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Swedish Council on Health Technology Assessment (SBU).

Version: March 13, 2013

Alcohol and hepatotropic viruses are major causes of liver fibrosis and liver cirrhosis. Colchicine is an anti‐inflammatory and anti‐fibrotic drug. This systematic review could not demonstrate any significant beneficial effects of colchicine on mortality, liver‐related mortality, liver complications, liver biochemistry, or liver histology of patients with liver fibrosis or liver cirrhosis due to alcohol, hepatitis B, hepatitis C, or unknown etiology. Colchicine was associated with a significant increase in adverse events. Accordingly, there seems to be no evidence for using colchicine for alcoholic, viral, or cryptogenic liver fibrosis/cirrhosis outside randomised clinical trials.

Cochrane Database of Systematic Reviews: Plain Language Summaries [Internet] - John Wiley & Sons, Ltd.

Version: April 20, 2005

Liver fibrosis is a change in the microscopic structure of the liver because of liver inflammation. After many years of excessive alcohol consumption, liver fibrosis progresses to cirrhosis. Abstaining from alcohol may stop the fibrosis from further progression into significant or severe fibrosis and cirrhosis. The latter lead to complications of underlying diseases, including cancer.

Cochrane Database of Systematic Reviews: Plain Language Summaries [Internet] - John Wiley & Sons, Ltd.

Version: January 22, 2015

Primary biliary cirrhosis (PBC) is a chronic disease of the liver that is characterised by destruction of bile ducts. Estimates of annual incidence range from 2 to 24 people per million population, and estimates of prevalence range from 19 to 240 people per million population. PBC primarily affects middle‐aged women. The forecast for the symptomatic patient after diagnosis is between 10 and 15 years. The cause of PBC is unknown, but the dynamics of the disease resemble the group 'autoimmune disease'. Therefore, one might expect a noticeable effect of administering an immune repressing drug (immunosuppressant). This review evaluates all clinical data on the immunosuppressant cyclosporin A for PBC.

Cochrane Database of Systematic Reviews: Plain Language Summaries [Internet] - John Wiley & Sons, Ltd.

Version: July 18, 2007

Heavy alcohol consumption causes alcoholic liver disease and may lead to a number of other concomitant diseases. Alcohol may damage the function of body organs and can cause cancer. Liver damage due to excessive alcohol consumption is usually presented as fatty liver (build‐up of fats in the liver), steatohepatitis (inflammation of the liver with concurrent fat accumulation in the liver), fibrosis (fibrous degeneration), alcoholic cirrhosis (scarring of the liver), and hepatocellular carcinoma (most common type of liver cancer). When liver fibrosis progresses, alcoholic cirrhosis occurs.

Cochrane Database of Systematic Reviews: Plain Language Summaries [Internet] - John Wiley & Sons, Ltd.

Version: March 2, 2016

The study found that treating all patients with chronic hepatitis C without a prior non-invasive liver test (NILT) is cost-effective; however, recently approved interferon-free regimens were not included. For hepatitis B e antigen (HBeAg)-negative patients, this strategy is cost-effective only if the higher cost-effectiveness threshold is appropriate. For HBeAg-positive patients, two NILTs applied sequentially were cost-effective but highly uncertain. No conclusive results could be obtained for alcoholic and non-alcoholic fatty liver disease. Most studies evaluating non-invasive fibrosis tests had a high risk of bias.

Health Technology Assessment - NIHR Journals Library.

Version: January 2015

Primary biliary cirrhosis is an uncommon, chronic liver disease of unknown etiology. D‐penicillamine, a cupruretic drug, has been tested in randomised clinical trials and is used to treat patients with primary biliary cirrhosis. After combining results from seven trials, D‐penicillamine did not appear to improve survival of patients. D‐penicillamine was associated with a four‐time increase of adverse events. There were no significant differences between D‐penicillamine and placebo/no intervention with respect to clinical changes, liver histology, and liver biochemistry.

Cochrane Database of Systematic Reviews: Plain Language Summaries [Internet] - John Wiley & Sons, Ltd.

Version: October 18, 2004

Primary biliary cirrhosis is a rare, chronic liver disease of unknown etiology. Colchicine, a plant alkaloid, has been used to treat patients with primary biliary cirrhosis and was tested in randomised clinical trials. When all identified trials were combined, colchicine appeared to be not significantly different from placebo/no intervention in respect to mortality, mortality and/or patients who underwent liver transplantation, liver complications, liver biochemistry, liver histology, and the occurrences of adverse events. Colchicine may reduce pruritus, but this finding may be due to bias. The addition of ursodeoxycholic acid did not significantly influence the effect of colchicine.

Cochrane Database of Systematic Reviews: Plain Language Summaries [Internet] - John Wiley & Sons, Ltd.

Version: April 19, 2004

Primary biliary cirrhosis (PBC) is a chronic disease of the liver that is characterised by destruction of bile ducts. Estimates of annual incidence range from 2 to 24 patients per million population, and estimates of prevalence range from 19 to 240 patients per million population. PBC primarily affects middle‐aged women. The forecast for the symptomatic patient after diagnosis is between 10 and 15 years. The cause of PBC is unknown, but the dynamics of the disease resemble the group 'autoimmune disease'. Therefore, one might expect a noticeable effect of administering an immune repressing drug (immunosuppressant). This review evaluates all clinical data on the immunosuppressant azathioprine in relation to PBC.

Cochrane Database of Systematic Reviews: Plain Language Summaries [Internet] - John Wiley & Sons, Ltd.

Version: July 18, 2007

Primary biliary cirrhosis is a chronic progressive cholestatic liver disease of presumed autoimmune aetiology. The clinical course might be improved by glucocorticosteroids. Only two small randomised clinical trials on this topic were identified. The trials were not large enough in terms of sample size or length of follow up to allow changes in mortality to be adequately evaluated. Glucocorticosteroids were associated with improvement in serum markers of inflammation and liver histology, both of which were of uncertain clinical significance. Glucocorticosteroids were also associated with adverse events, including reduced bone mineral density. Further trials are necessary if the effectiveness of glucocorticosteroids is to be properly evaluated.

Cochrane Database of Systematic Reviews: Plain Language Summaries [Internet] - John Wiley & Sons, Ltd.

Version: April 20, 2005

Primary biliary cirrhosis is an autoimmune disease of the liver. Chlorambucil has been used for patients with primary biliary cirrhosis as it possesses immunosuppressive properties. This review aimed to assess the beneficial or harmful effects of chlorambucil for primary biliary cirrhosis. The authors identified only one randomised trial, with 24 participants included. This trial compared chlorambucil with no intervention. The trial is small and at a high risk of bias, which suggests that the results may not be reliable. Meta‐analyses were not possible because of the inclusion of one trial only. Fisher's exact test and t‐test were used instead. Chlorambucil was not associated with significantly lower mortality when compared with no intervention. All patients on chlorambucil experienced adverse events, especially bone marrow suppression. Chlorambucil led to a significant improvement in mean serum levels of bilirubin, albumin, immunoglobulin M, serum aspartate aminotransferase activity, and hepatic inflammatory infiltrates. However, these outcomes are unvalidated surrogate outcomes for patient‐relevant outcomes. This means that improvement of these biochemistry measures cannot be taken as proof of improvement of patient‐relevant outcomes. It remains unclear whether chlorambucil can be supported or rejected for use in patients with primary biliary cirrhosis.

Cochrane Database of Systematic Reviews: Plain Language Summaries [Internet] - John Wiley & Sons, Ltd.

Version: September 12, 2012

Patients with primary biliary cirrhosis are mainly elderly women who are naturally prone to osteoporosis. Hormone replacement has been used worldwide to treat symptoms of menopause and to prevent chronic conditions such as osteoporosis. However, hormone replacement is associated with an increase in adverse events, several of which are serious. This review assessed the effect of hormone replacement on treatment of osteoporosis in women with primary biliary cirrhosis. We found no evidence of effect of hormone replacement on mortality and fractures in women with primary biliary cirrhosis. It seems that hormone replacement given to women with primary biliary cirrhosis is connected with a significant increase in the occurrence of adverse events compared with placebo or no intervention. Hormone replacement appears to have no effect on the lumbar bone mineral density compared with placebo or no intervention. Hormone replacement may decrease bone mineral density measured at the proximal femur. We did not find evidence to support the use of hormone replacement for osteoporosis in women with primary biliary cirrhosis.

Cochrane Database of Systematic Reviews: Plain Language Summaries [Internet] - John Wiley & Sons, Ltd.

Version: December 7, 2011

Primary biliary cirrhosis is an uncommon chronic liver disease of unknown aetiology, affecting mostly women. It is characterised by progressive inflammation and destruction of the liver tissue, eventually progressing to liver cirrhosis and the need for liver transplantation. Methotrexate, a folic acid antagonist with immunosuppressive properties, has been used to treat patients with primary biliary cirrhosis. However, the evidence did not show a clear benefit of methotrexate on mortality or the need for liver transplantation in patients with primary biliary cirrhosis. This review is based on five randomised trials; four comparing methotrexate with placebo, and one comparing methotrexate with colchicine. Methotrexate, compared with placebo, has no significant beneficial effect on mortality and the need for liver transplantation is not significantly reduced. The effects of methotrexate on pruritus, fatigue, clinical complications, liver biochemistry levels, liver histology, and adverse events were not significantly different from placebo. There may be some beneficial effect on pruritus score (ie, an objective measure of subjective feeling of pruritus), but we cannot recommend methotrexate for this indication only, taken into account possible adverse events. In the small trial comparing methotrexate versus colchicine, methotrexate seemed to work superior to colchicine, but it is not clear if this stems from the fact that methotrexate exerts beneficial effects as colchicine exerts harmful effects. In comparison with both placebo and colchicine, methotrexate was associated with large risks of mortality and adverse events, but the increase did not reach statistical significance.

Cochrane Database of Systematic Reviews: Plain Language Summaries [Internet] - John Wiley & Sons, Ltd.

Version: May 12, 2010

Bisphosphonates, such as etidronate, alendronate, ibandronate, are commonly used drugs for treatment of postmenopausal osteoporosis. This review looked at the effect of bisphosphonates for osteoporosis in patients with primary biliary cirrhosis. Six randomised trials, with 200 participants included, provided information for the review. These trials compared etidronate or alendronate with placebo or no intervention; etidronate or alendronate with alendronate or ibandronate; and etidronate with sodium fluoride.

Cochrane Database of Systematic Reviews: Plain Language Summaries [Internet] - John Wiley & Sons, Ltd.

Version: December 7, 2011

Primary biliary cirrhosis is a chronic disease of the liver that is characterised by progressive inflammation and destruction of the liver tissue, eventually progressing to liver cirrhosis and the need for liver transplantation. Primary biliary cirrhosis primarily affects middle‐aged women. Bezafibrate is a hypolipidaemic agent used in treatment of hypertriglyceridaemia. There are studies suggesting that bezafibrate, alone or in combination with ursodeoxycholic acid, is effective in treatment of primary biliary cirrhosis. Mechanisms through which bezafibrate improves lipid serum concentration balance and prevents biliary cell damage still need to be fully understood. This review evaluates all data on the benefits and harms of bezafibrate for patients with primary biliary cirrhosis in randomised clinical trials. The findings of this review are based on six randomised clinical trials with 151 Japanese patients. Bezafibrate was compared with no intervention in four trials (with co‐intervention of ursodeoxycholic acid in both the bezafibrate and control groups) and with ursodeoxycholic acid in two trials. The primary findings of the review are that bezafibrate has no statistically significant effects on mortality, liver‐related morbidity, adverse events, and quality of life of patients with primary biliary cirrhosis. A possible positive intervention effect of bezafibrate versus no intervention on liver biochemistry measures can be real but could also be due to systematic errors or random errors. The benefits and harms of bezafibrate for patients with primary biliary cirrhosis need further assessment in randomised clinical trials comparing bezafibrate with placebo. Such trials ought to be conducted with impeccable methodology to reduce the risks of random errors and sufficiently large patient groups to reduce the risks of random errors.

Cochrane Database of Systematic Reviews: Plain Language Summaries [Internet] - John Wiley & Sons, Ltd.

Version: January 18, 2012

Primary biliary cirrhosis is an uncommon and slowly progressive autoimmune disease of the liver that primarily affects middle‐aged women. The cause of the disease is unknown. Over the last 30 years, the prevalence of primary biliary cirrhosis has increased substantially. Primary biliary cirrhosis is now a frequent cause of liver morbidity, and the patients are significant users of health resources, including liver transplantation.

Cochrane Database of Systematic Reviews: Plain Language Summaries [Internet] - John Wiley & Sons, Ltd.

Version: December 12, 2012

Cirrhosis is a chronic disorder of the liver. People with cirrhosis may develop hepatic encephalopathy, a condition that results in poor brain functioning. Hepatic encephalopathy may be clinically obvious (overt) with changes including poor concentration, tremor, and alterations in consciousness. Others have no obvious clinical changes (minimal) but, when tested, some aspects of brain function such as attention and the ability to perform complex tasks are impaired.

Cochrane Database of Systematic Reviews: Plain Language Summaries [Internet] - John Wiley & Sons, Ltd.

Version: May 6, 2016

An estimated 250,000 Canadians have chronic hepatitis C virus (HCV) infection; however, the exact number affected is not known, as 30% to 70% of patients are unaware that they have been infected and limited population level surveillance has been carried out in Canada to document prevalent cases. While the incidence of HCV infection in the US and Canada appears to be stable or declining, liver-related morbidity and mortality are expected to increase over the coming decades, as those who are already infected age and develop progressive liver disease.

CADTH Therapeutic Review - Canadian Agency for Drugs and Technologies in Health.

Version: October 2014

Bibliographic details: Zhong L C, Jia H, Li C P, Ou S T, Yan P.  Endoscopic variceal ligation versus sclerotherapy variceal ligation for acute esophageal variceal bleeding patients with liver cirrhosis: a systematic review of the Chinese language literature. Chinese Journal of Evidence-Based Medicine 2007; 7(2): 135-141

Database of Abstracts of Reviews of Effects (DARE): Quality-assessed Reviews [Internet] - Centre for Reviews and Dissemination (UK).

Version: 2007

Esophageal varices are abnormal dilatations of veins in the lower part of the swallowing tube (oesophagus) that may develop in patients with chronic liver damage (cirrhosis). Bleeding from these varices is a life threatening complication with mortality between 20 and 50 per cent. Bleeding from varices may be treated with medications and/or with an endoscope which is a flexible tube with a camera at the end which allows direct visualization and treatment of bleeding varices. The reviewers evaluated the safety and effectiveness of a drug called terlipressin: they reported that terlipressin appears to be as safe as other treatments and that terlipressin may reduce the mortality from variceal bleeding as compared to placebo. The reviewers did not have sufficient data to decide whether terlipressin was better or worse than other available treatments such as other drugs (somatostatin, octreotide) or endoscopic treatment.

Cochrane Database of Systematic Reviews: Plain Language Summaries [Internet] - John Wiley & Sons, Ltd.

Version: January 20, 2003

Systematic Reviews in PubMed

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