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).

[Effect of tangtong recipe on the proliferation of cultured iliac arterial smooth muscle cells of diabetic rats in vitro].

OBJECTIVE: To explore the inhibition of Tangtong Recipe (TTR) on proliferation of vascular smooth muscle cells (VSMCs) in rat model of diabetes mellitus using seropharmacological and modern molecular biological technologies. METHODS: The drug-serum of TTR was prepared by feeding pure-breed New Zealand rabbits at various doses (18 mL/kg, 13 mL/kg, and 8 mL/kg) of TTR, and used to intervene the VSMCs get from the iliac artery of diabetic model rats cultured by tissue block plantation. The impact of drug-serum on VSMCs proliferation was estimated through measuring tritiated thymine deoxy-ribonucleotide (3H-TDR) incorporation using liquid-scintillation detector, and the cell cycle was detected using flow cytometry. RESULTS: The 3H-TDR incorporation in cells after intervention with various doses of TTR drug-serum were reduced significantly, in a concentration-dependent manner, to the level lower than that in the normal serum control group (P < 0.01). And the percentage of S and G2/M phase cells in the drug-serum treated groups also were markedly lower than that in the normal control group (P < 0.01). CONCLUSION: Drug-serum of TTR could inhibit the proliferation of VSMC of diabetic rat in vitro in a concentration-dependent manner.

[Effects of Jiangtang Bushen Recipe on serum C-reactive protein, tumor necrosis factor-alpha and interleukin-6 in patients with type 2 diabetes mellitus].

UNLABELLED: OBJECTIVE To observe the effect of Jiangtang Bushen Recipe (JBR) on inflammatory cytokines in patients with type 2 diabetes mellitus (T2DM), and explore its therapeutic mechanism. METHODS Sixty-four patients with T2DM were randomly divided into the treated group (n = 34) and the control group (n = 30). Education course, dietary treatment and conventional hypoglycemic agent were given to both groups, and JBR, mainly composed of Cibot Rhizome, Radix Dipsaci, Glossy Privet Fruit; Ecliptae Herba, Radicis Lycii, Radix Astragali, Rehmannia Dride Rhizome, etc., was given additionally to patients in the treated group, one dose a day for 4 weeks by boiled water and taking in two times. Fasting blood glucose (FBG), fasting insulin (FINS), interleukin-6 (IL-6), tumor necrosis factor-a (TNF-a) and C-reactive protein (CRP) were measured, and insulin sensitive index (ISI) and clinical TCM symptom score were calculated before and after treatment. RESULTS: After treatment, the clinical symptom score dropped in both groups (P < 0.01), and it was lower in the treated group than that in the control group (P < 0.01). At the same time, serum levels of FINS, CRP, TNF-alpha and IL-6 decreased and ISI increased significantly, the effect showed in the treated group was also superior to that in the control group (P < 0.05). CONCLUSION: JBR, which could tonify Pi and Shen, nourish Yin and clear away heat, can improve insulin resistance and alleviate clinical symptoms of T2DM patients, the mechanism may be related with its actions in regulating the production of inflammatory cytokines and inhibiting inflammatory reac-