Berberine and Prediabetes: A Clinical Observational Study

Objective: To observe the clinical efficacy and safety of berberine in treating patients with prediabetes. Methods: A total of 76 patients with prediabetes were enrolled, and at the end of a one-month run-in period, 70 patients were eligible to participate in the clinical trial and randomly assigned to two groups in a 1:1 ratio, namely a treatment group (n = 35) and a control group (n = 35). Members of the control group underwent lifestyle interventions, including dietary interventions and exercise prescriptions, while participants of the treatment group received both lifestyle interventions and oral administration of 300 mg berberine, three times daily for three months. Subsequently, the treatment group entered a washout period of two months, during which time the medication was stopped, and the lifestyle interventions continued. Following the washout period, the oral administration of berberine was resumed at the same dose and lasted for three months. Blood glucose parameters were evaluated after different treatment periods. Results: 1) Intra-group comparison: Following the first and the second treatment periods, the treatment group experienced a significant decrease in fasting plasma glucose (FPG), 2-hour PG (2hPG) based on oral glucose tolerance test (OGTT), HbA1c, and HOMA-IR (P < 0.05);for the control group, although the blood glucose parameters exhibited a downward trend, the differences lacked statistical significance. 2) Intergroup comparison: Compared to the control group, the treatment group showed a significant decline in the levels of FPG, 2hPG, and HbA1c, whereas the decrease in HOMA-IR had no statistical significance. 3) Safety evaluation: No serious adverse events occurred in either group. Conclusion: Berberine is safe and effective in controlling blood glucose levels in patients with prediabetes and deserves to be promoted in clinical practice.

Berberine and Metformin in the Treatment of Type 2 Diabetes Mellitus: A Systemic Review and Meta-Analysis of Randomized Clinical Trials

Objective: To assess the effects of berberine and metformin on glucose in patients with type 2 diabets mellitus (T2DM) with a systematic review and meta-analysis. Methods: The databases including PubMed, Excerpta Medica Database (EMBase), Cochrane Library, Chinese National Knowledge Infrastructure database (CNKI), WanFang, the Chinese Scientific and Technical Journals database (VIP), China Doctor Dissertation Full-text Database (CDFD) and China Master Dissertation Full-text Database (CMFD) from the inception to April 2021 in Chinese or English language were searched. Randomized controlled trials (RCTs) of berberine only or combined with metformin versus metformin were included. Data extraction and paper quality assessment were conducted according to the Cochrane Handbook. RevMan 5.4 was used for the meta-analysis. Results: A total of thirteen studies were included, covering 1173 participants. The clinical heterogeneity of the included trials was relatively high. The methodological quality of most trials was generally low with bias in terms of random sequence generation, allocation concealment, blinding method, outcome data and selective reporting. Interventions were divided into two subgroups for analysis. Meta-analysis suggested that there was no statistical significance in the hypoglycemic effect between berberine and metformin for T2DM. However, berberine combined with metformin could reduce fasting plasma glucose (FPG) [MD = −1.49, 95% CI (−2.22, −0.76), P < 0.0001], 2-hour postprandial blood glucose (2hPG) [MD = −1.89, 95% CI (−2.94, −0.84), P = 0.0004], glycosylated hemoglobin A1c (HbA1c) [MD = −0.65, 95% CI (−0.91, −0.40), P < 0.00001] and homeostasis model assessment of insulin resistance (HOMA-IR) [MD = −0.53, 95% CI (−1.03, −0.03), P = 0.04] levels significantly compared with metformin group. No severe adverse effects were reported in all trials. Conclusions: The hypoglycemic effect of berberine alone is not better than metformin. But berberine combined with metformin has good efficacy and safety in the treatment of T2DM. The current clinical studies are low in methodology and reporting quality, which needs to be further proved by more high quality, large sample size and multi-center RCTs.

Efficacy and Safety of Berberine for Prediabetes: A Systematic Evaluation and Meta-Analysis

Objective: To assess the efficacy and safety of berberine in the treatment of prediabetes. Methods: We searched the following databases, CNKI, WanFang, VIP, CBM, PubMed, Cochrane Library, Embase, and Medline (OVID) from the databases established to December 2020 in Chinese or English language. Randomized control trials (RCTs) of berberine compared with lifestyle modification, placebo, and/or hypoglycaemics intervention on treating prediabetes were included. Data extraction and paper quality assessment were conducted according to the Cochrane Handbook. RevMan 5.4 was used for the meta-analysis. Results: Seven studies involving 859 participants were included in the study and the control groups were all lifestyle modification or metformin treatment. The clinical heterogeneity of the trials was relatively high, and the methodological quality of most trials was generally low. Meta-analysis suggested that berberine could reduce FPG (P = 0.001), 2hPG (P = 0.001) and HbA1c (P = 0.002) levels significantly as compared with lifestyle group. There was no statistical significance between berberine and metformin. No serious adverse effects from berberine were reported. Conclusions: Berberine has good efficacy and safety in the treatment of prediabetes. Due to the quality limitations of the included trials, the above conclusions need to be further verified by high-quality, large sample size and multi-center clinical trials.

Cost-performance analysis of nutrient removal in a full-scale oxidation ditch process based on kinetic modeling

A full-scale oxidation ditch process for treating sewage was simulated with the ASM2d model and optimized for minimal cost with acceptable performance in terms of ammonium and phosphorus removal. A unified index was introduced by integrating operational costs （aeration energy and sludge production） with effluent violations for performance evaluation. Scenario analysis showed that, in comparison with the baseline （all of the 9 aerators activated）, the strategy of activating 5 aerators could save aeration energy significantly with an ammonium violation below 10%. Sludge discharge scenario analysis showed that a sludge discharge flow of 250- 300 ma/day （solid retention time （SRT）, 13-15 days） was appropriate for the enhancement of phosphorus removal without excessive sludge production. The proposed optimal control strategy was： activating 5 rotating disks operated with a mode of ＂111100100＂ （ ＂1＂ represents activation and ＂0＂ represents inactivation） for aeration and sludge discharge flow of 200 m3/day （SRT, 19 days）. Compared with the baseline, this strategy could achieve ammonium violation below 10% and TP violation below 30% with substantial reduction of aeration energy cost （46%） and minimal increment of sludge production （〈 2%）. This study provides a useful approach for the optimization of process operation and control.