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World J Hepatol. Aug 27, 2011; 3(8): 205-210
Published online Aug 27, 2011. doi: 10.4254/wjh.v3.i8.205
Published online Aug 27, 2011. doi: 10.4254/wjh.v3.i8.205
Ref. | Study design | Sample size | Mean age (yr) males (%) | Drug schedule | Main outcome /findings | Secondary findings | Causes of death |
Helman et al[19] 1971 | Randomized controlled trial: 3 groups: severe, moderate without encephalopathy, and ambulatory | 37 (20) | 48 (32) | Prednisolone 40 mg/d × 4 wk | Mortality benefit seen only for group I with severe alcoholic hepatitis (1/15 in treated vs 6/15 in untreated, P < 0.01) | No difference on histology at 4 wk and no effect on prevention to cirrhosis. Improved caloric intake was seen with steroids | Treated: (n = 1): liver failure. Untreated: (n = 6): hepatorenal syndrome (4), lower gastrointestinal bleed (1), variceal bleed (1) |
Porter et al[20] 1971 | Double blind Randomized controlled trial | 20 (11) | 45 (64) | 6-Methylprednisolone 40 mg/d in 3 d × 10 d followed by oral if possible | Survival 45% vs 22%, P = NS | No effect on biochemical parameters | Treated: (n = 1): tuberculosis |
Campra et al[21] 1973 | Prospective controlled trial | 45 (20) | 43 (75) | Prednisone 0.5 mg/kg per day × 3 wk then 0.25 mg/kg per day × 3 wk | Survival was no different (36% vs 35%). Trend for improved survival with encephalopathy (P = 0.2) | No effect on biochemical parameters | Treated: (n = 7): hepatic failure. Untreated (n = 9): hepatic failure, GIB (5), renal failure (4) |
Blitzer et al[22] 1977 | Prospective double blind | 28 (16) | 48.4 (not reported) | Prednisolone 40 mg × 14 d then tapering × 2 wk | Overall mortality higher in the treated group | No effect on biochemical parameters. Prothrombin time higher in non-survivors | Treated: (n = 11): GIB, Hepatorenal syndrome, spontaneous bacterial peritonitis fungal infections (33% cases): disseminated aspergillosis, candidemia disclosed on autopsy; Untreated (31%): GIB, hepatorenal syndrome, spontaneous bacterial peritonitis, fungal infections |
Shumaker et al[23] 1978 | Randomized controlled trial | 27 (12) | 44 (75) | 6 -methyl prednisolone 80 mg/d × 4-7 d po | No change in survival (50% vs 53%) | Patients with contraindication to steroids had higher mortality. Causes of death in the two groups were similar with > 50% dying from GIB | Treated: (n = 3): GIB, (n = 2): hepatic failure, (n = 1): acute pancreatitis. Untreated: (n = 3): GIB, (n = 2): sepsis, (n = 1): not reported |
Maddrey et al[24] 1978 | Randomized controlled trial | 55 | 40 (60) | prednisolone 40 mg/d × 28-32 d | Improved short-term mortality but no effect on development of portal hypertension even in short term | Serum bilirubin > 20, prothrombin time > 8 s, prolonged and encephalopathy predicted mortality | Treated: (n = 2): hepatic failure, (n = 1): cytomegalic inclusion disease and pneumocystis carinii pneumonia mono-lineal esophagitis, (n = 2): severe liver disease. Untreated: (n = 5): hepatic failure, coma and hepatorenal syndrome |
Lesesne et al[25] 1978 | Randomized controlled trial | 14 (7) | 49 (not reported) | Prednisolone 40 mg/d × 30 d then 2 wk of tapering | Improved survival of the treated group. Improved nutrition alone is not a factor for better survival | Infrequent complications from steroids could be cause of death | Treated: (n = 2): hepatic failure and hepatorenal syndrome, (n = 1): hemorrhagic pancreatitis, (n = 1): pneumococcal pneumonia. Untreated: (n = 7): hepatic failure, (n = 4): GIB, (n = 3): hepatorenal syndrome, (n = 1): aspiration pneumonia, (n = 1): klebsiella bacteremia |
Depew et al[26] 1980 | Randomized controlled trial | 28 (15) | 49 (66) | Prednisolone 40 mg/d × 28 d then taper × 14 d | Mortality in both groups similar (53% vs 54%). LOS: 66 d with prednisolone and 56 d with placebo | No effect on biochemical parameters and complications higher with steroids | Treated: (n = 7): urinary tract infection, (n = 3) pneumonia, (n = 2) septicemia, (n = 1) perinephric abscess. Untreated: (n = 6): urinary tract infection, (n = 1) pneumonia |
Ramond et al[27] 1992 | Randomized controlled trial | 61 (32) | 48 (not reported) | prednisolone 40 mg/d × 28 d (IV if unable to take orally) | Improved survival at 6 mo (84% vs 45%, P = 0.002) irrespective of encephalopathy for patients with discriminant function > 32 (21/23 vs 10/19, P < 0.001) | Death in steroids group occurred early. Patients should be started on steroids while awaiting biopsy results | Treated: (n = 2): gastritis and GIB, (n = 2): septicemia lung. Untreated: (n = 16): GIB, ascites, variceal rupture, pancreatitis, (n = 1 each): septicemia |
Theodossi et al[28] 1982 | Randomized controlled trial | 55 (27) | Not reported, 70% (treatment group), 30% (control group) | Methylprednisolone 1 g/d × 3 d | Patients survival predicted by: encephalopathy, discriminant function > 93, bilirubin 20 mg/dL, creatinine 3 mg/dL, and histological evidence of cirrhosis | Not reported | Treated: (n = 7):septicemia, (n = 2): pancreatitis. Untreated: (n = 6): septicemia, (n = 2): pancreatitis % mortality in patients of hepatic encephalopathy: 94% (treatment group) 69% (control group) |
Richardet et al[29] 19931 | Randomized controlled trial | 23 (12) | Not reported | Prednisolone 40 mg/d × 8 d | Tumor necrosis factor, interleukin-6, interleukin-8 decreased in treated group significantly at Day 8 from their baseline Day 0 levels | Not reported | Not reported |
Ref. | Sample size | Mean age (yr) males (%) | Drug schedule | Main outcome/findings | Secondary findings | Causes of death |
McHutchison et al[30] 19911 | 22 (12 pentoxifylline) | Not reported | Pentoxifylline 400 mg tid× 10 d | Renal impairment more with placebo (mean creatinine change -0.3 vs +2.1 | No difference on other biochemical parameters. Plasma tumor necrosis factor increased in controls only. Survival trend better with pentoxifylline (3 deaths vs 1 death) | Not reported |
Akriviadis et al[15] 2000 | 101 (49 pentoxifylline) | 42 (71% males) | Pentoxifylline 400 mg tid× 28 d | Mortality during the admission 25% vs 46% (P = 0.037) | Age, creatinine at randomization, and pentoxifylline treatment predicted survival. Tumor necrosis factor levels were no different with pentoxifylline and placebo. However, among non-survivors tumor necrosis factor levels decreased more in pentoxifylline group | Hepatorenal syndrome: treated vs untreated (50% vs 92%, P = 0.009) |
Paladugu et al[31] 20061 | 30 (14) | 50 (100%) | Pentoxifylline | Mortality at 28 d: 29% vs 46% (P = 0.09). Time to death 21 d vs 18 d (P = 0.041) | Tumor necrosis factor levels unchanged in both groups | Hepatorenal syndrome: treated vs untreated (50% vs 86%, P = 0.1) |
Sidhu et al[32] 20061 | 50 | Not reported | Pentoxifylline 400 mg tid× 28 d | Mortality at 28 d (24% vs 40%, P = NS) | Pentoxifylline reduced creatinine, tumor necrosis factor, discriminant function index, prothrombin time | Hepatorenal syndrome: treated vs untreated (83% vs 60%) |
Lebrec et al[33] 20071 | 132 | Not reported | Pentoxifylline | Mortality at 2 mo (14% vs 16%, P = 0.77) and at 6 mo (27% vs 31%, P = 0.3) were similar | No difference for serious adverse effects between the 2 groups. Subgroup with renal dysfunction also did not get benefit with pentoxifylline | Not reported |
- Citation: Singal AK, Walia I, Singal A, Soloway RD. Corticosteroids and pentoxifylline for the treatment of alcoholic hepatitis: Current status. World J Hepatol 2011; 3(8): 205-210
- URL: https://www.wjgnet.com/1948-5182/full/v3/i8/205.htm
- DOI: https://dx.doi.org/10.4254/wjh.v3.i8.205