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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