Banding ligation versus no intervention for primary prevention in adults with oesophageal varices

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Abstract

This is a protocol for a Cochrane Review (Intervention). The objectives are as follows: To assess the beneficial and harmful effects of banding ligation versus no intervention in adults with cirrhosis and gastro‐oesophageal varices that have not bled.

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Most cited references 23

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Prevention and management of gastroesophageal varices and variceal hemorrhage in cirrhosis.

Guadalupe Garcia-Tsao, Arun Sanyal, Norman D Grace … (2007)

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Pharmacological treatment of portal hypertension: an evidence-based approach.

Gennaro D'Amico, Luigi Pagliaro, Jaime Bosch (1999)

Continuing advances in the knowledge of the pathophysiology of portal hypertension result in the progressive expansion of the spectrum of drugs with a potential role for clinical practice, with objectives that now tend to include the prevention of the enlargement or even the development of esophageal varices. This systematic review summarizes the evidence of efficacy of drug therapy for portal hypertension and draws recommendations for clinical practice. Although there is not yet enough evidence to support the treatment for the prevention of the development or enlargement of varices, nonselective beta-blockers are the first-choice therapy to prevent the first bleeding in patients with medium or large-sized varices and rebleeding in patients surviving a bleeding episode. The clinical role of isosorbide-5-mononitrate either alone or in association with beta-blockers still remains unsettled. Vasoactive drugs are generally effective and safe in controlling acute variceal bleeding, although the evidence is not equivalent for each of them.

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Is the placebo powerless? An analysis of clinical trials comparing placebo with no treatment.

A Hróbjartsson, P C Gøtzsche (2001)

Placebo treatments have been reported to help patients with many diseases, but the quality of the evidence supporting this finding has not been rigorously evaluated. We conducted a systematic review of clinical trials in which patients were randomly assigned to either placebo or no treatment. A placebo could be pharmacologic (e.g., a tablet), physical (e.g., a manipulation), or psychological (e.g., a conversation). We identified 130 trials that met our inclusion criteria. After the exclusion of 16 trials without relevant data on outcomes, there were 32 with binary outcomes (involving 3795 patients, with a median of 51 patients per trial) and 82 with continuous outcomes (involving 4730 patients, with a median of 27 patients per trial). As compared with no treatment, placebo had no significant effect on binary outcomes (pooled relative risk of an unwanted outcome with placebo, 0.95; 95 percent confidence interval, 0.88 to 1.02), regardless of whether these outcomes were subjective or objective. For the trials with continuous outcomes, placebo had a beneficial effect (pooled standardized mean difference in the value for an unwanted outcome between the placebo and untreated groups, -0.28; 95 percent confidence interval, -0.38 to -0.19), but the effect decreased with increasing sample size, indicating a possible bias related to the effects of small trials. The pooled standardized mean difference was significant for the trials with subjective outcomes (-0.36; 95 percent confidence interval, -0.47 to -0.25) but not for those with objective outcomes. In 27 trials involving the treatment of pain, placebo had a beneficial effect (-0.27; 95 percent confidence interval, -0.40 to -0.15). This corresponded to a reduction in the intensity of pain of 6.5 mm on a 100-mm visual-analogue scale. We found little evidence in general that placebos had powerful clinical effects. Although placebos had no significant effects on objective or binary outcomes, they had possible small benefits in studies with continuous subjective outcomes and for the treatment of pain. Outside the setting of clinical trials, there is no justification for the use of placebos.

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Author and article information

Journal

Title: Cochrane Database of Systematic Reviews

Publisher: Wiley

ISSN (Electronic): 14651858

Publication date (Electronic): May 29 2017

Affiliations

[1 ]Division of Medicine, Royal Free Campus, University College London; UCL Institute for Liver and Digestive Health; Rowland Hill Street Hampstead London UK NW3 2PF

[2 ]Copenhagen University Hospital Hvidovre; Gastrounit, Medical Division; Kettegaards Alle Hvidovre Denmark 2650

Article

DOI: 10.1002/14651858.CD012673

PMC ID: 6481360

SO-VID: 7387b3fd-a6ef-4b2a-8da0-1b03b322b974

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Banding ligation versus no intervention for primary prevention in adults with oesophageal varices

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Abstract

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UCL: UN SDG 03 Good Health and Well-Being

Most cited references 23

Prevention and management of gastroesophageal varices and variceal hemorrhage in cirrhosis.

Pharmacological treatment of portal hypertension: an evidence-based approach.

Is the placebo powerless? An analysis of clinical trials comparing placebo with no treatment.

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Article

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