Treatment Of Non-erosive Reflux Disease Research Articles

Herbal Medicine for the Treatment of Non-Erosive Reflux Disease: A Systematic Review and Meta-Analysis Protocol

Introduction: Non-erosive reflux disease (NERD) is the most common subtype of gastroesophageal reflux disease (GERD). This study aims to synthesize evidence on the efficacy and safety of various herbal medicines for the treatment of NERD.Methods and analysis: Ten electronic databases will be examined: MEDLINE (via PubMed), Cochrane Central Register of Controlled Trials, Embase, Allied and Complementary Medicine Database, China National Knowledge Infrastructure Database, Citation Information by Nii, Korean Medical Database, Korean Studies Information Service System, National Digital Science Library, and Oriental Medicine Advanced Searching Integrated System. All randomized controlled trials published from inception to May 2023 that meet the eligibility criteria will be selected. Two independent researchers will extract data, such as publication year, study design, intervention details, outcome measures, main results, and adverse events. The risk of bias and quality of evidence will be assessed, and subgroup analyses will be performed according to the type of control intervention and herbal medicine. The analysis process will be conducted using Review Manager 5.4 software.Discussion: This review will present a summary and rationale for herbal medicine’s effectiveness in treating NERD. The findings of this review can help those who want to apply herbal medicine to the treatment of NERD. Systematic review registration: PROSPERO registration number CRD42023423052.

JianpiQinghua granule reduced PPI dosage in patients with nonerosive reflux disease: A multicenter, randomized, double-blind, double-dummy, noninferiority study

BackgroundProton pump inhibitors (PPIs) play an important role in the treatment of nonerosive reflux disease (NERD), but their long-term and excessive uses have been associated with safety concerns. Chinese herbal medicine (CHM) has become a popular alternative treatment for this condition. MethodsA total of 204 patients were randomly assigned to the combination group or PPI group (1:1 ratio). They were given JianpiQinghua (JQ) granules (34.8 g) plus omeprazole (10 mg) plus dummy omeprazole (10 mg) or dummy JQ granules (34.8 g) plus omeprazole (20 mg) daily for 4 weeks. The primary endpoints were the rate of sufficient relief and complete resolution of GERD Q at week 4. Metabonomics and the gut microbiota were also assessed. ResultsComplete resolution was observed in 40.8% of patients in the combination group and 26.8% of patients in the PPI group after 4 weeks (FAS analysis, OR, 1.88; 95% CI, 1.03–3.44; p = 0.039). Sufficient relief was observed in 50% of patients in the combination group and 43.30% of patients in the PPI group after 4 weeks (FAS analysis, OR, 1.31; 95% CI, 0.74–2.30; p = 0.35). Three patients had liver dysfunction, one of whom had a mild case and 2 of whom had moderate-to-severe cases in the combination group. Patients in the combination group showed a significant increase in richness and diversity of their gut microbiota compared with those in the PPI group. Metabonomics showed that the combination therapy could correct the glutamate metabolism pathway. ConclusionOur findings demonstrate the superior efficacy of JQ granules combined with omeprazole (10 mg) vs. omeprazole (20 mg) in terms of symptom relief in patients with NERD. Trial registration: ClinicalTrials.gov number NCT02892357. Registered on 14 February 2019.

Efficacy of S-pantoprazole 10 mg in the Symptom Control of Non-erosive Reflux Disease: A Phase III Placebo-controlled Trial.

Background/AimsS-isomer (S) pantoprazole is more bioavailable and less dependent on cytochrome 2C19 than is racemic pantoprazole. We aim to evaluate the efficacy and safety of 10 mg S-pantoprazole for treatment of non-erosive reflux disease (NERD).MethodsIn this phase 3, double-blind, randomized placebo controlled, multicenter study, 174 NERD patients were randomized to one of both treatment groups 10 mg S-pantoprazole, or placebo once daily for 4 weeks. Symptoms and safety were assessed. The efficacy endpoints were complete relief of symptoms, > 50% improvement of all reflux symptoms and recurrence.ResultsEighty-eight patients were assigned to the S-pantoprazole group (25 males, mean 43.7 years old) and 86 to the placebo group (32 males, mean 43.0 years old), and 163 patients were subjected to full Analysis Set. A higher proportion of patients in the S-pantoprazole group had complete symptom relief (42.0 % [34/81] vs 17.1% [14/82], P < 0.001) and > 50% symptom responses (66.0% vs 50.0%, P = 0.010 for heartburn; 64.2% vs 28.0%, P = 0.010 for acid regurgitation; and 51.9% vs 30.5%, P = 0.03 for epigastric discomfort) compared to the placebo group. The factors associated with poor responsiveness to PPI were older age, female, greater body mass index, and severe baseline symptoms.ConclusionsLow dose of S-pantoprazole (10 mg) for 4 weeks was more efficacious than placebo in providing reflux symptom relief in patients with NERD, especially acid regurgitation. More doses or longer periods of treatment with S-pantoprazole would be needed to completely eliminate symptoms.

Mechanism of Wumei Pill in the Treatment of Non-Erosive reflux disease from the Perspective of Network Pharmacology and Molecular docking

Mechanism of Wumei Pill in the Treatment of Non-Erosive reflux disease from the Perspective of Network Pharmacology and Molecular docking

Treatment of non-erosive reflux disease and dynamics of the esophageal microbiome: a prospective multicenter study

Non-erosive reflux disease (NERD) pathogenesis has not been thoroughly evaluated. Here, we assessed the response of patients with NERD to proton pump inhibitor (PPI) therapy; changes in the microbiome and biologic marker expression in the esophageal mucosa were also evaluated. Patients with NERD (n = 55) received esomeprazole (20 mg) for eight weeks. The treatment response was evaluated at baseline, week four, and week eight. Esophageal mucosal markers and oropharyngeal and esophageal microbiomes were analyzed in patients who underwent upper gastrointestinal endoscopy at screening (n = 18). Complete and partial response rates at week eight were 60.0% and 32.7% for heartburn, and 61.8% and 29.1% for regurgitation, respectively. The expressions of several inflammatory cytokines, including IL-6, IL-8, and NF-κB, were decreased at week eight. Streptococcus, Haemophilus, Prevotella, Veillonella, Neisseria, and Granulicatella were prevalent regardless of the time-point (baseline vs. week eight) and organ (oropharynx vs. esophagus). The overall composition of oropharyngeal and esophageal microbiomes showed significant difference (P = 0.004), which disappeared after PPI therapy. In conclusion, half-dose PPI therapy for eight weeks could effectively control NERD symptoms. The expression of several inflammatory cytokines was reduced in the esophagus, and oropharyngeal and esophageal microbiomes in patients with NERD showed significant difference. However, the microbial compositions in the oropharynx and esophagus were not affected by PPI therapy in this study. Impact of PPI on the microbiome in patients with NERD should be more investigated in future studies.

The effect of Heweijiangni-decoction on esophageal morphology in a rat model of OVA-induced visceral hypersensitivity followed by acid exposure

Heweijiangni decoction (HWJND) is an effective traditional Chinese medicine prescription in clinical treatment of nonerosive reflux disease (NERD). Esophageal hypersensitivity and acid contribute to the disease. However, the exact underlying mechanism of action remains unclear. In this study, we observed the effect of HWJND on esophageal morphology in a rat model of ovalbumin (OVA)-induced visceral hypersensitivity followed by acid exposure. Esophageal morphology was assessed by measuring the extent of dilated intercellular spaces (DIS), desmosome disruption, and mitochondrial fragmentation. HWJND in low, moderate, and high doses relieved DIS and desmosome disruption in esophageal epithelium compared with model group (P&lt;0.05 for all doses). In addition, HWJND in high dose protected mitochondria from fragmentation (P&lt;0.05). Other findings suggest that DIS and mitochondrial fragmentation are independent events, and that omeprazole protects mitochondria. Overall, HWJND significantly resists esophageal morphology changes in OVA-induced and acid exposure rat model.

On-Demand Therapy with Proton Pump Inhibitors for Maintenance Treatment of Nonerosive Reflux Disease or Mild Erosive Esophagitis: A Systematic Review and Meta-Analysis.

Background Proton pump inhibitors (PPIs) are widely used for the long-term management of gastroesophageal reflux disease (GERD). However, concerns about the cost and/or inconvenience of continuous maintenance PPI treatment have led to the evaluation of various alternative approaches. Aim To assess the effectiveness of on-demand PPI therapy in the maintenance treatment of nonerosive reflux disease (NERD) or mild erosive esophagitis (EE). Methods We searched MEDLINE, EMBASE, Web of Science, and Cochrane Library from inception until October 2, 2017, for randomized controlled trials (RCTs) comparing on-demand PPI versus placebo or daily PPI in the management of NERD or mild EE (Savary-Miller grade 1). Discontinuation of therapy during the trial was used as a surrogate for patient dissatisfaction and failure of symptomatic control. We calculated pooled odds ratios (OR) to evaluate the efficacy of on-demand PPI treatment. Separate analyses were conducted for studies comparing on-demand PPI with daily PPI and with placebo. Subgroup analysis was done based on NERD studies alone and on studies of both NERD and mild EE. These were analyzed using a random effects model. Results We included 10 RCTs with 4574 patients. On-demand PPI was superior to daily PPI (pooled OR = 0.50; 95% confidence interval (CI) = 0.35, 0.72). On subgroup analysis in NERD patients only, pooled OR was 0.44 (0.29, 0.66). In studies including patients with NERD and mild EE, pooled OR was 0.76 (0.36, 1.60). For studies comparing on-demand PPI with placebo, pooled OR was 0.21 (0.15, 0.29); subgroup analyses of studies evaluating NERD only and studies conducted in NERD and mild EE showed similar results (pooled OR was 0.22 (0.13, 0.36) and 0.18 (0.11, 0.31), resp.). Conclusions On-demand PPI treatment is effective for many patients with NERD or mild EE. Although not FDA-approved, it may be adequate for those patients whose symptoms are controlled to their satisfaction.

Efficacy and Safety of Traditional Chinese Medicine on Nonerosive Reflux Disease: A Meta-Analysis of Randomized Controlled Trials.

Objectives Traditional Chinese medicine (TCM) therapy for nonerosive reflux disease (NERD) remains controversial. The aim of this study was to evaluate the efficacy and safety of TCM regimens in NERD treatment. Methods Randomized controlled trials (RCTs) of TCM treatment for NERD through September 31, 2017, were systematically identified in PubMed, Wanfang Data, CNKI, VIP, CBM, Ovid, Web of Science, and Cochrane Library databases. Quality assessment was performed by employing the Cochrane Risk of Bias assessment tool. Results A total of 725 and 719 patients in 14 RCTs were randomly divided into TCM alone and conventional Western medicine groups, respectively. The clinical total effective rate of the TCM group was markedly higher than that of the single proton pump inhibitors (PPIs) or Prokinetics therapy group (RR = 1.19, 95% CI = 1.07–1.31, and P = 0.0008), while it was comparable to that of the combination of PPIs and Prokinetics therapy group (RR = 1.14, 95% CI = 1.00–1.29, and P = 0.05). Compared with Western medicine group, the TCM group showed improved symptom relief through a reduced RDQ score (SMD = −0.91; 95% CI = −1.68–−0.15; and P = 0.02). Additionally, TCM clearly decreased the recurrence rate (RR = 0.38, 95% CI = 0.28–0.52, and P < 0.00001). Adverse events, such as constipation, sickness, fever, abdominal distension, and stomach noise, were slight for both the TCM and Western medicine groups and disappeared after the easement of pharmacological intervention; in particular, TCM possessed fewer side effects. Conclusion Compared with PPIs or Prokinetics therapy alone, TCM single therapy can better improve the clinical total effective rate and symptom relief and decrease the recurrence rate and adverse events in the treatment of NERD. Our results suggest that TCM will be a promising alternative therapy for NERD patients in the future.

An open-label pilot study to explore usefulness of Homoeopathic treatment in nonerosive gastroesophageal reflux disease

Background and Aim: Nonerosive gastroesophageal reflux disease or nonerosive reflux disease (NERD) is characterized by troublesome reflux-related symptoms in the absence of esophageal erosions/breaks at conventional endoscopy. There are a number of medicines cited in homoeopathic literature which can be used for treatment of symptoms such as heartburn and regurgitation. A pilot study was undertaken to explore usefulness of homoeopathic medicines in treatment of NERD. Methodology: In this study, 78 patients were screened and 34 were enrolled, having symptoms of heartburn and/or regurgitation at least twice a week, having a gastroesophageal reflux disease (GERD) symptom score of more than 4. Homoeopathic medicine was prescribed on the basis of presenting symptoms. Response to treatment was assessed on GERD symptom score, visual analog scale (VAS) for heartburn, and World Health Organization quality of life-BREF (WHO-QOL) questionnaire evaluated at baseline and at end of 8 weeks of treatment . Results: Significant difference was found in pre- and post-treatment GERD symptom score (8.79 ± 2.7 vs. 0.76 ± 1.8; P = 0.001) and VAS for heartburn (47.47 ± 19.6 vs. 5.06 ± 11.8; P = 0.001). Statistically significant improvement was seen in three domains of WHO-QOL score, i.e. psychological health, social relationship, and environmental domain. Conclusion: The findings are encouraging to open avenues for further studies on reflux disease.

Psychological intervention for auxiliary treatment of non-erosive reflux disease

Psychological intervention for auxiliary treatment of non-erosive reflux disease

Alginate Therapy Is Effective in the Treatment of Non-erosive Reflux Disease: A Systematic Review and Meta-analysis

Alginate Therapy Is Effective in the Treatment of Non-erosive Reflux Disease: A Systematic Review and Meta-analysis

Indirect comparison of randomised controlled trials: comparative efficacy of dexlansoprazole vs. esomeprazole in the treatment of gastro‐oesophageal reflux disease

Dexlansoprazole is a new proton pump inhibitor (PPI) with a dual delayed-release system. Both dexlansoprazole and esomeprazole are an enantiomer of lansoprazole and omeprazole respectively. However, there is no head-to-head trial data or indirect comparison analyses between dexlansoprazole and esomeprazole. To compare the efficacy of dexlansoprazole with esomeprazole in healing erosive oesophagitis (EO), the maintenance of healed EO and the treatment of non-erosive reflux disease (NERD). Randomised Controlled Trials (RCTs) comparing dexlansoprazole or esomeprazole with either placebo or another PPI were systematically reviewed. Random-effect meta-analyses and adjusted indirect comparisons were conducted to compare the treatment effect of dexlansoprazole and esomeprazole using a common comparator. The relative risk (RR) and 95% confidence interval (CI) were calculated. The indirect comparisons revealed significant differences in symptom control of heartburn in patients with NERD at 4 weeks. Dexlansoprazole 30 mg was more effective than esomeprazole 20 mg or 40 mg (RR: 2.01, 95% CI: 1.15-3.51; RR: 2.17, 95% CI: 1.39-3.38). However, there were no statistically significant differences between the two drugs in EO healing and maintenance of healed EO. Comparison of symptom control in healed EO was not able to be made due to different definitions used in the RCTs. Adjusted indirect comparisons based on currently available RCT data suggested significantly better treatment effect in symptom control of heartburn in patients with NERD for dexlansoprazole against esomeprazole. No statistically significant differences were found in other EO outcomes. However, these study findings need to be interpreted with caution due to small number of studies and other limitations.

Diagnosis and Management of Gastroesophageal Reflux Disease

Gastroesophageal reflux disease (GERD) is one of the most common disorders in medical practice. It is the most common gastrointestinal diagnosis recorded during visits to outpatient clinics in the United States. Apart from the economic burden of the disease and its impact on quality of life, GERD is the most common predisposing factor for esophageal adenocarcinoma [1]. Recently, many important issues have emerged regarding the classification, pathogenesis, natural history, and treatment of GERD. Although use of proton-pump inhibitor (PPI) is the treatment of choice for GERD, approximately, one-third of patients with GERD fail to response symptomatically to a standard-dose proton-pump inhibitor (PPI), either partially or completely [2]. Additionally, most GERD patients need long-term treatment for frequent relapses after discontinuing acid inhibition therapy. This has led to great interest in new endoscopic therapies for the treatment of this disease. With regard to the diagnosis of GERD, patients with refractory reflux symptoms and normal upper endoscopy are more difficult to diagnose and treat. Combined 24-hour pH and impedance monitoring allows classifying the patients as having true nonerosive reflux disease (NERD), hypersensitive esophagus, or functional heartburn and is helpful for further management of the patients [3]. The main focus of this special issue is on recent advances in the treatment of erosive esophagitis, NERD and Barrett's esophagus. In addition, the emerging diagnostic methods, pharmacological treatments, and endoscopic therapies for GERD are also discussed. The paper entitled “The frequencies of gastroesophageal and extragastroesophageal symptoms in patients with mild erosive esophagitis, severe erosive esophagitis, and Barrett's esophagus, in Taiwan” is the first work simultaneously assessing the differences in reflux symptom profiles among the three different categories of GERD. The data showed that the frequencies of some esophageal and extraesophageal symptoms in patients with Los Angeles grade A/B erosive esophagitis were higher than those in patients with Los Angeles grade C/D erosive esophagitis and Barrett's esophagus. In the paper entitled “Current pharmacological management of gastroesophageal reflux disease,” Y.-K. Wang et al. present the current and developing therapeutic agents for GERD treatment. The efficacies of PPIs and potassium-competitive acid blocker in GERD therapy are well reviewed. Additionally, the article summarizes the development of novel therapeutic agents focusing on the underlying mechanisms of GERD. In the paper entitled “Pharmacological therapy of gastroesophageal reflux in preterm infants,” L. Corvaglia et al. review the pathogenesis, presentation, diagnosis, and treatment of gastroesophageal reflux in preterm infants. A stepwise approach is advisable for the treatment of gastroesophageal reflux in preterm infants, firstly, promoting nonpharmacological interventions and secondly, limiting drugs to selected infants unresponsive to the conservative measures or who are suffering from severe gastroesophageal reflux with clinical complications. In the paper entitled “Stretta radiofrequency treatment for GERD: a safe and effective modality,” M. Franciosa et al. focus on the safety, efficacy, and durability of the Stretta radiofrequency treatment for GERD therapy. The novel endoscopic treatment reduces esophageal acid exposure, decreases the frequency of transient lower esophageal relaxation, decreases medication use and improves quality of life in GERD patients. In the paper entitled “Duodenal tube feeding: an alternative approach for effectively promoting weight gain in children with gastroesophageal reflux and congenital heart disease,” S. Kuwata et al. showed that duodenal tube feeding improves the weight gain of infants with gastroesophageal reflux who need treatment for congenital-heart-disease-associated heart failure. In the paper entitled “Changes in ghrelin-related factors in gastroesophageal reflux disease in rats,” M. Nahata et al. examined gastrointestinal hormone profiles and functional changes in rats with GERD. The results suggest that aberrantly increased secretion of peripheral ghrelin and decreased ghrelin responsiveness may occur in GERD rats. In the paper entitled “Surgical management of pediatric gastroesophageal reflux disease,” H. T. Jackson and T. D. Kane review the clinical presentation of GERD in pediatric population and discuss the options for surgical management and outcome in these patients. In the paper entitled “Current advances in the diagnosis and treatment of nonerosive reflux disease,” C. L. Chen and P. I. Hsu, review the literature about the pathogenesis, natural history, diagnosis and treatment of NERD. The authors suggest that a combination of 24-hour esophageal impedance and pH monitoring is indicated to differentiate acid-reflux-related NERD, weakly acid reflux-related NERD (hypersensitive esophagus), nonacid-reflux-related NERD, and functional heartburn in patients with poor response to appropriate PPI treatment. In the paper entitled “Antireflux endoluminal therapies: past and present,” K. C. Yew et al. and S.-K. Chuah review, highlight, and discuss three commonly employed antireflux endoluminal procedures: fundoplication or suturing techniques (EndoCinch, NDO, EsophyX), intramural injection or implant techniques (enhancing LES volume and/or strengthening compliance of the LES-EnteryX, Gatekeeper), and radiofrequency ablation of lower esophageal sphincter and cardia (the Stretta system). Ping-I Hsu Nayoung Kim Khean Lee Goh Deng-Chyang Wu

Current Advances in the Diagnosis and Treatment of Nonerosive Reflux Disease

Nonerosive reflux disease (NERD) is a distinct pattern of gastroesophageal reflux disease (GERD). It is defined as a subcategory of GERD characterized by troublesome reflux-related symptoms in the absence of esophageal mucosal erosions/breaks at conventional endoscopy. In clinical practice, patients with reflux symptoms and negative endoscopic findings are markedly heterogeneous. The potential explanations for the symptom generation in NERD include microscopic inflammation, visceral hypersensitivity (stress and sleep), and sustained esophageal contractions. The use of 24-hour esophageal impedance and pH monitoring gives further insight into reflux characteristics and symptom association relevant to NERD. The treatment choice of NERD still relies on acid-suppression therapy. Initially, patients can be treated by a proton pump inhibitor (PPI; standard dose, once daily) for 2–4 weeks. If initial treatment fails to elicit adequate symptom control, increasing the PPI dose (standard dose PPI twice daily) is recommended. In patients with poor response to appropriate PPI treatment, 24-hour esophageal impedance and pH monitoring is indicated to differentiate acid-reflux-related NERD, weakly acid-reflux-related NERD (hypersensitive esophagus), nonacid-reflux-related NERD, and functional heartburn. The response is less effective in NERD as compared with erosive esophagitis.

Regurgitation Is Less Responsive to Acid Suppression Than Heartburn in Patients With Gastroesophageal Reflux Disease

Although most patients with gastroesophageal reflux disease (GERD) achieve substantial symptom relief with acid suppression, many have some residual symptoms. We evaluated the responsiveness of regurgitation, characterized by the reflux disease questionnaire (RDQ) to potent acid suppression. We analyzed data from 2 randomized controlled trials of AZD0865 (a potassium-competitive acid blocker) 25-75 mg/day vs esomeprazole 20-40 mg/day for the treatment of nonerosive reflux disease (NERD, n = 1460) or reflux esophagitis (RE, n = 1514). Inclusion criteria for both studies were high-severity substernal burning (≥4 days per week of at least moderate intensity) during the week before enrollment. Pooled data from all treatment arms were used to ascertain the response of the reflux disease questionnaire regurgitation items to potent acid suppression during the fourth week of treatment. When the study began, 93% of patients with NERD or RE had either "acid taste in the mouth" (regurgitation-taste) or "unpleasant movement of material upwards from the stomach" (regurgitation-movement). Either or both symptoms were present and severe in 53% of NERD (n = 717) and 54% of RE patients (n = 751) for the main study outcome. During week 4 of therapy, patients with severe "regurgitation-taste" and "regurgitation-movement" responded significantly less well than patients with NERD and high severity "substernal burning" (34% and 26% vs 49%) or those with RE (44% and 33% vs 55%). There were no differences in symptom response between patients with healed and nonhealed RE. Regurgitation was less responsive to acid suppression than heartburn in patients with gastroesophageal reflux disease, indicating that persistent regurgitation is a common cause of incomplete treatment response.

Treatment of non-erosive reflux disease with a proton pump inhibitor in Chinese patients: a randomized controlled trial

Evidence suggests that rates of gastroesophageal reflux disease are increasing in the Asia-Pacific region, where patients tend to have predominantly non-erosive reflux disease as opposed to erosive (reflux) esophagitis. At present, data for the responsiveness of non-erosive reflux disease to proton pump inhibition are scant. We aimed to study esomeprazole for the treatment of non-erosive reflux disease in Chinese patients. Patients with a clinical diagnosis of gastroesophageal reflux, and a locally validated reflux index, the Chinese GerdQ, of equal to or greater than 12 were recruited and randomized to receive esomeprazole 20mg daily or placebo for 8weeks. Reflux index scores, quality of life (SF-36), and the hospital anxiety and depression (HAD) scale and symptom relief were evaluated before, during, and after treatment. A total of 175 patients were randomized. Patients in the esomeprazole group (n=85) demonstrated statistically significant reductions in their GerdQ index, from 19.45 to 15.37 and to 14.32 (p=0.013, p=0.005) at weeks 4 and 8, respectively. Compared to placebo at week 8, 57.1% of patients on esomeprazole found that their symptoms had resolved or were acceptable compared with 37.2% in the placebo group (p=0.001). There were no statistically significant differences in overall quality-of-life measures or the HAD scale related to treatment. This study suggests that esomeprazole is efficacious in treating Chinese patients with non-erosive reflux disease.

A randomized, controlled, double-blinded and double-dummy trial of the effect of Tongjiang Granule (通降颗粒) on the nonerosive reflux disease of and Gan (肝)-Wei (胃) incoordination syndrome

To assess the effectiveness of tongjiang granule (TJG) on the patients with nonerosive reflux disease (NERD) of Gan-Wei incoordination syndrome, its impact on their quality of life, and its safety. A randomized, controlled, double-blinded, and double-dummy method was adopted in the trial. There were 120 NERD patients enrolled in the study and randomly divided into the experiment and control groups, each with 60 patients; drugs were distributed according to the drug number by patients' inclusion sequences. In the experiment group, patients were given TJG 10 g and mosapride citrate dummy 5 mg three times a day, and in the control group, patients were given mosapride citrate 5 mg and TJG dummy 10 g three times a day. The treatment courses of both groups were 4 weeks. Among 120 included patients, 112 were screened for full analysis set (FAS), and 105 were screened per-protocol set (PPS). The results were as follows: (1) the improvement of total scores of symptom in the experiment group (0-4 week) were 15.93±7.88 scores by FAS and 16.22 ±7.75 scores by PPS, and they were 10.43±10.16 scores and 10.79±10.27 scores in the control group, respectively. The 95% CI of net scores improvement between the two groups were 2.10-8.90 scores and 1.92-8.94 scores in FAS and PPS; it was significantly better in the experiment group than that in the control group (P<0.05). (2) The improvement of scores of major symptom in the experiment group (0-4 week) were 10.68±5.35 by FAS and 10.89±5.29 by PPS and 7.40±7.41 and 7.60±7.46 in the control group, respectively. The 95% CI of net scores improvement in the two groups were 0.85-5.71 and 0.71-5.69 in FAS and PPS separately, and the improvement in the experiment group was significantly better than that in the control group (P<0.05). (3) The total effective rates were 86.0% and 61.8% in the experiment and the control group separately, and the Ridit analysis results showed that it was better in the experiment group (P<0.05). (4) The improvement quality of life in the domain of physical functioning and general health in the experiment group was better than that in the control group (P<0.05). (5) One case of experiment group caught a cold and recovered in six days without drug suspension. No adverse event was found in the other cases. There was no meaningful safety examination indices change in pretreatment and posttreatment periods in both groups. TJG showed a definite effect on the treatment of NERD with Gan-Wei incoordination syndrome, and it could improve the quality of life of NERD patient without obvious toxic and side effects.

Dexlansoprazole: A proton pump inhibitor with a dual delayed-release system

Background: Dexlansoprazole, the dextrorotatory enantiomer of lansoprazole, is a proton pump inhibitor (PPI) formulated to have dual delayed-release properties. It is indicated for healing all grades of esophagitis, maintaining the healing of erosive esophagitis (EE), and treating heartburn associated with nonerosive gastroesophageal reflux disease. Objective: This article reviews the pharmacology, pharmacokinetics, and pharmacodynamics of dexlansoprazole, as well as its clinical efficacy and tolerability. Methods: MEDLINE (1966–April 2010) and International Pharmaceutical Abstracts (1970–April 2010) were searched for original research and review articles published in English using the terms dexlansoprazole and TAK-390MR. The reference lists of identified articles were reviewed for additional pertinent publications. Abstracts from 2007–2009 American College of Gastroenterology and Digestive Disease Week meetings were searched using the same terms. Results: By irreversibly binding to H +K +-ATPase, dexlansoprazole inhibits acid production by the parietal cell. Its dual delayed-release formulation provides 2 distinct releases of medication, prolonging the mean residence time compared with lansoprazole (5.56–6.43 vs 2.83–3.23 hours, respectively). In 2 identical Phase III trials of the healing of EE, there were no significant differences in rates of complete healing after 8 weeks between dexlansoprazole 60 and 90 mg once daily and lansoprazole 30 mg once daily. In 2 studies of the maintenance of healing of EE, rates of healing at 6 months were significantly higher with dexlansoprazole 30, 60, and 90 mg once daily compared with placebo ( P < 0.001). Patients with nonerosive reflux disease who received dexlansoprazole 30 or 60 mg once daily had significantly more 24-hour heartburn-free days compared with those who received placebo ( P < 0.001). Dexlansoprazole was well tolerated compared with placebo or lansoprazole in all studies. Conclusions: In the studies reviewed, dexlansoprazole was well tolerated and effective in the healing and maintenance of EE, and in the treatment of nonerosive reflux disease. However, most of the available evidence involved comparisons with placebo, making it difficult to draw meaningful conclusions about the place of dexlansoprazole among PPIs. More head-to-head comparative trials with other PPIs are needed to determine whether the unique formulation of dexlansoprazole translates into a clinically meaningful improvement in outcomes.

非びらん性胃食道逆流症（NERD）の病態と治療

非びらん性胃食道逆流症（NERD）の病態と治療

Gastro-esophageal reflux disease: the recent trend in Japan.

Gastro-esophageal reflux disease (GERD) has increased in Japan, as in other countries. This is probably due to increased acid secretion among Japanese due to Westernized foods and lifestyle as well as decreased prevalence of Helicobacter pylori infection. Proton pump inhibitor (PPI) is mainly used for treatment of this condition. PPI has recently been approved for treatment of nonerosive reflux disease (NERD) in Japan. NERD is known to have different characteristics to GERD, and effectiveness of PPI in NERD patients is lower than that in reflux esophagitis patients. Regarding therapeutic benefit of treatment, a recent study showed that PPI improved quality of life (QOL) of GERD patients also in Japan. For diagnosis of reflux esophagitis in Japan, we use a unique classification, a modified Los Angeles (LA) classification, which includes minimal change (grade M esophagitis) as one distinct criteria. However, recent studies from Japan showed poor interobserver agreement in diagnosis of grade M, although excess acid reflux in minimal change was shown in another study. Our definition of Barrett's esophagus is also different from that in the West. Nationwide consensus on diagnosis of reflux esophagitis and Barrett's esophagus should be achieved in Japan, preferably consistent with world standard.