The efficacy and safety of concentrated herbal extract granules, YH1, as an add-on medication in poorly controlled type 2 diabetes: A randomized, double-blind, placebo-controlled pilot trial

Abstract

Background In Asian countries, many patients with type 2 diabetes fail to achieve controlled glycated hemoglobin (HbA 1c ) levels while taking several classes of oral hypoglycemic agents (OHAs). Traditional Chinese medicine could be an alternative therapeutic option for poorly controlled type 2 diabetes. YH1 is a concentrated Chinese herbal extract formula that combines Rhizoma Coptidis and Shen-Ling-Bai-Zhu-San. This randomized, double-blind, placebo-controlled pilot study evaluated YH1 as an add-on medication for poorly controlled type 2 diabetes. Methods Forty-six patients with poorly controlled type 2 diabetes were randomly assigned 1:1 to the YH1 or placebo group. Before the trial, all subjects had received three or more classes of OHAs with HbA 1c > 7.0% (53 mmol/mol) and a body mass index ≥ 23 kg/m 2 . During the 12-week trial, participants continued to take OHAs without any dose or medication changes. The primary endpoint was the percentage change in HbA 1c level. Per-protocol analysis was applied to the final evaluation. Results At week 12, there was an 11.1% reduction in HbA 1c from baseline and a 68.9% increase in homeostatic model assessment (HOMA) of β cell function in the YH1 group, which also exhibited significant reductions in two-hour postprandial glucose (-26.2%), triglycerides (-29.5%), total cholesterol (-21.6%), low-density lipoprotein cholesterol (-17.4%), body weight (-0.5%), and waist circumference (-1.1%). The changes in fasting plasma glucose, HOMA insulin resistance and symptom scores were not significantly different between the YH1 and placebo groups. No serious adverse events occurred during this clinical trial. Conclusions This pilot study indicates that YH1 together with OHAs can improve hypoglycemic action and β-cell function in overweight/obese patients with poorly controlled type 2 diabetes. YH1 is a safe add-on medication for OHAs and has beneficial effects on weight control and lipid metabolism. A larger study population with longer treatment and follow-up periods is required for further verification.

Shen-ling-bai-zhu-san ameliorates inflammation and lung injury by increasing the gut microbiota in the murine model of Streptococcus pneumonia-induced pneumonia

“…Shen-ling-bai-zhu-san (SLBZS) is a TCM which has been extensively used in China. SLBZS improves hypoglycemic action and β-cell function, offers protection against ulcerative colitis, and alleviates inflammation and non-alcoholic steatohepatitis-induced liver injury, [11][12][13]. Additionally, SLBZS can promote beneficial gut microbiota abundance [14].…”

Effective Dose of Rhizoma Coptidis Extract Granules for Type 2 Diabetes Treatment: A Hospital-Based Retrospective Cohort Study

“…Regarding the safety concerns of RCEG, high-dose treatment for up to 60 weeks has been shown to be safe, without obvious hepatic or renal toxicity, which has previously been reported ( Huang et al, 2019 ). In this study, the range of RCEG in the high-dose group was between 0.08 and 0.23 g/kg/d, with a median of 0.14 g/kg/d ( Supplementary Material S2 ).…”

“…It is also possible that TCM doctors chose the low-dose RCEG to treat other symptoms instead of controlling the glycemic level. Importantly, a previous pilot clinical study reported that YH1, containing high-dose RCEG and SLBZS, can benefit patients with poorly controlled type 2 diabetes who have already been treated with three or more kinds of OHA ( Huang et al, 2019 ). After 3 months of YH1 add-on treatment, there were significant reductions in HbA1c and the lipid profile, as well as a significant increase in HOMA-β.…”

Prevention of Nonalcoholic Hepatic Steatosis by Shenling Baizhu Powder: Involvement of Adiponectin-Induced Inhibition of Hepatic SREBP-1c

“…Experimental evidence also shows that adiponectin and adiponectin receptor signaling may have a key role in improving nonalcoholic fatty liver disease [31]. According to current research, Shenling Baizhu powder has significant lipid-lowering effects, improves insulin resistance, and reduces the accumulation of triglycerides in the liver [32,33]. To further reveal the mechanisms underlying the hepatocyte protective effects of SL, we used the CDAA diet to establish NAFLD rats, which is the most commonly used and reproducible nutritional model.…”