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).

Short-Term Effect of Continuous Subcutaneous Insulin Infusion and Multiple Daily Injection in Perioperative Patients with Type 2 Diabetes Mellitus.

Background: Hyperglycemia is common and difficult to control in perioperative patients with type 2 diabetes mellitus (T2DM), which impacts their prognosis after operation. Our study investigated the short-term effect of continuous subcutaneous insulin infusion (CSII) and multiple daily injection (MDI) in perioperative T2DM patients using the data envelopment analysis (DEA). Methods: T2DM patients (n = 639) who underwent surgeries in Guangdong Provincial Hospital of Traditional Chinese Medicine (2009.01-2017.12) were included. Insulin was provided to each patient during the study and separated into a CSII group (n = 369) and an MDI group (n = 270). DEA was performed to compare the therapeutic indexes and investigate the short-term effect of the CSII group and MDI group. Results: Scale efficiencies of the CSII group with CCR model and BCC model were better than that of the MDI group. Regarding slack variables, with higher surgical levels, the CSII group was closer to the ideal state than the MDI group, which indicated in improving the average fasting blood glucose (AFBG), antibiotic use days (AUD), preoperative blood glucose control time (PBGCT), first postoperative day fasting blood glucose (FPDFBG), and postoperative hospitalization days (PHD). Conclusion: CSII could effectively control blood glucose levels and shorten perioperative hospitalizing time for T2DM patients, indicating that CSII was beneficial in perioperative period and should be promoted clinically.

Benefits of herbal formulae containing Poria cocos (Fuling) for type 2 diabetes mellitus: A systematic review and meta-analysis.

BACKGROUND: Poria cocos (Schw.) Wolf or Fuling is one of the top 10 most frequently prescribed herbs in China for the treatment of type 2 diabetes mellitus (T2DM). OBJECTIVE: The purpose of this systematic review is to determine the additional benefit of Fuling formulae use in addition to hypoglycaemic agents for T2DM in randomised clinical trials. METHODS: English (5) and Chinese (4) medical databases were searched from their inception to August 2021. RCTs that included Fuling in herbal formulae for T2DM were included. Risk of bias were assessed using the Cochrane Collaboration's procedures. Stata software (13.0) was used for data analysis. RESULTS: Seventy-three RCTs (6,489 participants) with herbal formulae containing Fuling were included. Most studies were at risk of bias and strength of the evidence were low to moderate. Meta-analysis findings showed that the addition of formulae containing Fuling to hypoglycaemic agent-treatments could benefit people with T2DM by reducing fasting blood glucose (MD -0.82 [-0.93, -0.71]; I2 = 79.6%, P = 0.00), 2-hour postprandial blood glucose (MD-1.15 [-1.31, -0.98], I2 = 80%, P = 0.00) and haemoglobin A1c (MD-0.64 [-0.75, -0.53], I2 = 84.7%, P = 0.00). Adverse events were also significantly lower in the integrative group than in the hypoglycaemic alone group (RR 0.99 [0.93, 1.06], P = 0.87). CONCLUSION: Evidence from this study supports the use of Fuling formulae combined with hypoglycaemic agents for T2DM. The combined therapies appear to be well tolerated. TRAIL REGISTRATION: This review is registered with the PROSPERO international prospective register of systematic reviews (CRD42020214635).

Flavonoids for viral acute respiratory tract infections: protocol for a systematic review and meta-analysis of randomised controlled trials.

INTRODUCTION: Herbal and 'natural' products are a growing industry in today's society because they reportedly help with numerous diseases and ailments. To date, there are some randomised controlled trials (RCTs) conducted on patients concerning the efficacy of flavonoids against viral acute respiratory tract infection (ARTI) showing inconsistent results. On this basis, we will summarise the available evidence to investigate the efficacy of flavonoids on viral ARTI by conducting a systematic review and meta-analysis. METHODS AND ANALYSIS: This protocol has been registered. The systematic review and meta-analysis will be conducted by Cochrane guidelines and reported according to the Preferred Reporting Items for Systematic Review and Meta-Analysis statement. RCTs comparing the flavonoids group with the control group for treating virus-induced ARTI will be included. RCTs published with relative outcomes will be searched through 12 databases. Data were searched from inception to 25 March 2022. Relevant literature search, data extraction and quality assessment will be performed by pairs of reviewers independently, and the third researcher will be involved in a discussion for disagreements. Stata V.16.0 software will be used for statistical analysis. Dichotomous data will use the ORs with 95% CIs. Continuous data will use the weighted mean difference with 95% CIs. Heterogeneity will be tested by χ2-based Cochran Q statistic and I2 statistic. Sensitivity analyses and subgroup analyses will be used to observe the heterogeneity between included studies. The funnel plot, Egger's test and Begg's test will be used to judge the publication bias. A p<0.05 will be considered to indicate a statistically significant result. TRAIL REGISTRATION NUMBER: INPLASY202180107.

Xiaoketongbi Formula vs pregabalin for painful diabetic neuropathy: A single-center, randomized, single-blind, double-dummy, and parallel controlled clinical trial.

BACKGROUND: We assessed the efficacy and safety of the Xiaoketongbi Formula (XF) vs. pregabalin in patients with painful diabetic neuropathy (PDN). METHODS: Patients with PDN (n = 68) were included in a single-center, randomized, single-blind, double-dummy, parallel controlled clinical trial. The primary outcome was the change in the Brief Pain Inventory for Diabetic Peripheral Neuropathy (BPI-DPN). Secondary outcomes evaluated included the reduction of BPI-DPN >50%, changes in the numeric rating scale-11 (NRS-11) score for pain, Daily Sleep Interference Diary (DSID), Patient Global Impression of Change (PGIC), nerve conduction velocity (NCV), and adverse events. RESULTS: After 10 weeks of treatment, the BPI-DPN score reduced from 42.44 ± 17.56 to 26.47 ± 22.22 and from 52.03 ± 14.30 to 37.85 ± 17.23 in the XF and pregabalin group (Ps < 0.001), respectively. The difference in the absolute change in BPI-DPN score between both groups was -1.79 (95% CI: -9.09, 5.50; p = 0.625). In the XF and pregabalin groups, 44.1% (15/34) and 20.6% (7/34) of patients reported a BPI-DPN reduction >50% (p = 0.038), respectively. There were no significant differences between groups in NRS-11 and DSID (Ps > 0.05). A significantly greater number of patients in the XF group felt "significantly improved" or "improved" than in the pregabalin group (35.3% (12/34) vs. 11.8% (4/34), p = 0.045). The absolute change in motor nerve conduction velocity of the right median nerve was significantly different between both groups (XF group 0.7 ± 2.3 vs. pregabalin group -2.2 ± 4.1, p = 0.004). No serious adverse events were reported in either group. CONCLUSIONS: XF is equivalent to pregabalin in reducing pain symptoms and improves the quality of life in patients with PDN. In addition, XF has the potential to improve nerve function by increasing NCV.

Flavonoid-containing supplements for preventing acute respiratory tract infections: A systematic review and meta-analysis of 20 randomized controlled trials.

BACKGROUND: This systematic review and meta-analysis was conducted to investigate the efficacy and safety of flavonoid-containing supplements in preventing acute respiratory tract infection (ARTI). METHODS: Randomized controlled trials (RCTs) investigating the effects of flavonoid-containing supplements on ARTI prevention in the aspects of ARTI incidence, mean ARTI sick days, symptoms, bio-immune markers, and adverse effects were searched in 5 databases. Data were searched from inception to November 26, 2021. Stata 16.0 was used to perform the meta-analysis. RESULTS: Twenty RCTs (n = 4521) were included in this systematic review and meta-analysis. Pooled results showed that in the flavonoid-containing supplement group, the ARTI incidence and mean ARTI sick days were significantly decreased compared to those in the control group (RR = 0.81, 95% CI: 0.74-0.89, p < 0.001; WMD = -0.56, 95% CI: -1.04 to -0.08, p = 0.021; respectively). In 8 RCTs, flavonoids were singly used for interventions, ARTI incidence in the experimental group significantly decreased compared to that in the control group (RR = 0.85, 95% CI: 0.72-1.00, p = 0.047). In ten RCTs, flavonoid-containing mixtures were applied for interventions, and ARTI incidence in the experimental group significantly decreased compared to that in the control group (RR = 0.79, 95% CI: 0.71-0.89, p < 0.001). Furthermore, the ARTI incidence and mean ARTI sick days were significantly decreased in the experimental group compared to those in the control group in the flavan-3-ols subgroup (RR = 0.79, 95% CI: 0.67-0.92, p = 0.002; WMD = -2.75, 95% CI: -4.30 to -1.21, p < 0.001; respectively) and the multiple subclasses subgroup (RR = 0.75, 95% CI: 0.63-0.88, p = 0.001; WMD = -0.56, 95% CI: -1.11 to -0.01, p = 0.046; respectively). However, the bio-immune markers including interleukin-6, hypersensitive-c-reactive-protein, tumor necrosis factor-α, and interferon-γ did not differ between the flavonoid group and the control group. Moreover, in the flavonoid-containing supplement group, the incidence of adverse reactions did not increase compared to that in the control group (RR = 1.16, 95% CI: 0.78-1.73, p = 0.469). CONCLUSIONS: This systematic review and meta-analysis showed that flavonoid-containing supplements were efficacious and safe in preventing ARTIs. The most important limitations result from the small number of trials, poor quality of some included RCTs, differences in the composition and types of interventions, principal subclasses of flavonoids, methods of administration, and methodology. Moreover, only a few RCTs conducted independent verification of the flavonoid supplements used in the trial in terms of purity and potency, which may lead to a potential source of bias. Thus, larger and better-designed studies are needed to further verify this conclusion.

Flavonoids for Treating Viral Acute Respiratory Tract Infections: A Systematic Review and Meta-Analysis of 30 Randomized Controlled Trials.

BACKGROUND: This meta-analysis aimed to investigate the efficacy and safety of flavonoids in treating viral acute respiratory tract infections (ARTIs). METHODS: Randomized controlled trials (RCTs) were entered into meta-analyses performed separately for each indication. Efficacy analyses were based on changes in disease-specific symptom scores. Safety was analyzed based on the pooled data from all eligible trials, by comparing the incidence of adverse events between flavonoids and the control. RESULTS: In this study, thirty RCTs (n = 5,166) were included. In common cold, results showed that the flavonoids group decreased total cold intensity score (CIS), the sum of sum of symptom intensity differences (SSID) of CIS, and duration of inability to work vs. the control group. In influenza, the flavonoids group improved the visual analog scores for symptoms. In COVID-19, the flavonoids group decreased the time taken for alleviation of symptoms, time taken for SARS-CoV-2 RT-PCR clearance, the RT-PCR positive subjects at day 7, time to achievement of the normal status of symptoms, patients needed oxygen, patients hospitalized and requiring mechanical ventilation, patients in ICU, days of hospitalization, and mortality vs. the control group. In acute non-streptococcal tonsillopharyngitis, the flavonoids group decreased the tonsillitis severity score (TSS) on day 7. In acute rhinosinusitis, the flavonoids group decreased the sinusitis severity score (SSS) on day 7, days off work, and duration of illness. In acute bronchitis, the flavonoids group decreased the bronchitis severity score (BSS) on day 7, days off work, and duration of illness. In bronchial pneumonia, the flavonoids group decreased the time to symptoms disappearance, the level of interleukin-6 (IL-6), interleukin-8 (IL-8), and tumor necrosis factor-α (TNF-α). In upper respiratory tract infections, the flavonoids group decreased total CIS on day 7 and increased the improvement rate of symptoms. Furthermore, the results of the incidence of adverse reactions did not differ between the flavonoids and the control group. CONCLUSION: Results from this systematic review and meta-analysis suggested that flavonoids were efficacious and safe in treating viral ARTIs including the common cold, influenza, COVID-19, acute non-streptococcal tonsillopharyngitis, acute rhinosinusitis, acute bronchitis, bronchial pneumonia, and upper respiratory tract infections. However, uncertainty remains because there were few RCTs per type of ARTI and many of the RCTs were small and of low quality with a substantial risk of bias. Given the limitations, we suggest that the conclusions need to be confirmed on a larger scale with more detailed instructions in future studies.Systematic Review Registration: inplasy.com/inplasy-2021-8-0107/, identifier: INPLASY20218010.

Efficacy of Integrated Traditional Chinese and Western Medicine for Treating COVID-19: A Systematic Review and Meta-Analysis of RCTs.

Background: Integrated Chinese and Western medicine (integrated medicine) is routinely used in the treatment of coronavirus disease 2019 (COVID-19) in China. In this study, we undertook a systematic review and meta-analysis of published randomized controlled trials (RCTs) to evaluate the efficacy of integrated medicine therapy for patients with COVID-19. Methods: In this meta-analysis, we searched PubMed, Embase, Web of Science, SinoMed, China National Knowledge Infrastructure (CNKI), Chongqing VIP (CQVIP), and Wanfang databases from inception to April 12, 2021, to identify RCTs of integrated medicine in the treatment of COVID-19. The quality of RCTs was assessed by the Cochrane risk of bias tool. RevMan v5.3 and Stata software packages were used for statistical analysis. Results: Nineteen RCTs involving 1,853 patients met our inclusion criteria. Compared with patients treated by conventional Western medicine (CWM), patients treated by integrated medicine have a higher overall effective rate [RR = 1.17, 95% CI: (1.10, 1.26), p < 0.00001], fever disappearance rate [RR = 1.25, 95% CI: (1.04, 1.50), p = 0.02], fatigue disappearance rate [RR = 1.28, 95% CI: (1.00, 1.63), p = 0.05], and chest CT improvement rate [RR = 1.24, 95% CI: (1.14, 1.34), p < 00001]. Beneficial effects of the integrated medicine therapy were also seen in C-reactive protein (CRP) level [WMD = -4.14, 95% CI: (-6.38, -1.91), p = 0.0003] and white blood cell (WBC) count [WMD = 0.35, 95% CI: (0.11, 0.58), p = 0.004]. Subgroup analyses showed that, when the treatment time is <2 weeks, the effect of integrated medicine treatment is more obvious in improving the overall effective rate, clinical symptoms (fever, fatigue, and cough), the CRP level, and WBC count compared with that of the CWM treatment. For patients with severe and non-severe COVID-19, integrated medicine is more effective in improving fever and cough symptoms and WBC count than using CWM alone. Conclusion: The results of the current meta-analysis suggested that the integrated medicine can improve the clinical symptoms, chest CT and infection indicators of COVID-19 patients. Even if the treatment time is <2 weeks, the effect of integrated medicine in improving symptoms is more obvious compared with the treatment of CWM. However, the results should be interpreted cautiously due to the heterogeneity among the studies.

Effects of acupoint therapy on nonalcoholic fatty liver disease: A systematic review and meta-analysis.

BACKGROUND: and purpose: Acupoint therapy is suggested as a potential intervention for treating nonalcoholic fatty liver disease (NAFLD). This review assessed current evidence for the effect of acupoint therapy on NAFLD. METHODS: Eight electronic databases were searched to identify randomized controlled trials (RCTs) of patients with NAFLD treated by acupoint therapy from their inception to August 2020. A meta-analysis of outcomes was conducted by RevMan 5.3. RESULTS: Sixteen RCTs with 1320 patients were included. Acupoint therapy was significantly associated with improvements in alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels. Additionally, acupoint therapy significantly reduced triglyceride (TG), total cholesterol (TC) and low-density lipoprotein (LDL) levels. High-density lipoprotein (HDL) levels were also increased in NAFLD patients. CONCLUSION: Compared with other treatments, acupoint therapy may improve liver function and lipid metabolism, making it an available treatment for NAFLD. However, these findings need to be confirmed in large-scale, rigorously designed RCTs.

Additional Benefit of Chinese Medicine Formulae Including Dioscoreae rhizome (Shanyao) for Diabetes Mellitus: Current State of Evidence.

Background: Chinese medicine has been used to treat diabetes symptoms for thousands of years. Dioscoreae rhizome or Shanyao is a Chinese medicinal herb that is routinely used in the treatment of diabetes mellitus (DM). Objective: The purpose of this study is to evaluate the evidence of the added benefits and safety of herbal formulae containing Shanyao in clinical studies and the possible mechanisms of Shanyao in the prevention and treatment of DM in experimental studies. Methods: We searched nine databases for randomized controlled trials (RCTs) that included Shanyao in the formulae in the treatment of type 2 DM. Furthermore, experimental studies on the prevention and treatment of DM by Shanyao in English- and Chinese-language databases were identified. Results: Fifty-three moderate quality RCTs with herbal formulae containing Shanyao were identified. Results from meta-analysis indicated that Shanyao alone or formulae containing Shanyao in addition to conventional treatments could benefit people with type 2 DM in lowering blood glucose, blood lipids and reducing insulin resistance. Moreover, adverse events were significantly lower in the CHM plus conventional group than those in the conventional group. Shanyao may exert the benefit through various mechanisms including inhibition of α-glucosidase and DPP-IV activity, increase of endogenous GLP-1 and immune regulating activities. Conclusion: Evidence from this review suggested that there appeared to be added clinical benefits associated with the use of Shanyao for DM, whether as a food supplement or as a CHM combined with hypoglycemic agents with a good safety profile.

Molecular Mechanism of the Effect of Huanglian Jiedu Decoction on Type 2 Diabetes Mellitus Based on Network Pharmacology and Molecular Docking.

BACKGROUND: Huanglian Jiedu Decoction (HLJDD) is a Traditional Chinese Medicine (TCM) formula comprising four herbal medicines. This decoction has long been used in China for clinically treating T2DM. However, the molecular mechanism of HLJDD treat for T2DM is still not fully known. Hence, this study was designed to reveal the synergistic mechanism of HLJDD formula in the treatment of T2DM by using network pharmacology method and molecular docking. METHODS: Retrieving and screening of active components of different herbs in HLJDD and corresponding T2DM-related target genes across multiple databases. Subsequently, STRING and Cytoscape were applied to analysis and construct PPI network. In addition, cluster and topological analysis were employed for the analysis of PPI networks. Then, the GO and KEGG enrichment analysis were performed by using ClueGO tool. Finally, the differentially expressed analysis was used to verify whether the expression of key target genes in T2DM and non-T2DM samples was statistically significant, and the binding capacity between active components and key targets was validated by molecular docking using AutoDock. RESULTS: There are 65 active components involved in 197 T2DM-related targets that are identified in HLJDD formula. What is more, 39 key targets (AKT1, IL-6, FOS, VEGFA, CASP3, etc.) and 3 clusters were obtained after topological and cluster analysis. Further, GO and KEGG analysis showed that HLJDD may play an important role in treating T2DM and its complications by synergistically regulating many biological processes and pathways which participated in signaling transduction, inflammatory response, apoptotic process, and vascular processes. Differentially expressed analysis showed that AKT1, IL-6, and FOS were upregulated in T2DM samples and a significant between sample differential expression. These results were validated by molecular docking, which identified 5 high-affinity active components in HLJDD, including quercetin, wogonin, baicalein, kaempferol, and oroxylin A. CONCLUSION: Our research firstly revealed the basic pharmacological effects and relevant mechanisms of the HLJDD in the treatment of T2DM and its complications. The prediction results might facilitate the development of HLJDD or its active compounds as alternative therapy for T2DM. However, more pharmacological experiments should be performed for verification.

[Intractable sudden deafness treated with acupuncture on the base of "heart housing the mind"].

Intractable sudden deafness is a kind of primary sudden deafness that is insensitive to the comprehensive treatment in modern medicine. Due to the close relationship between the ear and the "heart", combined with the characteristics of intractable sudden deafness, in the theoretic guidance of "the heart housing the mind", the acupuncture therapy for regulating the mind and nourishing the heart was introduced in treatment of intractable sudden deafness, the relevant theoretic evidences were explored and elaborated with the typical case.

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.

[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-

[Effect of jiangtang bushen recipe in intervention treatment of patients with impaired glucose tolerance].

OBJECTIVE: To evaluate the intervention effect of diet, exercise and Jiangtang Bushen Recipe (JBR, a Chinese herbal recipe) in preventing the progress of patients with impaired glucose tolerance (IGT) to diabetes mellitus (DM) type 2. METHODS: Fifty-one patients with IGT, with their diagnosis conformed to the diagnosis standard of WHO, 1999, were randomly divided into the control group (n = 26) and the TCM group (n = 25). Patients in the control group attended to the educational course for DM and received dietotherapy and kinetotherapy, and to those in the TCM group, under these treatments, JBR was given additionally. Oral glucose tolerance test (OGTT), body weight index (BWI), levels of blood lipids and fasting insulin of all the patients were examined after 3 months, 6 months and 12 months of treatment. The total observation time was 1 year. RESULTS: Except the 6 cases out of the 51 patients (11.7%), on whom the observation discontinued, in the control group, as compared with before treatment, levels of fasting insulin and fasting blood glucose after treatment were not changed significantly (P > 0.05), also insignificant difference was shown in levels of total cholesterol (TC) and triglyceride (TG), though the two indexes lowered slightly after treatment (P > 0.05), but significant difference was shown in comparison of OGTT/2 h, blood glucose and BWI (P < 0.05). While in the TCM group, fasting blood glucose was changed insignificantly (P > 0.05), but there was significant difference in comparison of fasting insulin, TC, BWI, OGTT/2 h and plasma glucose levels (P < 0.01) respectively before and after treatment. At the end of the study, the cumulative cases with conversion to diabetes were 3 (13.6%) in the control group, and 1 (4.3%) in the TCM group, chi 2 test showed insignificant difference in comparison of diabetes conversion rate between the two groups (P > 0.05), however, the TCM group showed a better year conversion rate of normal glucose tolerance than that in the control group (chi 2 = 8.31, P < 0.01). CONCLUSION: TCM intervention is possibly effective in delaying the conversion of IGT to DM type 2, and plays integrative effeciency in impelling IGT patients to health. The favorable education and treatment of DM controlling, including dieto- and kineto-therapy may also be advantageous in IGT intervention, but could not be effective in blocking the advance of IGT.