Publications by authors named "Shengsheng Zhang"

27 Publications

  • Page 1 of 1

Berberine-Loaded Carboxylmethyl Chitosan Nanoparticles Ameliorate DSS-Induced Colitis and Remodel Gut Microbiota in Mice.

Front Pharmacol 2021 20;12:644387. Epub 2021 Apr 20.

State Key Laboratory of Chemical Resource Engineering, Beijing University of Chemical Technology, Beijing, China.

Inflammatory bowel disease (IBD) is a refractory disorder characterized by chronic and recurrent inflammation. The progression and pathogenesis of IBD is closely related to oxidative stress and irregularly high concentrations of reactive oxygen species (ROS). A new oxidation-responsive nano prodrug was constructed from a phenylboronic esters-modified carboxylmethyl chitosan (OC-B) conjugated with berberine (BBR) that degrades selectively in response to ROS. The optimized micelles exhibited well-controlled physiochemical properties and stability in a physiological environment. OC-B-BBR micelles could effectively encapsulate the anti-inflammatory drug berberine and exhibit ideal HO-triggered release behavior as confirmed by drug loading and release studies. The anti-inflammatory effect and regulation of gut microbiota caused by it were explored in mice with colitis induced by dextran sodium sulfate (DSS). The results showed that OC-B-BBR significantly ameliorated colitis symptoms and colon damage by regulating the expression levels of IL-6 and remodeling gut microbiota. In summary, this study exhibited a novel BBR-loaded Carboxylmethyl Chitosan nano delivery system which may represent a promising approach for improving IBD treatment.
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http://dx.doi.org/10.3389/fphar.2021.644387DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8093821PMC
April 2021

Development of a novel green tea quality roadmap and the complex sensory-associated characteristics exploration using rapid near-infrared spectroscopy technology.

Spectrochim Acta A Mol Biomol Spectrosc 2021 Sep 17;258:119847. Epub 2021 Apr 17.

Guizhou Key Laboratory for Information System of Mountainous Areas and Protection of Ecological Environment, Guizhou Normal University, 116 Baoshan North Rd, Guiyang, Guizhou 550001, China; Innovation Laboratory, the Third Experiment Middle School in Guiyang, Guiyang, Guizhou 550001, China. Electronic address:

Nondestructive instrumental identification of the green tea quality instead of professional human panel tests is highly desired for industrial application recently. The special flavor is a key quality-trait that influence consumer preference. However, flavonoids, as well as sensory-associated compounds, which play a critical role in the quality-traits profile of green tea samples have been poorly investigated. In this study, we were proposing an objective and accurate near infrared spectroscopy (NIRS) profile to support quality control within the entire green tea sensory evaluation chain, the complexity of green tea samples' sensory analysis was performed by two complementary methods: the standard calculation and the novel NIRS roadmap coupled with chemometrics. The green tea samples' physical quality, gustatory index, and nutritional index were measured respectively, which taking into consideration the gustatory evaluation of green tea for five commercially representative overall quality ("very bad", "bad", "regular", "good" and "excellent"). Our findings highlight the underexplored role of NIRS in chemical-to-sensory relationships and its widespread importance and utility in green tea quality improvement. Collectively, the comprehensive characterization of sensory-associated attribution allowed the identification of a wide array of spectrometric features, mostly related to moisture, soluble solids (SS), tea polyphenol (TPP), epigallocatechin gallate (EGCG), epicatechin (EC) and tea polysaccharide (TPS), which can be used as putative biomarkers to rapidly evaluate the green tea flavor variations related to rank differences. Otherwise, the NIRS' data were split into the calibration (n = 80) and prediction (n = 40) set independently, which showed high correlation coefficient with Rp-values of 0.9024, 0.9020 in physical and total cup quality, respectively. In this research, we demonstrated that NIRS was an easily-generated strategy and able to close the loop to feedback into the process for advanced process control. However, the established models should be improved by more green tea samples from different regions.
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http://dx.doi.org/10.1016/j.saa.2021.119847DOI Listing
September 2021

Randomised clinical trial: Efficacy and safety of Qing-Chang-Hua-Shi granules in a multicenter, randomized, and double-blind clinical trial of patients with moderately active ulcerative colitis.

Biomed Pharmacother 2021 Jul 13;139:111580. Epub 2021 Apr 13.

Affiliated Hospital of Nanjing University of Chinese Medicine (Jiangsu Province Hospital of Chinese Medicine), Nanjing 210029, China. Electronic address:

Qing-Chang-Hua-Shi (QCHS) is a Chinese herbal formula, which is composed of 11 herbs. Studies have also shown that QCHS granules can alleviate colitis in animal models by preventing inflammatory responses and suppressing apoptosis through the MEK/ERK signaling pathway. To determine the efficacy and safety of QCHS granules in patients with moderately active UC. We performed a multicenter, randomized, placebo-controlled, double-blind study of patients with moderately active UC who did not respond to 4 weeks of mesalazine therapy at the maximum dose. Patients were randomly assigned to groups and administered QCHS granules (125 g/day, n = 59) or an identical placebo, which was similar to the QCHS granules in color and taste (125 g/day, n = 60), with continued 5-ASA 4 g/d therapy for 12 weeks. The primary outcome was the rate of clinical response and clinical remission at week 12. The secondary outcomes were health-related quality of life, endoscopic response rate, and mucosal healing rate. Any changes in mucus/bloody stool and diarrhea were recorded. Out of the 119 enrolled patients at 10 different centers in China, 102 patients completed the trial. Clinical remission and clinical response were seen in 31.48% and 92.59% of QCHS-treated patients, and 12.50% and 72.92% of placebo-treated patients, respectively. There was a significant difference between the two treatment groups. More patients receiving QCHS granules vs. placebo achieved remission of mucus/bloody stool (70.37% vs. 47.92%, P = 0.0361). Adverse event rates were similar (QCHS granules 38.33%; placebo 25.42%). In conclusion, QCHS granules were superior to the placebo in introducing clinical remission and mucosal healing, as well as in relieving mucus/blood stool in patients with moderately active and 5-ASA-refractory UC.
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http://dx.doi.org/10.1016/j.biopha.2021.111580DOI Listing
July 2021

Bu-Zhong-Yi-Qi Granule Enhances Colonic Tight Junction Integrity via TLR4/NF-B/MLCK Signaling Pathway in Ulcerative Colitis Rats.

Evid Based Complement Alternat Med 2021 9;2021:6657141. Epub 2021 Mar 9.

Digestive Disease Center, Beijing Hospital of Traditional Chinese Medicine, Capital Medical University, Beijing, China.

Background: Bu-zhong-yi-qi granule (BZYQ), a sort of Chinese herbal medicine, has exhibited therapeutic effects on ulcerative colitis (UC). However, the mechanism of BZYQ has not been fully clarified. This study was aimed at investigating the effects of BZYQ on UC rats model and at exploring its potential mechanism.

Methods: The UC rats were established by enema of trinitrobenzene sulfonic acid (TNBS). The therapeutic effects of BZYQ treatment were evaluated by disease activity index (DAI), colon macroscopic damage index (CMDI) scores, and histological observation. The mRNA levels of tumor necrosis factor- (TNF-), interleukin-1 (IL-1), and interleukin-10 (IL-10) were measured by quantitative real time-polymerase chain reaction (qPCR). The expression of tight junction (TJ) proteins, occludin and claudin-1, in the colon was determined by Western blot and immunofluorescence. The expression of toll-like receptors 4 (TLR4), nuclear factor-kappa B (NF-B), p-NF-B, myosin light chain kinase (MLCK), MLC, and p-MLC levels in colon was determined by Western blot or qPCR.

Results: The results showed that BZYQ could attenuate DAI, CMDI, and histological inflammation. TJ proteins expression was decreased in UC rats, but treatment with BZYQ restored the expression of occludin and claudin-1. In addition, BZYQ administration ameliorated UC-associated increase in the production of TNF-, IL-1, and the expression of TLR4, NF-B, p-NF-B, MLCK, MLC, and p-MLC, while BZYQ administration increased the production of IL-10.

Conclusions: The therapeutic effect of BZYQ on UC is at least partially through regulation of the secretion of some inflammatory cytokines and improvement of TJ integrity via TLR4/NF-B/MLCK pathway.
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http://dx.doi.org/10.1155/2021/6657141DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7963908PMC
March 2021

Qingre Jianpi decoction attenuates inflammatory responses by suppressing NOD-like receptor family pyrin domain-containing 3 inflammasome activation in dextran sulfate sodium-induced colitis mice.

J Tradit Chin Med 2021 02;41(1):68-78

Department of Digestive system, Beijing Hospital of Traditional Chinese Medicine Affiliated to Capital Medical University, Beijing 100010, China.

Objective: To investigate the effects of Qingre Jianpi decoction (,QRJPD) on dextran sulfate sodium (DSS)-induced colitis mice and explore its mechanism.

Methods: All mice were randomly divided into six groups. Weight changes, disease activity index values, and histological damage were detected. Inflammatory cytokines and immune cell infiltration were measured using enzyme-linked immunosorbent assays (ELISA) and immunohistochemistry (IHC) method. The key protein expression levels of the NOD-like receptor family pyrin domain-containing 3 (NLRP3) inflammasome were detected by western blot analysis, IHC, and quantitative reverse transcription polymerase chain reaction.

Results: QRJPD played an anti-inflammatory role in the treatment of ulcerative colitis (UC), reduced the secretion of inflammatory cytokines, and inhibited the inflammatory infiltration of immune cells by suppressing DSS-induced activation of the NLRP3 inflammasome.

Conclusion: QRJPD exerts protective effects by inhibiting DSS-induced NLRP3 inflammasome activation.
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http://dx.doi.org/10.19852/j.cnki.jtcm.2021.01.009DOI Listing
February 2021

Efficacy of Shenlingbaizhu formula on irritable bowel syndrome: a systematic review.

J Tradit Chin Med 2020 12;40(6):897-907

Beijing Hospital of Traditional Chinese Medicine, Capital Medical University, Beijing 100010, China.

Objective: To evaluate the effectiveness and safety of a Shenlingbaizhu (SLBZ) formula in the treatment of irritable bowel syndrome (IBS). The effectiveness of SLBZ with or without conventional treatment was compared to that of conventional treatment alone.

Methods: A comprehensive literature search of four Chinese electronic databases, three English language databases, and two English language trial registries from inception to June 2019 was performed. Two authors independently screened the citations and retrieved full publications of randomized trials on the use of SLBZ with or without conventional treatment for IBS. The methodological quality of the trials was assessed with the Cochrane Collaboration's tool for assessing the risk of bias. Data were extracted and subjected to Meta-analysis to compare the efficacy of the SLBZ formula with or without conventional treatment to conventional treatment alone.

Results: Thirteen trials (comprising a total of 868 patients with IBS) were included in this review. The risk of bias of all 13 included trials was assessed as moderate. The SLBZ formula was associated with significant improvements in cure rate [relative risk (RR) score of 2.38, 95% confidence interval (CI) 1.43 to 3.95, I 2 = 0%; 8 trials, n = 487, fixed-effects model (FEM)], diarrhea severity score [mean difference (MD) score of -0.62, 95% CI -1.05 to -0.20, I 2 = 88%; 4 trials, n = 286, random effects model (REM)], abdominal pain severity score (MD score of -0.61, 95% CI -0.70 to -0.52, I 2 = 63%; 4 trials, n = 286, FEM), and abdominal distention severity score (MD score of -0.88, 95% CI -1.54 to -0.21, I 2 = 91%; 3 trials, n = 226, REM) compared to the conventional treatment alone. Adverse events were reported in five trials but only one of these indicated any adverse events associated with SLBZ.

Conclusion: Based on the 13 trials reviewed here, the SLBZ formula with or without conventional treatment appeared to be safe and more effective in improving the cure rate and reducing the severity of diarrhea, abdominal pain, and abdominal distention compared to conventional treatment alone. However, these trials only generated a moderate quality of evidence, and well-designed and high-quality random controlled trials of the SLBZ formula for the treatment of IBS are required to confirm the efficacy of this treatment option.
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http://dx.doi.org/10.19852/j.cnki.jtcm.2020.06.001DOI Listing
December 2020

Near-Infrared Spectroscopy as a Process Analytical Technology Tool for Monitoring the Steaming Process of with Multiparameters and Chemometrics.

J Anal Methods Chem 2020 4;2020:8847277. Epub 2020 Nov 4.

Innovation Laboratory, The Third Experiment Middle School, Guizhou Key Laboratory for Information System of Mountainous Areas and Protection of Ecological Environment, Guizhou Normal University, 116 Baoshan North Rd, Guiyang, Guizhou 550001, China.

Steaming is a vital unit operation in traditional Chinese medicine (TCM), which greatly affects the active ingredients and the pharmacological efficacy of the products. Near-infrared (NIR) spectroscopy has already been widely used as a strong process analytical technology (PAT) tool. In this study, the potential usage of NIR spectroscopy to monitor the steaming process of was explored. About 10 lab scale batches were employed to construct quantitative models to determine four chemical ingredients and moisture change during the steaming process. Gastrodin, -hydroxybenzyl alcohol, parishin B, and parishin A were modeled by different multivariate calibration models (SMLR and PLS), while the content of the moisture was modeled by principal component regression (PCR). In the optimized models, the root mean square errors of prediction (RMSEP) for gastrodin, -hydroxybenzyl alcohol, parishin B, parishin A, and moisture were 0.0181, 0.0143, 0.0132, 0.0244, and 2.15, respectively, and correlation coefficients () were 0.9591, 0.9307, 0.9309, 0.9277, and 0.9201, respectively. Three other batches' results revealed that the accuracy of the model was acceptable and that was specific for next drying step. In addition, the results demonstrated the method was reliable in process performance and robustness. This method holds a great promise to replace current subjective color judgment and time-consuming HPLC or UV/Vis methods and is suitable for rapid online monitoring and quality control in the TCM industrial steaming process.
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http://dx.doi.org/10.1155/2020/8847277DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7657684PMC
November 2020

Gastro-Protective Effects of Calycosin Against Precancerous Lesions of Gastric Carcinoma in Rats.

Drug Des Devel Ther 2020 9;14:2207-2219. Epub 2020 Jun 9.

Digestive Disease Center, Beijing Hospital of Traditional Chinese Medicine, Capital Medical University, Beijing, People's Republic of China.

Aim: Gastric cancer is a leading cause of cancer death worldwide. In-depth research of precancerous lesions of gastric carcinoma (PLGC) with malignant transformation potential is a key measure to prevent the development of gastric carcinoma. Recently, calycosin has been shown to have anticancer effects in vitro and in vivo. The molecular mechanism by which calycosin affects PLGC, however, has not yet been elucidated. The purpose of this study was to evaluate the effect and mechanism of calycosin in -methyl-'-nitro--nitrosoguanidine (MNNG)-induced PLGC rats.

Methods: The effects of calycosin in the gastric mucosa of rats with PLGC were evaluated using histopathology and transmission electron microscopy (TEM). For further characterization, the expression levels of integrin β1, nuclear factor kappa B (NF-κB), p-NF-κB, DARPP-32 and signal transducer and activator of transcription 3 (STAT3) were determined by Western blot assay and immunohistochemistry.

Results: Hematoxylin-eosin and high iron diamine-Alcian blue-periodic acid-Schiff (HID-AB-PAS) staining showed that intestinal metaplasia and dysplasia were significantly ameliorated in the calycosin intervention groups compared with the model group. Further, TEM results showed that calycosin intervention tempered microvascular abnormalities and cell morphology of primary and parietal cells in PLGC tissues. The results suggested that calycosin had gastro-protective effects in MNNG-induced PLGC rats. Western blot and immunohistochemistry analysis showed that the increased protein expression levels of NF-κB, p-NF-κB, DARPP-32 and STAT3 in the model group were downregulated by calycosin. The upregulation of integrin β1 expression induced by MNNG was decreased in the calycosin groups.

Conclusion: Collectively, calycosin protected against gastric mucosal injury in part via regulation of the integrin β1/NF-κB/DARPP-32 pathway and suppressed the expression of STAT3 in PLGC. The elucidation of this effect and mechanism of calycosin in PLGC provides a potential therapeutic strategy for treatment of gastric precancerous lesions.
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http://dx.doi.org/10.2147/DDDT.S247958DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7294567PMC
March 2021

MiR-17-5p promotes cellular proliferation and invasiveness by targeting RUNX3 in gastric cancer.

Biomed Pharmacother 2020 Aug 21;128:110246. Epub 2020 May 21.

Beijing Hospital of Traditional Chinese Medicine, Capital Medical University, Beijing, 100010, China. Electronic address:

Background: Dysregulated microRNAs (miRNAs/miRs) directly modulate the biological functions of gastric cancer (GC) cells and contribute to the initiation and progression of GC. MiR-17-5p and runt-related transcription factor 3 (RUNX3) have been reported to be related to GC progression; however, the specific interaction between miR-17-5p and RUNX3 in GC require further investigation.

Methods: Western blotting, real-time PCR and immunohistochemistry were used to study the expression level of miR-17-5p and RUNX3 in gastric cancer tissues and plasma. The biological function of miR-17-5p was examined by measuring cell proliferation, apoptosis and cell invasion in vitro; the target gene of miR17-5p was identified by luciferase reporter assays, RNA Binding protein immunoprecipitation (RIP) and western blotting. In vivo animal study was conducted to confirm the role of miR-17-5p during tumorigensis of gastric cancer.

Results: This study showed that miR17-5p was upregulated in the plasma and tissues of patients with GC, while RUNX3 was downregulated in GC tissues. Functional experiments indicated that miR-17-5p mimics promoted the proliferation and invasion of GC via suppressing apoptosis in vitro. Furthermore, bioinformatics prediction, luciferase reporter assays, reverse transcription quantitative polymerase chain reaction assays, RIP and western blotting analysis demonstrated that RUNX3 was a direct target gene of miR-17-5p in GC. In addition, overexpression of RUNX3 suppressed the proliferation and invasiveness of GC cells. In vivo data indicated miR-17-5p agomir significantly promoted tumor growth. In contrast, miR-17-5p antagomir notably decreased tumor volume compared with control group.

Conclusions: MiR-17-5p promoted the progression of GC via directly targeting RUNX3, suggesting that miR-17-5p and RUNX3 could be considered as diagnostic and therapeutic targets for patients with GC.
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http://dx.doi.org/10.1016/j.biopha.2020.110246DOI Listing
August 2020

Sini-San Regulates the NO-cGMP-PKG Pathway in the Spinal Dorsal Horn in a Modified Rat Model of Functional Dyspepsia.

Evid Based Complement Alternat Med 2020 31;2020:3575231. Epub 2020 Mar 31.

Digestive Disease Center, Beijing Hospital of Traditional Chinese Medicine, Capital Medical University, Beijing 100010, China.

The present study investigated the effect of Chinese medicine Sini-San (SNS) on visceral hypersensitivity in a rat model of functional dyspepsia (FD), and it explored related underlying mechanisms. The rat model of FD was developed by combining neonatal iodoacetamide (IA) treatment and adult tail-clamping. After SNS treatment, the behavior and electromyographic testing were performed to evaluate the visceromotor responses of rats to gastric distention. Immunofluorescence was used to detect the distribution of iNOS-positive cells in the spinal dorsal horn, while the real-time quantitative PCR and western blot were used for detection of the gene expression of c-fos, iNOS, and GABAb and protein levels of iNOS and GABAb in the spinal dorsal horn, respectively. The protein concentration of cGMP and PKG proteins in the spinal dorsal horn were quantified by enzyme-linked immunosorbent assay. In this study, SNS treatment significantly reduced the behavioral score and electromyographic response to graded intragastric distension pressure. The middle-dose of SNS treatment significantly reduced the distribution of iNOS-positive cells in the spinal dorsal horn of FD model rats. The gene expression of c-fos, iNOS, and GABAb and the protein contents of iNOS, GABAb, cGMP, and PKG in the spinal dorsal horn of FD model rats were restored to a normal level by middle-dose of SNS treatment. Our results suggest that Sini-San may alleviate the visceral hypersensitivity in FD model rats via regulation of the NO/cGMP/PKG pathway in the spinal dorsal horn.
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http://dx.doi.org/10.1155/2020/3575231DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7150674PMC
March 2020

Modified Liu-Jun-Zi decoction alleviates visceral hypersensitivity in functional dyspepsia by regulating EC cell-5HT3r signaling in duodenum.

J Ethnopharmacol 2020 Mar 10;250:112468. Epub 2019 Dec 10.

Digestive Disease Center, Beijing Hospital of Traditional Chinese Medicine, Capital Medical University, Beijing, China. Electronic address:

Ethnopharmacological Relevance: Modified Liu-Jun-Zi (MLJZ) is derived from one of the most famous traditional Chinese prescription Liu-Jun-Zi. It exhibits therapeutic effects in functional dyspepsia (FD), but the underlying mechanisms remain not well understood. Enterochromaffin (EC) cells contribute to the pathogeneses of visceral hypersensitivity in functional gastrointestinal disorders. But whether and how EC cells in duodenum participate in the mechanism of FD remain unsettled.

Aim Of The Study: To detect the crucial factors related to EC cells, and to evaluate the therapeutic effect of MLJZ and to determine whether MLJZ relieves visceral hypersensitivity in FD by regulating EC cell-5-hydroxytryptamine 3 receptor (5HT3r) signaling.

Materials And Methods: FD rats were established by iodoacetamide gavage combined with tail clamping method. The verification of FD model and the evaluation of the therapeutic effect of MLJZ was taken place by hematoxylin-eosin (HE) staining and visceral sensitivity measurement. The expression of EC cells and 5-hydroxytryptamine (5HT) in duodenum was detected by Immunohistochemistry (IHC) staining and enzyme-linked immunosorbent assay (ELISA). IHC staining and quantitative polymerase chain reaction (qPCR) were applied to measure the expression of tryptophan hydroxylase-1 (TPH1), paired box gene 4 (PAX4), transient receptor potential A1 (TRPA1), transient receptor potential C4 (TRPC4) and 5HT3r. Duodenum sections were stained by double immunofluorescence (IF) to study the synthesis of 5HT in EC cells.

Results: The gastric sensitivity increased in FD rats while MLJZ decoction significantly attenuated visceral hypersensitivity. The duodenum of FD rats displayed increased expressions of EC cells, 5HT, TPH1, PAX4 and 5HT3r. And the overexpression was reduced in response to MLJZ decoction treatment.

Conclusions: EC cell-5HT3r signaling pathway is abnormally active in FD with visceral hypersensitivity. And MLJZ decoction can alleviates visceral hypersensitivity in FD by regulating EC cell-5HT3r signaling in duodenum.
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http://dx.doi.org/10.1016/j.jep.2019.112468DOI Listing
March 2020

Sini San ameliorates duodenal mucosal barrier injury and low‑grade inflammation via the CRF pathway in a rat model of functional dyspepsia.

Int J Mol Med 2020 Jan 4;45(1):53-60. Epub 2019 Nov 4.

Digestive Disease Center, Beijing Hospital of Traditional Chinese Medicine, Capital Medical University, Beijing 100010, P.R. China.

The gut‑brain interaction is associated with impaired duodenal mucosal integrity and low‑grade inflammation, which have been proven to be important pathological mechanisms of functional dyspepsia (FD). Sini San (SNS) is a classical Chinese medicine used to treat FD, but its underlying mechanisms are poorly understood. The aim of the present study was to evaluate the effects of SNS on duodenal mucosal barrier injury and low‑grade inflammation with FD, and to assess its potential molecular mechanisms on the brain‑gut axis. FD rats were established using the iodoacetamide and tail‑squeezed methods. The expression of corticotropin‑releasing factor (CRF), CRF receptor 1 (CRF‑R1) and CRF‑R2, were determined by western blot analysis and/or immunohistochemistry (IHC). In addition, mast cell (MC) migration was assessed by IHC with an anti‑tryptase antibody, and histamine concentration was quantified using ELISA. The mRNA expression levels of tryptase and protease‑activated receptor 2 (PAR‑2) were quantified using reverse transcription‑quantitative PCR, and the protein expression levels of zona occludens protein 1 (ZO‑1), junctional adhesion molecule 1 (JAM‑1), β‑catenin and E‑cadherin were determined via western blot analysis. It was demonstrated that the expression level of CRF was downregulated in the central nervous system and duodenum following SNS treatment, and that SNS modulated the expression of both CRF‑R1 and CRF‑R2. In addition, SNS suppressed MC infiltration and the activity of the tryptase/PAR‑2 pathway in the duodenum. Furthermore, treatment with SNS restored the normal expression levels of ZO‑1, JAM‑1 and β‑catenin in FD rats. These findings suggested that the therapeutic effects of SNS on FD were achieved by restoring mucosal barrier integrity and suppressing low‑grade inflammation in the duodenum, which was at least partially mediated via the CRF signaling pathway.
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http://dx.doi.org/10.3892/ijmm.2019.4394DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6889936PMC
January 2020

Development and validation of a prediction rule for estimating gastric cancer risk in the Chinese high-risk population: a nationwide multicentre study.

Gut 2019 09 29;68(9):1576-1587. Epub 2019 Mar 29.

Department of Gastroenterology, Changhai Hospital, Naval Medical University, Shanghai, China.

Objective: To develop a gastric cancer (GC) risk prediction rule as an initial prescreening tool to identify individuals with a high risk prior to gastroscopy.

Design: This was a nationwide multicentre cross-sectional study. Individuals aged 40-80 years who went to hospitals for a GC screening gastroscopy were recruited. Serum pepsinogen (PG) I, PG II, gastrin-17 (G-17) and anti- IgG antibody concentrations were tested prior to endoscopy. Eligible participants (n=14 929) were randomly assigned into the derivation and validation cohorts, with a ratio of 2:1. Risk factors for GC were identified by univariate and multivariate analyses and an optimal prediction rule was then settled.

Results: The novel GC risk prediction rule comprised seven variables (age, sex, PG I/II ratio, G-17 level, infection, pickled food and fried food), with scores ranging from 0 to 25. The observed prevalence rates of GC in the derivation cohort at low-risk (≤11), medium-risk (12-16) or high-risk (17-25) group were 1.2%, 4.4% and 12.3%, respectively (p<0.001).When gastroscopy was used for individuals with medium risk and high risk, 70.8% of total GC cases and 70.3% of early GC cases were detected. While endoscopy requirements could be reduced by 66.7% according to the low-risk proportion. The prediction rule owns a good discrimination, with an area under curve of 0.76, or calibration (p<0.001).

Conclusions: The developed and validated prediction rule showed good performance on identifying individuals at a higher risk in a Chinese high-risk population. Future studies are needed to validate its efficacy in a larger population.
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http://dx.doi.org/10.1136/gutjnl-2018-317556DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6709770PMC
September 2019

The differences in the esophageal motility between liquid and solid bolus swallows: A multicenter high-resolution manometry study in Chinese asymptomatic volunteers.

Neurogastroenterol Motil 2019 06 28;31(6):e13574. Epub 2019 Feb 28.

Division of Gastroenterology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.

Background: The results of the esophageal body motility differences between liquid and solid swallows from high-resolution manometry (HRM) studies are not consistent. The information of the frequency of ineffective liquid and solid bolus swallows in healthy individuals during HRM procedure is limited. The normative values of the HRM parameters of both liquid and solid swallows for Chinese population are lacking.

Methods: The esophageal HRM data of 101 healthy volunteers from multicenters in China were analyzed. The values of the HRM parameters were summarized and compared between liquid and solid swallows. The frequencies of ineffective liquid and solid swallows were summarized.

Results: Esophagus contracted stronger and slower in solid bolus swallows than water swallows with HREM. Ineffective water swallow (DCI < 450 mm Hg.s.cm) and ineffective bread swallow (DCI < 800 mm Hg.s.cm) were frequently seen in asymptomatic individuals. The adding of bread swallows to the HREM procedure might cause diagnostic change in about 15.8% (16/101) of the asymptomatic individuals.

Conclusions: The vigor and velocity of the esophageal peristalsis between liquid and solid bolus swallows are different. Ineffective water and solid bolus swallows are not rare. Adding solid bolus swallows brings diagnostic change, and it may be needed routinely for the HRM procedure.
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http://dx.doi.org/10.1111/nmo.13574DOI Listing
June 2019

Effects of Fengliao-Changweikang in Diarrhea-predominant Irritable Bowel Syndrome Rats and Its Mechanism Involving Colonic Motility.

J Neurogastroenterol Motil 2018 Jul;24(3):479-489

Digestive Disease Center, Beijing Hospital of Traditional Chinese Medicine Affiliated to Capital Medical University, Beijing, China.

Background/aims: This study was designed to investigate the effect of Fengliao-Changweikang (FLCWK) in diarrhea-predominant irritable bowel syndrome (IBS-D) rats and explore its underlying mechanisms.

Methods: IBS-D model rats were induced by neonatal maternal separation (NMS) combined with restraint stress (RS). In in vivo experiments, the model rats were randomly divided into 5 groups: NMS + RS, FLCWK (low dose, middle dose, and high dose), and pinaverium bromide. The normal control (no handling) rats were classified as the NH group. The therapeutic effect of FLCWK was evaluated by fecal characteristics, electromyographic response and abdominal withdrawal reflex scores. In in vitro experiments, the model rats were randomly divided into 2 groups: NMS + RS, FLCWK (middle dose), and no handling rats were used as the NH group. The differences in basic tension and ACh-induced tension of isolated colonic longitudinal smooth muscle strips (CLSMs) among the 3 groups were observed. In addition, different inhibitors (nifedipine, TMB-8, L-NAME, methylene blue, and 4-AP) were pretreated to explore the underlying mechanisms.

Results: In in vivo experiments, fecal characteristics, electromyographic response, and abdominal withdrawal reflex scores significantly improved in the FLCWK group, compared with the NMS + RS group. In in vitro experiments, the basic tension and ACh-induced tension of CLSMs in IBS-D rats were significantly inhibited by FLCWK. After pre-treatment with different inhibitors, the ACh-induced tension of CLSMs in each group showed no significant difference.

Conclusions: FLCWK manifested curative effect in IBS-D rats by inhibiting colonic contraction. The underlying mechanisms may be related to regulatory pathway of nitric oxide/cGMP/Ca²⁺ and specific potassium channels.
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http://dx.doi.org/10.5056/jnm17093DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6034674PMC
July 2018

Screening pathogenic genes in oral squamous cell carcinoma based on the mRNA expression microarray data.

Int J Mol Med 2018 Jun 27;41(6):3597-3603. Epub 2018 Feb 27.

Dental Materials Laboratory, National Engineering Laboratory for Digital and Material Technology of Stomatology, Peking University School and Hospital of Stomatology, Beijing 100081, P.R. China.

Oral squamous cell carcinoma (OSCC) is one of the most common malignancies and its survival rate has barely improved over the past few decades. The purpose of this study was to screen pathogenic genes of OSCC via microarray analysis. The mRNA expression microarray datasets (GSE2280 and GSE3524) were downloaded from the Gene Expression Omnibus (GEO) database. In GSE2280, there were 22 OSCC samples without metastasis and 5 OSCC samples with lymph node metastasis. In GSE3524, there were 16 OSCC samples and 4 normal tissue samples. The differentially expressed genes (DEGs) in OSCC samples with lymph node metastasis compared with those without metastasis (named as DEGs-1), and the DEGs in OSCC samples compared with normal tissue samples (named as DEGs-2), were obtained via limma package. The Database for Annotation, Visualization and Integrated Discovery (DAVID) was used to perform the functional enrichment analyses of DEGs-1 and DEGs-2. The miRNA-gene pairs of overlaps among DEGs were screened out with the TargetScan database, and the miRNA-gene regulated network was constructed by Cytoscape software. A total of 233 and 410 DEGs were identified in the sets of DEGs-1 and DEGs-2, respectively. DEGs-1 were enriched in 188 Gene Ontology (GO) terms and 8 Kyoto Encyclopedia of Genes and Genomes (KEGG) pathways, and DEGs-2 were enriched in 228 GO terms and 6 KEGG pathways. In total, 126 nodes and 135 regulated pairs were involved in the miRNA-gene regulated network. Our study indicated that transglutaminase 2 (TGM2) and Islet 1 (ISL1) may be biomarkers of OSCC and their metastases. Moreover, it provided some potential pathogenic genes (e.g. P2RY2 and RAPGEFL1) in OSCC.
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http://dx.doi.org/10.3892/ijmm.2018.3514DOI Listing
June 2018

Mechanistic Understanding of Herbal Therapy in Inflammatory Bowel Disease.

Curr Pharm Des 2017 ;23(34):5173-5179

Division of Digestive Diseases, Department of Medicine, Emory University, Atlanta, GA 30322, United States.

The incidence and prevalence of inflammatory bowel diseases (IBD), which comprise ulcerative colitis and Crohn's disease, are increasing dramatically worldwide. Immunomodulators and biological agents can help but cause severe side effects in long-term use. As such, complementary and alternative medicine, in particular herbal remedy, is becoming more and more popular in the treatment of IBD patients. Many natural compounds have been used in clinical trials and some have been proven promising in IBD treatment. To achieve a better understanding of herbal therapy, researchers focus on understanding the underlying mechanisms by using experimental rodent models. The mechanism of the pathogenesis of IBD is complex involving both environmental and genetic factors. IBD is considered as a consequence of impaired epithelial barrier function, gut microbiota dysbiosis, and aberrant immune response. Studies have demonstrated that herbal medicine can improve epithelial proliferation and barrier integrity, restore microbiota homeostasis, and suppress hyper-immune reaction. This review is to summarize current understanding of the molecular basis of herbal treatment of IBD at the levels of epithelial, microbial, and immune regulation.
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http://dx.doi.org/10.2174/1381612823666171010124414DOI Listing
April 2019

Sini-san improves duodenal tight junction integrity in a rat model of functional dyspepsia.

BMC Complement Altern Med 2017 Aug 30;17(1):432. Epub 2017 Aug 30.

Digestive Disease Center, Beijing Hospital of Traditional Chinese Medicine Affiliated to Capital Medical University, Beijing, China.

Background: Recent reports have demonstrated that impaired barrier function and local microinflammation in the duodenal mucosa contribute to the pathogeneses of functional dyspepsia (FD). Thus, restoring normal barrier integrity becomes a potential therapeutic strategy in the treatment of FD. Sini-San (SNS) is a traditional Chinese prescription that exhibits therapeutic effects in FD, but the underlying mechanisms remain not well understood.

Methods: FD rats were established by tail clamping method and the therapeutic effect of SNS was evaluated by measuring the visceral sensitivity and gastric compliance. Transepithelial electrical resistance (TEER) that reveals epithelial barrier integrity was measured by Ussing chamber. The expression of tight junction (TJ) proteins, occludin and claudin-1, in the duodenum was determined by Western blot and immunofluorescence. The amount of tumor necrosis factor alpha (TNF-α) and interferon gamma (INF-γ) in duodenal mucosa was detected by enzyme-linked immune sorbent assay (ELISA). The mRNA level of transient receptor potential vanilloid type 1 (TRPV1) was measured by quantitative real time-polymerase chain reaction (qPCR).

Results: SNS could improve gastric compliance and attenuate visceral hypersensitivity (VH) in FD rats. TEER was decreased in FD rats, but treatment with SNS restored normal level of TEER and the expression of occludin and claudin-1 in FD rats. In addition, SNS administration ameliorated FD-associated increase in the production of TNF-α, IFN-γ and the expression of TRPV1.

Conclusions: The therapeutic effect of SNS on FD is at least partially through improvement of TJ integrity and attenuation of FD-associated low-grade inflammation in the duodenum. Our findings highlight the molecular basis of SNS-based treatment of FD in human patients.
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http://dx.doi.org/10.1186/s12906-017-1938-2DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5577804PMC
August 2017

Inhibitory Effects and Mechanisms of Electroacupuncture via Chronically Implanted Electrodes on Stress-Induced Gastric Hypersensitivity in Rats With Neonatal Treatment of Iodoacetamide.

Neuromodulation 2017 Dec 10;20(8):767-773. Epub 2017 Apr 10.

Veterans Research and Education Foundation, VA Medical Center, Oklahoma City, OK, USA.

Background: Stress is considered an independent factor causing and aggravating gastrointestinal symptoms, including visceral pain. The aim of this study was to investigate effects and mechanisms of electroacupuncture (EA) on stress-induced gastric hypersensitivity in rats treated with neonatal iodoacetamide mimicking human functional dyspepsia (FD).

Methods: Neonatal rats were treated with gavage of 0.2 mL of 0.1% iodoacetamide in 2% sucrose daily for six days starting on tenth day after birth. The control group was given 0.2 mL of 2% sucrose. When the rats were eight weeks old, acute restraint stress was performed on them for 90 min. EA at ST36 (ZuSanLi) was performed during the acute stress or 30 min after the stress. Adrenoceptor blocking drugs (propranolol and phentolamine) were injected intraperitoneally 30 min before acute restraint stress to explore possible sympathetic mechanisms. Visceral-motor responses to gastric distention were assessed by electromyogram (EMG).

Results: 1) Stress-induced gastric hypersensitivity was significantly more severe in the FD rats, compared to the control rats. It was blocked by the adrenoceptor antagonists. 2) EA inhibited stress-induced gastric hypersensitivity; the preventive effect of EA (given during stress) was more remarkable than the curative effect (given after stress). Stress resulted in a higher sympathovagal ratio and this was suppressed by EA.

Conclusions: Rats treated with neonatal iodoacetamide mimicking FD are more vulnerable to stress. Stress-induced gastric hypersensitivity can be prevented or suppressed by EA at ST36 via the restoration of sympathovagal balance.
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http://dx.doi.org/10.1111/ner.12602DOI Listing
December 2017

Effect of Aurantii Fructus Immaturus Flavonoid on the Contraction of Isolated Gastric Smooth Muscle Strips in Rats.

Evid Based Complement Alternat Med 2016 27;2016:5616905. Epub 2016 Jun 27.

Digestive Disease Center, Beijing Hospital of Traditional Chinese Medicine Affiliated to Capital Medical University, Beijing 100010, China.

This study was designed to investigate the effect of Aurantii fructus immaturus flavonoid (AFIF) on the contraction of isolated gastric smooth muscle in rats and explore its underlying mechanisms. Isolated antral longitudinal smooth muscle strip (ALSMS) and pyloric circular smooth muscle strip (PCSMS) of rats were suspended in tissue chambers. The responses of ALSMS and PCSMS to administration of AFIF were observed. Cyclic guanosine monophosphate (cGMP) and protein kinase G (PKG) levels of PCSMS were measured by ELISA kits. In this study, AFIF showed no significant effect on ALSMS contraction, but it dose-dependently reduced the mean contraction amplitude of PCSMS. When the concentration of AFIF reached 3000 μg/mL, 6000 μg/mL, and 10000 μg/mL, its inhibitory effect on PCSMS contraction was significant. This effect of AFIF was weakened in Ca(2+)-rich environment. And Nω-nitro-L-arginine methyl (L-NAME), the inhibitor of nitric oxide synthase (NOS), significantly inhibited AFIF's action in comparison with control (P < 0.05). After incubation with AFIF for 30 min, levels of cGMP and PKG in PCSMS were significantly increased compared with control (P < 0.05). Our results suggest that AFIF has a dose-dependent diastolic effect on PCSMS in rats, which may be related to the regulatory pathway of NO/cGMP/PKG/Ca(2+).
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http://dx.doi.org/10.1155/2016/5616905DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4939329PMC
July 2016

Effect of TongXie-YaoFang on Cl(-) and HCO3 (-) Transport in Diarrhea-Predominant Irritable Bowel Syndrome Rats.

Evid Based Complement Alternat Med 2016 14;2016:7954982. Epub 2016 Jun 14.

Digestive Disease Center, Beijing Hospital of Traditional Chinese Medicine Affiliated to Capital Medical University, Beijing 100010, China.

TongXie-YaoFang (TXYF) can effectively alleviate the symptoms of diarrhea-predominant irritable bowel syndrome (D-IBS) patients. However, the curative mechanism has not been fully clarified. The study was designed to investigate the effect of TXYF on the colonic ion transport induced by serotonin (5-HT) in D-IBS rats. A method of multiple stress (neonatal maternal separation (NMS) combined with restraint stress (RS)) was used to induce the D-IBS model. The model rats were randomly divided into two groups: NMS + RS group and TXYF-formula group, and the normal control (no handling) rats were classified as NH group. In the NMS + RS group, the change of short-circuit current (ΔI sc) induced by 5-HT was lower than that in the NH and TXYF-formula groups. After removing of the extracellular Cl(-) or HCO3 (-) or basolateral Na(+) or blocking the cystic fibrosis transmembrane conductance regulator (CFTR), Na(+)-K(+)-2Cl(-) cotransporter (NKCC), Na(+)-HCO3 (-) cotransporter, Cl(-)/HCO3 (-) exchanger, K(+) channel, or Na(+)/K(+)-ATPase, respectively, there was no difference in 5-HT-induced ΔI sc among the three groups. These data suggest that TXYF can regulate 5-HT-induced Cl(-) and HCO3 (-) secretion, possibly mediated by the combined action of CFTR, NKCC, Na(+)-HCO3 (-) cotransporter, Cl(-)/HCO3 (-) exchanger, K(+) channel, and Na(+)/K(+)-ATPase.
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http://dx.doi.org/10.1155/2016/7954982DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4923577PMC
July 2016

Health-related quality of life in Chinese patients with mild and moderately active ulcerative colitis.

PLoS One 2015 27;10(4):e0124211. Epub 2015 Apr 27.

Department of Gastroenterology, Affiliated Hospital of Nanjing University of Chinese Medicine, Nanjing, Jiangsu, China.

Background: Ulcerative colitis (UC) impairs the health-related quality of life (HRQOL). The difference in HRQOL between patients with mild and moderately active UC is not well-defined. Few studies have been conducted to explore the factors that influence HRQOL in Chinese patients. Our study aims were to (1) compare HRQOL of mildly active UC patients with moderate patients; (2) explore the factors that influence HRQOL in Chinese patients with UC; and (3) analyze demographic and disease characteristics of UC in China.

Methods: A total of 110 mild and 114 moderate patients with UC were enrolled. The demographic and disease characteristics were recorded. HRQOL was measured by the Chinese version of the inflammatory bowel disease questionnaire (IBDQ) between mild and moderate patients, male and female patients, and different disease distributions. Stepwise regression analysis was used to assess factors influencing the IBDQ score.

Results: Patients with moderate UC had significantly lower IBDQ total scores compared to patients with mild UC (P=0.001). The IBDQ total score had a negative correlation with the Mayo score (r=-0.263, P<0.001). Stepwise regression analysis showed that the disease activity index and gender had an influence on the IBDQ total score (P<0.05). The female patients had a lower score than the male patients (P<0.05), especially in the emotional function domain (P=0.002). Different disease distributions were not statistically significant in the IBDQ total score (P=0.183).

Conclusions: UC has a negative influence on HRQOL. HRQOL in patients with moderate UC was lower than HRQOL in patients with mild UC, as measured by the IBDQ. UC disease activity has a negative correlation with HRQOL. Gender and the disease activity index are important factors involved in the impairment of HRQOL in Chinese patients with UC. Chinese females may benefit from increased psychological care as part of UC therapy.
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http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0124211PLOS
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4411120PMC
January 2016

Study on the antithrombotic activity of Umbilicaria esculenta polysaccharide.

Carbohydr Polym 2014 May 2;105:231-6. Epub 2014 Feb 2.

College of Food Science and Technology, Nanjing Agricultural University, Nanjing 210095, China.

Umbilicaria esculenta as a traditional food is known to have many pharmacological activities, such as cholesterol synthesis inhibition, anti-inflammation and anti-tumor. The antithrombotic activities of UEP isolated from the lichen were examined in vitro and in vivo for the first time. The in vitro anticoagulant activity of UEP was tested by its PT, APTT and TT. The more prolongation of APTT suggested a more obvious inhibition of the intrinsic coagulation systems than the extrinsic. Its antithrombotic properties were evaluated using an arteriovenous shunt thrombosis model in rats, and its inhibition of thrombus formation increased in a dose-dependent manner. It also caused a dose-dependent increase in tail transection bleeding time. Oral administration of UEP also showed a significant dose dependent preventive effect against thrombotic death or paralysis. UEP has a potent antithrombotic effect in vitro and in vivo, which may be used as a novel, effective and promising antithrombotic agent.
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http://dx.doi.org/10.1016/j.carbpol.2014.01.082DOI Listing
May 2014

Efficacy of modified ban xia xie xin decoction on functional dyspepsia of cold and heat in complexity syndrome: a randomized controlled trial.

Evid Based Complement Alternat Med 2013 17;2013:812143. Epub 2013 Mar 17.

Department of Gastroenterology, Beijing Hospital of Traditional Chinese Medicine Affiliated to Capital Medical University, No. 23 Meishuguan Back Street, Dongcheng District, Beijing 100010, China.

Background. Chinese herbal medicine (CHM) has been used in China and elsewhere to treat patients with functional dyspepsia (FD). However, controlled studies supporting the efficacy of such treatment are lacking. Objective. To assess the efficacy and safety of modified Ban xia xie xin decoction in patients with FD of cold and heat in complexity syndrome. Methods. We performed a randomized, double-blind, placebo-controlled trial involving patients from five centers. Patients with FD of cold and heat in complexity syndrome (n = 101) were randomly assigned to groups given either CHM modified Ban Xia Xie Xin decoction or placebo in a 2 : 1 ratio. Herbal or placebo granules were dissolved in 300 mL of boiled water cooled to 70°C. Patients in both groups were administered 150 mL (50°C) twice daily. The trial included a 4-week treatment period and a 4-week followup period. The primary outcomes were dyspepsia symptom scores, measured by the total dyspepsia symptom scale and the single dyspepsia symptom scale at weeks 0, 1, 2, 3, 4, and 8. Results. Compared with patients in the placebo group, patients in the CHM group showed significant improvements according to the total and single dyspepsia symptom scores obtained from patients (P < 0.01) and investigators (P < 0.01). Conclusions. CHM modified Ban Xia Xie Xin decoction appears to offer symptomatic improvement in patients with FD of cold and heat in complexity syndrome. Trial Registration. Chinese Clinical Trial Registry (ChiCTR): ChiCTR-TRC-10001074.
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http://dx.doi.org/10.1155/2013/812143DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3613065PMC
April 2013

Efficacy of modified LiuJunZi decoction on functional dyspepsia of spleen-deficiency and qi-stagnation syndrome: a randomized controlled trial.

BMC Complement Altern Med 2013 Mar 2;13:54. Epub 2013 Mar 2.

Beijing Hospital of Traditional Chinese Medicine Affiliated to Capital Medical University, No, 23 Meishuguan Back Street, Dongcheng District, Beijing, 100010, China.

Background: Chinese herbal medicine (CHM) has been used in China and some other countries for the treatment of patients with functional dyspepsia (FD). However, controlled studies supporting the efficacy of such treatments in patients with FD are lacking. In this trial, we aimed to assess the efficacy and safety of modified LiuJunZi decoction in patients with FD of spleen-deficiency and qi-stagnation syndrome.

Methods: We performed a randomized, double-blind, placebo-controlled trial with patients from five centers. Patients with FD of spleen-deficiency and qi-stagnation syndrome (n = 160) were randomly assigned to groups given CHM modified LiuJunZi decoction or placebo in a 2:1 ratio. Herbal or placebo granules were dissolved in 300 ml of boiled water cooled to 70°C. Patients in both groups were administered 150 ml (50°C) twice daily. The trial included a 4-week treatment period and a 4-week follow-up period. The primary outcomes were dyspepsia symptom scores, measured by the total dyspepsia symptom scale and the single dyspepsia symptom scale at weeks 0, 1, 2, 3, 4 and 8. The secondary outcome was the change of radiopaque barium markers emptied from the stomach between week 0 and week 4 of treatment.

Results: Compared with patients in the placebo group, patients in the CHM group showed significant improvements according to the scores of total dyspepsia symptoms and single dyspepsia symptoms obtained from patients (P < 0.01) and investigators (P < 0.01). They also showed an improvement in the number of radiopaque barium markers emptied from the stomach (P < 0.05).

Conclusions: CHM modified LiuJunZi decoction appears to offer symptomatic improvement in patients with FD of spleen-deficiency and qi-stagnation syndrome.

Trial Registration: Chinese Clinical Trial Registry (ChiCTR): http://ChiCTR-TRC-10001074.
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http://dx.doi.org/10.1186/1472-6882-13-54DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3599864PMC
March 2013

To compare the efficacy of two kinds of Zhizhu pills in the treatment of functional dyspepsia of spleen-deficiency and qi-stagnation syndrome: a randomized group sequential comparative trial.

BMC Gastroenterol 2011 Jul 15;11:81. Epub 2011 Jul 15.

Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, No. 16 Nanxiaojie, Dongzhimen nei, Beijing, 100700, China.

Background: In Traditional Chinese Medicine (TCM) theory, functional dyspepsia (FD) can be divided into different syndromes according to different clinical symptoms and signs, and the most common one is spleen-deficiency and qi-stagnation syndrome that can be treated by Chinese traditional patent medicine--two kinds of Zhizhu pills, between which the primary difference in ingredients is that one contains immature orange fruit of Citrus aurantium L.(IFCA) and the other contains that of Citrus sinensis Osbeck (IFCS). The trial's objective was to compare the efficacy of two kinds of Zhizhu pills on symptom changes in patients with FD of spleen-deficiency and qi-stagnation syndrome.

Methods: A randomized, group sequential, double-blinded, multicenter trial was conducted in patients with FD of spleen-deficiency and qi-stagnation syndrome at 3 hospitals in Beijing between June 2003 and May 2005. Participants were randomly allocated into two groups (IFCA group and IFCS group) in a 1:1 ratio, and respectively took one of the two kinds of Zhizhu pills orally, 6 g each time, 3 times a day, for 4 weeks. Statistical analysis was performed with use of a group sequential method, the triangular test (TT).

Results: A total of 163 patients were randomized, and 3 patients were excluded from analysis because of early dropouts, leaving 160 patients (IFCA group: n = 82; IFCS group: n = 78) for statistical analysis. Three interim analyses were done after 62, 116, and 160 patients had completed their 4-week treatment, respectively. At the third interim analysis, the sample path crossed the upper boundary and the trial was stopped, the cure-markedly effective rates were 45% for IFCS group and 67% for IFCA group, respectively, the one-sided p-value was 0.0036, the median unbiased estimate of the odds ratio (OR) for the benefit of IFCA relative to IFCS was 2.91 with 95%CI: 1.40 to 6.06.No adverse events were observed in the two groups.

Conclusions: Zhizhu pills containing IFCA was superior to Zhizhu pills containing IFCS in the treatment of FD of spleen-deficiency and qi-stagnation syndrome. The application of group sequential analysis in clinical trials of TCM may offer some financial and ethical benefits.

Trial Registration: Chinese Clinical Trial Registry (ChiCTR): ChiCTR-TRC-00000485.
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http://dx.doi.org/10.1186/1471-230X-11-81DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3160401PMC
July 2011