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*

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*

BACKGROUND: Given the general unavailability, common adverse effects, and complicated administration of tetracycline, the clinical application of classic bismuth quadruple therapy (BQT) is greatly limited. Whether minocycline can replace tetracycline for Helicobacter pylori ( H . pylori ) eradication is unknown. We aimed to compare the eradication rate, safety, and compliance between minocycline- and tetracycline-containing BQT as first-line regimens. METHODS: This randomized controlled trial was conducted on 434 naïve patients with H . pylori infection. The participants were randomly assigned to 14-day minocycline-containing BQT group (bismuth potassium citrate 110 mg q.i.d., esomeprazole 20 mg b.i.d., metronidazole 400 mg q.i.d., and minocycline 100 mg b.i.d.) and tetracycline-containing BQT group (bismuth potassium citrate/esomeprazole/metronidazole with doses same as above and tetracycline 500 mg q.i.d.). Safety and compliance were assessed within 3 days after eradication. Urea breath test was performed at 4-8 weeks after eradication to evaluate outcome. We used a noninferiority test to compare the eradication rates of the two groups. The intergroup differences were evaluated using Pearson chi-squared or Fisher's exact test for categorical variables and Student's t -test for continuous variables. RESULTS: As for the eradication rates of minocycline- and tetracycline-containing BQT, the results of both intention-to-treat (ITT) and per-protocol (PP) analyses showed that the difference rate of lower limit of 95% confidence interval (CI) was >-10.0% (ITT analysis: 181/217 [83.4%] vs . 180/217 [82.9%], with a rate difference of 0.5% [-6.9% to 7.9%]; PP analysis: 177/193 [91.7%] vs . 176/191 [92.1%], with a rate difference of -0.4% [-5.6% to 6.4%]). Except for dizziness more common (35/215 [16.3%] vs . 13/214 [6.1%], P = 0.001) in minocycline-containing therapy groups, the incidences of adverse events (75/215 [34.9%] vs . 88/214 [41.1%]) and compliance (195/215 [90.7%] vs . 192/214 [89.7%]) were similar between the two groups. CONCLUSION: The eradication efficacy of minocycline-containing BQT was noninferior to tetracycline-containing BQT as first-line regimen for H . pylori eradication with similar safety and compliance. TRIAL REGISTRATION ClinicalTrials.gov, ChiCTR 1900023646.
Humans ; Bismuth/therapeutic use* ; Metronidazole/therapeutic use* ; Esomeprazole/pharmacology* ; Minocycline/pharmacology* ; Helicobacter pylori ; Potassium Citrate/therapeutic use* ; Anti-Bacterial Agents ; Tetracycline/adverse effects* ; Helicobacter Infections/drug therapy* ; Drug Therapy, Combination ; Amoxicillin

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

Objective To evaluate the efficacy and safety of amoxicillin-clarithromycin-containing bismuth quadruple regimen as a primary therapy for Helicobacter pylori (Hp) eradication.Methods A total of 102 Hp-infected outpatients diagnosed by C-or C-urea breath test from December 2015 to June 2017 were enrolled and received 14-day bismuth quadruple therapy (esomeprazole 20 mg bid,bismuth potassium citrate 220 mg bid,amoxicillin 1000 mg bid,and clarithromycin 500 mg bid for 14 days). Hp status was assessed by C-or C-urea breath test 4 weeks,8 weeks,6 months,and 12 months after the treatment. The primary outcome was Hp eradication rate,which was analyzed by intention-to-treat (ITT) and per-protocol (PP) analyses. The second outcomes were Hp infection recurrence,symptomatic benefit from Hp eradication,and safety. Results A total of 101 patients,of which 65 patients had dyspeptic symptoms before eradication,completed the study. Hp eradication rates by ITT analysis and by PP analysis were 88.2% and 89.1%,respectively. Only in two of 84 patients,who were followed for 8 weeks after eradication,Hp became positive. No Hp recurrence happened at the 6-month and 12-month follow-up and the annual recurrence rate was 2.4%. The symptomatic relief rates at the 4-week,8-week,6-month and 12-month follow-up were 81.5%,75.4%,71.2%,and 70.2% respectively. Eleven of 101 patients had mild and similar side-effects,which were well tolerated.Conclusion Amoxicillin-clarithromycin-containing bismuth quadruple regimen can be used as the standard therapy for Hp eradication.
Amoxicillin ; therapeutic use ; Anti-Bacterial Agents ; Bismuth ; Clarithromycin ; therapeutic use ; Drug Therapy, Combination ; Helicobacter Infections ; drug therapy ; Helicobacter pylori ; Humans ; Treatment Outcome

To investigate the efficacy of bismuth containing quadruple therapies on Helicobacter pylori (Hp) eradication in patients with history of antibiotic treatment. 
 Methods: Hp infected patients (n=327) were allocated into 3 groups. Group A (n=52), patients had no antibiotic history and they took medicine of proton pump inhibitors (PPI) and livzon triple (clarithromycin, tinidazole, and bismuth); group B (n=80), patients had the antibiotic history except for amoxicillin and clarithromycin, and they were treated with PPI, amoxicillin, clarithromycin, and bismuth; group C (n=195), patients suffered failures of Hp therapy or with history of antibiotic abuse, and they were treated with PPI, doxycycline, furazolidone, and bismuth.
 Results: Both the intention-to-treat (ITT) analysis (group A 63.5%, group B 76.2%, group C 82.6%, P<0.05) and the pre-protocol (PP) analysis (group A 76.7%, group B 92.4%, group C 96.4%, P<0.05) showed significant difference among the 3 groups, revealing higher elimination in group B and C. The side-effects (20.2%) were mild and tolerable (group A, 28.0%; group B, 10.7%; group C, 22.0%).
 Conclusion: Proton pump inhibitors together with the livzon triple regimen have a low rate of Hp eradication and a higher incidence of adverse reactions. The quadruple therapy containing clarithromycin and metronidazole drugs can achieve the satisfactory outcomes based on patient's antibiotic history. For patients with multiple antibiotics, the quadruple therapy containing furazolidone and doxycycline may achieve the satisfactory outcomes, but the adverse resction would be relatively higher.
Amoxicillin ; therapeutic use ; Anti-Bacterial Agents ; therapeutic use ; Bismuth ; therapeutic use ; Clarithromycin ; therapeutic use ; Drug Therapy, Combination ; methods ; Furazolidone ; therapeutic use ; Helicobacter Infections ; drug therapy ; Helicobacter pylori ; Humans ; Metronidazole ; therapeutic use ; Proton Pump Inhibitors ; therapeutic use ; Tinidazole ; therapeutic use ; Treatment Outcome

BACKGROUND/AIMS: Ten-day sequential therapy has been evaluated as the first line therapy for Helicobacter pylori eradication but studies on sequential therapy as a second line therapy is lacking. The aim of this study was to compare the efficacy of 10-day sequential therapy and quadruple therapy as second line treatment for H. pylori eradication after failure of standard triple therapy. METHODS: Patients who did not respond to standard triple therapy for H. pylori eradication were assigned to either 10-day sequential or bismuth based quadruple therapy as second line treatment from January 2009 to December 2014 at Yeungnam University Medical Center. Post treatment H. pylori status was determined by rapid urease test, giemsa staining, or 13C-urea breath test. Eradication rate and side effects of both therapies were compared. RESULTS: A total of 158 H. pylori infected patients were included and 70 patients were treated by bismuth based quadruple therapy and 88 patients by 10-day sequential therapy. Age and sex were not significantly different between the two groups. Eradication rate was 84.3% (59/70) in quadruple group and 56.8% (50/88) in sequential group. Side effects occurred significantly higher in quadruple group than sequential group (27.1% vs. 11.4%, p=0.011). CONCLUSIONS: For second line H. pylori eradication after failure of standard triple therapy, bismuth based quadruple therapy showed significantly higher H. pylori eradication rate than 10-day sequential therapy. Further prospective studies are needed to evaluate the efficacy of 10-day sequential therapy as a second line H. pylori eradication treatment.
Adult ; Aged ; Aged, 80 and over ; Anti-Bacterial Agents/adverse effects/pharmacology/*therapeutic use ; Bismuth/adverse effects/pharmacology/*therapeutic use ; Diarrhea/etiology ; Drug Administration Schedule ; Drug Therapy, Combination ; Female ; Helicobacter Infections/*drug therapy ; Helicobacter pylori/drug effects ; Humans ; Male ; Middle Aged ; Proton Pump Inhibitors/adverse effects/pharmacology/therapeutic use ; Retrospective Studies ; Risk Factors ; Taste Disorders/etiology ; Treatment Outcome ; Young Adult

Korea and Japan show the highest incidence of gastric cancer and Helicobacter pylori infection. New 2013 guidelines on H. pylori infection differ between the two countries with regard to the indications for H. pylori eradication, diagnostic methods, and treatment regimens. Indications for eradication in Korean guideline focus on specific diseases such as peptic ulcer disease, low-grade gastric mucosa-associated lymphoid tissue lymphoma, and after resection of early gastric cancer, while Japanese guideline includes all H. pylori-associated gastritis for the prevention of dissemination. With regard to the diagnosis, either noninvasive or invasive method (except for bacterial culture) is recommended in Korea, while two noninvasive tests including serum anti-H. pylori IgG antibody level are preferred in Japan. As for the treatment regimens, second-line treatment (quadruple bismuth-containing regimen) is recommended without first-line triple therapy in areas of high clarithromycin resistance in Korea. However, there is no bismuth-based second-line treatment in Japan, and the Japanese regimen consists of a lower dose of antibiotics for a shorter duration (7 days). Such discrepancies between the two countries are based not only on the differences in the literature search and interpretation, but also on the different approvals granted by the national health insurance system, manufacturing process of the antibiotics, and diagnostic techniques in each country. Collaborations are required to minimize the discrepancies between the two countries based on cost-effectiveness.
Anti-Bacterial Agents/pharmacology/*therapeutic use ; Antibodies/blood ; Bismuth/pharmacology/therapeutic use ; Disease Eradication/trends ; Drug Administration Schedule ; Guidelines as Topic ; Helicobacter Infections/complications/diagnosis/*drug therapy ; *Helicobacter pylori/drug effects/immunology ; Humans ; Japan ; Lymphoma, B-Cell, Marginal Zone/complications/surgery ; Republic of Korea ; Stomach Neoplasms/complications/surgery

Since the Korean College of Helicobacter and Upper Gastrointestinal Research has first developed the guideline for the diagnosis and treatment of Helicobacter pylori infection in 1998, the revised guideline was proposed in 2009 by the same group. Although the revised guideline was made by comprehensive review of previous articles and consensus of authoritative expert opinions, the evidence-based developmental process was not applied in the revision of the guideline. This new guideline has been revised especially in terms of changes in the indication and treatment of H. pylori infection in Korea, and developed by the adaptation process as evidence-based method; 6 guidelines were retrieved by systematic review and the Appraisal of Guidelines for Research and Evaluation (AGREE) II process, 21 statements were made with grading system and revised by modified Delphi method. After revision, 11 statements for the indication of test and treatment, 4 statements for the diagnosis and 4 statements for the treatment have been developed, respectively. The revised guideline has been reviewed by external experts before the official endorsement, and will be disseminated for usual clinical practice in Korea. Also, the scheduled update and revision of the guideline will be made periodically.
Amoxicillin/therapeutic use ; Anti-Bacterial Agents/therapeutic use ; Aspirin/therapeutic use ; Bismuth/therapeutic use ; Breath Tests ; Clarithromycin/therapeutic use ; Gastroesophageal Reflux/etiology ; Gastroscopy ; Helicobacter Infections/complications/*diagnosis/drug therapy ; *Helicobacter pylori ; Humans ; Lymphoma, B-Cell, Marginal Zone/complications ; Metaplasia/complications ; Metronidazole/therapeutic use ; Peptic Ulcer/complications/drug therapy ; Proton Pump Inhibitors/therapeutic use ; Republic of Korea ; Stomach Neoplasms/complications/surgery ; Tetracycline/therapeutic use

OBJECTIVETo evaluate the efficacy of bismuth-based quadruple therapy as the first-line treatment for H.pylori infection.

METHODSA total of 136 patients with H.pylori related peptic ulcer or chronic gastritis were randomized into two groups: 67 patients in bismuth-based quadruple group received esomeprazole 20 mg, clarithromycin 0.5 g,amoxicillin 1.0 g,and bismuth potassium citrate 220 mg for 7 d; 69 patients in standard triple group received esomeprazole 20 mg, clarithromycin 0.5 g and amoxicillin 1.0 g for 7 d. Outcome of eradication therapy was assessed by (14)C-UBT. On ITT and PP analysis, calculating the cost-effectiveness ratio (C/E) and the incremental cost-effectiveness ratio (delta C/delta E).

RESULTOn ITT and PP analysis, the eradication rates of the quadruple therapy group were 82.09% and 88.71%, and those of the triple therapy group were 66.67% and 73.02% (P<0.05). The cost-effectiveness ratio of two groups was 4.15 and 4.82; The incremental cost-effectiveness ratio of quadruple therapy group was 1.02 as against triple therapy group.

CONCLUSIONCompared to the standard triple therapy regimen, the bismuth-containing quadruple therapy regimen has higher eradication rate and cost-effectiveness, which can be recommended as the fist-line treatment for H.pylori infection.

Adult ; Anti-Bacterial Agents ; administration & dosage ; economics ; therapeutic use ; Anti-Ulcer Agents ; administration & dosage ; economics ; therapeutic use ; Bismuth ; administration & dosage ; economics ; therapeutic use ; Cost-Benefit Analysis ; Drug Therapy, Combination ; economics ; Female ; Follow-Up Studies ; Helicobacter Infections ; drug therapy ; Humans ; Male ; Middle Aged ; Treatment Outcome