BACKGROUNDAlcoholic hepatitis is a

BACKGROUND
Alcoholic hepatitis is a clinical syndrome characterized by jaundice and liver impairment
that occurs in patients with a history of heavy and prolonged alcohol use.
The short-term mortality among patients with severe disease exceeds 30%. Prednisolone
and pentoxifylline are both recommended for the treatment of severe alcoholic
hepatitis, but uncertainty about their benefit persists.
METHODS
We conducted a multicenter, double-blind, randomized trial with a 2-by-2 factorial
design to evaluate the effect of treatment with prednisolone or pentoxifylline. The
primary end point was mortality at 28 days. Secondary end points included death
or liver transplantation at 90 days and at 1 year. Patients with a clinical diagnosis of
alcoholic hepatitis and severe disease were randomly assigned to one of four groups:
a group that received a pentoxifylline-matched placebo and a prednisolone-matched
placebo, a group that received prednisolone and a pentoxifylline-matched placebo,
a group that received pentoxifylline and a prednisolone-matched placebo, or a group
that received both prednisolone and pentoxifylline.
RESULTS
A total of 1103 patients underwent randomization, and data from 1053 were available
for the primary end-point analysis. Mortality at 28 days was 17% (45 of 269 patients)
in the placebo–placebo group, 14% (38 of 266 patients) in the prednisolone–placebo
group, 19% (50 of 258 patients) in the pentoxifylline–placebo group, and 13% (35 of
260 patients) in the prednisolone–pentoxifylline group. The odds ratio for 28-day
mortality with pentoxifylline was 1.07 (95% confidence interval [CI], 0.77 to 1.49;
P = 0.69), and that with prednisolone was 0.72 (95% CI, 0.52 to 1.01; P = 0.06). At
90 days and at 1 year, there were no significant between-group differences. Serious
infections occurred in 13% of the patients treated with prednisolone versus 7% of
those who did not receive prednisolone (P = 0.002).
CONCLUSIONS
Pentoxifylline did not improve survival in patients with alcoholic hepatitis. Prednisolone
was associated with a reduction in 28-day mortality that did not reach significance and
with no improvement in outcomes at 90 days or 1 year. (Funded by the National Institute
for Health Research Health Technology Assessment program; STOPAH EudraCT
number, 2009-013897-42, and Current Controlled Trials number, ISRCTN88782125.)

Results (Indonesian) 1:

LATAR BELAKANGHepatitis alkohol adalah sindrom klinis yang ditandai oleh penyakit kuning dan penurunan fungsi liveryang terjadi pada pasien dengan riwayat penggunaan alkohol berat dan berkepanjangan.Jangka pendek mortalitas di antara pasien dengan penyakit berat melebihi 30%. Prednisolonedan pentoxifylline yang keduanya dianjurkan untuk pengobatan alkohol beratHepatitis, namun ketidakpastian tentang keuntungan mereka bertahan.METODEKami melakukan percobaan multicenter double blind, acak dengan faktorial 2-oleh-2desain untuk mengevaluasi efek pengobatan dengan prednisolone atau pentoxifylline. Thetitik akhir primer pada mortalitas 28 hari. Sekunder titik akhir termasuk kematianatau transplantasi hati di 90 hari dan 1 tahun. Pasien dengan diagnosis klinishepatitis alkohol dan penyakit parah ditugaskan secara acak untuk salah satu dari empat kelompok:sebuah kelompok yang menerima plasebo cocok pentoxifylline dan prednisolone-cocokplasebo, kelompok yang menerima plasebo cocok pentoxifylline, dan prednisolonesebuah kelompok yang menerima plasebo cocok prednisolone dan pentoxifylline, atau grupyang menerima prednisolone dan pentoxifylline.HASILTotal 1103 pasien menjalani pengacakan, dan data dari 1053 yang tersediauntuk analisis utama end-point. Mortalitas 28 hari adalah 17% (45 pasien 269)dalam kelompok plasebo-plasebo, 14% (38 pasien 266) di prednisolone-plaseboGrup, 19% (50 pasien 258) dalam kelompok plasebo-pentoxifylline, dan 13% (35260 patients) in the prednisolone–pentoxifylline group. The odds ratio for 28-daymortality with pentoxifylline was 1.07 (95% confidence interval [CI], 0.77 to 1.49;P = 0.69), and that with prednisolone was 0.72 (95% CI, 0.52 to 1.01; P = 0.06). At90 days and at 1 year, there were no significant between-group differences. Seriousinfections occurred in 13% of the patients treated with prednisolone versus 7% ofthose who did not receive prednisolone (P = 0.002).CONCLUSIONSPentoxifylline did not improve survival in patients with alcoholic hepatitis. Prednisolonewas associated with a reduction in 28-day mortality that did not reach significance andwith no improvement in outcomes at 90 days or 1 year. (Funded by the National Institutefor Health Research Health Technology Assessment program; STOPAH EudraCTnumber, 2009-013897-42, and Current Controlled Trials number, ISRCTN88782125.)