Pharmacological treatment for buerger's disease

dc.contributor.authorCacione, Daniel G. [UNIFESP]
dc.contributor.authorBaptista-Silva, Jose C. C. [UNIFESP]
dc.contributor.authorMacedo, Cristiane R. [UNIFESP]
dc.date.accessioned2019-01-21T10:30:03Z
dc.date.available2019-01-21T10:30:03Z
dc.date.issued2016
dc.description.abstractBackground Buerger's disease (thromboangiitis obliterans) is a non-atherosclerotic, segmental inflammatory pathology that most commonly affects the small and medium sized arteries, veins, and nerves in the upper and lower extremities. The etiology is unknown, but involves hereditary susceptibility, tobacco exposure, immune and coagulation responses. Inmany cases, there is no possibility of revascularization to improve the condition. Pharmacological treatment is an option for patients with severe complications, such as ischaemic ulcers or rest pain. Objectives To assess the effectiveness of any pharmacological agent (intravenous or oral) compared with placebo or any other pharmacological agent in patients with Buerger's disease. Search methods The Cochrane Vascular Trials Search Co-ordinator searched their Specialised Register (last searched in April 2015) and the Cochrane Register of Studies (Issue 3, 2015). The review authors searched trial registers and the European grey literatureen
dc.description.abstractscreened reference lists of relevant studies, and contacted study authors and major pharmaceutical companies. Selection criteria Randomised controlled trials (RCTs) involving pharmacological agents used in the treatment of Buerger's disease. Data collection and analysis Two review authors, independently assessed the studies, extracted data and performed data analysis. Main results Five randomised controlled trials (total 602 participants) compared prostacyclin analogue with placebo, aspirin, or a prostaglandin analogue, and folic acid with placebo. No studies assessed other pharmacological agents such as cilostazol, clopidogrel and pentoxifylline or compared oral versus intravenous prostanoid. Compared with aspirin, intravenous prostacyclin analogue iloprost improved ulcer healing (risk ratio (RR) 2.65en
dc.description.abstract95% confidence interval (CI) 1.15 to 6.11en
dc.description.abstract98 participantsen
dc.description.abstractone studyen
dc.description.abstractmoderate quality evidence), and helped to eradicate rest pain after 28 days (RR 2.28en
dc.description.abstract95% CI 1.48 to 3.52en
dc.description.abstract133 participantsen
dc.description.abstractone studyen
dc.description.abstractmoderate quality evidence), although amputation rates were similar six months after treatment (RR 0.32en
dc.description.abstract95% CI 0.09 to 1.15en
dc.description.abstract95 participantsen
dc.description.abstractone studyen
dc.description.abstractmoderate quality evidence). When comparing prostacyclin (iloprost and clinprost) with prostaglandin (alprostadil) analogues, ulcer healing was similar (RR 1.13en
dc.description.abstract95% CI 0.76 to 1.69en
dc.description.abstract89 participantsen
dc.description.abstracttwo studiesen
dc.description.abstractI-2 = 0%en
dc.description.abstractvery low quality evidence), as was the eradication of rest pain after 28 days (RR 1.57en
dc.description.abstract95% CI 0.72 to 3.44en
dc.description.abstract38 participantsen
dc.description.abstractone studyen
dc.description.abstractlow quality evidence), while amputation rates were not measured. Compared with placebo, the effects of oral prostacyclin analogue iloprost were similar for: healing ischaemic ulcers (iloprost 200 mcg: RR 1.11en
dc.description.abstract95% CI 0.54 to 2.29en
dc.description.abstract133 participantsen
dc.description.abstractone studyen
dc.description.abstractmoderate quality evidence, and iloprost 400 mcg: RR 0.90en
dc.description.abstract95% CI 0.42 to 1.93en
dc.description.abstract135 participantsen
dc.description.abstractone studyen
dc.description.abstractmoderate quality evidence), eradication of rest pain after eight weeks (iloprost 200 mcg: RR 1.14en
dc.description.abstract95% CI 0.79 to 1.63en
dc.description.abstract207 participantsen
dc.description.abstractone studyen
dc.description.abstractmoderate quality evidence, and iloprost 400 mcg: RR 1.11en
dc.description.abstract95% CI 0.77 to 1.59en
dc.description.abstract201 participantsen
dc.description.abstractone studyen
dc.description.abstractmoderate quality evidence), and amputation rates after six months (iloprost 200 mcg: RR 0.54en
dc.description.abstract95% CI 0.19 to 1.56en
dc.description.abstract209 participantsen
dc.description.abstractone study, and iloprost 400 mcg: RR 0.42en
dc.description.abstract95% CI 0.13 to 1.31en
dc.description.abstract213 participantsen
dc.description.abstractone study). When comparing folic acid with placebo in patients with Buerger's disease and hyperhomocysteinaemia, pain scores were similar, there were no new cases of amputation in either group, and ulcer healing was not assessed (very low quality evidence). Treatment side effects such as headaches, flushing or nausea were not associated with treatment interruptions or more serious consequences. Outcomes such as amputation-free survival, walking distance or pain-free walking distance, and ankle brachial index were not assessed by any study. Overall, the quality of the evidence was very low to moderate, with few studies, small numbers of participants, variation in severity of disease of participants between studies and missing information regarding for example baseline tobacco exposure. Authors' conclusions Moderate quality evidence suggests that intravenous iloprost (prostacyclin analogue) is more effective than aspirin for eradicating rest pain and healing ischaemic ulcers in Buerger's disease, but oral iloprost is not more effective than placebo. Verylow and low quality evidence suggests there is no difference between prostacyclin (iloprost and clinprost) and the prostaglandin analogue alprostadil for healing ulcers and relieving pain respectively in severe Buerger's disease. Very-low quality evidence suggests there is no difference in pain scores and amputation rates between folic acid and placebo, in people with Buerger's disease and hyperhomocysteinaemia. High quality trials assessing the effectiveness of pharmacological agents (intravenous or oral) in people with Buerger's disease are needed.en
dc.description.affiliationDepartment of Surgery, UNIFESP - Escola Paulista de Medicina, São Paulo, Brazil
dc.description.affiliationSurgery and Evidence Based Medicine, Brazilian Cochrane Centre, Universidade Federal de São Paulo, São Paulo, Brazil
dc.description.affiliationBrazilian Cochrane Centre, Centro de Estudos de Saúde Baseada em Evidências e Avaliação Tecnológica em Saúde, São Paulo, Brazil
dc.description.affiliationUnifespDepartment of Surgery, UNIFESP - Escola Paulista de Medicina, Rua Borges Lagoa, 564 cj 124, Vila Clementino, São Paulo, Brazil, 04038000
dc.description.sourceWeb of Science
dc.description.sponsorshipChief Scientist Office, Scottish Government Health Directorates, The Scottish Government, UK
dc.format.extentCD011033
dc.identifierhttp://dx.doi.org/10.1002/14651858.CD011033.pub2
dc.identifier.citationCochrane Database Of Systematic Reviews. Hoboken, n. 2, p. CD011033, 2016.
dc.identifier.doi10.1002/14651858.CD011033.pub2
dc.identifier.fileWOS000373285000067.pdf
dc.identifier.issn1469-493X
dc.identifier.urihttp://repositorio.unifesp.br/handle/11600/49546
dc.identifier.wosWOS:000373285000067
dc.language.isoeng
dc.publisherWiley
dc.relation.ispartofCochrane Database Of Systematic Reviews
dc.rightsinfo:eu-repo/semantics/openAccess
dc.subjectPlacebo-Controlled Trialen
dc.subjectThromboangiitis-Obliteransen
dc.subjectSystemic-Sclerosisen
dc.subjectDigital Ulcersen
dc.subjectDouble-Blinden
dc.subjectIloprosten
dc.subjectBosentanen
dc.subjectProstacyclinen
dc.subjectIschemiaen
dc.subjectArteriesen
dc.titlePharmacological treatment for buerger's diseaseen
dc.typeinfo:eu-repo/semantics/review
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