Effectiveness and safety of Daixie Decoction granules combined with metformin for the treatment of T2DM patients with obesity: study protocol for a randomized, double-blinded, placebo-controlled, multicentre clinical trial.

BACKGROUND: Type 2 diabetes mellitus (T2DM) with obesity is a glycolipid metabolism disorder, which makes hypoglycaemic treatment more complex and increases the proportion of multidrug combinations. In addition, patients are more prone to adverse reactions and gradually lose compliance with treatment. Previous clinical trials have demonstrated that Daixie Decoction granules (DDG) can reduce body weight and blood lipids and improve the quality of life of T2DM with obesity. But there are a lack of further evaluations for the efficacy and safety of DDG combined with metformin. METHODS/DESIGN: The study is designed as a multicentre, randomized, double-blind, placebo-controlled clinical trial. Participants who meet the Nathrow criteria will be randomly assigned to the intervention group and control group (n 1 = n 2 = 133). Based on a unified diet control and exercise therapy, the intervention group will be treated with DDG and metformin, and the control group will be treated with DDG placebo and metformin. All subjects will receive a 6-month treatment followed by a 6-month follow-up. Effective rate of a 1% decrease in HbA1c and 3% decrease in body weight will serve as the primary outcome. The secondary outcome include fasting plasma glucose, blood lipids, C-peptides, insulin, inflammatory factors, insulin resistance index (HOMA-IR) and the subcutaneous and visceral fat content in the upper abdomen measured by MRI. Blood routine, urine routine, stool routine, liver and kidney function, EKG and other safety indicators and major adverse reactions were monitored during total treatment and follow-up time. DISCUSSION: We aimed to determine the efficacy and safety of DDG combined with metformin for the treatment of T2DM patients with obesity. TRIAL REGISTRATION: Trial registration: ChiCTR, ChiCTR2000036290. Registered 22 August 2014,  http://www.chictr.org.cn/showprojen.aspx? proj=59001.

Efficacy and Safety of Longyizhengqi Granule in Treatment of Mild COVID-19 Patients Caused by SARS-CoV-2 Omicron Variant: A Prospective Study.

Purpose: This study aimed to evaluate the clinical efficacy of Longyizhengqi granule, a traditional Chinese medicine, in patients with mild COVID-19. Patients and Methods: We conducted a prospective study including mild COVID-19 participants conducted at Mobile Cabin Hospital in Shanghai, China. Participants were assigned to receive Longyizhengqi granule or conventional treatment. The primary outcome was the time for nucleic acid to turn negative and the secondary outcomes are hospital stay and changes in cycle threshold (Ct) values for N gene and Orf gene. Multilevel random-intercept model was performed to analyze the effects of treatment. Results: A total of 3243 patients were included in this study (Longyizhengqi granule 667 patients; conventional treatment 2576 patients). Age (43.5 vs 42.1, p<0.01) and vaccination doses (not vaccinated: 15.8% vs 21.7%, 1 dose: 3.5% vs 2.9%, 2 doses: 27.9% vs 25.6%, 3 doses: 52.8% vs 49.8%. p<0.01) show statistical difference between Conventional treatment group and LYZQ granules group. The use of Longyizhengqi granule could significantly reduce the time for nucleic acid to turn negative (14.2 days vs 10.7 days, p<0.01), shorten hospital stay (12.5 days vs 9.9 days, p<0.01), and increase the changes in Ct value for N gene (8.44 vs 10.33, p<0.01) and Orf gene (7.31 vs 8.44, p<0.01) to approximately 1.5. Moreover, the difference in the changes of Ct values on the 4th, 6th, 8th, and 10th days seem to increase between two groups. No serious adverse events were reported. Conclusion: Longyizhengqi granule might be a promising drug for the treatment of mild COVID-19, and it might be beneficial to effectively shorten the negative transition time of nucleic acid, the total days of hospitalization, and increase the changes of Ct values. Long-term randomized controlled trials with follow-up evaluations are required to confirm its long-term efficacy.

Modified acupuncture therapy, long-term acupoint stimulation versus sham control for weight control: a multicenter, randomized controlled trial.

Objective: Long-term acupoint stimulation (LAS), also called embedding acupuncture, is a modified acupuncture technique. The preliminary results have demonstrated its efficacy in body-weight control. However, the low quality of available trials limited its application. This study aimed to evaluate the efficacy and safety of LAS in body-weight control by using a randomized, parallel, sham-controlled clinical trial design. Methods: This was a randomized, single-blind, sham-controlled clinical trial including 84 adult participants (18-60 years) with a body mass index (BMI) of ≥ 24 kg/m2 conducted in three general hospitals in Shanghai, China. Participants were equally assigned to receive LAS or sham LAS (SLAS) once per 10 days, eight times in total. After completion, an additional intervention with a 3-month follow-up period was set to examine the continued effect of LAS. The primary outcome was the change in body weight from baseline to treatment endpoint within the intention-to-treat (ITT) analysis. Secondary outcomes contained changes in waist-to-hip ratio (WHR), lipid metabolism, and visceral and subcutaneous adipose tissues. Results: From 14 May 2018 to 03 November 2019, 84 participants out of 201 screened individuals met the eligibility criteria, were randomized, and were analyzed (42 participants in each group). From baseline to treatment endpoint, the body-weight reduction in the LAS group was significantly larger than in the sham control (net difference: 1.57 kg, 95% CI: 0.29-2.86, p = 0.012). The superior weight reduction effect persisted in the follow-up period (net difference: 3.20 kg, 95% CI: 1.17-5.21, p = 0.001). LAS therapy also showed improvement in triglyceride and subcutaneous adipose tissue (SAT) compared with sham control. One participant in the LAS group reported a slightly uncomfortable and tingling sensation after the additional intervention. No other adverse events (AEs) were documented. Conclusion: LAS, a modified acupuncture technique, is safe and effective in body-weight control. It could be used as an alternative choice to classical acupuncture for obesity management. Clinical Trial Registration: [www.chictr.org.cn], identifier [ChiCTR1800015498].

Acupuncture on Obesity: Clinical Evidence and Possible Neuroendocrine Mechanisms.

OBJECTIVE: Acupuncture, as one of the complementary and alternative medicines, represents an efficient therapeutic option for obesity control. We conducted a meta-analysis to investigate the effectiveness of acupuncture in obesity and also summarized the available studies on exploring the mechanisms. DESIGN: We searched six databases from the inception to April 2017 without language restriction. Eligible studies consisted of acupuncture with comparative controls ((1) sham acupuncture, (2) no treatment, (3) diet and exercise, and (4) conventional medicine). The primary outcomes consisted of BMI, body weight reduction, and incidence of cardiovascular events (CVD). Secondary outcomes included waist circumference (WC), waist-to-hip ratio (WHR), body fat mass percent, body fat mass (kg), total cholesterol (TC), triglyceride (TG), glucose, low density lipoprotein cholesterol (LDL-c) reduction, high density lipoprotein cholesterol (HDL-c) increase, and adverse effects. The quality of RCTs was assessed by the Cochrane Risk of Bias Tool. Subgroup analyses were performed according to types of acupuncture. A random effects model was used to adjust for the heterogeneity of the included studies. Publication bias was assessed using funnel plots. MAIN RESULTS: We included 21 studies with 1389 participants. When compared with sham acupuncture, significant reductions in BMI (MD=-1.22, 95%CI=-1.87 to -0.56), weight (MD=-1.54, 95%CI=-2.98 to -0.11), body fat mass (kg) (MD=-1.31, 95%CI=-2.47 to -0.16), and TC (SMD=-0.63, 95%CI=-1.00 to -0.25) were found. When compared with no treatment group, significant reductions of BMI (MD=-1.92, 95%CI=-3.04 to -0.79), WHR (MD=-0.05, 95%CI=-0.09 to -0.02), TC (MD=-0.26, 95%CI=-0.48 to -0.03), and TG (MD=-0.29 95%CI=-0.39 to -0.18) were found. When compared with diet and exercise group, significant reduction in BMI (MD=-1.24, 95%CI=-1.87 to -0.62) and weight (MD=-3.27 95%CI=-5.07 to -1.47) was found. Adverse effects were reported in 5 studies. CONCLUSIONS: We concluded that acupuncture is an effective treatment for obesity and inferred that neuroendocrine regulation might be involved.