Efficacy of electro-acupuncture versus sham acupuncture for diabetic peripheral neuropathy: study protocol for a three-armed randomised controlled trial.

INTRODUCTION: Specific treatment for diabetic peripheral neuropathy (DPN) is still lacking, and acupuncture may relieve the symptoms. We intend to investigate the efficacy and safety of electro-acupuncture (EA) in alleviating symptoms associated with DPN in diabetes. METHODS AND ANALYSIS: This multicentre, three-armed, participant- and assessor-blind, randomised, sham-controlled trial will recruit 240 eligible participants from four hospitals in China and will randomly assign (1:1:1) them to EA, sham acupuncture (SA) or usual care (UC) group. Participants in the EA and SA groups willl receive either 24-session EA or SA treatment over 8 weeks, followed by an 8-week follow-up period, while participants in the UC group will be followed up for 16 weeks. The primary outcome of this trial is the change in DPN symptoms from baseline to week 8, as rated by using the Total Symptom Score. The scale assesses four symptoms: pain, burning, paraesthesia and numbness, by evaluating the frequency and severity of each. All results will be analysed with the intention-to-treat population. ETHICS AND DISSEMINATION: The protocol has been approved by the Ethics Committee of the Beijing University of Chinese Medicine (Identifier: 2022BZYLL0509). Every participant will be informed of detailed information about the study before signing informed consent. The results of this trial will be published in a peer-reviewed journal. TRIAL REGISTRATION NUMBER: ChiCTR2200061408.

Acupotomy combined with metformin hydrochloride tablet for type 2 diabetes mellitus and its effect on serum inflammatory factors. / é’ˆåˆ€è”åˆç›é ¸äºŒç”²åŒèƒç‰‡æ²»ç–—2åž‹ç³–å°¿ç— çš„ä¸´åºŠç–—æ•ˆåŠå¯¹è¡€æ¸ ç‚Žæ€§å› å­å«é‡çš„å½±å“.

OBJECTIVES: To observe the clinical efficacy of acupotomy combined with metformin hydrochloride tablet for type 2 diabetes mellitus (T2DM) and its effect on serum levels of inflammatory factors. METHODS: A total of 68 patients with T2DM were randomized into an acupotomy group (34 cases, 2 cases dropped out) and a western medication group (34 cases, 2 cases dropped out). Metformin hydrochloride tablet was given orally in the western medication group, 0.5-1 g each time, twice a day, for continuous 8 weeks. On the basis of the treatment in the western medication group, acupotomy was applied at bilateral Geshu (BL 17), Weiwanxiashu (EX-B 3), Ganshu (BL 18) in the acupotomy group, once a week for continuous 8 weeks. Before and after treatment, in the two groups, blood glucose (fasting blood glucose [FBG], 2-hour plasma glucose [2 h PG] and glycosylated hemoglobin [HbA1c]), TCM syndrome score, blood lipids (total cholesterol [TC], triglyceride [TG], low density lipoprotein cholesterol [LDL-C] and high density lipoprotein cholesterol [HDL-C]), insulin (fasting insulin [FINS] and 2-hour insulin [2 h INS]), C-peptide indexes (fasting C-peptide [FC-P] and 2-hour C-peptide [2 h C-P]), dosage of metformin hydrochloride tablet and diabetes specific quality of life (DSQL) score were observed, the serum levels of tumor necrosis factor (TNF)-α, interleukin (IL)-6 and IL-17 were measured by ELISA. RESULTS: After treatment, the FBG, 2 h PG, HbA1c, TCM syndrome scores, TC, TG, LDL-C, FINS, 2 h INS, FC-P, 2 h C-P, DSQL scores as well as the serum levels of TNF-α, IL-6, IL-17 were decreased compared with those before treatment (P<0.01), HDL-C was increased compared with that before treatment (P<0.01) in the two groups; the dosage of metformin hydrochloride tablet was decreased compared with that before treatment in the acupotomy group (P<0.01). After treatment, in the acupotomy group, the FBG, HbA1c, TCM syndrome score, TC, TG, LDL-C, FINS, 2 h INS, FC-P, 2 h C-P, dosage of metformin hydrochloride tablet, DSQL score as well as the serum level of TNF-α were lower than those in the western medication group (P<0.05). CONCLUSIONS: Acupotomy combined with metformin hydrochloride tablet can improve the blood glucose, clinical symptoms and quality of life in patients with T2DM, its mechanism may be related to the regulation of inflammatory reaction.

[Regulation effects of electroacupuncture with different acupoint combinations on blood lipid in rats with hyperlipemia].

OBJECTIVE: To observe the regulatory effects of electroacupuncture with different acupoints combinations on blood lipid and atherosclerosis index (AI) in rats with hyperlipemia, so as to make a preliminary screening for the optimal acupoints combination for hyperlipemia. METHODS: One hundred and five clean-grade SD male rats were randomly divided into 9 groups, including a normal group, a model group, a Quchi group, a Zhongwan group, a Fenglong group, a Quchi+Zhongwan group, a Quchi+Fenglong group, a Zhongwan+Fenglong group and a Quchi+Zhongwan+Fenglong group (three acupoints group), 17 rats in the normal group and 11 rats in the rest groups. The normal group was fed with normal diet, while the rest groups were fed with high-fat diet for 3 weeks to prepare the hyperlipemia model. All the rats were given unlimited water. After the establishment of model, the normal group was fed freely without any treatment; the model group was bundled and immobilized everyday; the rest groups were bundled, immobilized and treated with electroacupuncture at corresponding acupoints with disperse-dense wave, 20 min per time, once a day. After 4 weeks, the blood examples were collected from abdominal aorta to measure the total cholesterol (TC), triglyceride (TG), high-density lipoprotein (HDL-C) and low-density lipoprotein (LDL-C), and analyzed the AI in each group. RESULTS: After the treatment, TC, TG, HDL-C, LDL-C and AI in each acupuncture group were all lower than those in the model group (P<0.05, P<0.01). Compared with single acupoint group and the Quchi+Zhongwan group, the content of TC in the three acupoints group was lower (P<0.01). The differences of content of TG among each acupuncture group were not significant (all P>0.05). Compared with the rest 6 acupuncture groups, the content of HDL-C and AI in the three acupoints group were significantly different (all P<0.05). The content of LDL-C in the three acupoints group was decreased as compared with the Quchi group and the Zhong-wan group. CONCLUSION: The electroacupuncture at "Quchi" (LI 11), "Zhongwan" (CV 12) and "Fenglong" (ST 40) has more advantages on regulating the content of HDL-C and LDL-C as well as improving AI in hyperlipemia rats, and it has superior effects on blood lipid metabolism.