Janssens MM, McKendry RJ, Murray GD, Nielsen SL. International study of ketanserin in Raynaud's phenomenon. American Journal of Medicine 1989;87(3):264‐8. - PubMed
Davinroy 1993 {published data only}
    1. Davinroy M, Mosnier M. Double‐blind clinical evaluation of naftidrofuryl in Raynaud's phenomenon. Semaine des Hopitaux 1993;69(36):1322‐6.
Engelhart 1988 {published data only}
    1. Engelhart M. Ketanserin in the treatment of Raynaud's phenomenon associated with generalized scleroderma. British Journal of Dermatology 1988;119(6):751‐4. - PubMed
Hansteen 1976 {published data only}
    1. Hansteen V. Medical treatment in Raynaud's disease. Acta Chirurgica Scandinavica. Supplementum 1976;465:87‐91. - PubMed
Klimiuk 1989 {published data only}
    1. Klimiuk PS, Kay EA, Mitchell WS, Taylor L, Gush R, Gould S, Jayson MIV. Ketanserin: An Effective Treatment Regimen for Digital Ischaemia in Systemic Sclerosis. Scandinavian Journal of Rheumatology 1989;18:107‐11. - PubMed
Kunnen 1988 {published data only}
    1. Kunnen JJ, Dahler HP, Doorenspleet JG, Oene JC. Effects of intra‐arterial ketanserin in Raynaud's phenomenon assessed by 99MTc‐pertechnetate scintigraphy. European Journal of Clinical Pharmacology 1988;34(3):267‐71. - PubMed
Longstaff 1985 {published data only}
    1. Longstaff J, Gush R, Williams EH, Jayson MI. Effects of ketanserin on peripheral blood flow, haemorheology, and platelet function in patients with Raynaud's phenomenon. Journal of Cardiovascular Pharmacology 1985;7 Suppl 7:S99‐101. - PubMed
Lukac 1991 {published data only}
    1. Lukac J, Rovensky J, Tauchmannova H, Zitnan D. Long‐term ketanserin treatment in patients with systemic sclerosis in Raynaud's phenomenon. Current Therapeutic Research 1991;50(6):869‐77.
Marasini 1988 {published data only}
    1. Marasini B, Biondi ML, Bianchi E, Dell'Orto P, Agostoni A. Ketanserin treatment and serotonin in patients with primary and secondary Raynaud's phenomenon. European Journal of Clinical Pharmacology 1988;35(4):419‐21. - PubMed
Marasini 1990 {published data only}
    1. Marasini B, Bassani C. Digital blood flow and 5‐hydroxytryptamine receptor blockade after ketanserin in patients with Raynaud's phenomenon. British Journal of Clinical Pharmacology 1990;30:847‐51. - PMC - PubMed
Roald 1984 {published data only}
    1. Roald OK, Seem E. Treatment of Raynaud's phenomenon with ketanserin in patients with connective tissue disorders. British Medical Journal Clinical Research Ed 1984;289(6445):577‐9. - PMC - PubMed
Seibold 1984 {published data only}
    1. Seibold JR, Jageneau AHM. Treatment of Raynaud's Phenomenon with Ketanserin, a Selective Antagonist of the Serotonin2 (5‐HT2) Receptor. Arthritis and Rheumatism 1984;27(2):139‐46. - PubMed
Tooke 1990 {published data only}
    1. Tooke JE, Williams SA, Rawlinson DW, Black C. Ketanserin and capillary flow in Raynaud's phenomenon. International Journal of Microcirculation: Clinical & Experimental 1990;9(3):249‐55. - PubMed
van de Wal 1985 {published data only}
    1. Wal HJCM, Wijn PFF, Leer HJJ, Skotnicki SH. Quantitative study of the effects of ketanserin in patients with primary Raynaud's phenomenon. Microcirculation, Endothelium, and Lymphatics 1985;2:657‐85. - PubMed

Additional references

ACR criteria
    1. Masi AT, Rodnan GP, Medsger TA Jr, et al. ACR Preliminary criteria for the classification of systemic sclerosis (scleroderma): Special article. Arthritis and Rheumatism 1980;23:581‐90. - PubMed
Altman 2001
    1. Altman DG, Schulz KF, Moher D, Egger M, Davidoff F, Elbournse D, Gotzsche PC, Lang T. The revised CONSORT statement for reporting randomized trials: explanation and elaboration. Annals of Internal Medicine 2001;134:663‐94. - PubMed
Cohen 1988
    1. Cohen J. Statistical Power Analysis for the Behavioral Sciences. Hillside, New Jersey: Lawrence Erlbaum Associates, Inc, 1988:21‐34.
Dickersin 1994
    1. Dickersin K, Scherer R, Lefebvre C. Identifying relevant studies for systematic reviews. BMJ 1994;309:1286‐91. - PMC - PubMed
Freedman 1984
    1. Freedman RR, Ianni P, Wenig P. Behavioral treatment of Raynaud's phenomenon in scleroderma. Journal of Behavioral Medicine 1984;7(4):343‐53. - PubMed
Jadad 1996
    1. Jadad A, Moore A, Carrol D, et al. Assessing the quality of reports of randomized clinical trials: is blinding necessary?. Controlled Clinical Trials 1996;17:1‐12. - PubMed
Kahaleh 1994
    1. Kahaleh MB. Raynaud's phenomenon and vascular disease in scleroderma. Current Opinion in Rheumatology 1994;6:621‐7. - PubMed
LeRoy 1992
    1. LeRoy EC, Medsger TA. Raynaud's Phenomenon: A Prosposal for Classification. Clinical and Experimental Rheumatology 1992;10:485‐8. - PubMed
Medsger 1985
    1. Medsger TA JR. Systemic sclerosis (scleroderma), eosinophilic fasciitis, and calcinosis. In: McCarty DJ editor(s). Arthritis and Allied Conditions. 10. Philadelphia: Lea & Febiger.
Petitti 1994
    1. Petitti D. Meta‐analysis, decision analysis, and cost‐effectiveness analysis: methods for quantitative synthesis in medicine. New York: Oxford University Press, 1994:90‐114.
Sapira 1972
    1. Sapira JD, Rodnan GP, Scheib ET, Klaniecki T, Rizk M. Studies of Endogenous Catecholamines in Patients with Raynaud's Phenomenon Secondary to Progressive Systemic Sclerosis (Scleroderma). The American Journal of Medicine 1972;52:330‐7. - PubMed

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