Evidence map›Paper›PMID 22388710›Full record

Trial reportDigestive diseases and sciences2012

Corticosteroid plus pentoxifylline is not better than corticosteroid alone for improving survival in severe alcoholic hepatitis (COPE trial).

Sandeep Singh Sidhu, Omesh Goyal, Preeti Singla, Dinesh Gupta, Ajit Sood, Rajoo Singh Chhina, Ravinder Kumar Soni

Registry-linked trialAbstract readComparative StudyRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Digestive diseases and sciences, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02473341 (Efficacy Of Bovine Colostrum In The Treatment Of Severe Alcohol-Associated Hepatitis), which is not on this map. Cited by 32 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
32citing papers in PubMed, 5 pooled it
6.3field-weighted citation impact, top 3% of its field
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.

NCT02473341 phase3active not recruitingnot on this mapstarted 2017, after this paper: background citation

Efficacy Of Bovine Colostrum In The Treatment Of Severe Alcohol-Associated Hepatitis: A Randomized Controlled Trial

TypeinterventionalSponsorDayanand Medical College and HospitalRan2017 to 2026Enrolled174ConditionsAlcoholic HepatitisArmsBovine Colostrum, Placebo
3 · Its place in the literature

Who cites it

32 citing papers in PubMed, 5 syntheses or guidelines pooled it, 77 citations in OpenAlex.

  1. Network Meta-Analysis: Treatments for Acute Alcohol-Associated Hepatitis.Liver international : official journal of the International Association for the Study of the Liver · 2026
    Pooled it
  2. Pooled it
  3. ACG Clinical Guideline: Alcoholic Liver Disease.The American journal of gastroenterology · 2018
    Guideline
  4. Diagnosis and Treatment of Alcoholic Hepatitis: A Systematic Review.Alcoholism, clinical and experimental research · 2016
    Pooled it
  5. Guideline
  6. Trial
  7. Review
  8. Review
  9. Recommendation Reversals in Gastroenterology Clinical Practice Guidelines.Journal of the Canadian Association of Gastroenterology · 2022
    Article
  10. Review
  11. Article
  12. Predictors of 90-day mortality in patients with severe alcoholic hepatitis: Experience with 183 patients at a tertiary care center from India.Indian journal of gastroenterology : official journal of the Indian Society of Gastroenterology · 2018
    Article
  13. Review
  14. Emerging concepts in alcoholic hepatitis.World journal of hepatology · 2017
    Review
  15. Review
  16. Observational
  17. Infections in severe alcoholic hepatitis.Annals of gastroenterology · 2017
    Review
  18. Medical Management of Severe Alcoholic Hepatitis: Expert Review from the Clinical Practice Updates Committee of the AGA Institute.Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association · 2017
    Review
  19. Article
  20. Current Management of Alcoholic Hepatitis and Future Therapies.Journal of clinical and translational hepatology · 2016
    Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

7 authors at 1 institution in 1 country.

Sandeep Singh SidhuDepartment of Gastroenterology, Dayanand Medical College and Hospital, Ludhiana, Punjab, India. sandeepsidhu1963@gmail.com
Omesh Goyal
Preeti Singla
Dinesh Gupta
Ajit Sood
Rajoo Singh Chhina
Ravinder Kumar Soni
Dayanand Medical College & Hospital · IN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundCorticosteroids and pentoxifylline reduce short-term mortality in severe alcoholic hepatitis (SAH), but not to the extent desired. Combining both drugs may lead to better survival, but has not yet been studied.

aimTo compare the efficacy of corticosteroids plus pentoxifylline with that of corticosteroids alone in improving survival of SAH patients.

methodsOf the 111 patients screened, 70 patients with SAH (Maddrey discriminant function (MDF) ≥ 32) were enrolled. Patients with active infection, bleeding, renal failure, or pancreatitis were excluded. Treatment was given for four weeks to group A (n = 36; prednisolone 40 mg/day plus pentoxifylline 400 mg thrice/day) and group B (n = 34; prednisolone 40 mg/day). Patients were followed up for 6 months. Data are expressed as median (range) or percentage.

resultsBaseline characteristics of the two groups were similar (MDF group A 78.5 (36.8-140.9), group B 74.9 (45.6-140.2)). Four-week and six-month survival in groups A and B were not significantly different (four-week 72.2 and 73.5%, respectively, p = 1.00; six-month 30.6 and 23.5%, respectively, p = 0.417). At seven days, 55.6% of patients in group A and 64.7% in group B had a Lille score <0.45 (p = 0.473). Six-month survival was significantly higher for patients with a Lille Score <0.45 than for those with a Lille score ≥0.45 (group A 55.5 vs. 0%, p = 0.0006; group B 36 vs. 0%, p = 0.0304). Biological improvement at 28 days was significant for both groups; however, the difference between the groups was not significant.

conclusionsFor patients with severe alcoholic hepatitis, a combination of corticosteroids and pentoxifylline has no additional survival advantage compared with corticosteroids alone.

Indexed as

Cause of DeathAdrenal Cortex HormonesAdultAgedAnalysis of VarianceDisease-Free SurvivalDose-Response Relationship, DrugDrug Administration ScheduleDrug Therapy, CombinationHepatitis, AlcoholicHospitalizationHumansIndiaKaplan-Meier EstimateMaleMiddle AgedAdrenal Cortex HormonesPentoxifylline

Identifiers

PMID22388710
OpenAlexW2045765874

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

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.