Prevention of type 2 diabetes with the traditional Chinese patent medicine: A systematic review and meta-analysis.

AIM: Early interventions in prediabetes can prevent or delay the incidence of type 2 diabetes mellitus (T2DM). The aim of this review was to assess the efficacy and safety of traditional Chinese patent medicine (TCPM) on the prevention of T2DM. METHODS: Seven electronic databases were searched to identify eligible trials published until June 1, 2016. Randomized controlled trials (RCTs) that compared TCPM plus lifestyle modification (LM) versus LM alone were included for in the. RCTs that used TCPM plus LM compared with placebo plus LM were also included. Methodological quality was assessed using the Cochrane Collaboration Risk of Bias tool. A random- or fixed-effect model was used to analyze outcomes that were expressed as risk ratios (RRs) or mean differences (MD), and the I2 statistic was used to assess heterogeneity. RESULTS: Twenty-six trials with a total of 4169 participants met the inclusion criteria. Subgroup analysis confirmed that, compared with LM alone, TCPM and LM together were significantly better at reducing diabetes (RR, 0.47; 95% CI, 0.38-0.59) and normalizing blood glucose (RR, 0.76; 95% CI, 0.69-0.85). They also caused a greater reduction in fasting plasma glucose (FBG) (MD, -0.37; 95% CI, -0.62 to -0.13), 2-h plasma glucose (2h PG) (MD, -0.91; 95% CI, -1.35 to -0.47) and body mass index (BMI) (MD, -0.45; 95% CI, -0.76 to -0.14). Compared with placebo plus LM, TCPM plus LM was superior at reducing diabetes (RR, 0.55; 95% CI, 0.45-0.68) and normalizing blood glucose (RR, 0.62; 95% CI, 0.50-0.76). The interventions were also associated with a decline in FBG levels (MD, -0.68; 95% CI, -1.25 to -0.11) and 2h PG levels (MD, -1.07; 95% CI, -1.85 to -0.29). There were no significant differences in adverse events in either group. Subgroup and sensitivity analyses found no significant difference in overall effects among all study characteristics, indicating that the overall effects were stable. Generally, the quality of evidence was low for the effect of TCPM on the incidence of diabetes and normalization of blood glucose, and was very low for the effects of TCPM on FBG, 2h PG, and BMI. CONCLUSIONS: Based on this systematic review, TCPM may reduce the risk of progression to T2DM and increase the possibility of regression toward normoglycemia. As a result of the methodological drawbacks of the included studies, more rigorously designed RCTs are required to more reliably assess the efficacy of TCPM and long-term follow-up is needed before TCPM can be recommended for prediabetic patients.

[Current application of placebo in Chinese clinical studies in past 30 years].

To analyze and discuss placebo-related information in clinical research literatures in the past 30 years, including placebo's dosage form, ingredients, preparation process and quality control. Effort were made to research the CNKI. full-text database to preliminary find 700 placebo-related clinical research literature, screen out 301 eligible articles by hand, read the literatures to extract placebo-related information and make statistics and discussions. According to the results, Chinese randomized placebo-controlled clinical studies were characterized by diverse dosage forms of placebo with lack of reports for components, as evidenced by the only 17 literatures describing placebo's preparation or specific composition among the 301 literatures. Placebo-controlled clinical trials covered a wide range of disease spectra, but with a specific tropism of diseases in terms of system classification. Although placebo plays a key role in blinded clinical studies, researchers made less records of placebo, perhaps because they paid less attention to placebo or more attention to the research process or restricted by other objective conditions. Moreover, placebo production, quality control and quality evaluation also need to be further standardized.

Combination of symptoms, syndrome and disease: treatment of refractory diabetic gastroparesis.

AIM: To assess effect of combination of symptoms, syndrome and disease on treatment of diabetic gastroparesis with severe nausea and vomiting. METHODS: Professor Tong Xiaolin's clinical electronic medical records of patients who were treated between January 1, 2006 and October 1, 2012 were used as a database. Patients who met the inclusion criteria were enrolled. General information (name, sex and age), symptoms and blood glucose levels were obtained from the clinic electronic medical record, which was supplemented by a telephone interview. The patient-rated Gastroparesis Cardinal Symptom Index (GCSI) was used to evaluate the severity of the symptoms of gastroparesis. The effects of the treatment were assessed by the change in the severity of the symptoms of gastroparesis and the change in blood glucose between the baseline levels and the post-treatment levels at 1, 2, 4, 8 and 12 wk. RESULTS: Forty-five patients had a mean GCSI nausea and vomiting severity score of 4.21 ± 0.67 and a total GCSI score of 2.77 ± 0.63 before treatment. There was a significant improvement in the nausea and vomiting score at every return visit compared with the baseline score (1 wk: 3.02 ± 1.04 vs 4.18 ± 0.71, P < 0.001; 2 wk: 2.32 ± 1.25 vs 4.16 ± 0.73, P < 0.001; 4 wk: 2.12 ± 1.26 vs 4.12 ± 0.73, P < 0.001; 8 wk: 1.79 ± 1.09 vs 4.24 ± 0.77, P < 0.001; 12 wk: 0.69 ± 0.92 vs 4.25 ± 0.70, P < 0.001). Twenty-five of the 45 patients had complete resolution of vomiting during the observation period (mean time to resolution was 37.9 ± 27.3 d). The postprandial fullness and early satiety subscale, bloating subscale and total GCSI scores were also improved. Finally, the blood glucose levels improved after treatment, although the change was not significant. CONCLUSION: Use of the combination of symptoms, syndrome and disease to treat diabetic gastroparesis with refractory nausea and vomiting may be a new treatment option.