Randomised clinical trial: 3-year interim analysis results of the VISION trial to evaluate the long-term safety of vonoprazan as maintenance treatment in patients with erosive oesophagitis.

BACKGROUND: VISION is a randomised, phase 4, open-label, parallel-group, multicentre study conducted in 33 centres in Japan. The aim of this study was to assess the long-term safety of vonoprazan for maintenance treatment of healed erosive oesophagitis versus lansoprazole. METHODS: Patients with endoscopically diagnosed erosive oesophagitis were randomised 2:1 to once-daily vonoprazan 20 mg or lansoprazole 30 mg, for a 4- to 8-week healing phase. Patients with endoscopically confirmed healing entered a 260-week maintenance phase with a once-daily starting dose of vonoprazan 10 mg or lansoprazole 15 mg. Primary endpoint was change in gastric mucosal histopathology. RESULTS: Of 208 patients (vonoprazan, n = 139; lansoprazole, n = 69) entering the healing phase, 202 entered the maintenance phase (vonoprazan, n = 135; lansoprazole, n = 67). At 3 years, 109 vonoprazan-treated and 58 lansoprazole-treated patients remained on treatment. Histopathological evaluation of gastric mucosa showed that hyperplasia of parietal, foveolar and G cells was more common with vonoprazan than lansoprazole at week 156 of the maintenance phase. There was no marked increase in the occurrence of parietal, foveolar and G cell hyperplasia among patients in the vonoprazan group from week 48 to week 156. Histopathological evaluation of the gastric mucosa also showed no neoplastic changes in either group. No new safety issues were identified. CONCLUSIONS: In this interim analysis of VISION, no new safety concerns were identified in Japanese patients with healed erosive oesophagitis receiving vonoprazan or lansoprazole as maintenance treatment for 3 years. (CT.gov identifier: NCT02679508; JapicCTI-163153; Japan Registry of Clinical Trials: jRCTs031180040).

Patient journey in erosive oesophagitis: real-world perspectives from US physicians and patients.

OBJECTIVE: Management of erosive oesophagitis (EE) remains suboptimal, with many patients experiencing incomplete healing, ongoing symptoms, and relapse despite proton pump inhibitor (PPI) treatment. The Study of Acid-Related Disorders investigated patient burden of individuals with EE in a real-world setting. DESIGN: US gastroenterologists (GIs) or family physicians (FPs)/general practitioners (GPs) treating patients with EE completed a physician survey and enrolled up to four patients with EE for a patient survey, with prespecified data extracted from medical records. RESULTS: 102 GIs and 149 FPs/GPs completed the survey; data were available for 73 patients (mean age at diagnosis, 45.4 years). Omeprazole was healthcare professional (HCP)-preferred first-line treatment (60.8% GIs; 56.4% FPs/GPs), and pantoprazole preferred second line (29.4% and 32.9%, respectively). Price and insurance coverage (both 55.5% HCPs) and familiarity (47.9%) key drivers for omeprazole; insurance coverage (52.0%), price (50.0%), familiarity (48.0%), initial symptom relief (46.0%), and safety (44.0%) key drivers for pantoprazole. Only 49.3% patients took medication as instructed all the time; 56.8% independently increased medication frequency some of the time. Despite treatment, 57.5% patients experienced heartburn and 30.1% regurgitation; heartburn was the most bothersome symptom. 58.9% patients believed that their symptoms could be better controlled; only 28.3% HCPs were very satisfied with current treatment options. 83.6% patients wanted long-lasting treatment options. Fast symptom relief for patients was a top priority for 66.1% HCPs, while 56.6% would welcome alternatives to PPIs. CONCLUSION: This real-world multicentre study highlights the need for new, rapidly acting treatments in EE that reduce symptom burden, offer durable healing and provide symptom control.

Proton Pump Inhibitors Are Associated with Increased Risk of Psoriasis: A Nationwide Nested Case-Control Study.

BACKGROUND: Proton pump inhibitors (PPIs) are among the most widely used drugs. Little is known about the association between PPI use and risk of psoriasis. OBJECTIVE: To investigate the association between PPI use and subsequent psoriasis risk. METHODS: We included participants from the Taiwan National Health Insurance Research Database. Patients with PPI use and an incidence of psoriasis (n = 5,756) were assigned to the case cohort and 1:1 matched to controls. PPI use was defined as >30 cumulative defined daily doses (cDDDs); PPI nonuse was defined as ≤30 cDDDs. Logistic regression was used for the analyses. RESULTS: There was a significant association between PPI use and psoriasis risk. The confounder-adjusted odd ratios (95% confidence interval [CI]) were 1.52 (1.31-1.76) and 1.54 (1.22-1.93) for patients with 120-365 cDDDs and >365 cDDDs, respectively, compared with PPI nonusers. Stratified analyses based on PPI type showed that exposure to lansoprazole (OR, 1.25; 95% CI, 1.11-1.41) was associated with subsequent psoriasis risk. CONCLUSIONS: PPI use might be associated with an increased risk of developing psoriasis or as an epiphenomenon. Further prospective studies are needed to elucidate the association and underlying mechanisms.

Effectiveness and safety of proton pump inhibitors for treating acute pancreatitis: A protocol for systematic review and meta analysis.

BACKGROUND: Previous studies have showed that anti-acid therapy with proton pump inhibitors (PPIs) can inhibit pancreatic secretion and it may be used in treating acute pancreatitis (AP). But at present, there is no systematic reviews for the evidence and the therapeutic effectiveness and safety of anti-acid therapy with PPIs in AP were not unclear. Therefore, we will undertake a systematic review of the literature to summarize previous evidence regarding this topic, in order to clarify the effectiveness and safety of anti-acid therapy with PPIs in AP. METHODS: We will search the EMBASE, WANFANG DATA, Web of Knowledge, China National Knowledge Infrastructure, PubMed, ClinicalTrials.gov and Cochrane Library from inception to June 30,2021 to retrieve relevant studies using the search strategy: ("Proton pump inhibitors" OR "PPI" OR "PPIs" OR "Omeprazole" OR "Tenatoprazole" OR "Pantoprazole" OR "acid suppression therapy" OR "acid suppression drugs") AND ("pancreatitis" OR "pancreatitides"). Two authors independently judged study eligibility and extracted data. Heterogeneity will be examined by computing the Q statistic and I2 statistic. RESULTS: This study assessed the efficiency and safety of proton pump inhibitors for treating acute pancreatitis. CONCLUSIONS: This study will provide reliable evidence-based evidence for the clinical application of PPIs for treating AP. ETHICS AND DISSEMINATION: Ethical approval is unnecessary as this protocol is only for systematic review and does not involve privacy data. The findings of this study will be disseminated electronically through a peer-review publication or presented at a relevant conference.

The giardicidal activity of lobendazole, fabomotizole, tenatoprazole and ipriflavone: A ligand-based virtual screening and in vitro study.

A ligand-based virtual screening study to search for giardicidal compounds on a 6551 ChEMBL drugs database was carried out using molecular similarity. Three fingerprints implemented in MayaChemTools with different design and validated by ROC curves, were used. Twelve compounds were retrieved from this screening, from which, four representative compounds were selected to carry out biological assays. Whereas two compounds were commercially available, the additional two compounds were synthesized during the development of this work. The biological assays revealed that the compounds possess in vitro activity against five strains of Giardia intestinalis, each with different susceptibility/resistance rates to metronidazole, albendazole and nitazoxanide. Particularly, tenatoprazole showed the best effect against the WB and IMSS strains. Furthermore, fabomotizole, tenatoprazole and ipriflavone showed a higher activity against resistant strains than the reference drugs: metronidazole, albendazole and nitazoxanide.

The status of proton pump inhibitor use: a prescription survey of 45 hospitals in China.

BACKGROUND: proton pump inhibitors (PPI) have been widely used in the clinic but inappropriate prescribing has also increased dramatically. OBJECTIVE: to describe the prescribing patterns and assess the appropriateness of the prescribed PPI use in 45 hospitals in China. MATERIALS AND METHODS: PPI prescriptions for non-hospitalized patients were collected from hospitals in Beijing, Chengdu, Guangzhou and Hangzhou of China over a 40-day period in 2016. These data were analyzed using the prescription number, proportion and economic indicators (defined daily dose system [DDD], defined daily cost [DDC] and drug utilization index [DUI]). The evaluation criteria of PPI use was based on Martindale: The Complete Drug Reference, New Materia Medica and drug instructions. RESULTS: in total, 357,687 prescriptions using oral PPI and 38,216 prescriptions using injectable PPI were assessed. The average age of PPI users was 53 years. The most commonly used oral PPI was rabeprazole, while the most common injectable PPI was pantoprazole. The DDD of oral rabeprazole and DDC of injectable rabeprazole were the highest. Meanwhile, only the DUI values of oral rabeprazole, lansoprazole and ilaprazole were less than 1.0. The clinical diagnosis of some users included well identified risky comorbidities such as kidney disease (2.9%). Furthermore, between 32.6% and 56.8% of the PPI prescriptions were used for inappropriate indications. CONCLUSION: this survey demonstrated that PPI use was accompanied by unapproved indications and excessive dosages. Comprehensive measures are urgently needed to improve PPI use and reduce unnecessary drug costs.

Effect of ilaprazole on the healing of endoscopic submucosal dissection-induced gastric ulcer: randomized-controlled, multicenter study.

BACKGROUND: The optimal treatment regimen or the duration of treatment for an endoscopic submucosal dissection (ESD)-induced gastric ulcer has not been established. The aim of this study was to assess the efficacy of novel proton-pump inhibitor, ilaprazole, for the treatment of ESD-induced gastric ulcer. METHODS: This was a prospective, open-label, randomized multicenter study. Between June 2015 and March 2018, a total of 176 patients (178 lesions) who underwent ESD for a gastric neoplasm were randomly allocated to receive the oral proton-pump inhibitor ilaprazole 20 mg or rabeprazole 20 mg daily for 8 weeks. The primary outcome was the ulcer healing rate at 4 and 8 weeks. RESULTS: A total of 155 (157 lesions) and 154 patients (156 lesions) were included in the modified intention-to-treat (mITT) and per-protocol analyses, respectively. There was no significant difference in the ulcer healing rate (ilaprazole vs. rabeprazole, 97.4% vs. 97.0 p = 0.78 at 4 weeks, 100% vs. 100%, p = 0.95 at 8 weeks in the mITT analysis) or stage of ulcer (scar stage, 25.6% vs. 17.7%, p = 0.25 at 4 weeks, 92.3% vs. 88.6%, p = 0.59 at 8 weeks in the mITT analysis) between the treatment groups. The quality of ulcer healing was not significantly different between the two groups. No independent predictive factor for higher-quality ulcer healing was found in the multivariate analysis. CONCLUSIONS: According to this trial, ilaprazole and rabeprazole showed no significant difference in the healing of artificial gastric ulcers. Most of the ulcers achieved complete healing within 4-8 weeks. TRIAL REGISTRATION: ClinicalTrial.gov NCT02638584.

Prospective Single Arm Study on the Effect of Ilaprazole in Patients with Heartburn but No Reflux Esophagitis.

PURPOSE: Patients with gastroesophageal reflux disease without esophagitis show varying responses to proton pump inhibitors (PPIs). The aim of this study was to objectively evaluate the effect of a new PPI, ilaprazole, on patients with heartburn but without reflux esophagitis. MATERIALS AND METHODS: This prospective study was performed on 20 patients with heartburn but without reflux esophagitis. All patients underwent upper endoscopy and 24-hr combined multichannel intraluminal impedance and pH esophageal monitoring (MII-pH). They were then treated with ilaprazole (20 mg) once daily for 4 weeks. The GerdQ questionnaire, histologic findings, and inflammatory biomarkers were used for assessment before and after ilaprazole. RESULTS: Among the 20 patients, 13 (65%) showed GerdQ score ≥8. Based on MII-pH results, patients were classified as true nonerosive reflux disease (n=2), hypersensitive esophagus (n=10), and functional heartburn (n=8). After treatment, patients showed a statistically significant improvement in GerdQ score (p<0.001). Among histopathologic findings, basal cell hyperplasia, papillary elongation, and infiltration of intraepithelial T lymphocytes improved significantly (p=0.008, p=0.021, and p=0.008; respectively). Expression of TNF-α, IL-8, TRPV1, and MCP-1 decreased marginally after treatment (p=0.049, p=0.046, p=0.045, and p=0.042; respectively). CONCLUSION: Daily ilaprazole (20 mg) is efficacious in improving symptom scores, histopathologic findings, and inflammatory biomarkers in patients with heartburn but no reflux esophagitis.

Helicobacter pylori eradication with bismuth quadruple therapy leads to dysbiosis of gut microbiota with an increased relative abundance of Proteobacteria and decreased relative abundances of Bacteroidetes and Actinobacteria.

BACKGROUND: Bismuth quadruple therapy is the treatment of choice for the first-line therapy of Helicobacter pylori infection in areas of high clarithromycin resistance. Currently, the impact of the promising treatment on gut microbiota remains unclear. AIM: To investigate the short-term and long-term impacts of bismuth quadruple therapy on gut microbiota. METHODS: Adult patients with H. pylori-related gastritis were treated with 14-day bismuth quadruple therapy. Fecal samples were collected before treatment at week 2, week 8, and week 48. Nucleic acid extraction from fecal samples was performed. The V3-V4 region of the bacterial 16S rRNA gene was amplified by polymerase chain reaction and sequenced with the MiSeq followed by data analysis using Qiime pipeline. RESULTS: Eleven patients received complete follow-up. Before treatment, the most abundant phyla were Firmicutes (45.3%), Bacteroidetes (24.3%), Proteobacteria (9.9%), and Actinobacteria (5.0%). At the end of bismuth therapy, the relative abundances of Bacteroidetes and Actinobacteria decreased to 0.5% (P < .001) and 1.3% (P = .038), respectively. Additionally, the relative abundance of Verrucomicrobia also decreased from 3.2% to 1.11E-3% (P = .034). In contrast, the relative abundances of Proteobacteria and Cyanobacteria increased (P < .001 and P = .003, respectively). At week 8, the relative abundances of all phyla restored to the levels at baseline. The relative abundances of all phyla at week 48 also did not significantly differ from those at baseline. During eradication therapy, 6 patients (55%) reported at least 1 adverse event. The relative abundance of phylum Proteobacteria in patients with adverse effects was more than that in patients without adverse effects (68.7% ± 8.8% vs 43.4% ± 25.5%; P = .048). CONCLUSIONS: Bismuth quadruple therapy for H. pylori eradication can lead to short-term dysbiosis of gut microbiota. The increase in Proteobacteria in gut microbiota may attribute to the development of adverse effects during bismuth quadruple therapy.

[Features of exchange of calcium saliva in patients with gastroesophageal reflux disease].

OBJECTIVE: Introduction: The pathogenesis of gastroesophageal reflux disease (GERD) is a topical issue of modern gastroenterology. There are a number of scientific papers on changes in the qualitative and quantitative composition of saliva, which triggers a cascade of biochemical reactions, the consequence of which is the destruction of the resistance of the mucous membrane of the esophagus. Calcium is a macro element that provides the normal functioning of cells. Parathormone also regulates the metabolism of calcium in the body. The aim: To study the level of calcium of saliva in patients with GERD before and after 6 months after treatment, to investigate the correlation with the concentration of parathyroid hormone. PATIENTS AND METHODS: Materials and methods: The samples of saliva of patients with GERD before and after treatment are analyzed. The content of calcium in saliva was determined by photometric method. To test the level of parathyroid hormone, the Intact-PTH ELISA test was used. The treatment was carried out with pantoprazole doses of 40 mg per day. Normal values of electrolyte levels in human saliva are set on 10 virtually healthy volunteers. Data processing was carried out using Microsoft Excel. Correlations were calculated using the Pearson method. RESULTS: Results: 25 samples of saliva have been analyzed: 15 patients with GERD and 10 healthy individuals. Concentration of parathormonone in plasma was consistent with normal values. The concentration of calcium saliva for practically healthy individuals was 2.48 ± 0.07 mmol / L, in patients with GERD before treatment 1.92 ± 0.16 mmol / L, after treatment 2.04 ± 0.07 mmol / L. The correlation coefficient between the level of calcium salivation in patients with GERD and the plasma parathyroid hormone concentration before treatment was 0.21, after treatment 0.73. CONCLUSION: Conclusions: The concentration of calcium is statistically significantly reduced in patients with GERD by 22.5% and increased by 10% after treatment. There is a high correlation between the concentration of calcium after treatment and the level of plasma parathyroid hormone.

[Clinical observation of acupuncture at Zhiyang (GV 9) Bazhen points combined with pantoprazole for gastroesophageal reflux cough with damp-heat type].

OBJECTIVE: On the basic treatment, to observed the effect difference between acupuncture at Zhiyang (GV 9) Bazhen points combined with pantoprazole and simple pantoprazole for gastroesophageal reflux cough with damp-heat type. METHODS: A total of 102 patients were randomly assigned into an observation group and a control group, 51 cases in each group. The patients in the two groups were given domperidone tablets (10 mg each time, 3 times a day). The patients in the control group were treated with pantoprazole capsule (40 mg each time, once a day). On the basis of the control group, the patients in the observation group were treated with Zhiyang (GV 9) Bazhen points, once a day, 5 times a week. All the treatment was given for 8 weeks. The indexes were observed before and after treatment, including cough symptom at daytime and nighttime scores, TCM symptom (heartburn, acid regurgitation, chest pain, epigastric pain, throat discomfort) scores and quality of life scores of cough questionnaire in Leicester (physiological, psychological and social aspects). The clinical effects were compared. RESULTS: After treatment, the daytime and nighttime cough scores, TCM symptom (heartburn, acid regurgitation, chest pain, epigastric pain, throat discomfort) scores were lower, and the quality of life scores of cough questionnaire in Leicester (physiological, psychological and social aspects) were higher than those before treatment in the two groups (all P<0.05), with better results in the observation group (all P<0.05). The total effective rate of the observation group was 94.1% (48/51), which was better than 80.4% (41/51) of the control group (P<0.05). CONCLUSION: On the basic treatment, acupuncture at Zhiyang (GV 9) Bazhen points combined with pantoprazole can improve TCM symptoms, such as cough, of the patients with gastroesophageal reflux cough with damp-heat type, and improve their quality of life.

Empirical treatment of outpatients with gastroesophageal reflux disease with proton pump inhibitors: A survey of Chinese patients (the ENLIGHT Study).

BACKGROUND AND AIM: Empirical proton pump inhibitor (PPI) treatment is recommended as a diagnostic indicator for gastroesophageal reflux disease (GERD) and as a therapy for symptomatic control, with responses generally seen within 4 weeks. However, there are no real-world data assessing the effectiveness of short-term empirical treatment with PPIs in patients with GERD in China. METHODS: The ENLIGHT study was a multicenter, prospective, observational study conducted in China. The primary outcome was the overall response rate after 4 weeks' empirical treatment with PPIs. Adult patients aged between 18 and 65 years of age, with a gastroesophageal reflux disease questionnaire score of ≥ 8, prescribed empirical PPI treatment by their physicians and with no planned endoscopy were eligible to participate. Statistical analyses were primarily descriptive. RESULTS: Overall, 987 patients were eligible to participate and were included in the full analysis set (FAS); 707 patients were included in the per protocol set. In the FAS, esomeprazole was received by 57.1% of patients and was the most commonly used PPI. After 4-week treatment, 71.1% (95% confidence interval [CI], 67.9% to 74.2%) of patients were considered responders to PPI. The response rate at the end of 2-week PPI treatment reached 57.0% (95% CI, 52.5% to 61.7%). The median time to response was 13 days (95% CI, 12 to 15). Response rates at 2 and 4 weeks of the per protocol set were similar to those of the FAS. CONCLUSIONS: Short-term empirical PPI treatment can provide an effective relief of GERD symptoms in most Chinese patients in real-world practice.

Gender differences in the presentation of dysphonia related to laryngopharyngeal reflux disease: a case-control study.

OBJECTIVE: To investigate the voice quality impairments in patients with laryngopharyngeal reflux (LPR) according to the gender. DESIGN: Controlled multi-center study. MATERIALS AND METHODS: 80 LPR patients (40 males and 40 females) with reflux finding score (RFS) > 7 and reflux symptom index (RSI) > 13 were included and clinically compared according to gender. To be considered as LPR patients, subjects responded to an empiric therapeutic trial based on pantoprazole intake and diet recommendations for 3 months or had positive pH/Impedance metry. Voice Handicap Index (VHI); Short Form Healthy Survey 36 (SF36), blinded Grade, Roughness, Breathiness, Asthenia, Strain and Instability (GRBASI); aerodynamic and acoustic measurements were assessed in all patients and compared with 80 healthy controls (40 males and 40 females) according to gender. RESULTS: The most common reasons for the consultation were, respectively, globus sensation in males (22.5%) and dysphonia (27.5%) in female who complained more of breathing difficulties and choking episodes related to LPR than males (p = 0.024). From a quality of life standpoint, female had increased significant impact of LPR disease on vitality and mental health than male. Compared to healthy subjects, both LPR male and female patients had stronger values of G, R, B, S, I, VHI, percent jitter, percent shimmer, and soft palate index than controls. In addition, LPR female had stronger values of lowest fundamental frequency and all aerodynamic measurements than controls. CONCLUSION: As showed in many other laryngeal conditions, voice quality of female could be more impaired by LPR than male. Some anatomical, histological and functional factors can be suspected and need additional future researches.

Direct costs for nonsurgical management of Chronic Pancreatitis in a tertiary care teaching hospital.

BACKGROUND: Chronic pancreatitis (CP) is a leading cause of hospitalization among gastrointestinal diseases resulting in considerable financial burden to patients. However the direct costs for nonsurgical management in CP remains unexplored. METHODS: A cross sectional study was carried out (2011-14) in the Department of Gastroenterology, Kasturba Hospital, Manipal, India. Demographic and clinical data on laboratory investigations, interventions and follow up were obtained from the medical records department. Item costs were derived from the hospital electronic billing section. Cost was expressed as median annual cost per patient. RESULTS: 65 (male 48; 73.8%) patients were included. Their median age was 31 (range 12-68) years. The annual median (IQR) total cost per patient was INR 88,892 (70,550.5-116,004); [USD 1410(1119-1841); € 1155(916-1507)], comprising of INR 61,089 (39,102.5-90,360.5) [USD 970 (621-1434); € 793(508-1174)] for outpatient management and INR 32,450 (11,016-46,958) [USD 515 (175-745); €421(143-610)] for hospitalization. 69.5% of the treatment cost was attributed to outpatient treatment. Drugs contributed to 54%, hospitalization incurred 30.5%, investigations 12% and professional fees (3.5%) of the total cost. Pancreatic enzyme replacement therapy (PERT) cost contributed to three-quarters of drug therapy. Use of rabeprazole as against pantoprazole reduced the overall annual cost of therapy by 4%. CONCLUSIONS: This study depicts the first nonsurgical management of accrued direct costs associated with CP due to expensive medications. Due to the high cost for PERT, its usefulness needs proper validation by cost benefit analysis.

Lansoprazole use and tuberculosis incidence in the United Kingdom Clinical Practice Research Datalink: A population based cohort.

BACKGROUND: Recent in vitro and animal studies have found the proton pump inhibitor (PPI) lansoprazole to be highly active against Mycobacterium tuberculosis. Omeprazole and pantoprazole have no activity. There is no evidence that, in clinical practice, lansoprazole can treat or prevent incident tuberculosis (TB) disease. METHODS AND FINDINGS: We studied a cohort of new users of lansoprazole, omeprazole, or pantoprazole from the United Kingdom Clinical Practice Research Datalink to determine whether lansoprazole users have a lower incidence of TB disease than omeprazole or pantoprazole users. Negative control outcomes of myocardial infarction (MI) and herpes zoster were also studied. Multivariable Cox proportional hazards regression was used to adjust for potential confounding by a wide range of factors. We identified 527,364 lansoprazole initiators and 923,500 omeprazole or pantoprazole initiators. Lansoprazole users had a lower rate of TB disease (n = 86; 10.0 cases per 100,000 person years; 95% confidence interval 8.1-12.4) than omeprazole or pantoprazole users (n = 193; 15.3 cases per 100,000 person years; 95% confidence interval 13.3-17.7), with an adjusted hazard ratio (HR) of 0.68 (0.52-0.89). No association was found with MI (adjusted HR 1.04; 95% confidence interval 1.00-1.08) or herpes zoster (adjusted HR 1.03; 95% confidence interval 1.00-1.06). Limitations of this study are that we could not determine whether TB disease was due to reactivation of latent infection or a result of recent transmission, nor could we determine whether lansoprazole would have a beneficial effect if given to people presenting with TB disease. CONCLUSIONS: In this study, use of the commonly prescribed and cheaply available PPI lansoprazole was associated with reduced incidence of TB disease. Given the serious problem of drug resistance and the adverse side effect profiles of many TB drugs, further investigation of lansoprazole as a potential antituberculosis agent is warranted.

[Trend in the Eradication Rates of Helicobacter pylori Infection Over the Last 10 Years in West Gyeonggi-do, Korea: A Single Center Experience].

Background/Aims: The eradication rate of Helicobacter pylori (H. pylori) has been decreasing recently in Korea due to antibiotics resistance. The aim of this study was to investigate the trend of eradication rate and clinical factors affecting the eradication rate of H. pylori in the last 10 years in west Gyeonggi-do, Korea. Methods: The trends of eradication rate of H. pylori, gender, age, concomitant mediations, and clinical factors were retrospectively evaluated in patients with H. pylori infection between 2006 and 2015 (n=2,485). Results: The overall H. pylori eradication rate for the standard triple therapy was 82.5%. The annual eradication rates from 2006 to 2015 were 90%, 77.9%, 75.8%, 83.2%, 85.6%, 90.1%, 81.3%, 81.1%, 78.7%, and 78.8%, respectively, showing a significant decrement during the last five years (p<0.001). Higher eradication rate was observed in males than in females (p<0.001). Esomeprazole showed a higher eradication rate compared with pantoprazole between 2006 and 2010 (p<0.022). Age and the use of probiotics and mucosal protective agents played no significant role in the H. pylori eradication rate. The overall eradication rate for bismuth-based quadruple therapy was 94.4%. Conclusions: The eradication rate of H. pylori over the last 10 years for first-line therapy ranged from 75.8 to 90.1%; the eradication rate for triple therapy has declined. However, the eradication rate for quadruple therapy has remained unchanged over the last 10 years.

A Randomized Controlled Trial Shows that both 14-Day Hybrid and Bismuth Quadruple Therapies Cure Most Patients with Helicobacter pylori Infection in Populations with Moderate Antibiotic Resistance.

Hybrid therapy is a novel two-step treatment achieving a high eradication rate for Helicobacter pylori infection. Currently, whether this new therapy achieves a higher eradication rate than bismuth quadruple therapy remains an unanswered question. The aim of this prospective, randomized comparative study was to investigate the efficacies of 14-day hybrid therapy and bismuth quadruple therapy in the treatment of H. pylori infection. From July 2013 to June 2015, eligible H. pylori-infected subjects were randomly assigned to receive either 14-day bismuth quadruple therapy (pantoprazole, bismuth subcitrate, tetracycline, and metronidazole for 14 days) or 14-day hybrid therapy (a 7-day dual therapy with pantoprazole plus amoxicillin, followed by a 7-day quadruple therapy with pantoprazole plus amoxicillin, clarithromycin, and metronidazole). H. pylori status was examined 6 weeks after the end of treatment. Three hundred thirty H. pylori-infected participants were randomized to receive 14-day bismuth quadruple therapy (n = 164) or 14-day hybrid therapy (n = 166). The eradication rates by intention-to-treat analysis were similar: 93.9% versus 92.8%, respectively (95% confidence interval [CI], -4.3% to 5.4%; P = 0.68). Per-protocol analysis yielded similar results (96.7% versus 94.9%, respectively; P = 0.44). However, bismuth quadruple therapy had a higher frequency of adverse events than hybrid therapy (55.5% versus 15.7%, respectively; 95% CI, 30.4% to 49.2%; P < 0.001). The two treatments exhibited comparable drug adherence (93.9% versus 97%, respectively). The resistance rates of antibiotics were: clarithromycin, 16.7% of patients; amoxicillin, 1.3%; metronidazole, 25%; and tetracycline, 0%. In the bismuth quadruple therapy group, the eradication rate of metronidazole-resistant strains was lower than that of metronidazole-susceptible strains (70.0% versus 96.4%, respectively; P = 0.04). In the hybrid therapy group, no significant impact of clarithromycin or metronidazole resistance on eradication rates was identified. Both 14-day hybrid and bismuth quadruple therapies cure most patients with H. pylori infection in populations with moderate antibiotic resistance. However, the 14-day hybrid therapy has fewer adverse effects than the bismuth quadruple therapy. (This study has been registered at ClinicalTrials.gov under identifier NCT02541864.).

Proton pump inhibitor and selective serotonin reuptake inhibitor therapy for the management of noncardiac chest pain.

INTRODUCTION: Although gastroesophageal reflux disease is the main cause of noncardiac chest pain (NCCP), proton pump inhibitors (PPIs) benefit a minority of patients. Our prospective study evaluated the effect of PPI and selective serotonin reuptake inhibitors on the different subtypes of NCCP characterized by impedance-pH monitoring. METHODS: All NCCP patients underwent impedance-pH monitoring and on the basis of the results, those with abnormal distal esophageal acid exposure received PPIs twice daily (group A), those with a positive symptom index for chest pain received citalopram 20 mg and PPI once daily (group B), and those with a negative symptom index for chest pain received citalopram 20 mg once daily (group C). Therapy was administered for 12 weeks and treatment success was defined as complete disappearance of chest pain. RESULTS: From March 2015 to March 2016, 63 patients were included (group A=9, group B=18, group C=36). After 12 weeks of therapy, complete resolution of chest pain was noted in 8/9 (88.9%) group A, 13/18 (72.2%) group B, and 24/36 (66.7%) group C patients. CONCLUSION: Combined impedance-pH monitoring identifies different subtypes of NCCP patients who can receive tailored management. Targeted therapy with PPIs and/or citalopram offers complete symptom relief in the great majority of them.