De 2014

Methods	A randomised controlled clinical trial Country: India (the Medical College and Hospital, Kolkata); January 2010 ‐ August 2012 The study protocol was approved by the institutional ethical committee.
Participants	Demographic characteristics Age: mean (year) (PTX +prednisolone)/PTX 42.73 (0.43)/41.33 + 7.81 Sex: male Inclusion criteria and degree of severity "Patients who had a history of chronic alcohol intake of more than 50 g/day with clinical and biochemical features of severe alcoholic hepatitis (MDF score ≥ 32 and aspartate aminotransferase (AST): alanine aminotransferase (ALT) > 2:1 with absolute value of AST < 500 IU/L and ALT < 200 IU/L)" Model for end‑stage liver disease (MELD) score and Glasgow alcoholic hepatitis score (GAHS) and Child‑Pugh score were calculated for all participants who were included in the study. Exclusion criteria "..Patients with any other potential etiology of liver injury (acute or chronic viral hepatitis, autoimmune liver disease, Wilson’s disease) even in the background of chronic alcohol intake, positive for HIV antibodies or patients with a history of abstinence from alcohol in the last month, infection, sepsis or spontaneous bacterial peritonitis, acute pancreatitis, gastrointestinal bleeding, hepatorenal syndrome or any other severe associated disease such as uncontrolled diabetes mellitus, systemic hypertension, heart failure, pulmonary disease or malignancy at the time of inclusion or in the previous 3 months". Randomisation procedure "The recruited patients were then divided into 2 groups by a computer generated randomization table" Number of participants randomised n = 62 "... who fulfilled the inclusion and exclusion criteria and who gave informed written consent were randomized and divided into 2 groups: Group 1 (PTX only) had 31 patients Group 2 (prednisolone plus PTX) had 31 patients. One patient in Group 1 developed severe vertigo within 7 days after starting PTX and one patient in Group 2 withdrew voluntarily from the study, and hence they were excluded. Hence, a total of 60 patients, 30 in each group, were considered for the final analysis." Prednisolone group n = 31 (1 voluntary dropped out) Control group n = 31 (1 vertigo and withdrew)
Interventions	Experimental group: "received prednisolone tablet (Wysolone, Wreath, Mumbai, India) at a dose of 40 mg once daily for 4 weeks and PTX tablets at a dose of 400 mg thrice daily for the duration for the first 4 weeks". Dose: 40 mg prednisolone Control group: "received PTX (Trental tablets, Sanofi Aventis, Mumbai, India) at a dose of 400 mg thrice daily orally and a placebo tablet in the place of prednisolone for the first 4 weeks." Dose: 40 mg placebo Duration of treatment: 12 weeks "After the initial 4 weeks, the study was opened and the patients allocated to different groups were revealed. Patients in Group 1 (PTX) who tolerated the drug well, continued to receive the medication at the same dose for the next 8 weeks and then stopped. After 4 weeks of initial therapy, the dose of prednisolone in Group 2 was tapered by 5 mg/week over a period of 7 weeks and then stopped and received PTX like Group 1 patients". (Thus, we can use only 3 months.) Duration of follow‐up: 12 months
Outcomes	The trial outcomes were: Mortality Adverse events Morbidity
Notes	"One patient in Group 1 developed severe vertigo within 7 days after starting PTX, and one patient in Group 2 withdrew voluntarily from the study and hence they were excluded. A total of 60 patients, 30 in each group, were considered for the final analysis." Letter sent to SK Mandal 12.10.2016. No reply received
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	"The recruited patients were then divided into 2 groups by a computer generated randomization table"
Allocation concealment (selection bias)	Unclear risk	Unclear
Blinding of participants and personnel (performance bias) All outcomes	Low risk	"The investigator, who allocated the patients to the groups, administered the drugs and collected the clinical and laboratory data, as well as statisticians were all blinded regarding the nature of the pharmacotherapy."
Blinding of outcome assessment (detection bias) All outcomes	Low risk	"as well as statisticians were all blinded regarding the nature of the pharmacotherapy."
Incomplete outcome data (attrition bias) All outcomes	Low risk	1.6% "One patient in Group 1 developed severe vertigo within 7 days after starting PTX, and one patient in Group 2 withdrew voluntarily from the study and hence they were excluded." 1/31 prednisolone/1/31 placebo group
Selective reporting (reporting bias)	Low risk	All‐cause mortality, serious adverse events, and liver‐related mortality are reported.
For‐profit bias	Unclear risk	"Prednisolone tablet (Wysolone, Wreath, Mumbai, India) and ptx (trental tablets, Sanofi Aventis, Mumbai, India"
Other bias	Low risk	Not suspected