Evidence map›Paper›PMID 37568158›Full record

SynthesisTrials2023

A multicenter double-blind, placebo-controlled randomized trial to evaluate the safety and efficacy of bovine colostrum in the treatment of severe alcoholic hepatitis (SAH).

S S Sidhu, A Dusseja, Shalimar, S Nijhawan, D Kapoor, O Goyal, H Kishore

Registry-linked trialOpen access · goldAbstract readMeta-Analysis
PubMed Full text at PMC Publisher
In one paragraph

Synthesis in Trials, 2023. 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 4 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed, 1 pooled it
2.0field-weighted citation impact, top 14% 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 map

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

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

  1. Pooled it
  2. Review
  3. Current Clinical Trials for Alcohol-Associated Hepatitis.The American journal of pathology · 2026
    Review
  4. 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 5 institutions in 1 country.

S S SidhuDepartment of Gastroenterology, Dayanand Medical College and Hospital, Ludhiana, Punjab, India. sandeepsidhu1963@gmail.com.ORCID http://orcid.org/0000-0002-9194-2110
A DussejaDepartment of Hepatology, Post Graduate Institute of Medical Education & Research, Chandigarh, India.
ShalimarDepartment of Gastroenterology & Human Nutrition Unit, All India Institute of Medical Sciences, Delhi, India.
S NijhawanDepartment of Gastroenterology, Sawai Man Singh Hospital, Jaipur, India.
D KapoorDepartment of Hepatology, Global Hospital, Hyderabad, India.
O GoyalDepartment of Gastroenterology, Dayanand Medical College and Hospital, Ludhiana, Punjab, India.
H KishoreDepartment of Gastroenterology, Dayanand Medical College and Hospital, Ludhiana, Punjab, India.
Dayanand Medical College & Hospital · INAll India Institute of Medical Sciences · INGlobal Hospitals · INPost Graduate Institute of Medical Education and Research · INSawai Man Singh Hospital · IN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundSevere alcoholic hepatitis (SAH) is associated with high mortality. Numerous studies and meta-analysis have reported that corticosteroids reduce the 28-day mortality in SAH, but not the 6-month mortality. Therefore, newer treatments for SAH need to be studied. A pilot study from our group had recently treated ten patients with SAH with bovine colostrum (BC) [20 g thrice in a day for 8 weeks] and prednisolone. This therapy improved the biological functions and 3-month mortality. However, as more and more data showed the failure of corticosteroids to improve the 3- and 6-month mortality, especially in patients with high mDF and MELD scores, we planned this trial to study the safety and efficacy of BC (without corticosteroids) in the treatment of SAH.

methodThis is a multicenter, parallel, double-blind, randomized (1:1) placebo-controlled trial, which will enroll 174 patients with SAH from 5 academic centers in the India. Patients will receive freeze-dried BC or placebo by random 1:1 allocation for 4 weeks. The primary outcome measure is survival at 3 months. The secondary outcome measures are survival at 1 month, change in mDF and MELD scores, change in endotoxin and cytokines (alpha TNF, IL6, and IL8) levels, number of episodes of sepsis [pneumonia, spontaneous bacterial peritonitis (SBP), cellulitis, urinary tract infection (UTI)] from baseline to 4 weeks. DISCUSSION: This study will evaluate the safety and efficacy of bovine colostrum in improving the survival of patients with SAH.

trial registrationClinicalTrials.gov NCT02473341. Prospectively registered on June 16, 2015.

Indexed as

Hepatitis, AlcoholicAdrenal Cortex HormonesAnimalsCattleColostrumDouble-Blind MethodFemaleHumansMulticenter Studies as TopicPilot ProjectsPregnancyRandomized Controlled Trials as TopicTreatment OutcomeAdrenal Cortex Hormones

Identifiers

PMID37568158
PMCPMC10416362
OpenAlexW4385763882

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.