Table 2 Responses to therapy.

From: A phase 2, proof of concept, randomised controlled trial of berberine ursodeoxycholate in patients with presumed non-alcoholic steatohepatitis and type 2 diabetes

 

Treatment group

Placebo

500 mg BID

1000 mg BID

Absolute change in LFC (%)*

 N

32

30

27

 Mean (SD)

−2.0 (4.88)

−2.9 (4.02)

−4.8 (4.35)

 Min, max

−13.9, 6.3

−11.5, 5.9

−14.2, 2.9

 LS mean (SE)

−1.8 (0.74)

−3.2 (0.77)

−4.7 (0.81)

 Difference in LS means (SE) vs. placebo

 

−1.4 (1.06)

−2.9 (1.10)

 p-value

 

0.199

0.011

Relative change in LFC (%)**

 N

32

30

27

 Mean (SD)

−8.3 (24.48)

−15.1 (22.78)

−24.1 (21.70)

 Min, max

−58.3, 46.6

−66.4, 35.3

−60.7, 22.1

 LS mean (SE)

−8.2 (4.09)

−15.9 (4.27)

−23.3 (4.53)

 p-value

 

0.196

0.016

Proportion achieving ≥5% absolute reduction in LFC**a

8/33 (24%)

10/31 (32%)

12/30 (40%)

p-value (Chi squared test)–post hoc

 

0.476

0.180

Proportion achieving ≥30% relative reduction in LFC**a

7/33 (21%)

6/31 (19%)

10/30 (33%)

p-value (Chi squared test)–post hoc

 

0.854

0.279

Mean change in HbA1c (%)**

 N

32

29

26

 Mean (SD)

0.1 (0.82)

−0.3 (0.68)

−0.6 (0.96)

 Min, max

−1.4, 2.7

−1.8, 1.3

−2.9, 1.6

 LS mean (SE)

0.1 (0.14)

−0.4 (0.15)

−0.5 (0.16)

 p-value

 

0.029

0.005

Mean change in ALT (U/L)**

 N

32

29

26

 Mean (SD)

−3 (19.2)

−4 (17.9)

−19 (27.2)

 Min, max

−50, 47

−33, 52

−89, 18

 LS mean (SE)

−2 (3.5)

−5 (3.7)

−16 (3.8)

 p-value

 

0.674

0.007

Mean change in GGT (U/L)**

 N

32

29

26

 Mean (SD)

−2 (34.9)

−19 (26.4)

−30 (47.9)

 Min, max

−120, 124

−104, 21

−213, 18

 LS mean (SE)

−1 (4.6)

−20 (4.8)

−25 (5.0)

 p-value

 

0.005

<0.001

Mean change in LDL-c (mg/dL)**

 N

29

27

25

 Mean (SD)

0 (20.5)

5 (34.1)

−16 (26.5)

 Min, max

−54, 48

−33, 147

−103, 31

 LS mean (SE)

1 (5.3)

1 (5.4)

−12 (5.5)

 p-value

 

0.955

0.072

Mean change in triglycerides (mg/dL)**

 N

32

29

26

 Mean (SD)

18 (142.9)

−41 (136.3)

−24 (70.4)

 Min, max

−242, 632

−710, 98

−161, 154

 LS mean (SE)

19 (18.5)

−36 (19.4)

−24 (20.4)

 p-value

 

0.041

0.120

Mean change in body weight (kg)***

 N

32

29

27

 Mean (SD)

−1.1 (2.86)

−1.6 (3.02)

−3.5 (4.77)

 Min, max

−9.1, 3.8

−7.2, 5.9

−18.9, 4.5

 LS mean (SE)

−1.1 (0.64)

−1.6 (0.67)

−3.5 (0.70)

 p-value

 

0.554

0.012

  1. Note: Unless indicated otherwise statistical tests are two-sided p-values and LS Means are obtained from an ANCOVA model with treatment group as a fixed effect, and Baseline value of associated parameters as covariates. Tests are 1000 mg or 500 mg vs. placebo.
  2. aA placebo subject had data available at Week 18/ET but did not have baseline data, so they were not included in the absolute and relative change from baseline analyses in the Efficacy Set.
  3. *Primary endpoint results for efficacy set.
  4. **Modified efficacy set.
  5. ***Safety set.