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.

BACKGROUND: In Asian countries, many patients with type 2 diabetes fail to achieve controlled glycated hemoglobin (HbA1c) 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 HbA1c > 7.0% (53 mmol/mol) and a body mass index ≥ 23 kg/m2. During the 12-week trial, participants continued to take OHAs without any dose or medication changes. The primary endpoint was the percentage change in HbA1c level. Per-protocol analysis was applied to the final evaluation. RESULTS: At week 12, there was an 11.1% reduction in HbA1c from baseline and a 68.9% increase in homeostatic model assessment (HOMA) of ß 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 ß-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.

Effect of growth hormone on dawn phenomenon in patients with type 2 diabetes.

We aimed to investigate the involvement of growth hormone in dawn phenomenon and insulin sensitivity in patients with type 2 diabetes mellitus (T2DM). On six occasions separated by intervals of at least 3 days, subjects received early evening (16:00 hours) or late night (23:00 hours) pretreatment with subcutaneous injection of normal saline, human growth hormone, or octreotide. Modified euglycemic insulin clamp test was done 16 hours later and variable glucose infusion (M values) was determined. Plasma glucose, serum insulin, insulin-like growth factor-1, non-esterified fatty acids, and metabolic clearance rate of insulin (MCRI) were measured. Early evening application of growth hormone decreased MCRI 16 hours later, suggesting reduction in insulin sensitivity. Exogenous growth hormone injection reduced insulin sensitivity in T2DM patients. Results provide direct evidence for the role of growth hormone in regulating the insulin sensitivity in insulin-resistant patients.

Evaluation of the efficacy and tolerability of miglitol in Chinese patients with type 2 diabetes mellitus inadequately controlled by diet and sulfonylureas.

The objective of this study is to examine the efficacy and tolerability of miglitol with respect to improving glycemic control in Chinese patients with type 2 diabetes mellitus inadequately controlled by diet and sulfonylurea treatment. This was a randomized, double-blinded, placebo-controlled, multicenter study. A total of 105 patients were randomized to receive 24 weeks of treatment with miglitol (n = 52; titrated from 50 mg to 100 mg 3 times daily) or placebo (n = 53). Concomitant sulfonylurea treatment and diet remained unchanged. The primary endpoint was change in glycated hemoglobin (HbA1c) from baseline at 24 weeks. Secondary endpoints were changes in fasting plasma glucose (FPG), postprandial plasma glucose (PPG), and postprandial serum insulin (PSI). The miglitol treatment group showed significantly greater reductions in HbA1c and PPG levels compared with the placebo group. With respect to adverse events, abdominal discomfort, diarrhea, and hypoglycemia occurred with similar frequency in both groups. Results of this study indicate that miglitol significantly improves metabolic control in Chinese patients with type 2 diabetes mellitus. Miglitol is safe and well tolerated, with the exception of abdominal discomfort. Therefore, miglitol may be a useful adjuvant therapy for Chinese patients with type 2 diabetes mellitus inadequately controlled by diet and sulfonylurea treatment.

Effects of acupuncture at Neiguan (PC 6) on electroencephalogram.

The aim of this study was to investigate if there were any effects on the electroencephalogram (EEG) of human brain by the manual stimulation of Neiguan (PC 6) acupuncture site. In this paper, two groups of six healthy male volunteers of ages 27.6 +/- 14.2 (mean +/- SD) and 28.5 +/- 13.0 (mean +/- SD) and no neurological disease participated in this study. A digital storage of 12-channel EEG recorder was used and spectral analyses of the data set of 18 trials were obtained before, during, and after sham/ manual acupuncture. To minimize artefacts, all data were collected with the subjects alert but eyes closed. No significant changes (P > 0.05) were obtained for the sham acupuncture group. As for the manual acupuncture group, the needle was inserted perpendicularly into the PC 6 acupuncture site and manually stimulated about 15 to 30 seconds to achieve De Qi sensation. Needles were left in place for 30 min and then removed. Analysis of the EEG data due to acupuncture was compared to the baseline data and changes were obtained. First, all trials had an increase in the amplitude and power of the alpha band during manual acupuncture (P < 0.05) when compared with the baseline data. Secondly, in the mean time, the frequency peaks in alpha band of 12-channels were all synchronized with much smaller standard deviation (P < 0.01). Thirdly, the manual acupuncture effects of higher power and synchronized frequencies persisted for at least 10 minutes after the experiment (P < 0.05) and did not disappear immediately for all 18 experiments. Finally, we hypothesized that the higher power and synchronized rhythms in brain oscillations may have to do with autonomic nervous system.

Effects of acupuncture at Neiguan (PC 6) of the pericardial meridian on blood pressure and heart rate variability.

The aims of this study were to investigate (i) if and when the blood pressure would rise or fall and (ii) the associated changes of human heart rate variability (HRV) by manual stimulation of the Neiguan (PC 6) acupuncture site. In this paper, two groups of six healthy male volunteers with ranges of ages 20-56 and 20-55 and with no neurological diseases participated in this study. In order to minimize artefacts, the electrocardiogram (ECG) and radial arterial pulse pressure wave were collected with the subjects alert but eyes closed before, during, and after sham/manual acupuncture. No statistically significant changes (P > 0.05) were found in the sham acupuncture group. As for the manual acupuncture group, the needle was inserted into the PC 6 acupoint and manually stimulated about 15 to 30 seconds to achieve De Qi sensation. Needles were left in place for 30 min and then removed. Analysis of the data due to acupuncture was then compared with the baseline values. Results indicate that the blood pressures of different subject can either rise (P < 0.01) or fall (P < 0.01). To further determine the indicator for one subject who exhibited both rise and fall of blood pressures, 7 more trials were given conducted with the same protocol until statistically significant results were obtained (P < 0.01). We found that his change of blood pressure was highly correlated (p = -0.94 and -0.99 for rise and fall, respectively) with the ratio of the magnitude of pulse pressure to that of the dicrotic notch in the local radial pulse wave (P < 0.01). As to the heart rate variability (HRV) spectra, significant changes in the low frequency (LF) and very low frequency (VLF) ranges were also detected. These results indicate that the autonomic innervations of heart have been modified. However, the information on the power of LF, high frequency (HF), and LF/HF of HRV are not conclusive to statistically differentiate the sympathetic contribution from that of the parasympathetic nervous systems at present stage.

Postmarketing surveillance of acarbose treatment in Taiwanese patients with type 2 diabetes mellitus.

OBJECTIVE: This postmarketing surveillance (PMS) study was conducted to assess the efficacy, safety and acceptance of acarbose treatment in patients with type 2 diabetes mellitus. METHODS: Patients were recruited in this open, prospective, uncontrolled, non-randomised multicentre study by 159 physicians throughout Taiwan, following the guidelines of the Bureau of National Health Insurance (BNHI) of Taiwan. Primary efficacy parameters were changes in fasting blood glucose, postprandial blood glucose and glycosylated haemoglobin (HbA(1c)) values during treatment with acarbose. RESULTS: The majority of the 1558 enrolled patients received acarbose 50 mg three times daily, had previously been treated with a sulphonylurea and/or biguanide, and were observed for a mean period of 13.9 weeks. Most patients (91.8%) received concomitant oral antihyperglycaemic agents. Acarbose reduced fasting blood glucose concentrations by 32.0 mg/dL and 2-hour postprandial blood glucose levels by 52.2 mg/dL. HbA(1c) was reduced by 1.0% from 9.9% to 8.9%, and bodyweight remained stable. The attending physicians assessed that acarbose was associated with 'very good' or 'good' general efficacy in 46.0% of patients, 'very good' or 'good' tolerability in 60.6% and 'very good' or 'good' patient acceptance in 63.4%. These ratings were higher for patients receiving acarbose monotherapy compared with those taking other antihyperglycaemic therapies in addition to acarbose. Only 2.0% of all patients experienced drug-related adverse events. CONCLUSION: Acarbose treatment provides an efficacious, safe and well accepted alternative for metabolic improvement in Taiwanese patients with type 2 diabetes under daily-life treatment conditions.