Banding Ligation Versus Beta-Blockers as Primary Prophylaxis in Esophageal Varices: Systematic Review of Randomized Trials

Gluud, Lise Lotte; Klingenberg, Sarah Louise; Nikolova, Dimitrinka; Gluud, Christian

doi:10.1111/j.1572-0241.2007.01564.x

Cited by 129 publications

(81 citation statements)

References 34 publications

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“…13,14 Metaanalysis of the many studies devoted to this issue shows that EVL is more effective in preventing bleeding, without survival benefit. 1,15,16 However, a recent Cochrane review 15 questioned this conclusion on the basis that restricting the analysis to studies with good quality standards shows no difference in bleeding rates, on the fact that these studies have a short follow-up, and on its uncertain effects in patients with relatively small varices. Analysis according to size of trials also showed no differences in efficacy in trials including more than 100 patients, 1,17 indicating that the reported benefit from EVL over beta-blockers comes from small and/or low-quality studies.…”

Section: The Problemmentioning

confidence: 99%

Carvedilol for Portal Hypertension in Patients With Cirrhosis

Bosch

2010

Hepatology

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A 48-year-old male with hepatitis C-related cirrhosis is found on endoscopy to have large esophageal varices with red signs. He has never previously had variceal bleeding, and there is no evidence of hepatic encephalopathy. He does have mild ascites. Comorbidity includes diabetes which has been present for many years and is well-controlled on a stable dose of insulin. He has no cardiopulmonary disease. The hemoglobin is 12.4 g/dL, white blood cell count is 6800/mm 3 , and platelets are 112 Â 10 9 /L. Serum bilirubin is 1.8 mg/ dL, creatinine is 1.2 mg/dL, international normalized ratio is 1.3, and the serum albumin is 3.5 g/dL. The electrocardiogram and chest x-ray are normal. The ultrasound examination does not show portal vein thrombosis or hepatocellular carcinoma.What is the role of carvedilol in the prevention of variceal bleeding in this patient? How will the dose of carvedilol be adjusted and how is the patient to be monitored for adverse drug events? When would carvedilol be preferred over nadolol or propranolol? Would the approach be different if the patient was of Child-Pugh class C cirrhosis? The ProblemPortal hypertension is an almost unavoidable complication of cirrhosis, and provides the driving force for most of its complications, such as esophageal and gastric varices, variceal bleeding, portal hypertensive gastropathy, ascites, spontaneous bacterial peritonitis, hepatorenal syndrome, thrombopenia, leukopenia and anemia, and portal-systemic encephalopathy.1 Recent studies have shown that for these complications to develop, the portacaval pressure gradient-evaluated clinically by the hepatic venous pressure gradient (HVPG)-should increase above 10 mm Hg and should be above 12 mm Hg for variceal bleeding. 2,3The prevalence of varices is about 40% in asymptomatic compensated patients.2 Development of varices follows an incidence of approximately 6% per year. The incidence is nearly double in patients with a baseline HVPG >10 mm Hg, who therefore represent a high-risk group.2 These patients are also at higher risk of developing decompensation (ascites, bleeding, jaundice, encephalopathy) and hepatocellular carcinoma. 4,5 Because of this, there is a great interest in strategies to revert portal hypertension, since these would prevent portal hypertension-related complications, clinical decompensation, and death. The benefit of reduction of HVPG has actually been proven for patients exhibiting a ''good hemodynamic response'' to nonselective beta-adrenergic blockers; i.e., those who exhibit a decrease in HVPG > 20% of baseline or to values below 12 mm Hg during continued therapy, 6,7 or who show a decrease in HVPG >10% of baseline 20 minutes after an intravenous infusion of propranolol. 8,9 Besides the increased intravascular pressure, the risk of bleeding from varices is further influenced by other factors, such as the diameter of the varices and the thickness of the variceal wall.10 These factors are interrelated by Laplace's law in the concept of wall tension (t), according to which: t ¼ variceal tran...

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Section: The Problemmentioning

confidence: 99%

Carvedilol for Portal Hypertension in Patients With Cirrhosis

Bosch

2010

Hepatology

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“…Although EVL and beta-blocker therapy is considered to have same efficacy, 24 EVL therapy in pharmacotherapy nonresponders would be a logical and a definitely more effective choice. In our study, the stepwise haemodynamic approach allowed us to identify nonresponders by the end of 8 weeks itself.…”

Section: Pharmacotherap Y For P Rimar Y Pr Ophylaxis Of High-risk Varmentioning

confidence: 99%

Early identification of haemodynamic response to pharmacotherapy is essential for primary prophylaxis of variceal bleeding in patients with ‘high‐risk’ varices

Sharma

Kumar

Sharma

et al. 2009

Aliment Pharmacol Ther

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“…Intriguingly, in female participants, the addition of metformin to the standard of care for chronic HCV infection doubled the SVR rate. 1 Since 1994, the U.S. National Institutes of Health requires that at least half of all clinical trial participants enrolled are females, 2 and increasing interest in women's health and sex-specific outcomes have led to the increase in subgroup analyses stratified by sex. However, improperly conducted sex-based subgroup analysis in clinical trials can yield incorrect conclusions that may result in adverse effects on women's health.…”

Section: Metformin In Chronic Hepatitis C Virus Hepatitis: Caution Nementioning

confidence: 99%

Metformin in Chronic Hepatitis C Virus Hepatitis: Caution Needed With Sex-Based Subgroup Analysis

Geroldi

Emanuele

2010

Hepatology

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the American Association for the Study of Liver Diseases. 4 A previous report showed that longer interbanding interval (more than 3 weeks) had lower risk of rebleeding in secondary prophylaxis. 5 Therefore, whether short intervals between banding sessions could accelerate eradication of esophageal varices or contradictorily increased the risk of bleeding remained unclear.In summary, carvedilol and VBL are alternative options for primary prophylaxis of esophageal varices. Defining the optimum banding protocol and benefit-to-risk ratio in patients classified as having Child C cirrhosis are needed to improve the efficacy of VBL. CHIA-CHI Metformin in Chronic Hepatitis C Virus Hepatitis: Caution Needed with Sex-Based Subgroup AnalysisTo the Editor:We read with great interest the study by Romero-Gómez et al. 1 demonstrating that the combination of metformin, peginterferon alfa-2, and ribavirin improved insulin resistance in Ͼ50% of patients and increased sustained virological response (SVR) rate in 10% of patients with hepatitis C genotype 1 and homeostasis model assessment (HOMA) Ͼ2. Intriguingly, in female participants, the addition of metformin to the standard of care for chronic HCV infection doubled the SVR rate. 1 Since 1994, the U.S. National Institutes of Health requires that at least half of all clinical trial participants enrolled are females, 2 and increasing interest in women's health and sex-specific outcomes have led to the increase in subgroup analyses stratified by sex. However, improperly conducted sex-based subgroup analysis in clinical trials can yield incorrect conclusions that may result in adverse effects on women's health. It has been therefore suggested that: (1) sex-based subgroup analysis should be planned a priori to the study commencement; (2) hypothesis or rationale for the analysis should be provided; (3) a statistical tests for interaction with sex should be performed when analyzing the outcomes; and (4) the overall treatment results should be emphasized more than the findings of the sex-based subgroup analysis. 3 The study by RomeroGómez et al. 1 clearly had not planned the sex-based subgroup analysis a priori because the authors did not mention any adjustment by sex in the Methods section of the article. In addition, there is no clear hypothesis or rationale for a sex-based subgroup analysis in the Introduction or Methods section. The Methods and Results sections were searched for information regarding a statistical test for interaction between sex and the SVR, but no mention was found. In contrast, the authors properly placed equal emphasis on sex-based subgroup results as they did with the overall trial results.Given the frequency with which subgroup analyses by sex are now being performed, it is paramount that investigators should caution the scientific community in their interpretation. Discussion of the sex-specific effects of metformin in chronic HCV infection should be considered proper only when sex-specific analysis are viewed as hypothesis-generating, and further resear...

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Banding Ligation Versus Beta-Blockers as Primary Prophylaxis in Esophageal Varices: Systematic Review of Randomized Trials

Abstract: Banding ligation and beta-blockers may be used as primary prophylaxis in high-risk esophageal varices. The estimated effect of banding ligation in some trials may be biased and was associated with the duration of follow-up. Further high-quality trials are still needed.

Cited by 129 publications

References 34 publications

Carvedilol for Portal Hypertension in Patients With Cirrhosis

Carvedilol for Portal Hypertension in Patients With Cirrhosis

Early identification of haemodynamic response to pharmacotherapy is essential for primary prophylaxis of variceal bleeding in patients with ‘high‐risk’ varices

Metformin in Chronic Hepatitis C Virus Hepatitis: Caution Needed With Sex-Based Subgroup Analysis

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