Dimitrinka Nikolova

Rigshospitalet | rigshospitalet · Copenhagen Trial Unit

Background: Clinical practice guidelines (CPGs) contain recommendations intended to aid clinicians in providing optimal care for patients and should be derived from the best quality evidence available. The highest quality evidence is obtained through systematic reviews using Cochrane methodology. This exploratory study aimed to determine the propor...

Background: Vitamin D deficiency is often reported in people with chronic liver diseases. Improving vitamin D status could therefore be beneficial for people with chronic liver diseases. Objectives: To assess the beneficial and harmful effects of vitamin D supplementation in adults with chronic liver diseases. Search methods: We searched the C...

Background: Chronic hepatitis B is associated with high morbidity and mortality. Chronic hepatitis B requires long-term management aiming at reduction of the risks of hepatocellular inflammatory necrosis, liver fibrosis, decompensated liver cirrhosis, liver failure, and liver cancer, and improving health-related quality of life. The Chinese herbal...

Our Cochrane systematic review on glucocorticosteroids versus placebo or no intervention for people with alcoholic hepatitis found no evidence of a difference on clinically important outcomes at either of the three timepoints of follow‐up.(4) Our review (last search 18.01.2019) was based on a pre‐published, peer‐reviewed protocol. In a subgroup met...

Background: Chronic hepatitis B is a liver disease associated with high morbidity and mortality. Chronic hepatitis B requires long-term management aiming to reduce the risks of hepatocellular inflammatory necrosis, liver fibrosis, decompensated liver cirrhosis, liver failure, and liver cancer, as well as to improve health-related quality of life....

Alcoholic hepatitis (AH) is a form of alcoholic liver disease. Glucocorticosteroids (GCS) are used as anti - inflammatory drugs for people with alcoholic hepatitis. Aim: To assess the benefits and harms of GCS in people with AH. Material and methods: We identified trials through electronic searches in Cochrane Hepato-Biliary's (CHB) Controlled...

Background: Intrahepatic cholestasis of pregnancy is a pregnancy-specific liver disorder, possibly associated with an increased risk of severe fetal adverse events. Total serum bile acids (TSBA) concentration, alone or in combination with serum aminotransferases, have been the most often used biomarkers for the diagnosis of intrahepatic cholestasi...

Background: Plasma volume expanders are used in connection to paracentesis in people with cirrhosis to prevent reduction of effective plasma volume, which may trigger deleterious effect on haemodynamic balance, and increase morbidity and mortality. Albumin is considered the standard product against which no plasma expansion or other plasma expande...

Background: Hepatitis B virus (HBV) infection is a liver disease caused by hepatitis B virus, which may lead to serious complications such as cirrhosis and hepatocellular carcinoma. People with HBV infection may also have coinfections including HIV and other hepatitis viruses (hepatitis C or D), and coinfections may increase the risk of all-cause...

Background: Alcoholic hepatitis is a form of alcoholic liver disease characterised by steatosis, necroinflammation, fibrosis, and complications to the liver. Typically, alcoholic hepatitis presents in people between 40 and 50 years of age. Alcoholic hepatitis can be resolved if people abstain from drinking, but the risk of death will depend on the...

Background Alcoholic hepatitis is a form of alcoholic liver disease characterised by steatosis, necroinflammation, fibrosis, and complications to the liver. Typically, alcoholic hepatitis presents in people between 40 and 50 years of age. Alcoholic hepatitis can be resolved if people abstain from drinking, but the risk of death will depend on the s...

Background: Hepatitis B virus (HBV) infection, a liver disease caused by hepatitis B virus, may lead to serious complications such as cirrhosis and hepatocellular carcinoma. People with HBV infection may have co-infections including HIV and other hepatitis viruses (hepatitis C or D), and co-infection may increase the risk of all-cause mortality. C...

Non-alcoholic fatty liver disease (NAFLD) covers conditions related to accumulation of fat in the liver if specific causes, such as significant alcohol consumption, long-term use of a steatogenic medication, or monogenic hereditary disorders can be excluded (WGO 2014). Non-alcoholic fatty liver disease features a wide spectrum of histologically con...

This is a protocol for a Cochrane Review (Intervention). The objectives are as follows: To assess the benefits and harms of antibiotic prophylaxis in people with cirrhosis and variceal bleeding.

A commentary [1] criticized our systematic review regarding the use of direct‐acting agents (DAAs) in chronic hepatitis C [2]. The following represents our major disagreements. Sustained virological response (SVR) is a non‐validated surrogate outcome. The principles of evidence‐based medicine require that it be validated in randomized clinical tria...

This is a protocol for a Cochrane Review (Intervention). The objectives are as follows: To assess the benefits and harms of Radix Sophorae flavescentis versus antiviral drugs in people with chronic hepatitis B.

This is a protocol for a Cochrane Review (Intervention). The objectives are as follows: To assess the benefits and harms of acupuncture versus no intervention or sham acupuncture for people with chronic hepatitis B.

Background: Hepatosplenic schistosomiasis is an important cause of variceal bleeding in low-income countries. Randomised clinical trials have evaluated the outcomes of two categories of surgical interventions, shunts and devascularisation procedures, for the prevention of variceal rebleeding in people with hepatosplenic schistosomiasis. The compar...

This is a protocol for a Cochrane Review (Intervention). The objectives are as follows: To assess the benefits and harms of Radix Sophorae flavescentis compared with placebo or no intervention in people with chronic hepatitis B.

This is a protocol for a Cochrane Review (Intervention). The objectives are as follows: To assess the benefits and harms of Xiao Chai Hu Tang formula versus placebo or no intervention in people with chronic hepatitis B.

Background: Vitamin D deficiency is often reported in people with chronic liver diseases. Therefore, improving vitamin D status could have a beneficial effect on people with chronic liver diseases. Objectives: To assess the beneficial and harmful effects of vitamin D supplementation in people with chronic liver diseases. Search methods: We sea...

Background: Alcoholic hepatitis is a form of alcoholic liver disease, characterised by steatosis, necroinflammation, fibrosis, and potential complications to the liver disease. Typically, alcoholic hepatitis presents in people between 40 and 50 years of age. Alcoholic hepatitis can be resolved if people abstain from drinking, but the risk of death...

Background: Millions of people worldwide suffer from hepatitis C, which can lead to severe liver disease, liver cancer, and death. Direct-acting antivirals (DAAs), e.g. sofosbuvir, are relatively new and expensive interventions for chronic hepatitis C, and preliminary results suggest that DAAs may eradicate hepatitis C virus (HCV) from the blood (...

Background: Millions of people worldwide suffer from hepatitis C, which can lead to severe liver disease, liver cancer, and death. Direct-acting antivirals (DAAs) are relatively new and expensive interventions for chronic hepatitis C, and preliminary results suggest that DAAs may eradicate hepatitis C virus (HCV) from the blood (sustained virologi...

This is a protocol for a Cochrane Review (Intervention). The objectives are as follows: This systematic review will evaluate the beneficial and harmful effects of beta-blockers on preventing oesophageal variceal rebleeding in cirrhotic patients who survived a variceal bleeding. © 2017 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

This is a protocol for a Cochrane Review (Diagnostic test accuracy). The objectives are as follows: To determine the diagnostic accuracy of total serum bile acids or total serum bile acids profile, or both for the diagnosis of intrahepatic cholestasis of pregnancy in pregnant women presenting with pruritus. To compare the diagnostic accuracy of tot...

This is a protocol for a Cochrane Review (Intervention). The objectives are as follows: To assess the benefits and harms of clevudine versus placebo, no intervention, or any of the nucleoside/nucleotide analogues, in people with chronic HBV infection.

This is the protocol for a review and there is no abstract. The objectives are as follows: To determine the diagnostic accuracy of FibroTest, transient elastography method, combined FibroTest and transient elastography method, no matter the sequence, using liver biopsy as reference standard, for assessment of severe hepatic fibrosis and cirrhosis i...

This is the protocol for a review and there is no abstract. The objectives are as follows: To determine the diagnostic accuracy of FibroTest, transient elastography method, combined FibroTest and transient elastography method, no matter the sequence, using liver biopsy as reference standard, for assessment of severe hepatic fibrosis and cirrhosis i...

This is the protocol for a review and there is no abstract. The objectives are as follows: To assess the benefits and harms of glucocorticosteroids in people with alcoholic hepatitis.

This is the protocol for a review and there is no abstract. The objectives are as follows: To assess the benefits and harms of glucocorticosteroids in people with alcoholic hepatitis.

This is a protocol for a Cochrane Review (Intervention). The objectives are as follows: To assess the benefits and harms of direct-acting antivirals (DAAs) in patients with chronic hepatitis C virus infection.

Background: Heavy alcohol consumption causes alcoholic liver disease and is a causal factor of many types of liver injuries and concomitant diseases. It is a true systemic disease that may damage the digestive tract, the nervous system, the heart and vascular system, the bone and skeletal muscle system, and the endocrine and immune system, and can...

BACKGROUND: Heavy alcohol consumption causes alcoholic liver disease and is a causal factor of many types of liver injuries and concomitant diseases. It is a true systemic disease that may damage the digestive tract, the nervous system, the heart and vascular system, the bone and skeletal muscle system, and the endocrine and immune system, and can...

Background The progression of hepatic fibrosis into cirrhosis is a main prognostic factor for survival in people with alcoholic liver disease. The range of cut-off values characterising the stage of hepatic fibrosis seems to be dependent on the aetiology of the liver disease. AimsTo determine the diagnostic accuracy of transient elastography (the i...

BACKGROUND: Our previous systematic review has demonstrated that antioxidant supplements may increase mortality. We have now updated this review. OBJECTIVES: To assess the beneficial and harmful effects of antioxidant supplements for prevention of mortality in adults. METHODS: Search methods: We searched The Cochrane Library, Medline, Embase, Lil...

This is the protocol for a review and there is no abstract. The objectives are as follows: To determine the diagnostic accuracy of ultrasonography for detecting the presence or absence of cirrhosis in people with alcoholic liver disease compared with liver biopsy as reference standard. To determine the diagnostic accuracy of any of the ultrasonogra...

This is the protocol for a review and there is no abstract. The objectives are as follows: To assess the beneficial and harmful effects of vitamin D supplementation in people with chronic liver diseases.

Background: The presence and progression of hepatic (liver) fibrosis into cirrhosis is a prognostic variable having impact on survival in people with alcoholic liver disease. Liver biopsy, although an invasive method, is the recommended 'reference standard' for diagnosis and staging of hepatic fibrosis in people with liver diseases. Transient elas...

Unlabelled: The diagnostic research process can be divided into five phases, designed to establish the clinical utility of a new diagnostic test--the index test. The aim of the present review is to illustrate the study designs that are appropriate for each diagnostic phase, using clinical examples regarding liver fibrosis diagnosed with transient...

Background: The evidence on whether vitamin D supplementation is effective in decreasing cancers is contradictory. Objectives: To assess the beneficial and harmful effects of vitamin D supplementation for prevention of cancer in adults. Search methods: We searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, L...

Oxidative damage to cells and tissues is considered involved in the aging process and in the development of chronic diseases in humans, including cancer and cardiovascular diseases, the leading causes of death in high-income countries. This has stimulated interest in the preventive potential of antioxidant supplements. Today, more than one half of...

Are antioxidant supplements associated with higher or lower all-cause mortality? Antioxidant supplements are not associated with lower all-cause mortality. Beta carotene, vitamin E, and higher doses of vitamin A may be associated with higher all-cause mortality.

Evidence shows that antioxidant supplements may increase mortality. Our aims were to assess whether different doses of beta-carotene, vitamin A, and vitamin E affect mortality in primary and secondary prevention randomized clinical trials with low risk of bias. The present study is based on our 2012 Cochrane systematic review analyzing beneficial a...

This is the protocol for a review and there is no abstract. The objectives are as follows: To determine the diagnostic accuracy of transient elastography for detecting hepatic fibrosis in people with alcoholic liver disease when compared with liver biopsy as reference standard. In particular, no significant hepatic fibrosis (F0, F1) and significant...

Our systematic review has demonstrated that antioxidant supplements may increase mortality. We have now updated this review. To assess the beneficial and harmful effects of antioxidant supplements for prevention of mortality in adults. We searched The Cochrane Library, MEDLINE, EMBASE, LILACS, the Science Citation Index Expanded, and Conference Pro...

The major issues of the modern medicine in high-income countries are how to prevent chronic diseases including cancer and cardiovascular diseases in order to prolong life span. It has been speculated that the aging process and development of chronic diseases are consequences of oxidative damage to cells and tissues. Oxidative stress defined as an i...

Background: Available evidence on the effects of vitamin D on mortality has been inconclusive. In a recent systematic review, we found evidence that vitamin D3 may decrease mortality in mostly elderly women. The present systematic review updates and reassesses the benefits and harms of vitamin D supplementation used in primary and secondary prophy...

The Cochrane Hepato-Biliary Group (CHBG) is one of the 52 collaborative review groups within The Cochrane Collaboration. The activities of the CHBG focus on collecting hepato-biliary randomized clinical trials (RCT) and controlled clinical trials (CCT), and including them in systematic reviews with meta-analyses of the trials. In this overview, we...

Several liver diseases have been associated with oxidative stress. Accordingly, antioxidants have been suggested as potential therapeutics for various liver diseases. The evidence supporting these suggestions is equivocal. To assess the benefits and harms of antioxidant supplements for patients with liver diseases. We searched The Cochrane Library,...

Surgical trials evaluating multiple interventions can be carried out by using parallel or factorial trial design. The optimal trial method has not been established. Trials involving interventions to facilitate day-case laparoscopic cholecystectomy have been chosen to illustrate the strengths and weaknesses of these two trials designs. The parallel...

Several liver diseases have been associated with oxidative stress. Accordingly, antioxidants have been suggested as potential therapeutics for various liver diseases. The evidence supporting these suggestions is equivocal. To assess the benefits and harms of antioxidant supplements for patients with liver diseases. We identified trials through elec...

Meta-analysis of randomized clinical trials (RCTs) with low risk of bias is considered the highest level of evidence available for evaluating an intervention. Bias in RCTs may overestimate or underestimate the true effectiveness of an intervention. The causes of bias in surgical trials as described by The Cochrane Collaboration, and the methods tha...

Hepatitis A is a common, contagious viral disease in low-income countries. Hepatitis A is transmitted primarily by faecal-oral spread from person to person. Passive immunoprophylaxis for hepatitis A using immunoglobulin preparations were essential for prevention before development of specific hepatitis A vaccine (active immunisation). This review c...

The evidence on whether antioxidant supplements prevent gastrointestinal cancers is contradictory. To assess the beneficial and harmful effects of antioxidant supplements in preventing gastrointestinal cancers. Using the Cochrane Collaboration methodology, we reviewed the randomized trials comparing antioxidant supplements with placebo or no interv...

Oxidative stress may cause gastrointestinal cancers. The evidence on whether antioxidant supplements are effective in preventing gastrointestinal cancers is contradictory. To assess the beneficial and harmful effects of antioxidant supplements in preventing gastrointestinal cancers. We identified trials through the trials registers of the four Coch...

Animal and physiological research as well as observational studies suggest that antioxidant supplements may improve survival. To assess the effect of antioxidant supplements on mortality in primary or secondary prevention randomised clinical trials. We searched The Cochrane Library (Issue 3, 2005), MEDLINE (1966 to October 2005), EMBASE (1985 to Oc...

To compare banding ligation versus beta-blockers as primary prophylaxis in patients with esophageal varices and no previous bleeding. Randomized trials were identified through electronic databases, reference lists in relevant articles, and correspondence with experts. Three authors extracted data. Random effects meta-analysis and metaregression wer...

Letters Section Editor Robert M. Golub, MD, Senior Editor.

Antioxidant supplements are used for prevention of several diseases. To assess the effect of antioxidant supplements on mortality in randomized primary and secondary prevention trials. DATA SOURCES AND TRIAL SELECTION: We searched electronic databases and bibliographies published by October 2005. All randomized trials involving adults comparing bet...

Identified country and type of trial of the 906 randomly selected records. The data provided represent the findings of an in-depth scrutiny of a random sample of 906 records.

The number of publications on clinical trials is unknown as well as the countries publishing most trial reports. To try to examine these questions we performed an ecological study. We searched the 454,449 records on publications in The Cochrane Central Register of Controlled Trials (CENTRAL) in The Cochrane Library, Issue 3, 2005 (CD-ROM version) f...

On page 845 in the first paragraph of the “All Randomized Trials” subsection, the sentence that read “Heterogeneity was not significant (I²=18.6%, P=.10)” should have read “Heterogeneity was significant (I²=18.9%, P=.10).” In the following sentence that begins “Adjusted-rank correlation test (P=.08), but not the regression asymmetry test (P=.26), s...

Colorectal cancer may be prevented by reducing the development of adenomatous polyps. To assess the benefits and harms of antioxidant supplements in preventing colorectal adenoma. Using the Cochrane Collaboration methodology we reviewed all randomized clinical trials comparing antioxidant supplements with placebo or no intervention. We searched ele...

Cited By (since 1996):6, Export Date: 18 October 2014

Oxidative stress can cause cancer. Our aim was to establish whether antioxidant supplements reduce the incidence of gastrointestinal cancer and mortality. With the Cochrane Collaboration methodology, we reviewed all randomised trials comparing antioxidant supplements with placebo for prevention of gastrointestinal cancers. We searched electronic da...

Oxidative stress may cause gastrointestinal cancers. The evidence on whether antioxidant supplements are effective in preventing gastrointestinal cancers is contradictory. To assess the beneficial and harmful effects of antioxidant supplements in preventing gastrointestinal cancers. We identified trials through the trials registers of the four Coch...

Evidence shows that the quality of randomized clinical trials (RCTs) affects estimates of intervention efficacy, which is significantly exaggerated in low-quality trials. The present study examines the quality of all 235 RCTs published in HEPATOLOGY from the initiation in 1981 through August 1998. Quality was assessed by means of a validated 5-poin...

Electronic searches on databases for randomised clinical trials and controlled clinical trials do not identify as many trials as handsearches, and trial reporting may be flawed. The aims were to identify all fully reported randomised clinical trials in the Journal of Hepatology and to make a qualitative assessment of the reporting. The publications...