Table 4.

Change From Baseline to End of Treatment in Serum Biochemistry Test Results, Lipid Levels, Metabolic Characteristics, and Quality of Life by Treatment Group

	Mean (95% CI)			P Valuea
	Vitamin E (n = 50)	Metformin (n = 51)	Placebo (n = 49)	Vitamin E vs Placebo	Metformin vs Placebo
Change in self-reported QOLb
Physical health	7.6 (2.7 to 12.5)	5.4 (0.8 to 10.0)	5.4 (−0.7 to 11.5)	.08	.63
Psychosocial health	6.0 (1.4 to 10.6)	4.0 (−0.4 to 8.4)	5.6 (−0.0 to 11.2)	.15	.96
Change in parent/guardian-reported QOLb
Physical health	1.5 (−7.9 to 11.0)	4.1 (−3.8 to 12.0)	4.8 (−1.5 to 11.0)	.96	.87
Psychosocial health	4.3 (−1.6 to 10.1)	1.9 (−4.0 to 7.8)	6.1 (0.1 to 12.2)	.48	.39
Change in serum biochemistry tests
ALT, U/L	−48.3 (−66.8 to −29.8)	−41.7 (−62.9 to −20.5)	−35.2 (−56.9 to −13.5)	.07	.40
AST, U/L	−22.8 (−33.3 to −12.3)	−21.5 (−34.6 to −8.4)	−20.4 (−32.7 to −8.0)	.32	.29
GGT, U/L	−7.4 (−33.3 to −12.3)	−14.3 (−24.9 to −3.7)	−4.4 (−11.6 to 2.8)	.37	.09
Alkaline phosphatase, U/L	−49.2 (−68.5 to −29.9)	−70.0 (−91.2 to −48.8)	−50.2 (−66.7 to −33.6)	.92	.20
Total bilirubin, mg/dL	0.05 (−0.05 to 0.15)	0.03 (−0.05 to 0.10)	0.12 (0.04 to 0.20)	.38	.11
α-Tocopherol, mg/L	9.4 (6.2 to 12.6)	−0.5 (−1.1 to 0.2)	−0.9 (−2.1 to 0.4)	<.001	.44
Changes in lipids
Triglycerides, mg/dL	35.2 (9.8 to 60.6)	2.1 (−21.3 to 25.5)	18.9 (1.3 to 36.5)	.30	.24
Total cholesterol, mg/dL	−2.5 (−10.6 to 5.7)	−6.7 (−14.7 to 1.3)	−7.5 (−15.2 to 0.3)	.29	.96
HDL, mg/dL	−3.7 (−5.3 to −2.2)	−0.8 (−2.6 to 1.0)	−2.6 (−4.6 to −0.6)	.09	.25
LDL, mg/dL	−5.2 (−13.0 to 2.6)	−6.1 (−11.9 to −0.3)	−6.2 (−13.2 to 0.7)	.48	.93
Change in metabolic characteristics
HOMA-IR, mg/dL × μU/mL/405	0.6 (−2.7 to 3.9)	−0.0 (−1.9 to 1.8)	−1.4 (−8.3 to 5.6)	.71	.42
Fasting serum glucose, mg/dL	1.1 (−2.6 to 4.7)	−1.0 (−4.3 to 2.2)	4.2 (−2.7 to 11.2)	.10	.14
Weight, kg	13.3 (10.2 to 16.4)	12.0 (9.3 to 14.6)	12.7 (9.7 to 15.6)	.65	.78
Waist circumference, cm	5.7 (3.5 to 7.9)	3.9 (1.7 to 6.2)	5.6 (2.5 to 8.6)	.81	.50
BMIc	2.1 (1.2 to 3.0)	1.3 (0.6 to 2.0)	1.9 (1.1 to 2.7)	.77	.25
BMI z score	−0.03 (−0.11 to 0.06)	−0.06 (−0.13 to 0.00)	−0.01 (−0.08 to 0.06)	.78	.25
Body composition, % total fatd	−1.1 (−2.6 to 0.4)	−2.4 (−3.6 to −1.2)	−1.9 (−3.5 to −0.3)	.43	.67
Tanner stage	1.3 (1.0 to 1.6)	1.3 (1.0 to 1.7)	1.2 (1.0 to 1.5)	.79	.33

Abbreviations: ALT, alanine aminotransferase; AST aspartate aminotransferase; BMI, body mass index; CI, confidence interval; GGT, γ-glutamyltransferase; HDL, high-density lipoprotein cholesterol; HOMA-IR, homeostasis model assessment of insulin resistance; LDL, low-density lipoprotein cholesterol; NAFLD, nonalcoholic fatty liver disease; NASH, nonalcoholic steatohepatitis; QOL, quality of life.

SI conversion factors: To convert AST, ALT, GGT, and alkaline phosphatase to μkat/L, multiply by 0.0167; to convert total bilirubin to μmol/L, multiply by 17.104; to convert α-tocopherol to μmol/L, multiply by 23.22; to convert triglycerides to mmol/L, multiply by 0.0113; to convert total, HDL, and LDL cholesterol to mmol/L, multiply by 0.0259; and to convert glucose to mmol/L, multiply by 0.0555.

^aP values derived from analysis-of-covariance model regressing change from baseline to 96 weeks on treatment group and baseline value of the outcome.

^bPediatric Quality of Life Inventory (version 4.0) scores were recoded to range from 0 to 100 with increasing scores indicating better quality of life.

^cCalculated as weight in kilograms divided by height in meters squared.

^dTwo patients assigned to vitamin E and 1 patient assigned to metformin were too obese to be assessed at week 96. Their values at 96 weeks were imputed with the 95th percentile value at baseline.