Jiaxing Tian

Clinical Efficacy of Aconitum-Containing Traditional Chinese Medicine for Diabetic Peripheral Neuropathic Pain

Diabetic peripheral neuropathy is a common chronic complication of diabetes. Routine clinical management uses analgesics to relieve pain in combination with drugs for nerve repair. The drugs are often not effective for the severe pain cases, and these western medications also have side effects. We report a more effective treatment of diabetic peripheral neuropathic pain using a high dose of a traditional Chinese medicine, aconitum (including both Radix aconite preparata and Radix aconite kusnezoffii), in combination with Huangqi Guizhi Wuwu Tang (i.e., astragalus, cassia twig, white peony root, and spatholobi). In order to achieve stronger analgesic effects, we increased the clinical dosage of aconitum from 15 to 120 g. The aconitum was boiled for 6-8 hours, and licorice was also used to reduce potential toxicities of aconitum. In the four reported cases, the patients neuropathic pain was remarkably reduced and the EMG profile was also improved with this treatment regimen. Adverse reactions were not observed during the therapy. Thus, aconitum represents a promising and safe treatment for the well-being of patients and their diabetic peripheral neuropathic pain. Future controlled clinical trials using traditional Chinese medicines containing aconitum in treating the neuropathic pain are warranted.

The effectiveness and safety of a danshen-containing Chinese herbal medicine for diabetic retinopathy: A randomized, double-blind, placebo-controlled multicenter clinical trial

ETHNOPHARMACOLOGICAL RELEVANCEnSalvia miltiorrhiza (Danshen in Chinese) is a common traditional Chinese herbal medicine often used to treat many medical conditions. The Compound Danshen Dripping Pill (CDDP) is a danshen-containing Chinese herbal product for the treatment of cardiovascular diseases. However, to date, no controlled clinical studies have been conducted to evaluate the effects of CDDP on diabetic retinopathy (DR).nnnAIM OF THE STUDYnThe present large-scale clinical trial was designed to assess the effectiveness and safety of CDDP in treating patients with non-proliferative diabetic retinopathy (NPDR).nnnMATERIALS AND METHODSn223 NPDR patients were enrolled in this controlled trial. Subjects received oral study medications three times daily for 24 weeks. The four groups were placebo, low-dose (270 mg), mid-dose (540 mg) and high dose (810 mg herbal medicine). Primary endpoints were changes in fluorescence fundus angiography (FFA) and fundoscopic examination parameters.nnnRESULTS AND DISCUSSIONnAt 24 weeks, for the FFA, the percent of Excellent and Effective in the high-dose and mid-dose CDDP groups was 74% and 77%, respectively, very significantly higher than 28% in the placebo group (P<0.001). For fundoscopic examination, the percent of Excellent and Effective in the high-dose and mid-dose CDDP groups was 42% and 59%, respectively, very significantly higher than 11% in the placebo group (P<0.001). No adverse events with clinical significance were observed.nnnCONCLUSIONSnDR is a severe microvascular complication of diabetes and a major cause of adult blindness worldwide. Our clinical trial data demonstrated the therapeutic value and safety of a danshen-containing Chinese herbal medicine in patients with diabetic retinopathy.

The Efficacy and Safety of Chinese Herbal Medicine Jinlida as Add-On Medication in Type 2 Diabetes Patients Ineffectively Managed by Metformin Monotherapy: A Double-Blind, Randomized, Placebo-Controlled, Multicenter Trial.

Background Metformin plays an important role in diabetes treatment. Studies have shown that the combined use of oral hypoglycemic medications is more effective than metformin monotherapy. In this double-blind, randomized, placebo-controlled, multicenter trial, we evaluated whether Jinlida, a Chinese herbal medicine, enhances the glycemic control of metformin in type 2 diabetes patients whose HbA1c was ineffectively controlled with metformin alone. Methods A total of 186 diabetes patients were enrolled in this double-Blind, randomized, placebo-controlled, multicenter trial. Subjects were randomly allocated to receive either Jinlida (9 g) or the placebo TID for 12 consecutive weeks. All subjects in both groups also continuously received their metformin without any dose change. During this 12-week period, the HbA1c, FPG, 2h PG, body weight, BMI were assessed. HOMA insulin resistance (HOMA-IR) and β-cell function (HOMA- β) were also evaluated. Results At week 12, compared to the HbA1c level from week 0, the level of the Jinlida group was reduced by 0.92 ± 1.09% and that of the placebo group was reduced by 0.53 ± 0.94%. The 95% CI was 0.69 - 1.14 for the Jinlida group vs. 0.34 - 0.72 for the placebo group. There was a very significant HbA1c reduction between the two groups after 12 weeks (p < 0.01). Both FG and 2h PG levels of the Jinlida group and placebo group were reduced from week 0. There were a very significant FG and 2h PG level reductions between the two groups after 12 weeks (both p < 0.01). The Jinlida group also showed improved β-cell function with a HOMA-β increase (p < 0.05). No statistical significance was observed in the body weight and BMI changes. No serious adverse events were reported. Conclusion Jinlida significantly enhanced the hypoglycemic action of metformin when the drug was used alone. This Chinese herbal medicine may have a clinical value as an add-on medication to metformin monotherapy. Trial Registration Chinese Clinical Trial Register ChiCTR-TRC-13003159

Combination of symptoms, syndrome and disease: Treatment of refractory diabetic gastroparesis

AIMnTo assess effect of combination of symptoms, syndrome and disease on treatment of diabetic gastroparesis with severe nausea and vomiting.nnnMETHODSnProfessor Tong Xiaolins clinical electronic medical records of patients who were treated between January 1, 2006 and October 1, 2012 were used as a database. Patients who met the inclusion criteria were enrolled. General information (name, sex and age), symptoms and blood glucose levels were obtained from the clinic electronic medical record, which was supplemented by a telephone interview. The patient-rated Gastroparesis Cardinal Symptom Index (GCSI) was used to evaluate the severity of the symptoms of gastroparesis. The effects of the treatment were assessed by the change in the severity of the symptoms of gastroparesis and the change in blood glucose between the baseline levels and the post-treatment levels at 1, 2, 4, 8 and 12 wk.nnnRESULTSnForty-five patients had a mean GCSI nausea and vomiting severity score of 4.21 ± 0.67 and a total GCSI score of 2.77 ± 0.63 before treatment. There was a significant improvement in the nausea and vomiting score at every return visit compared with the baseline score (1 wk: 3.02 ± 1.04 vs 4.18 ± 0.71, P < 0.001; 2 wk: 2.32 ± 1.25 vs 4.16 ± 0.73, P < 0.001; 4 wk: 2.12 ± 1.26 vs 4.12 ± 0.73, P < 0.001; 8 wk: 1.79 ± 1.09 vs 4.24 ± 0.77, P < 0.001; 12 wk: 0.69 ± 0.92 vs 4.25 ± 0.70, P < 0.001). Twenty-five of the 45 patients had complete resolution of vomiting during the observation period (mean time to resolution was 37.9 ± 27.3 d). The postprandial fullness and early satiety subscale, bloating subscale and total GCSI scores were also improved. Finally, the blood glucose levels improved after treatment, although the change was not significant.nnnCONCLUSIONnUse of the combination of symptoms, syndrome and disease to treat diabetic gastroparesis with refractory nausea and vomiting may be a new treatment option.

Successful treatment of latent autoimmune diabetes in adults with traditional Chinese medicine: a case report.

INTRODUCTIONnLatent autoimmune diabetes in adults (LADA) is regarded as one of the Insulin-dependent diabetes mellitus that progress slowly. It gradually became understood since 1970s. The onset usually appears in adulthood, the islet autoantibodies are positive and the function of beta cell is declined rapidly.The treatment is insulin injection.nnnCASE PRESENTATIONnThe case reported followed is a 37-year-old male patient who was newly diagnosed with type 2 diabetes. He abandoned oral hypoglycemic agents since they caused stomach indisposed. Before visiting, his islet autoantibodies were detected positive and he had never injected insulin before. We treated him with traditional Chinese herbals under the guidance of Traditional Chinese Medicine and differentiation, and achieved fine efficacy.nnnCONCLUSIONnBecause the initial presentation of LADA is similar to Type 2 Diabetes Mellitus and examination is not in common use, misdiagnosis is not rare. Once LADA is diagnosed, the therapy must be adjusted. This case report indicated that Traditional Chinese Medicine might be an alternative treatment for LADA.

Structural Alteration of Gut Microbiota during the Amelioration of Human Type 2 Diabetes with Hyperlipidemia by Metformin and a Traditional Chinese Herbal Formula: a Multicenter, Randomized, Open Label Clinical Trial

ABSTRACT Accumulating evidence implicates gut microbiota as promising targets for the treatment of type 2 diabetes mellitus (T2DM). With a randomized clinical trial, we tested the hypothesis that alteration of gut microbiota may be involved in the alleviation of T2DM with hyperlipidemia by metformin and a specifically designed herbal formula (AMC). Four hundred fifty patients with T2DM and hyperlipidemia were randomly assigned to either the metformin- or AMC-treated group. After 12 weeks of treatment, 100 patients were randomly selected from each group and assessed for clinical improvement. The effects of the two drugs on the intestinal microbiota were evaluated by analyzing the V3 and V4 regions of the 16S rRNA gene by Illumina sequencing and multivariate statistical methods. Both metformin and AMC significantly alleviated hyperglycemia and hyperlipidemia and shifted gut microbiota structure in diabetic patients. They significantly increased a coabundant group represented by Blautia spp., which significantly correlated with the improvements in glucose and lipid homeostasis. However, AMC showed better efficacies in improving homeostasis model assessment of insulin resistance (HOMA-IR) and plasma triglyceride and also exerted a larger effect on gut microbiota. Furthermore, only AMC increased the coabundant group represented by Faecalibacterium spp., which was previously reported to be associated with the alleviation of T2DM in a randomized clinical trial. Metformin and the Chinese herbal formula may ameliorate type 2 diabetes with hyperlipidemia via enriching beneficial bacteria, such as Blautia and Faecalibacterium spp. IMPORTANCE Metabolic diseases such as T2DM and obesity have become a worldwide public health threat. Accumulating evidence indicates that gut microbiota can causatively arouse metabolic diseases, and thus the gut microbiota serves as a promising target for disease control. In this study, we evaluated the role of gut microbiota during improvements in hyperglycemia and hyperlipidemia by two drugs: metformin and a specifically designed Chinese herbal formula (AMC) for diabetic patients with hyperlipidemia. Both drugs significantly ameliorated blood glucose and lipid levels and shifted the gut microbiota. Blautia spp. were identified as being associated with improvements in glucose and lipid homeostasis for both drugs. AMC exerted larger effects on the gut microbiota together with better efficacies in improving HOMA-IR and plasma triglyceride levels, which were associated with the enrichment of Faecalibacterium spp. In brief, these data suggest that gut microbiota might be involved in the alleviation of diabetes with hyperlipidemia by metformin and the AMC herbal formula. Metabolic diseases such as T2DM and obesity have become a worldwide public health threat. Accumulating evidence indicates that gut microbiota can causatively arouse metabolic diseases, and thus the gut microbiota serves as a promising target for disease control. In this study, we evaluated the role of gut microbiota during improvements in hyperglycemia and hyperlipidemia by two drugs: metformin and a specifically designed Chinese herbal formula (AMC) for diabetic patients with hyperlipidemia. Both drugs significantly ameliorated blood glucose and lipid levels and shifted the gut microbiota. Blautia spp. were identified as being associated with improvements in glucose and lipid homeostasis for both drugs. AMC exerted larger effects on the gut microbiota together with better efficacies in improving HOMA-IR and plasma triglyceride levels, which were associated with the enrichment of Faecalibacterium spp. In brief, these data suggest that gut microbiota might be involved in the alleviation of diabetes with hyperlipidemia by metformin and the AMC herbal formula.

Evaluation of Chinese Herbal Medicine Jinlida in Type 2 Diabetes Patients based on Stratification: Results of Subgroup Analysis from 12-Week Trial

The Chinese herbal medicine Jinlida can significantly enhance the hypoglycemic action of metformin. However, the population showing the best responses to Jinlida has not been clarified. The aim of the present study was to compare the efficacy of Jinlida in type 2 diabetes mellitus (T2DM) after stratification.

Xiangshaliujunzi Decoction for the treatment of diabetic gastroparesis: A systematic review

AIMnTo assess the current clinical evidence of the effectiveness of Xiangshaliujunzi Decoction (XSLJZD) for the treatment of diabetic gastroparesis (DGP).nnnMETHODSnRandomized controlled trials (RCTs) were retrieved from seven major electronic databases including Medline, the Cochrane Library, Embase, Chinese Biomedical Literature Database (CBM), Chinese National Knowledge Infrastructure, Chinese Scientific Journal Database (VIP), and Wanfang Databases, using search dates from the beginning of the databases to May 2013. No language limitations were applied. We included RCTs that used XSLJZD or a modified XSLJZD compared with a control group for the treatment of DGP. The control groups included conventional treatment (Western medicinal treatment), placebo, and no treatment (blank), but not acupuncture. The main outcome index was clinical effectiveness, which was based on the gastric emptying test and variations in the gastrointestinal (GI) symptoms between the treatment and control groups after intervention. Data extraction, analysis, and quality assessment were conducted according to the Cochrane Handbook for Systematic Review of Interventions, Version 5.1.0.nnnRESULTSnTen RCTs involving 867 patients (441 in the experimental groups, and 426 in the control groups) were identified, and the overall methodological quality was evaluated as generally low. In the treatment groups, all 10 trials used herbs alone as the treatment, whereas all control groups used prokinetic medicine. The period of intervention ranged from 2 to 8 wk. Three classes were used to evaluate treatment efficacy: significant effective, effective, and ineffective, and all trials used the clinical effective rate (based on the gastric emptying test and changes in GI symptoms) to evaluate efficacy. The data showed that the effects of XSLJZD for the treatment of DGP were superior to the control group (n = 867, RR =1.33, 95%CI: 1.24-1.42, Z = 8.11, P < 0.00001). Two trials recorded adverse events, and one trial reported follow-up.nnnCONCLUSIONnXSLJZD could restore the gastric emptying rate and improve symptoms. However, the evidence remains weak due to the poor methodological quality of the included studies.

Chinese Herbal Medicine Banxiaxiexin Decoction Treating Diabetic Gastroparesis: A Systematic Review of Randomized Controlled Trials

Objective. To assess the current clinical evidence of Banxiaxiexin decoction for diabetic gastroparesis (DGP). Methods. Electronic databases were searched until December 2012. No language limitations were applied. We included RCTs using Banxiaxiexin decoction/modified Banxiaxiexin decoction for DGP. No restriction for the control group except acupuncture. Applying clinical effective rate as the main outcome index. Data extraction, analyses and quality assessment were conducted according to the Cochrane review standards. Results. 16 RCTs involving 1302 patients were finally identified, and the methodological quality was evaluated as generally low. The data showed that the effect of Banxiaxiexin decoction (BXXD) for DGP was superior to the control group (n = 1302, RR 1.23, 95% CI 1.17 to 1.29, Z = 8.04, P < 0.00001). Only one trial recorded adverse events, no obvious adverse event occurred. Conclusions. Banxiaxiexin decoction could regain the gastric emptying rate and improve diabetic gastrointestinal symptoms. However, the methodological quality of included studies is low, and long term efficacy and safety are still uncertain, which indicates that the findings above should be read with caution. Thereby, well-designed, large-scale, and high-quality randomized controlled clinical trials with scientific rigor are warranted for stronger evidence in future research.

The Efficacy and Safety of Chinese Herbal Decoction in Type 2 Diabetes: A 5-Year Retrospective Study

Background. The study was designed to assess the efficacy and safety of Chinese herbal decoction in treating outpatients with T2DM. Methods. All patients enrolled received decoction for at least 6 months. The primary outcome was the control rate of HbA1c and the change in HbA1c. FPG, 2hPG, HOMA-IR, and HOMA-β were also collected and evaluated. Results. The control rates after treatment at months 6, 12, 18, 24, 36, 48, and 60 were 45.07%, 52.78%, 47.22%, 45.83%, 50.00%, 57.14%, and 40.00%. Multiple linear regression showed the change of HbA1c has a significant relationship with the baseline HbA1c and duration of DM and BMI (p < 0.05). Both FPG and 2hPG levels significantly decreased compared to the baseline (p < 0.05). Chinese herbal decoction also improved islet cell function with decreased HOMA-IR and increased HOMA-β (p < 0.05). 19 and 4 subjects deactivated the antidiabetes drugs or insulin, respectively, after taking decoction. One subject developed DKD and one developed DPN, and another subject showed abnormal liver function which was irrelevant to decoction treatment. Conclusions. Chinese herbal decoction significantly enhanced the hypoglycemic action and had certain effect on protecting islet cell function. As a candidate diabetes therapy, it may reduce the use of antidiabetes drugs and slow the progression to diabetes complications.