Pentoxifylline versus prednisolone for severe alcoholic hepatitis: A randomized controlled trial

Table 1 Comparison of baseline parameters of patients receiving pentoxifylline (group I) vs those receiving prednisolone (group II) in the treatment of severe alcoholic hepatitis (mean ± SD)

Parameter	Group I (pentoxifylline) (n = 34)	Group II (prednisolone) (n = 34)	P value
Age (yr)	47.53 ± 11.16	46.47 ± 9.67	0.68
Male:female	34:0	33:1	-
Ascites	31	33	0.37
Encephalopathy	20	23	0.61
Varices	23	22	0.80
Maddrey DF score	54.25 ± 16.24	57.78 ± 17.08	0.39
MELD score	23.14 ± 3.97	22.65 ± 3.33	0.58
GAHS	8.23 ± 1.07	7.94 ± 0.95	0.24
Child’s score	11.85 ± 1.62	12.15 ± 1.28	0.41
Mean TLC (/cm3)	13926.47 ± 3068.15	15225 ± 11836.18	0.5379
Serum Na (mEq/L)	135.26 ± 8.26	132.80 ± 6.90	0.1908
Serum K (mEq/L)	4.18 ± 0.72	4.293 ± 0.98	0.6207
Urea (mg/dL)	31.68 ± 27.63	25.74 ± 16.92	0.2889
Creatinine (mg/dL)	1.42 ± 0.61	1.19 ± 0.32	0.057
Bilirubin (mg/dL)	5.40 ± 2.50	6.604 ± 3.90	0.1345
Albumin (gm/dL)	3.19 ± 0.67	3.040 ± 0.75	0.3870
ALT (IU/L)	54.88 ± 23.25	57.38 ± 20.50	0.6397
INR	1.97 ± 0.34	2.04 ± 0.31	0.3493

P < 0.05 considered statistically significant. TLC: Total leucocyte count.

Table 2 Causes of death in patients receiving pentoxifylline or prednisolone in the treatment of severe alcoholic hepatitis (n = 34)

Cause of death	Group I (pentoxifylline)	Group II (prednisolone)
Hepatorenal syndrome	0	6
Sepsis	1	2
Gastrointestinal bleed	2	2
Encephalopathy	2	1
Unknown	0	1
Total	5	12

Table 3 Morbidity/complication profile of patients receiving pentoxifylline (group I) or prednisolone (group II) in the treatment of severe alcoholic hepatitis

Complications	Duration of follow-up
	0-3 mo		3 mo to 1 yr
	Group I (n = 34)	Group II (n = 34)	Group I (n = 29)	Group II (n = 22)
Nausea	24	19	14	4
Vomiting	12	8	4	1
Dyspepsia	3	7	1	1
GI bleed	-	2	2	4
Oral thrush	-	6	-	-
Sepsis	2	2		3
Recurrent encephalopathy	2	-	5	-
Worsening ascites	-	2	-	2
Impaired glucose tolerance	-	2	-	2
Delayed wound healing	-	2	-	1
Deep vein thrombosis	-	1	-	-
Pancreatitis	-	1	-	-
Hepatorenal syndrome	-	6	-	-

Table 4 Comparison of baseline parameters of patients succumbing to various complications to those surviving at the end of the study (12 mo)

Parameter	Patients succumbing to complications (n = 17)	Surviving patients (n = 51)	P value
Age (yr)	44.53 ± 11.19	47.82 ± 10.07	0.26
Male:female	17:0	50:1	-
Ascites	17	47	0.23
Encephalopathy	8	35	0.19
Maddrey DF score	63.22 ± 18.58	53.61 ± 15.39	0.038
MELD score	23 ± 4.15	22.86 ± 3.50	0.89
GAHS	8.35 ± 0.99	8 ± 1.02	0.21
Child’s score	12 ± 1.06	12 ± 1.57	1.00
Mean TLC (/cm3)	14008.82 ± 2804.14	14764.71 ± 9827.88	0.77
Serum Na (mEq/L)	131.76 ± 4.51	134.80 ± 8.35	0.16
Serum K (mEq/L)	4.22 ± 1.12	4.25 ± 0.76	0.90
Urea (mg/dL)	31.94 ± 27.95	27.63 ± 21.22	0.51
Creatinine (mg/dL)	1.19 ± 0.32	1.33 ± 0.55	0.34
Bilirubin (mg/dL)	6.88 ± 4.92	5.71 ± 2.56	0.21
Albumin (gm/dL)	2.97 ± 0.74	3.16 ± 0.70	0.32
ALT (IU/L)	52 ± 20.66	57.51 ± 22.18	0.37
INR	2.14 ± 0.32	1.96 ± 0.31	0.049

All values are expressed as mean ± SD. P < 0.05 considered statistically significant.

Table 5 Progression of scores evaluating the severity of liver disease of patients receiving pentoxifylline (group I) as compared to those receiving prednisolone (group II) in the treatment of severe alcoholic hepatitis (mean ± SD)

Liver disease score	Baseline	Duration of follow-up
		4 wk	3 mo	6 mo	1 yr
Maddrey DF score
Group I1	54.25 ± 16.24	23.29 ± 12.07	14.3 ± 4.53	10.24 ± 4.27	7.79 ± 3.2
Group II2	57.78 ± 17.08	27.82 ± 11.73	15.60 ± 6.21	11.16 ± 3.70	7.27 ± 2.67
P value	0.39	0.15	0.39	0.43	0.94
MELD Score
Group I1	23.14 ± 3.97	15.53 ± 3.63	12.41 ± 2.88	10.37 ± 2.32	9.18 ± 1.59
Group II2	22.65 ± 3.33	17.78 ± 4.56	13.45 ± 2.77	11.14 ± 1.83	9.4 ± 1.88
P value	0.58	0.04	0.20	0.21	0.67
GAHS
Group I1	8.23 ± 1.07	6.37 ± 0.79	6.10 ± 0.77	5.96 ± 0.90	5.74 ± 0.66
Group II2	7.94 ± 0.95	6.52 ± 1.09	5.91 ± 0.61	5.91 ± 0.61	5.7 ± 0.57
P value	0.24	0.56	0.34	0.81	0.83
Child’s score
Group I1	11.85 ± 1.62	9.69 ± 2.57	7.14 ± 1.60	5.96 ± 1.09	5.78 ± 0.89
Group II2	12.15 ± 1.28	9.81 ± 2.08	7.59 ± 1.68	6.23 ± 0.97	5.9 ± 0.79
P value	0.41	0.84	0.33	0.38	0.63

P < 0.05 considered statistically significant.

¹In group I: n = 34 at baseline, n = 32 at 4 wk and n = 29 at 3 mo, n = 27 at 6 mo and 1 year.

²In group II: n = 34 at baseline, n = 27 at 4 wk and n = 22 at 3 mo, 6 mo and n = 20 at 1 year.