New botanical drug, HL tablet, reduces hepatic fat as measured by magnetic resonance spectroscopy in patients with nonalcoholic fatty liver disease: A placebo-controlled, randomized, phase II trial

Table 3 Secondary endpoint changes from baseline after 12 wk of treatment (full analysis set)

Variable	High dose (n = 22)	Low dose (n = 23)	Placebo (n = 23)	P value
				High dose vs placebo	Low dose vs placebo
AST, IU/L	-7.82 ± 20.59	-2.74 ± 33.79	-2.96 ± 21.19	0.865	0.397
ALT, IU/L	-12.73 ± 29.30	-13.65 ± 39.56	-0.17 ± 19.58	0.097	0.153
Total cholesterol, mg/dL	-7.86 ± 27.92	2.22 ± 32.89	-0.61 ± 22.47	0.532	0.613
Triglyceride, mg/dL	-16.50 ± 52.47	29.57 ± 186.19	-86.91 ± 157.20	0.041	0.031
HDL cholesterol, mg/dL	1.32 ± 14.98	-1.78 ± 8.71	1.83 ± 8.62	0.289	0.567
LDL cholesterol, mg/dL	9.05 ± 27.78	-5.35 ± 23.63	5.74 ± 19.98	0.088	0.253
VLDL cholesterol, mg/dL	0.43 ± 12.05	9.52 ± 27.85	-9.77 ± 17.47	0.047	0.007
Free fatty acid, μEq/L	-73.23 ± 283.52	15.70 ± 304.68	-73.87 ± 666.93	0.146	0.921
HOMA IR	-0.01 ± 1.41	0.18 ± 0.77	-1.32 ± 2.44	0.174	0.019
BMI, kg/m2	0.01 ± 0.81	-0.06 ± 0.97	-0.20 ± 0.80	0.608	0.904

Continuous data are expressed as mean ± SD. AST: Aspartate aminotransferase; ALT: Alanine aminotransferase; HDL: High density lipoprotein cholesterol; LDL: Low density lipoprotein cholesterol; VLDL: Very low density lipoprotein cholesterol; HOMA-IR: Homeostasis model assessment-estimated insulin resistance.