Early mortality of alcoholic hepatitis: A review of data from placebo-controlled clinical trials

Table 1 Description of studies included in pooled analysis

Study	Country	Study type	Severity of alcoholic hepatitis	Placebo size	Mean age	Gender (M/F)	Active therapy	Therapeutic time	Follow-up time	Death (1-mo/overall)
Helman et al[24], 1971	US	Single center	Unclassified	17	47.7	NA	Prednisolone	4 wk	3 mo	NA/6
Blitzer et al[25], 1977	US	Single center	Unclassified	16	48.4	NA	Prednisolone	26 d	9 wk	NA/5
Maddrey et al[26], 1978	US	Single center	Moderate to severe	31	42.3	23/8	Prednisolone	28-32 d	4 wk	6/6
Baker et al[27], 1981	US	Single center	Unclassified	25	41.0	13/12	Insulin/glucagon	3 wk	3 wk	NA/6
Hallé et al[28], 1982	US	Single center	Severe	36	38.9	32/4	Propylthiouracil	6 wk	8 wk	7/7
Mendenhall et al[29], 1984	US	Multi-center	Moderate to severe	88	50.4	NA	Oxandrolone and prednisolone	1 mo	2 yr	NA/50
Fehér et al[30], 1987	Hungary and Spain	Multi-center	Unclassified	33	46.0	18/15	Insulin/glucagon	3 wk	3 wk	NA/14
Carithers et al[31], 1989	US	Multi-center	Severe	31	44.4	21/10	Methylprednisolone	4 wk	4 wk	11/11
Trinchet et al[32], 1989	Belgique	Multi-center	Unclassified	34	52.0	17/17	Colchicine	6 mo	6 mo	0/0
Akriviadis et al[33], 1990	US	Single center	Severe	36	40.8	25/11	Colchicine	1 mo	4 mo	6/8
Panos et al[34], 1990	UK	Single center	Unclassified	51	49.3	22/29	Polyunsaturated phosphatidyl choline	2 yr	2 yr	NA/20
Bird et al[35], 1991	UK	Single center	Severe	43	51.0	16/14	Insulin/glucagon	3 wk	6 mo	14/15
Mezey et al[36], 1991	Spain	Multi-center	Severe	26	43.7	12/14	Amino acid suppl.	3 wk	23 mo	5/16
Ramond et al[23], 1992	France	Multi-center	Severe	29	48.2	9/20	Prednisolone	4 wk	6 mo	NA/16
Trinchet et al[37], 1992	France	Multi-center	Severe	35	48.0	17/18	Insulin/glucagon	3 wk	1 mo	5/5
Bird et al[38], 1998	UK	Multi-center	Unclassified	30	51.0	16/14	Amlodipine	4 wk	4 wk	7/7
Akriviadis et al[9], 2000	US	Single center	Severe	52	40.8	40/17	Pentoxifylline	4 wk	160 d	NA/24
Mezey et al[39], 2004	US and Spain	Multi-center	Unclassified	26	49.0	16/10	Vitamin E	3 mo	1 yr	NA/5
Boetticher et al[40], 2008	US	Multi-center	Moderate to severe	22	49.1	17/5	Etanercept	3 wk	6 mo	5/5

NA: Not available.

Table 2 Comparison of pooled one-month mortality by different variables

	Studies (n)	Placebo-treated patients (n)	Gender (M/F)	One-month death (n)	One-month mortality rate (%)	χ2	P value
Severity of disease
Unclassified	2	64	33/31	7	10.94	4.375	0.038
Moderate to severe	8	260	171/89	59	22.69
Geographical area(s)
US	5	156	119/37	35	22.44	0.791	0.409
Europe	5	168	85/83	31	18.45
Publication year
Before 1990	5	168	118/50	30	17.86	1.359	0.271
After 1991	5	156	86/70	36	23.08