De 2014.
Methods | Randomised controlled clinical trial Country: Medical College and Hospital, Kolkata, India Dates: January 2010 to August 2012 Study protocol approved by the institutional ethical committee. |
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Participants |
Demographic characteristics Age (mean): pentoxifylline + prednisolone group: 42.73 (SD 0.43) years; pentoxifylline group: 41.33 (SD 7.81) years Sex: 100% men Inclusion criteria and degree of severity History of chronic alcohol intake > 50 g/day with clinical and biochemical features of severe alcoholic hepatitis (MDF score ≥ 32 and AST:ALT > 2:1 with absolute value of AST < 500 IU/L and ALT < 200 IU/L MELD score, GAHS, and Child‐Pugh score calculated for all included participants. Exclusion criteria Other potential aetiology 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 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 Computer‐generated randomisation table Number of participants randomised: 62 Pentoxifylline + prednisolone group: n = 31 (1 voluntary dropped out) Pentoxifylline group: n = 31 (1 vertigo and withdrew) |
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Interventions |
Experimental group: prednisolone (Wysolone, Wreath, Mumbai, India) 40 mg once daily for 4 weeks + pentoxifylline (Trental tablets, Sanofi Aventis, Mumbai, India) tablets 400 mg 3 times daily for first 4 weeks Control group: placebo tablet for 4 weeks + pentoxifylline 400 mg 3 times daily orally first 4 weeks Duration of treatment: 11 weeks (12 weeks in group 1 (the control) and 11 weeks in group 2 (the experimental)) Quote: "After the initial 4 weeks, the study was opened and the patients allocated to different groups were revealed. Patients in Group 1 (PTX [pentoxifylline]) 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 could use only 3 months.) Duration of follow‐up: 12 months |
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Outcomes | Mortality Adverse events Morbidity |
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Notes | Quote: "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 December 2016. No reply received Quote: "Prednisolone tablet (Wysolone, Wreath, Mumbai, India) and PTX (trental tablets, Sanofi Aventis, Mumbai, India" |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "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 | Quote: "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 | Quote: "as well as statisticians were all blinded regarding the nature of the pharmacotherapy." |
Incomplete outcome data (attrition bias) All outcomes | Low risk | 1.6% Quote: "One patient in Group 1 developed severe vertigo within 7 days after starting PTX [pentoxifylline], and one patient in Group 2 withdrew voluntarily from the study and hence they were excluded." |
Selective reporting (reporting bias) | Low risk | No protocol available. However, all‐cause mortality, serious adverse events, and liver‐related mortality were reported. |
Other bias | Low risk | Not suspected |