Table 2 Primary outcomes in all and older participants (age ≥ 50 years).

From: Gut microbiome-related effects of berberine and probiotics on type 2 diabetes (the PREMOTE study)

  

HbA1c 0 w (%)

HbA1c 13 w (%)

Change in HbA1c (95% CI)a

Change in HbA1c (95% CI)b

Model 1

Model 2

P-valuec

P-valued

P-valuec

P-valued

All participants

  Plac

 

7.81 ± 0.81

7.23 ± 0.97

−0.59 (−0.75, −0.44)

 

/

5.99E − 04

/

6.31E − 04

  Prob

 

7.78 ± 0.82

7.27 ± 0.90

−0.53 (−0.68, −0.37)

0.07 (−0.20, 0.34)

0.53

5.15E − 05

0.52

5.11E − 05

  BBR

 

7.68 ± 0.76

6.71 ± 0.77

−0.99 (−1.16, −0.83)

−0.40 (−0.67, −0.13)

5.99E − 04

/

6.31E − 04

/

  Prob + BBR

 

7.66 ± 0.82

6.62 ± 0.66

−1.04 (−1.19, −0.89)

−0.44 (−0.71, −0.18)

8.41E − 05

0.70

6.99E − 05

0.66

Age ≥ 50 years

  Plac

 

7.76 ± 0.77

7.24 ± 1.13

−0.59 (−0.78, −0.39)

 

/

0.03

/

/

  Prob

 

7.64 ± 0.69

7.07 ± 0.61

−0.52 (−0.72, −0.33)

0.06 (−0.26, 0.39)

0.65

8.65 E − 03

/

/

  BBR

 

7.58 ± 0.69

6.82 ± 0.81

−0.90 (−1.10, −0.70)

−0.31 (−0.65, 0.02)

0.03

/

/

/

  Prob + BBR

 

7.61 ± 0.73

6.62±0.57

−0.99 (−1.17, −0.82)

−0.41 (−0.72, −0.09)

2.39E − 03

0.48

/

/

  1. BBR berberine treatment, HbA1c glycated haemoglobin, Plac placebo, Prob probiotics treatment, Prob+BBR berberine plus probiotics treatment.
  2. Data were presented as mean ± SD. Model 1: analysis of variance (ANOVA) were performed to compare the Change in HbA1c between groups. Model 2: Multivariate ANOVA were performed to compare the Change in HbA1c between groups adjust for age group (age group defined as <50 and ≥50 years).
  3. All P-values reported were two-sided for multiple comparisons using Bonferroni correction. A statistical significance level was set at P < 0.008.
  4. aThe values are least-squares means.
  5. bPlacebo subtracted change in HbA1c, least-squares means.
  6. cP-values refer to comparison of change in HbA1c between Plac group and the other groups using ANOVA on the basis of intention-to-treat (ITT) analysis.
  7. dP-values refer to comparison of change in HbA1c between BBR group and the other groups using ANOVA on the basis of ITT analysis.