Randomised controlled trials of ursodeoxycholic-acid therapy for primary biliary cirrhosis: a meta-analysis.
Background: Ursodeoxycholic acid (UDCA) is the only approved treatment for primary biliary cirrhosis, but its effect on disease progression and survival is uncertain. The aim of this study was to clarify the efficacy of UDCA in primary biliary cirrhosis.Methods: A systematic review, including the us...
| Publicado en: | Lancet Vol. 354; no. 9184; pp. 1053 - 1061 |
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| Autores principales: | , , , , , |
| Formato: | research systematic review tables/charts Journal Article |
| Publicado: |
Lancet
9/25/1999
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| Acceso en línea: | Ver este registro en EBSCOhost |
| fields | @attributes: recordID: 1 pdfLink: plink: https://search.ebscohost.com/login.aspx?direct=true&db=ccm&AN=107081906&site=ehost-live header: @attributes: shortDbName: ccm uiTerm: 107081906 longDbName: CINAHL Complete uiTag: AN controlInfo: bkinfo: dissinfo: jinfo: jid: 01406736 LAN jtl: Lancet issn: 01406736 maglogo: N pubinfo: dt: 9/25/1999 vid: 354 iid: 9184 pid: 1297 pub: Lancet place: Philadelphia, Pennsylvania artinfo: ui: 107081906 107081906 NLM10509495 2000003611 10.1016/s0140-6736(98)11293-x NLM10509495 107081906 ppf: 1053 ppct: 8 formats: fmt: @attributes: type: P tig: atl: Randomised controlled trials of ursodeoxycholic-acid therapy for primary biliary cirrhosis: a meta-analysis. aug: au: Goulis J Leandro G Burroughs AK Goulis, J Leandro, G Burroughs, A K affil: Liver Transplantation and Hepatobiliary Medicine, Royal Free Hospital, London, UK sug: subj: Gastrointestinal Agents Therapeutic Use Liver Cirrhosis Drug Therapy Bile Duct Diseases Drug Therapy Gastrointestinal Agents Adverse Effects Human Liver Cirrhosis Mortality Liver Drug Effects Meta Analysis Randomized Controlled Trials Sensitivity and Specificity ab: Background: Ursodeoxycholic acid (UDCA) is the only approved treatment for primary biliary cirrhosis, but its effect on disease progression and survival is uncertain. The aim of this study was to clarify the efficacy of UDCA in primary biliary cirrhosis.Methods: A systematic review, including the use of meta-analysis, was done for the randomised and switch-over phases of trials comparing UDCA with placebo, obtained from Medline and Embase databases, and from manual searches derived from review articles and abstracts of major international meetings. All trials had more than a mean of 6 months' follow-up and only included patients with primary biliary cirrhosis (PBC) according to established diagnostic criteria.Findings: 17 relevant articles were identified: 11 randomised controlled trials, including 1272 patients, and six reports of the switch-over phases. UCDA had a favourable effect on liver biochemistry in most of the studies but not on symptoms or the progression of histological stage; two studies did not assess survival, liver transplantation, or complications of liver disease. Meta-analysis showed no difference between UDCA and placebo in the incidence of death (odds ratio 1.21, 95% CI 0.71-2.04), liver related death (0.72, 0.22-2.32), liver transplantation (1.27, 0.78-2.07), death or liver transplantation (1.26, 0.87-1.82), and in the development of complications of liver disease (1.11, 0.64-1.92). With the primary end point defined by the authors (a combined end point in three studies, and death or liver transplantation in the others) an odds ratio of 1.53 (0.97-2.42) was obtained. Assessment of the switch-over phases, during which there was a longer follow-up, did not change the results of the meta-analysis.Interpretation: Published randomised controlled trials of UDCA do not show evidence of therapeutic benefit in PBC and its use as standard therapy needs to be re-examined. pubtype: Academic Journal doctype: research systematic review tables/charts Journal Article ougenre: Article language: English refInfo: holdings: @attributes: islocal: N |
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