The Efficacy and Safety of Chinese Medicine Fufang Zhenzhu Tiaozhi Capsule (FTZ) in the Treatment of Diabetic Coronary Heart Disease: Study Protocol for Multicenter, Randomized, Double-Blind, Placebo-Controlled Clinical Trial.

BACKGROUND: Diabetic coronary heart disease (DCHD), the main macrovascular complication of type 2 diabetes mellitus (T2DM), is greatly harmful to T2DM patients. Traditional Chinese medicine (TCM) is an alternative and effective therapy to delay the development of macrovascular diseases, but the existing evidence of its efficacy and safety is insufficient. The aim of this multicenter, randomized, double-blind, placebo-controlled trial is to evaluate the efficacy and safety of Chinese Medicine Fufang Zhenzhu Tiaozhi capsule (FTZ) in treating DCHD. PATIENTS AND METHODS: This study includes a 2-week run-in, 52-week treatment, and 52-week post-treatment follow-up. A total of 160 participants will be recruited and randomized into two groups. The treatment group will receive FTZ and basic treatment, while the control group will receive the placebo and basic treatment. The primary outcome is the combined outcome including the major adverse cardiovascular events, coronary restenosis, and unplanned revascularization. The combined secondary outcomes include all-cause mortality, acute coronary syndrome, ischemic stroke, heart failure, unplanned re-hospitalization mainly caused by acute complications of diabetes, other thromboembolic events, and TCM symptom indicators. The safety outcomes and adverse events will also be evaluated in this trial. DISCUSSION: This trial evaluates the clinical effectiveness and safety of FTZ in patients with DCHD. The results are important to further explore the effectiveness of the comprehensive strategy "Tiao Gan Qi Shu Hua Zhuo" (modulating Gan, trigging key metabolic system to resolve pathogenic factors such as phlegm retention and dampness) in the prevention and control of glucolipid metabolic disorders (GLMD) including DCHD and T2DM. On the other hand, this study is the first trial of FTZ to observe cardiovascular outcomes through long-term follow-up after treatment of DCHD, which is of great value. TRIAL REGISTRATION: This trial was registered in the Chinese Clinical Trial Registry on April 07, 2019 (No. ChiCTR1900022345).

Efficacy and safety of traditional Chinese medicine injection with mecobalamin in treating diabetic peripheral neuropathy: A protocol for systematic review and meta-analysis.

BACKGROUND: Diabetic peripheral neuropathy is a common complication of diabetes and the main cause of disability. At present, there is no specific therapeutic regimen. Mecobalamin is often used as a neurotrophic drug, and its long-term effects are not satisfactory when used alone. Clinical practice indicates that traditional Chinese medicine injection with mecobalamin has a therapeutic advantage in treating diabetic peripheral neuropathy while it lacks evidence-based medicine. In this scheme, the efficacy and safety of traditional Chinese medicine injection with mecobalamin in treating diabetic peripheral neuropathy has been studied. METHODS: Computers were used to search the English database (PubMed, the Cochrane Library, Embase, Web of Science), and Chinese database (CNKI, Wanfang, CBMDISC, VIP). Besides, manual searching was conducted to search for Baidu Scholar, CHICTR, Google Scholar. During the establishment of the database to November 2020, a randomized controlled trial on traditional Chinese medicine injection with mecobalamin in treating diabetic peripheral neuropathy was conducted. There were 2 researchers independently conducting data extraction and quality evaluation of literature on the included studies, RevMan5.3 was performed for meta-analysis on the included literature. RESULTS: In this study, the efficacy and safety of traditional Chinese medicine injection with mecobalamin in treating diabetic peripheral neuropathy was evaluated by the total effective rate, motor nerve conduction velocity, sensory nerve conduction velocity, adverse reactions, and glucose metabolism level. CONCLUSION: This study can provide an evidence-based basis on the clinical applications of traditional Chinese medicine injection with mecobalamin in the treatment of diabetic peripheral neuropathy. ETHICS AND DISSEMINATION: The study does not involve patient privacy or rights and does not require approval from an ethics committee. The results may be published in peer-reviewed journals or disseminated at relevant conferences. OSF REGISTRATION NUMBER: DOI 10.17605/OSF.IO/KPW5E.

[Moxibustion at Geshu (BL 17) for diabetic limb arterial obliteration at early stage].

OBJECTIVE: To compare the efficacy differences between moxibustion at Geshu (BL 17) and oral administration of cilostazol on diabetic limb arterial obliteration (DLAO) at early stage as well as the impacts on hemorheology and arterial inner dimension of lower extremity. METHODS: Seventy patients of DLAO at early stage were randomly divided into an observation group and a control group, 35 cases in each one. The two groups were treated with regular treatment of blood glucose and blood lipid. The patients in the control group was treated with oral administration of cilostazol, 50 mg, twice a day; the patients in the observation group were treated with moxibustion at Geshu (BL 17), once a day. The consecution treatment of two weeks constituted one session, and totally 4 sessions were given. The total syndrome score, hemorheology index (including low and high shear viscosity of blood, plasma viscosity, hematocrit and erythrocyte aggregation index) and arterial inner dimension of lower extremity (including popliteal artery, posterior tibial artery and dorsalis pedis artery) were compared before and after treatment. RESULTS: Compared with those before treatment, the total syndrome score, hemorheology index and arterial inner dimension of lower extremity were significantly improved after treatment in the two groups (all P<0.05). The total syndrome score, hemorheology index in the observation group were superior to those in the control group (all P<0.05), but the improvement of arterial inner dimension of lower extremity was not significantly different between the two groups (P>0.05). After treatment, the total effective rate was 91.4% (32/35) in the observation group, which was significantly superior to 85.7% (30/35) in the control group (P<0.05). CONCLUSION: Moxibustion at Geshu (BL 17) is superior to oral administration of cilostazol for DLAO at early stage, which could effectively improve the clinical symptoms, blood flow and blood vessel and increase the blood flow of lower limb.

[Effects of acupuncture at stellate ganglion on lower limb atherosclerosis of early diabetes mellitus].

OBJECTIVE: To compare the efficacy between acupuncture at stellate ganglion combined with intravenous administration of alprostadil and simple intravenous administration of alprostadil on lower limb atherosclerosis of early diabetes mellitus. METHODS: Sixty patients of lower limb atherosclerosis of early diabetes mellitus were randomly divided into an observation group and a control group, 30 cases in each one. Patients in the two groups were treated with basic treatment to control blood glucose and lipid. In addition, patients in the control group were treated with intravenous administration of alprostadil (10 µg) and sodium chloride solution (100 mL); based on this, patients in the observation group were treated with acupuncture at stellate ganglion. The treatment was given once a day; the consecutive treatment of two weeks constituted one session, and totally 4 sessions were given. The total syndrome score, glycosylated hemoglobin (HbA1c), blood flow of posterior tibial artery and dorsal artery of foot were observed before and after treatment; the clinical efficacy was compared between the two groups. RESULTS: Compared before treatment, the total syndrome score, HbA1c, blood flow of posterior tibial artery and dorsal artery of foot were significantly improved after treatment (all P < 0.05), which were more obvious in the observation group (all P < 0.05). After treatment, the total effective rate was 93.3% (28/30) in the observation group, which was significantly superior to 86.7% (26/30) in the control group (P < 0.05). CONCLUSION Acupuncture at stellate ganglion combined with intravenous administration of alprostadil achieve better effect than simple intravenous administration of alprostadil for lower limb atherosclerosis of early diabetes mellitus, which improve the clinical symptoms, regulate blood sugar and increase the blood flow of lower limb.

[Clinical observation on effect of Yiqi Yangyin Huoxue Tongfu principle in treating diabetes mellitus type 2 of secondary failure to sulfonylurea agents].

OBJECTIVE: To observe the effect of Yiqi Yangyin Huoxue Tongfu (YYHT) principle in treating diabetes mellitus type 2 of secondary failure to sulfonylurea agents. METHODS: Forty patients were randomly divided into two groups, based on the unchanged previous treatment of sulfonylurea agents, Chinese decoction prescribed according to YYHT principle was given to the treated group and rosiglitazone was given to the control group. Changes of insulin sensitivity (SI), insulin response to glucose (IRG), insulin sensitive index (ISI), tumor necrosis factor-alpha (TNF-alpha), endothelin-1 (ET-1), 6-keto-prostaglandin F1alpha(6-keto-PGF1alpha) and thromboxane B2 (TXB2) were observed. RESULTS: The total effective rate in the treated group was 71.4%, that on improving peripheral insulin resistance was 76.2%, the two parameters were similar to those in the control group. In the treated group, SI, ISI were significantly improved, and TNF-alpha, ET-1 and TXB2 significantly lowered, but no change of IRR was found. CONCLUSION: Application of YYHT principle in treating patients with diabetes mellitus type 2 of secondary failure to sulfonylurea agents could alleviate the peripheral resistance to insulin, inhibit TNF-alpha, and protect the vascular endothelial cells.