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Table 2 The primary and secondary endpoints after treatments (full analysis set)

From: Effectiveness and safety of Bifidobacterium and berberine in human hyperglycemia and their regulatory effect on the gut microbiota: a multi-center, double-blind, randomized, parallel-controlled study

Variable

Be

Bi

BB

Placebo

P value

Pchange value

16 weeks

Change

16 weeks

Change

16 weeks

Change

16 weeks

Change

Primary efficacy endpoint

 FBG, mmol/L

6.20 ± 0.80

− 0.37 (− 0.69, − 0.06)a

6.43 ± 0.93

− 0.06 (− 0.28, 0.16)b

6.16 ± 0.91

− 0.42 (− 0.73, − 0.12)a

6.67 ± 1.34

0.13 (− 0.09, 0.35)

0.067

0.004

Secondary efficacy endpoint

 2-hr PPG, mmol/L

9.84 ± 2.93

− 1.16 (− 2.09, − 0.23)a

11.33 ± 3.50

0.01 (− 0.64, 0.65)b

9.79 ± 2.49

− 1.37 (− 2.27, − 0.48)a

11.49 ± 3.66

0.21 (− 0.44, 0.87)

0.004

0.004

 HbA1c, %

6.08 ± 0.52

− 0.05 (− 0.19, 0.08)

6.15 ± 0.61

0.02 (− 0.07, 0.12)b

5.90 ± 0.52

− 0.22 (− 0.36, − 0.09)a

6.14 ± 0.66

0.00 (− 0.10, 0.10)

0.111

0.016

 TG, mmol/L

1.77 (1.19–2.47)

− 0.14 (− 0.46, 0.19)

1.81 (1.32–2.54)

0.04 (− 0.18, 0.27)

1.41 (0.99–2.05)

− 0.18 (− 0.50, 0.15)

1.73 (1.12–2.13)

− 0.06 (− 0.29, 0.17)

0.514

0.605

 TC, mmol/L

4.64 ± 1.15

− 0.25 (− 0.50, 0.00)a

4.81 ± 1.03

0.02 (− 0.15, 0.19)b

4.14 ± 0.94

− 0.38 (− 0.63, − 0.13)a

4.79 ± 0.94

0.06 (− 0.12, 0.24)

0.002

0.004

 HDL-C, mmol/L

1.14 ± 0.26

0.00 (− 0.06, 0.07)a

1.21 ± 0.33

0.04 (0.00, 0.09)a

1.15 ± 0.22

0.03 (− 0.03, 0.10)a

1.25 ± 0.31

0.11 (0.07, 0.16)

0.161

0.012

 LDL-C, mmol/L

2.76 ± 0.81

− 0.15 (− 0.34, 0.05)

2.90 ± 0.81

− 0.00 (0.14, 0.14)b

2.41 ± 0.76

− 0.32 (− 0.52, − 0.12)a

2.85 ± 0.85

0.01 (− 0.13, 0.15)

0.011

0.018

 BMI, kg/m2

24.47 ± 2.78

− 0.42 (− 0.70, − 0.14)

24.90 ± 2.19

− 0.37 (− 0.56, − 0.17)

24.96 ± 2.81

− 0.30 (− 0.57, − 0.03)

24.88 ± 2.61

− 0.19 (− 0.39, 0.01)

0.797

0.409

 BW, kg

66.69 ± 10.12

− 1.29 (− 2.09, − 0.48)

68.39 ± 8.56

− 1.03 (− 1.59, − 0.46)

68.67 ± 10.74

− 0.93 (− 1.71, − 0.15)

69.31 ± 10.64

− 0.42 (− 0.99, 0.16)

0.576

0.204

 Waist circumference, cm

86.64 ± 8.75

− 2.19 (− 3.41, − 0.96)

89.78 ± 7.40

− 1.26 (− 2.11, − 0.41)

90.50 ± 8.32

− 0.81 (− 2.00, 0.37)

90.22 ± 8.22

− 0.92 (− 1.79, − 0.05)

0.087

0.284

 HOMA-IR

2.56 (1.87–3.36)

0.04 (− 0.62, 0.71)

2.70 (1.89–4.25)

− 0.10 (− 0.58, 0.38)

2.28 (1.78–3.02)

− 0.63 (− 1.29, 0.03)

2.72 (1.58–3.86)

− 0.12 (− 0.61, 0.36)

0.815

0.446

 HOMA-β

68.8 (51.98–111.85)

6.52 (− 4.59, 17.62)

67.51 (49.80–101.45)

0.49 (− 7.56, 8.54)

69.03 (46.59–111.06)

4.42 (− 6.54, 15.38)

61.51 (43.24–95.42)

− 5.78 (− 13.87, 2.31)

0.313

0.215

 Fasting GLP-1, pmol/L

2.26 (1.08–4.63)

1.36 (− 0.64, 3.36)

1.93 (1.27–3.89)

− 1.67 (− 3.10, − 0.25)

2.40 (1.34–3.68)

− 1.71 (− 3.66, 0.23)

2.23 (1.20–5.16)

− 0.87 (− 2.32, 0.57)

0.901

0.055

 30 min post-GLP-1, pmol/L

3.17 (1.77–7.81)

− 0.70 (− 4.11, 2.71)

3.03 (1.98–6.11)

− 1.54 (− 3.96, 0.88)

3.18 (2.31–6.07)

− 0.72 (− 4.04, 2.59)

2.33 (1.54–5.73)

0.77 (− 1.67, 3.21)

0.572

0.529

 2-hr post-GLP-1, pmol/L

3.17 (2.26–5.22)

0.94 (− 0.25, 2.12)

2.31 (1.93–4.10)

− 0.89 (− 1.73, − 0.05)

2.68 (1.83–3.91)

− 0.70 (− 1.86, 0.45)

2.78 (1.80–4.08)

− 0.40 (− 1.25, 0.44)

0.153

0.062

 AUC GLP-1

6.43 (3.81–11.75)

− 0.25 (− 4.34, 3.83)

6.02 (4.05–9.67)

− 2.83 (− 5.75, 0.09)

5.70 (4.22–7.62)

− 2.31 (− 6.24, 1.62)

5.48 (3.68–11.54)

0.02 (–2.93, 2.97)

0.470

0.427

  1. Data after treatment were presented as mean ± standard deviation and median (range interquartile); P value: comparison among the groups after treatment
  2. Change: values were least-squares means represent changes from baseline (95%CI). Pchange value: changes comparison among groups; Be: treatment with berberine; Bi: treatment with Bifidobacterium; BB: treatment with berberine and Bifidobacterium
  3. FPG fasting plasma glucose, 2-hr PPG 2-hour postprandial plasma glucose, TG triglyceride, TC total cholesterol, HDL-C high-density lipoprotein cholesterol, LDL-C low-density lipoprotein cholesterol, BW body weight, BMI body mass index
  4. aSignificant differences between the group and placebo group
  5. bSignificant differences between the group and BB group