Evidence map›Paper›PMID 34129159›Full record

Trial reportIndian journal of gastroenterology : official journal of the Indian Society of Gastroenterology2021

Role of lactulose for prophylaxis against hepatic encephalopathy in cirrhotic patients with upper gastrointestinal bleeding: A randomized trial.

Attapon Rattanasupar, Arunchai Chang, Keerati Akarapatima, Thanongsak Chaojin, Teerha Piratvisuth

Abstract readMulticenter StudyRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Indian journal of gastroenterology : official journal of the Indian Society of Gastroenterology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

8 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Article
  3. Article
  4. Review
  5. Review
  6. Review
  7. Article
  8. Review
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

5 authors.

Attapon RattanasuparDivision of Gastroenterology, Department of Internal Medicine, Hatyai Hospital, 182 Ratthakanl Road, Hatyai, Songkhla, 90110, Thailand.
Arunchai ChangDivision of Gastroenterology, Department of Internal Medicine, Hatyai Hospital, 182 Ratthakanl Road, Hatyai, Songkhla, 90110, Thailand. busmdcu58@gmail.com.ORCID http://orcid.org/0000-0002-0158-2685
Keerati AkarapatimaDivision of Gastroenterology, Department of Internal Medicine, Hatyai Hospital, 182 Ratthakanl Road, Hatyai, Songkhla, 90110, Thailand.
Thanongsak ChaojinDivision of Gastroenterology, Department of Internal Medicine, Yala Hospital, Yala, Thailand.
Teerha PiratvisuthNKC Institute of Gastroenterology and Hepatology, Songklanagarind Hospital, Faculty of Medicine, Prince of Songkla University, Songkhla, Thailand.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundWe aimed to assess the efficacy of lactulose as prophylaxis against hepatic encephalopathy (HE) in cirrhotic patients with acute upper gastrointestinal bleeding (AUGIB).

methodsWe conducted a randomized, double-blinded, placebo-controlled, multicenter study from October 2012 to February 2014. Cirrhotic patients presenting with AUGIB (aged 18-80 years, without HE at the time of admission) were enrolled and randomized to receive blinded medications (both physically indistinguishable), labeled "Lactulose A" and "Lactulose B" for 5 days along with standard treatment depending on the type of bleeding (variceal and nonvariceal). The primary endpoint was the development of overt HE according to the West-Haven criteria. Modified intention-to-treat analysis was performed.

resultsForty-six patients completed the protocol: Lactulose A (placebo, n = 22) and Lactulose B (lactulose, n = 24). There was no significant difference in baseline characteristics and clinical outcomes between the two groups. Nine (19.6%) patients developed HE: five (22.7%) in the placebo group and four (16.7%) in the lactulose group (p = 0.718). One patient (2.2%) died in lactulose group. All patients tolerated the medication and no significant difference in adverse effects was detected (59.1% in placebo vs. 50.0% in lactulose group, p = 0.536). On multivariate analysis, increased baseline Child-Turcotte-Pugh (CTP) score (odds ratio [OR] 2.176; 95% confidence interval [CI] 1.012-4.681, p = 0.047) and presence of diarrhea (OR 16.261; 95% CI 1.395-189.608, p = 0.026) were independent risk factors for the development of HE.

conclusionFive-day lactulose is ineffective as prophylaxis against HE in cirrhotic patients with AUGIB. Unnecessary treatment with laxatives should be avoided in these patients.

trial registrationClinical trial registry number TCTR20200526003 (retrospectively registered).

Indexed as

Hepatic EncephalopathyLactuloseAcute DiseaseGastrointestinal AgentsGastrointestinal HemorrhageHumansLiver CirrhosisTreatment OutcomeGastrointestinal AgentsLactuloseCirrhosisHepatic encephalopathyLactuloseProphylaxisUpper gastrointestinal bleeding

Identifiers

PMID34129159

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.