Effect and Safety of Herbal Medicine Foot Baths in Patients with Diabetic Peripheral Neuropathy: A Multicenter Double-Blind Randomized Controlled Trial.

OBJECTIVE: To evaluate the effect and safety of foot baths with Tangbi Waixi Decoction (TW) in treating patients with diabetic peripheral neuropathy (DPN). METHODS: It is a multicenter double-blinded randomized controlled trial. Participants with DPN were recruited between November 18, 2016 and May 30, 2018 from 8 hospitals in China. All patients received basic treatments for glycemic management. Patients received foot baths with TW herbal granules either 66.9 g (intervention group) or 6.69 g (control group) for 30 min once a day for 2 weeks and followed by a 2-week rest, as a therapeutic course. If the Toronto Clinical Scoring System total score (TCSS-TS) ⩾6 points, the patients received a total of 3 therapeutic courses (for 12 weeks) and were followed up for 12 weeks. The primary outcome was change in TCSS-TS score at 12 and 24 weeks. Secondary outcomes included changes in bilateral motor nerve conduction velocity (MNCV) and sensory nerve conduction velocity (SNCV) of the median and common peroneal nerve. Safety was also assessed. RESULTS: Totally 632 patients were enrolled, and 317 and 315 were randomized to the intervention and control groups, respectively. After the 12-week intervention, patients in both groups showed significant declines in TCSSTS scores, and significant increases in MNCV and SNCV of the median and common peroneal nerves compared with pre-treatment (P<0.05). The reduction of TCSS-TS score at 12 weeks and the increase of SNCV of median nerve at 24 weeks in the control group were greater than those in the intervention group (P<0.05). The number of adverse events did not differ significantly between groups (P>0.05), and no serious adverse event was related with treatment. CONCLUSION: Treatment of TW foot baths was safe and significantly benefitted patients with DPN. A low dose of TW appeared to be more effective than a high dose. (Registry No. ChiCTR-IOR-16009331).

The Value of Rivaroxaban Combined with Ticagrelor in Antithrombotic Therapy after PCI in Patients with Nonvalvular Atrial Fibrillation with Acute Coronary Syndrome.

Objective: Based on a retrospective cohort study, to investigate the value of rivaroxaban combined with ticagrelor in antithrombotic therapy after PCI in patients with nonvalvular atrial fibrillation with acute coronary syndrome. Methods: A total of 60 patients from January 2019 to May 2021 accepted therapy with antithrombotic therapy after PCI. The patients treated with ticagrelor were set as the control group, and those given rivaroxaban combined with ticagrelor were set as the research group. The curative effect, myocardial level, TIMI blood flow grade, platelet aggregation rate, and the incidence of cardiovascular events were taken from the comparisons. Results: The research group's therapeutic impact was superior to the control group's therapeutic impact, and the value was higher. After treatment, the myocardial levels of the two groups decreased, and the levels of troponin I, creatine kinase isoenzyme, and hypersensitive C-reactive protein in the research group were greatly less than those in the control group, and the difference was statistically significant (P < 0.05). After operation, the TIMI blood flow classification in the experimental group was better than that in the control group, and the difference was statistically significant (P < 0.05). The experimental group's platelet aggregation incidence was considerably lower than the control group's platelet aggregation incidence at 0.5 and 2 hours following surgery, and the difference was statistically significant (P < 0.05). The incidence of acute myocardial infarction, cardiogenic death, and intractable angina pectoris in the research group was significantly lower than that in the control group. Conclusion: Rivaroxaban combined with ticagrelor in the treatment of nonvalvular atrial fibrillation with acute coronary syndrome after percutaneous coronary intervention; the TIMI blood flow grade is better than ticagrelor, which is of great significance to reduce mortality and has high safety in clinical application.

Herbal medicine foot bath for the treatment of diabetic peripheral neuropathy: protocol for a randomized, double-blind and controlled trial.

BACKGROUND: As a common complication of diabetes, the incidence of diabetic peripheral neuropathy (DPN) is 60-70% worldwide. DPN is a major risk factor for diabetic foot, which may lead to foot ulceration and even amputation. The treatment of DPN remains challenging. Our preliminary study demonstrated that the external application of Tangbi Waixi (TW) decoction to the lower extremities relieved clinical symptoms and improved nerve conduction velocity in DPN patients. The aim of this study was to verify the efficacy of TW among DPN patients and evaluate the herb mixture's safety using rigorous methodological designs. METHODS/DESIGN: This study is a multicenter, double-blind, randomized controlled trial. A total of 640 DPN patients will be recruited and randomized to receive a foot bath with either the TW decoction or control drug. Participants will be assessed at baseline and 12 and 24 weeks after treatment. The primary outcome was the change of the Toronto Clinical Scoring System (TCSS). Secondary outcomes were nerve conduction velocity, blood glucose, blood lipids, serum inflammatory cytokines, and the European Quality of Life Five-Dimension Scale (EQ-5D) and TCM symptom scores. DISCUSSION: This multicenter, prospective, randomized clinical trial will provide valuable data regarding the efficacy and safety of foot bath treatment with TW decoction. Positive results would provide a novel treatment regimen for DPN patients. TRIAL REGISTRATION: Chinese Clinical Trial Registry, ChiCTR-IOR-16009331 . Registered on 8 October 2016.