Efficacy and Safety of Mulberry Twig Alkaloids Tablet for Treatment of Type 2 Diabetes: A Randomized, Double-Blind, Placebo-Controlled Multicenter Clinical Study / 中国结合医学杂志

OBJECTIVE@#To assess the efficacy and safety of mulberry twig alkaloids (Sangzhi alkaloids, SZ-A) for treatment of type 2 diabetes in a randomized, double-blind, placebo-controlled multicenter clinical trial.@*METHODS@#A total of 200 patients were randomized to receive SZ-A (n=100) or placebo (n=100) for 16 weeks. The data analysis system for electronic data capture clinical trial central randomization system was used for randomization and dispensing of drugs. The primary outcome was the change in glycosylated hemoglobin (HbA1c) level. The secondary outcome included the proportions of cases with HbA1c <7.0% and HbA1c <6.5%, fasting blood glucose (FBG), postprandial blood glucose (PBG), area under curve for the PBG (AUC0-2h), body weight, and body mass index (BMI). Adverse events (AEs), severe adverse events (SAEs), treatment-related adverse events (TAEs), gastrointestinal disorders (GDs), blood pressure, routine blood tests, and liver and kidney function were monitored.@*RESULTS@#Compared with baseline, the change of HbA1c at week 16 was -0.80% (95% CI: -0.98% to -0.62%) and -0.09% (95% CI: -0.27% to 0.09%) in SZ-A group and placebo group, respectively. The proportion of patients with HbA1c <7% and <6.5% was higher in the SZ-A group than in the placebo group (46.8% vs. 21.6% and 29.9% vs. 10.8%). The observed values and changes in FBG, 1 h-PBG, 2 h-PBG, and AUC0-2h differed significantly between groups (P<0.001), but differences were not significant in body weight and BMI (P>0.05). The incidence rates of AEs, TAEs, and GDs differed significantly between groups (P=0.010, P=0.005, and P=0.006, respectively), whereas the incidence rates of SAEs showed no significant differences between groups (P=1.000).@*CONCLUSION@#SZ-A are effective and safe for treatment of type 2 diabetes. The protocol was registered in http://www.chictr.org.cn/showproj.aspx?proj=60117 (ChiCTR2000038550).

Expert consensus statement on treatment of type 2 diabetes with Xiaoke Pills in clinical practice / 中国中药杂志

Xiaoke Pills are Chinese and Western medicine compound preparations with effects of nourishing kidney and Yin,and supplementing Qi and promoting fluid. It is widely used in clinical treatment of type 2 diabetes( Qi and Yin deficiency syndrome),and continuously included in 2010,2013 and 2017 editions of Chinese prevention guide for type 2 diabetes. For the purpose of accurate positioning and rational use in clinic,it is necessary to further define the curative effect,indications,medication precautions and contraindications of Xiaoke Pills,in order to improve medication safety. This consensus was reached by reference of international clinical guidelines and expert consensus approach based on clinical evidence-based evidence,expert experience and standard specification. The evidence-based evaluation was oriented to clinical problems summarized by no less than 200 front-line clinical physicians in two rounds.GRADE system was adopted for quality classification and evaluation of the evidences,and then the nominal group method was used to form consensus recommendations or suggestions. This consensus defined the curative effect advantages,target users,dosage,administration method,contraindications and precautions of Xiaoke Pills,and provided valuable reference for the clinical use of the drug. Thisconsensus still needs to be updated and revised based on new clinical problems and evidence-based evidence in practical application in the future.

Analysis on Professor WEI Zi-xiao's Experience in Using Paired Medicine / 中国中医药信息杂志

"Paired medicine" belongs to the TCM compatibility, and is often relatively fixed applied in some special cases, with advantages of positive efficacy and simplified medication. The efficacy of paired medicine is not derived from the use of single medicine. It's new function can be realized through the compatibility between single medicine. Professor WEI Zi-xiao is expert in using paired medicine. Most of his commonly used paired medicine comes from some famous TCM prescriptions. Professor WEI Zi-xiao brings forth new ideas on the basis of his own experience and the outcome of modern research, with obvious clinical efficacy.

Retrospective study on Chinese medicine syndrome patterns and their associated factors in patients with type 2 diabetic nephropathy stage III / 中国中西医结合杂志

<p><b>OBJECTIVE</b>To explore the relationship between Chinese medicine syndrome patterns (CMSP) and their associated factors in patients with type 2 diabetic nephropathy stage III (DN2-3).</p><p><b>METHODS</b>Retrospective analysis was conducted on 209 patients with type 2 diabetes mellitus (T2DM). The patients were allocated into two groups, the DN2-3 group and the control group. Some related clinical materials and laboratory indexes, including age, course of disease, body mass index (BMI), glycosylated hemoglobin A1c (HbA1c), systolic blood pressure (SBP), diastolic blood pressure (DBP), blood levels of total cholesterol (TC), triglyceride (TG), high and low density lipoprotein (HDL and LDL), serum creatinine (Scr) and microalbuminuria (MALB) as well as their CMSP (both the essential syndrome and the superficial syndrome) in the DN2-3 group were collected and compared.</p><p><b>RESULTS</b>Significant differences were found between the DN2-3 group and the control group in aspects of course of disease (months, 107.74 +/- 96.19 vs. 82.03 +/- 79.10), BMI (kg/m2, 26.25 +/- 4.02 vs. 24.95 +/- 3.56) and Scr level (mmoL/L, 71.93 +/- 24.24 vs. 65.91 +/- 13.70, P < 0.05). The qi-yin deficiency SP (38 cases, 36.19%), and the blood stasis (51 cases, 48.58%) presented as the dominant essential and superficial CM-SP respectively in DN2-3 patients, holding the highest proportion. Analysis on the relationship of associated indices among patients with different CMSP showed statistical differences presented in level of MALB, i.e. which in pi-shen qi-deficiency SP (128.77 +/- 103.59 mg/24 h) was higher than in yin-deficiency dryness-fire SP and qi-yin deficiency SP (88.43 +/- 68.93 mg/24h and 82.60 +/- 55.22 mg/24 h, P < 0.05); it also presented in HbA1c (%) and TG levels(mmol/L), those in stasis SP were 10.73 +/- 2.71 and 2.29 +/- 1.58 ), in dampness SP were 8.80 +/- 2.19% and 4.37 +/- 5.92, and in stasis-phlegm SP were 8.83 +/- 2.09 and 2.40 +/- 2.18 (all P < 0.05).</p><p><b>CONCLUSIONS</b>The risk factors for occurrence of DN2-3 may be the course of disease, BMI and Scr. Qi-yin deficiency with blood-stasis is the most commonly encountered syndrome in patients with DN2-3. Relations of MALB with Pi-Shen qi-deficiency pattern; HbA1c with blood-stasis pattern, and TG with dampness syndrome are distinctly exhibited in them.</p>