BACKGROUND: With the development of traditional Chinese medicine research, berberine has shown good efficacy and safety in the eradication of Helicobacter pylori (H. pylori). The present study aimed to evaluate the efficacy and safety of triple therapy containing berberine, amoxicillin, and vonoprazan for the initial treatment of H. pylori. METHODS: This study was a single-center, open-label, parallel, randomized controlled clinical trial. Patients with H. pylori infection were randomly (1:1:1) assigned to receive berberine triple therapy (berberine 500 mg, amoxicillin 1000 mg, vonoprazan 20 mg, A group), vonoprazan quadruple therapy (vonoprazan 20 mg, amoxicillin 1000 mg, clarithromycin 500 mg, colloidal bismuth tartrate 220 mg, B group), or rabeprazole quadruple therapy (rabeprazole 10 mg, amoxicillin 1000 mg, clarithromycin 500 mg, colloidal bismuth tartrate 220 mg, C group). The drugs were taken twice daily for 14 days. The main outcome was the H. pylori eradication rate. The secondary outcomes were symptom improvement rate, patient compliance, and incidence of adverse events. Furthermore, factors affecting the eradication rate of H. pylori were further analyzed. RESULTS: A total of 300 H. pylori-infected patients were included in this study, and 263 patients completed the study. An intention-to-treat (ITT) analysis showed that the eradication rates of H. pylori in berberine triple therapy, vonoprazan quadruple therapy, and rabeprazole quadruple therapy were 70.0% (70/100), 77.0% (77/100), and 69.0% (69/100), respectively. The per-protocol (PP) analysis showed that the eradication rates of H. pylori in these three groups were 81.4% (70/86), 86.5% (77/89), and 78.4% (69/88), respectively. Both ITT analysis and PP analysis showed that the H. pylori eradication rate did not significantly differ among the three groups (P >0.05). In addition, the symptom improvement rate, overall adverse reaction rate, and patient compliance were similar among the three groups (P >0.05). CONCLUSIONS The efficacy of berberine triple therapy for H. pylori initial treatment was comparable to that of vonoprazan quadruple therapy and rabeprazole quadruple therapy, and it was well tolerated. It could be used as one choice of H. pylori initial treatment.
Humans ; Amoxicillin/therapeutic use* ; Helicobacter pylori ; Anti-Bacterial Agents ; Clarithromycin/therapeutic use* ; Rabeprazole/therapeutic use* ; Berberine/therapeutic use* ; Bismuth ; Helicobacter Infections/drug therapy* ; Drug Therapy, Combination ; Treatment Outcome ; Proton Pump Inhibitors/therapeutic use*

Humans ; Proton Pump Inhibitors/therapeutic use* ; Deprescriptions

Bismuth-containing quadruple therapy (BQT) has long been recommended for Helicobacter pylori ( H. pylori ) eradication in China. Meanwhile, in the latest national consensus in China, dual therapy (DT) comprising an acid suppressor and amoxicillin has also been recommended. In recent years, the eradication rate of H. pylori has reached >90% using DT, which has been used not only as a first-line treatment but also as a rescue treatment. Compared with BQT, DT has great potential for H. pylori eradication; however, it has some limitations. This review summarizes the development of DT and its application in H. pylori eradication. The H. pylori eradication rates of DT were comparable to or even higher than those of BQT or standard triple therapy, especially in the first-line treatment. The incidence of adverse events associated with DT was lower than that with other therapies. Furthermore, there were no significant differences in the effects of dual and quadruple therapies on gastrointestinal microecology. In the short term, H. pylori eradication causes certain fluctuations in the gastrointestinal microbiota; however, in the long term, the gastrointestinal microbiota eventually returns to its normal state. In the penicillin-naïve population, patients receiving DT have a high eradiation rate, better compliance, lower incidence of adverse reactions, and lower primary and secondary resistance to amoxicillin. These findings suggest the safety, efficacy, and potential of DT for H. pylori eradication.
Humans ; Helicobacter Infections/drug therapy* ; Anti-Bacterial Agents/pharmacology* ; Helicobacter pylori ; Proton Pump Inhibitors ; Drug Therapy, Combination ; Amoxicillin/therapeutic use* ; Treatment Outcome

Objective: To assess the efficacy and cost-effectiveness of high-dose dual therapy compared with bismuth-containing quadruple therapy for treating Helicobacter pylori(H.pylori) infection in servicemen patients. Methods: A total of 160 H. pylori-infected, treatment-naive servicemen, including 74 men and 86 women, aged from 20 years to 74 years, with a mean (SD) age of 43 (13) years, tested in the First Center of Chinese PLA General Hospital from March 2022 to May 2022 were enrolled in this open-label, randomized controlled clinical trial. Patients were randomly allocated into 2 groups: the 14-day high-dose dual therapy group and the bismuth-containing quadruple therapy group. Eradication rates, adverse events, patient compliance, and drug costs were compared between the two groups. The t-test was used for continuous variables, and the Chi-square test for categorical variables. Results: No significant difference in H. pylori eradication rates were found between high-dose dual therapy and bismuth-containing quadruple therapy by ITT, mITT and PP analysis[ITT:90.0% (95%CI 81.2%-95.6%) vs. 87.5% (95%CI 78.2%-93.8%), χ²=0.25, P=0.617;mITT:93.5% (95%CI 85.5%-97.9%) vs. 93.3% (95%CI 85.1%-97.8%), χ²<0.01, P=1.000; PP: 93.5% (95%CI 85.5%-97.9%) vs. 94.5% (95%CI 86.6%-98.5%), χ²<0.01, P=1.000 ]. The dual therapy group exhibited significantly less overall side effects compared with the quadruple therapy group [21.8% (17/78) vs. 38.5% (30/78), χ²=5.15,P=0.023]. There were no significant differences in the compliance rates between the two groups [98.7%(77/78) vs. 94.9%(74/78), χ²=0.83,P=0.363]. The cost of medications in the dual therapy was 32.0% lower compared with that in the quadruple therapy (472.10 RMB vs. 693.94 RMB). Conclusions: The dual regimen has a favorable effect on the eradication of H. pylori infection in servicemen patients. Based on the ITT analysis, the eradication rate of the dual regimen is grade B (90%, good). Additionally, it exhibited a lower incidence of adverse events, better compliance and significantly reduced cost. The dual regimen is expected to be a new choice for the first-line treatment of H. pylori infection in servicemen but needs further evaluation.
Male ; Humans ; Female ; Young Adult ; Adult ; Helicobacter Infections ; Helicobacter pylori ; Bismuth ; Anti-Bacterial Agents/therapeutic use* ; Amoxicillin/adverse effects* ; Drug Therapy, Combination ; Treatment Outcome ; Proton Pump Inhibitors/therapeutic use*

Humans ; Proton Pump Inhibitors/adverse effects*

INTRODUCTION: Proton pump inhibitors (PPIs) are effective treatments for upper gastrointestinal pathologies and short-term courses are well-tolerated. However, indiscriminate use of PPIs is undesirable due to its potential harms. We implemented a series of deprescribing interventions between 2016 and 2017 to curb PPI overutilisation in our institution. The aim of this study was to evaluate the effectiveness and safety of these interventions. METHODS: An institutional PPI deprescribing guide was disseminated by email and educational roadshows were conducted to prescribers. Interrupted time series analysis was used to evaluate the effectiveness of the deprescribing interventions over a 7-year period from 2013 to 2019. To ascertain the safety of PPI deprescribing, we analysed the peptic ulcer disease incidence from 2015 to 2018 and conducted a retrospective chart review of 262 inpatients who were deprescribed PPIs. RESULTS: Following the first intervention, there was a significant decrease in mean oral PPI utilisation by 2,324.46 defined daily doses (DDD) per 1,000 prescriptions (95% confidence interval [CI] -3,542.66, -1,106.26) per month, followed by a month-to-month decrease of 302.61 DDD per 1,000 prescriptions per month thereafter (95% CI -473.95, -131.27). A second targeted educational intervention was only effective in sustaining the decline in the outpatient, but not in the inpatient setting. There were no significant changes in incidence of peptic ulcer disease. In the retrospective chart review, a majority (62.6%) of patients remained deprescribed at 6 months. CONCLUSION We observed a sustained decrease in PPI utilisation in our institution for more than 12 months following our educational interventions. Cautious deprescribing of PPIs in eligible candidates was found to be safe with low recurrence rates of upper gastrointestinal events.
Deprescriptions ; Humans ; Proton Pump Inhibitors ; Quality Improvement ; Retrospective Studies ; Singapore/epidemiology* ; Tertiary Care Centers

Objective: To produce the Chinese version of a new reflux symptom score (RSS) of laryngopharyngeal reflux disease (LPRD) and to evaluate its reliability, validity and clinical value. Methods: This was a retrospective study which contained 42 healthy volunteers and 135 possible LPRD patients. RSI,RFS,oropharyngeal pH monitoring (Dx-pH monitoring) and RSS of each patient were performed. RSS was performed again after 1 week. Confirmed LPRD patients were treated with proton pump inhibitor for 8 week. And RSS was performed again after treatment. Reliability and validity of RSS were evaluated. Results: The Cronbach's α coefficient of RSS was 0.77, which indicated good internal reliability of the new score. The results of test-retest found all P values were less than 0.05, which supported good external reliability. Comparing RSS with laryngopharyngeal reflux test results, the diagnostic coincidence rate was 84.44% (114/135), and the positive predictive value was 85.71% (114/133), which showed good criterion validity. After 8 weeks treatment of PPI, RSS decreased significantly (pretreatment 84.79±42.50,posttreatment 20.11±22.82,t=-10.54, P<0.001), indicating good reactivity of RSS. The score of quality of life impact (Qol) in possible LPRD patients was obviously higher than that of healthy volunteers (t=7.15,P<0.001). All patients and volunteers believed that RSS was a good way to evaluate their symptoms. Conclusions: The new score RSS have good internal and external reliability, criterion validity and reactivity. RSS can be one of the important reference indexes to evaluate LPRD.
Humans ; Laryngopharyngeal Reflux/diagnosis* ; Reproducibility of Results ; Retrospective Studies ; Quality of Life ; Proton Pump Inhibitors/therapeutic use* ; China

INTRODUCTION: H. pylori eradication reduces the risk of gastric malignancies and peptic ulcer disease. First-line therapies include 14-day PAC (proton pump inhibitor [PPI], amoxicillin, clarithromycin) and PBMT (PPI, bismuth, metronidazole, tetracycline). Second-line therapies include 14-day PBMT and PAL (PPI, amoxicillin, levofloxacin). This clinical audit examined current treatment outcomes in Singapore. METHODS: Clinical data of H. pylori-positive patientswho underwent empirical first- and second-line eradication therapies from 1 January 2017 to 31 December 2018 were reviewed. Treatment success was determined by ¹³C urea breath test performed at least 4 weeks after treatment and 2 weeks off PPI. RESULTS: A total of 963 patients (862 PAC, 36 PMC [PPI, metronidazole, clarithromycin], 18 PBMT, 13 PBAC [PAC with bismuth], 34 others) and 98 patients (62 PMBT, 15 PAL, 21 others) received first-and second-line therapies respectively. A 14-day treatment duration was appropriately prescribed for first- and second-line therapies in 65.2% and 82.7% of patients, respectively. First-line treatment success rates were noted for PAC (seven-day: 76.9%, ten-day: 88.3%, 14-day: 92.0%), PMC (seven-day: 0, ten-day: 75.0%, 14-day: 69.8%), PBMT (ten-day: 100%, 14-day: 87.5%) and PBAC (14-day: 100%). 14-day treatment was superior to seven-day treatment (90.8% vs. 71.4%; P = 0.028). PAC was superior to PMC (P < 0.001) but similar to PBMT (P = 0.518) and PBAC (P = 0.288) in 14-day therapies. 14-day second-line PAL and PBMT had similar efficacy (90.9% vs. 82.4%; P = 0.674). CONCLUSION First-line empirical treatment using PAC, PBMT and PBAC for 14 days had similar efficacy. Success rates for second-line PBMT and PAL were similar.
Humans ; Helicobacter pylori ; Clarithromycin/therapeutic use* ; Helicobacter Infections/drug therapy* ; Metronidazole/therapeutic use* ; Bismuth/therapeutic use* ; Singapore ; Drug Therapy, Combination ; Amoxicillin/therapeutic use* ; Proton Pump Inhibitors/therapeutic use* ; Anti-Bacterial Agents/therapeutic use* ; Treatment Outcome ; Clinical Audit

Gastric acid suppressants, such as proton pump inhibitors, are one of the most widey used drugs worldwide. There is a very high frequency of abuse of gastric acid suppressants, leading huge waste of medical resources. Moreover, numerous studies have showed that acid suppressants were associated with a variety of adverse events, such as fractures and intestinal infections. Increasing guidelines and consensuses have been made to guide the appropriate use of acid suppressants. Gastrointestinal surgery is one of the fields with the largest prescriptions of acid suppressants. Acid suppressants are widely used for preventing anastomotic bleeding after upper gastrointestinal surgery, treating gastrointestinal bleeding and etc. However, most of these prescriptions are off-label uses lacking adequate evidentiary basis. Thus far, there is no guideline specific for appropriate use of acid suppressants in digestive surgeries. Therefore, Chinese Society of Upper Gastrointestinal Surgeons (CSUGS) and Chinese Gastric Cancer Association (CGCA) developed this clinical practice guideline based on the best research evidence and clinical expertise. The aim is to guide the appropriate use of gastric acid suppressants in gastrointestinal surgery, which in turn, increase the benefits of patients.
Humans ; Digestive System Surgical Procedures ; Gastric Acid ; Gastrointestinal Hemorrhage/prevention & control* ; Proton Pump Inhibitors/therapeutic use*

Objectives: The purpose of this study was to determine the efficacy of proton pump inhibitor (PPI) therapy in treating the symptoms and laryngeal findings of laryngopharyngeal reflux (LPR). Methods: Placebo-controlled, randomized clinical trials published after June 2001 to January 2021 which used PPI as the sole intervention and the RSI or RFS as outcome measures were eligible for inclusion. Studies that were published prior to June 2001, those which only made use of questionnaires other than the RSI or RFS, those which used PPI in combination with other treatments, or those with unavailable full-text manuscripts were excluded. These studies were identified from MEDLINE, Scopus, Cochrane Library, Embase, and HERDIN Plus databases which were searched from May 21 to 26, 2020. The primary outcome was the mean difference between baseline/pre-treatment and post-treatment RSI scores for both PPI and placebo groups. The secondary outcome was the mean difference between pre-treatment and post-treatment RFS scores for PPI and placebo groups. Aggregate results of these outcomes were analyzed using forest plots. Heterogeneity was determined through prediction intervals. Risk of bias of individual studies was assessed using the Cochrane Collaboration’s Tool in Assessing Risk of Bias. Results: Nine randomized control trials were included with a total of 737 patients randomized and 595 patients analyzed – 294 from the PPI group and 301 from the placebo group. There were notable variations among the studies in terms of choice of PPI, dosage and frequency. Out of nine studies, four used both RSI and RFS in their analysis. Two studies used RSI alone and three used the RFS in combination with symptom questionnaires other than the RSI. There was a significant decrease in the RSI of the PPI group versus the placebo group with a mean difference of -2.83 (95% CI, -5.13 to -0.53, p = .02). However, there was no significant decrease in the RFS between PPI and placebo groups with a mean difference of -0.84 (95% CI, -2.66 to 0.98, p = .37). For two clinical trials which only reported post-treatment RFS, there was also no significant difference between the two treatment groups with a mean difference of 1.27 (95% CI, -0.22 to 2.76, p = .10). Conclusion This meta-analysis found that, although a statistically significant benefit in RSI was noted with PPI therapy, this difference may not translate to a clinically significant change in symptoms; therefore, there is insufficient evidence to recommend for or against the treatment of LPR with PPIs.
Laryngopharyngeal Reflux ; Proton Pump Inhibitors ; Laryngitis ; Hoarseness