To compare the efficacy of corticosteroid monotherapy and combination therapy with corticosteroids and GCSF in severe alcoholic hepatitis patients.

AIMS AND OBJECTIVES

AIM:

A randomised controlled trial to compare the efficacy of corticosteroid monotherapy and combination therapy with corticosteroids and GCSF in severe alcoholic hepatitis patients.

OBJECTIVE:

Primary outcome:

To compare 30 days and 90-days mortality risk between the groups.

Secondary outcome:

To study improvement in MELD scores in the two groups at 30 and 90-days.

1. Patients who qualifies the criteria for severe alcoholic hepatitis, Inclusion and Exclusion criteria, valid consent will be taken from the study population,in the language best understood by them and after explaining them the study in detail.

2. Patients will be randomly allocated to one of the two groups on a 1:1 randomization ratio(Group A and Group B)

Randomization will be performed using computer generated random number list

Group A: participants who were started on steroids with standard medical therapy. Response to steroids was assessed by Lille Model score with<0.45 on day 7 and those responding to steroids were continued in group A and those not responding were excluded from the study.

Group B: participants in this group were started on GCSF and Steroids and were assessed by Lille Model score with<0.45 on day 7 responders were continued on combination therapy while non responders were continued with GCSF alone.

Group A with Group B outcomes were compared and also Group A with non-responders of subgroup of B in which GCSF alone was continued, were also compared. At the end of study, we analyzed and compared 30- and 90-days mortality risk and adverse events in both the study groups.

Intervention/Treatment:

Arm 1: Drug Prednisolone 40 mg for initial 7 days. Responders as per Lille model score of <0.45 on day 7 were continued Prednisolone 40 mg daily for a total of 28 days and were taper steroids accordingly.

Arm 2: Drug Granulocyte colony stimulating factor (GCSF) 300 mcg daily and Prednisolone 40 mg for 7 days and who were favorable to Lille model score were continued both Granulocyte colony stimulating factor (GCSF) 300 mcg every three days and Prednisolone 40 mg daily for total 28 days and were tapered the steroids accordingly. Patients who were non-responders as per Lille model score were given only Granulocyte colony stimulating factor (GCSF) 300 mcg once in every 3 days for 28 days.

The enrolled subjects were asked to follow- up weekly for improvement in symptoms and various predefined parameters , primary and secondary outcomes were measured.