Table 2.

ALT responses and changes in histological features

	Vitamin E			Placebo
Histological feature	ALT R* (n = 34)	ALT NR* (n = 37)	P value	ALT R* (n = 11)	NR* (n = 57)	P value
Mean change in steatosis score	−1.1	−0.4	<0.001	−0.7	−0.0	<0.001
Mean change in inflammation score	−1.1	−0.3	<0.001	−0.5	−0.2	0.14
Mean change in Ballooning score	−0.8	−0.2	0.01	−0.5	−0.2	0.42
Mean change in NAS† score	−3.0	−0.8	<0.001	−1.6	−0.4	0.03
Mean change in Fibrosis score	−0.5	−0.2	0.34	−0.8	−0.0	0.04
Decrease in NAS by ≥2 points	82%	32%	<0.001	55%	25%	0.07
Resolution of NASH‡	44%	22%	0.07	45%	14%	0.03
Mean change in Weight (kg)	−0.9	1.8	0.03	−3.7	1.8	0.01

^*ALT R = response defined as decrease to 40 U/L or less and by 30% or more from baseline. ALT NR = lack of ALT response.

^†Total non-alcoholic fatty liver activity score (NAS), comprising the sum of scores for steatosis, inflammation and ballooning cell injury.

^‡Resolution of histological features that fulfil the criteria for diagnosis of non-alcoholic steatohepatitis (NASH).