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Probiotics Plus Berberine as an Anti-Diabetic Regimen in Patients with Type 2 Diabetes, Particularly in the Elderly: A Multicentre Randomised Controlled Trial
98 Pages Posted: 24 Jul 2018
More...Abstract
Background: Gut microbial dysbiosis has been targeted for treating diabetes, and both probiotics and berberine (BBR) have shown gut-regulating properties and hypoglycaemic effect. The combined effects of these two on glycaemic control remain unclear, especially in the elderly. Methods: This multicentre, randomised, double-blind, placebo-controlled trial was conducted in patients with newly diagnosed type 2 diabetes mellitus (T2DM) in 20 medical centers in China. After run-in, participants were randomly assigned (1:1:1:1) to receive probiotics-plus-BBR, BBR-alone, probiotics-alone, or placebo, orally for 12 weeks. The primary outcomes were change in HbA1c from baseline to 13-week follow-up (1) in all participants, and (2) in participants aged ≥ 50 years. Findings: From August 2016, to November 2017, 409 participants (mean [SD] age, 52·5 [9·7] years) were enrolled. Analysis of variance (ANOVA) indicated that change in HbA1c from baseline to 13-week follow-up in the probiotics-plus-BBR group (-1·04[0·79]%) was significantly greater than that in the placebo group (-0·60[0·87]%, p<0·0001), and the probiotics-alone group (-0·53[0·73]%, p<0·0001), but not significantly different from the BBR-alone group (-0·99[0·76]%, p=0·71). Multivariate generalized estimating equation (GEE) analysis confirmed the above findings. Among participants aged ≥ 50 years, ANOVA showed that change in HbA1c in the probiotics-plus-BBR group (-0·99[0·74]%) was significantly greater than that in the placebo group (-0·59[0·92]%, p=0·0024) and the probiotics-alone group (-0·52[0·61]%, p=0·0005), but not significantly different from the BBR-alone group (-0·90[0·72]%, p=0·48). Multivariate GEE analysis revealed that change in HbA1c in the probiotics-plus-BBR group was also significantly greater than that in the BBR-alone group (adjusted Regression coefficient, 0·12, 95% CI, 0·02 to 0·21, p=0·023). Interpretation. This trial suggested that the intervention with probiotics-plus-BBR may be a safe and effective option for those who are looking for alternative approach to managing T2DM.
Trial Registry: This trial is registered with ClinicalTrials.gov, number NCT02861261.
Funding Information: National Key R&D Program of China
Declaration of Interests: All the authors report no conflicts of interest in this work.
Ethical Approval Statement: The trial will be conducted in compliance with GCP and applicable regulatory requirements. Ethics committee of each hospital in charge of this trial has deliberated the protocol and issued approval document. Only after all required legal documentation has been reviewed and approved by the respective Institutional Review Board (IRB) / Independent Ethics Committee (IEC), the trial will initiate. The same applies for the implementation of alteration introduced by amendments.
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