scholarly journals 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

2017 ◽  
Vol 61 (11) ◽  
Author(s):  
Feng-Woei Tsay ◽  
Deng-Chyang Wu ◽  
Hsien-Chung Yu ◽  
Sung-Shuo Kao ◽  
Kung-Hung Lin ◽  
...  
Keyword(s):  
Helicobacter Pylori ◽  
Antibiotic Resistance ◽  
Eradication Rate ◽  
Therapy Group ◽  
Controlled Trial ◽  
Hybrid Therapy ◽  
Content Type ◽  
Quadruple Therapy ◽  
H Pylori ◽  
To Receive

ABSTRACT 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.)

scholarly journals Comparison of Levofloxacin-Based, 10-day Sequential Therapy with 14-day Quadruple Therapy for Helicobacter Pylori Eradication: A Randomized Clinical Trial

2018 ◽  
Vol 10 (4) ◽  
pp. 242-248 ◽  
Author(s):  
Eskandar Hajiani ◽  
Pezhman Alavinejad ◽  
Nahid Avandi ◽  
Abdol Rahim Masjedizadeh ◽  
Ali Akbar Shayesteh
Keyword(s):  
Clinical Trial ◽  
Helicobacter Pylori ◽  
Eradication Rate ◽  
Therapy Group ◽  
Sequential Therapy ◽  
Quadruple Therapy ◽  
Group A ◽  
H Pylori ◽  
Group B ◽  
To Receive

BACKGROUND Considering the importance of Helicobacter pylori (H. pylori) eradication, this clinical trial was designed to prospectively evaluate the efficacy of levofloxacin-based, sequential therapy in comparison with quadruple therapy for eradicating H. pylori. METHODS Overall 156 patients with dyspepsia and H. pylori infection were included in this study and were randomly allocated to either 10-day sequential therapy group (group A) to receive pantoprazole (40 mg twice daily), amoxicillin (1 gr twice daily), levofloxacin (500 mg twice daily), and tinidazole (500 mg twice daily) (PALT) or 14-day quadruple therapy group (group B) to receive pantoprazole, clarithromycin, bismuth subcitrate, and amoxicillin (PABC). At the end of the study the eradication rate in each group was assessed by urea breath test (UBT). RESULTS Age range of the participants was 18-65 years (average 36.9 years) and 50% of them (78 patients) were men. 78 patients were allocated to group A and 78 patients to groupe B. After antibiotic therapy, all the patients received acid suppression therapy with Proton Pump Inhibitor (PPI) for 4 weeks and then the eradication rate was confirmed by UBT (Heli FAN plus 13C, Germany). Before performing UBT, all the participants were requested to halt consumption of PPI for at least 1 week. During the treatment there was not any major complication but in group A (sequential therapy), two patients complained of minor complications including musculoskeletal pain. None of the patients in group B had any complaint or side effect. The rate of H. pylori eradication in group A was 78.2% (61 patients) while this rate in group B was 83.3% (65 patients) with no significant difference between the two groups (p = 0.42). In subgroup analysis, the rate of eradication among men in group A and B were 76.9% and 89.7%, respectively (p = 0.22) while the eradication rate among women were 79.4% and 76.9%, respectively (p = 1.00). CONCLUSION It seems that levofloxacin base sequential therapy does not have any advantage in comparison with quadruple regimen and until finding any more effective short course therapy for H. Pylori eradication; we encourage quadruple regimen to be used as the first line therapy.

scholarly journals COMPARISON OF EFFECTIVENESS OF STANDARD TRIPLE THERAPY VERSUS BISMUTH-BASED THERAPY FOR THE MANAGEMENT OF PEPTIC ULCER DISEASE DUE TO HELICOBACTER PYLORI

2020 ◽  
pp. 192-195
Author(s):  
MIRZA MISBA ALI BAIG ◽  
UZMA PARVEEN ◽  
RUQAIAH FAROOQ ◽  
MAIMUNA TABASSUM ◽  
FATIMA NAAZ ◽  
...  
Keyword(s):  
Helicobacter Pylori ◽  
Peptic Ulcer ◽  
Peptic Ulcer Disease ◽  
Triple Therapy ◽  
Eradication Rate ◽  
Therapy Group ◽  
Quadruple Therapy ◽  
Ulcer Disease ◽  
Standard Triple Therapy ◽  
H Pylori

Objective: Helicobacter pylori is the primary agent causing peptic ulcer, therefore imposing a significant impact on health elated quality of life, consequently affecting nearly 50% of global population. The objective of this study is to determine and assess the effectiveness of triple therapy versus bismuth containing quadruple therapy for eradication of peptic ulcer disease due to H. pylori. Methods: A prospective randomized observational study was conducted at Princess Esra Hospital, Department of Gastroenterology for a period of 6 months. A total of 100 patients were randomly allocated in tow groups. The data were assessed using various parameters. H. pylori eradication was validated using rapid urease test done at the start treatment 4 weeks after the completion. Results: A total of 100 patients were recruited in the study. In triple therapy group medication adherence rate was found to be 82% in triple and 92% in quadruple therapy. The eradication rate was assessed using Chi-square test it was 82% and 97% in triple and quadruple therapy group, respectively. Hence, the difference was found to be statistically significant value <0.005. In addition, increased recurrence rate has been observed in triple therapy (17%) in contrast with quadruple therapy (2%). Conclusion: Addition of bismuth to significant triple therapy improves cure rates with minimal side effects. Interestingly, we observed that when bismuth was added, it produced a significant higher eradication rate (97%) when compared with standard triple therapy (82%). According to our study, bismuth is highly effective treatment of peptic ulcer disease.

scholarly journals Trends in Secondary Antibiotic Resistance of Helicobacter pylori from 2007 to 2014: Has the Tide Turned?

2014 ◽  
Vol 53 (2) ◽  
pp. 522-527 ◽  
Author(s):  
Doron Boltin ◽  
Haim Ben-Zvi ◽  
Tsachi Tsadok Perets ◽  
Zvi Kamenetsky ◽  
Zmira Samra ◽  
...  
Keyword(s):  
Helicobacter Pylori ◽  
Antibiotic Resistance ◽  
Susceptibility Testing ◽  
Demographic Data ◽  
Epidemiological Data ◽  
Secondary Resistance ◽  
Content Type ◽  
Metronidazole Resistance ◽  
H Pylori ◽  
Rational Use Of Antibiotics

The current guidelines recommend culture and antibiotic susceptibility testing ofHelicobacter pylorifollowing two failed eradication attempts. Where testing is unavailable, epidemiological data for secondaryH. pyloriresistance are essential to allow for the rational use of antibiotics. The aim of this study was to describe the temporal changes in antibiotic resistance among adults previously treated forH. pyloriinfections and to identify predictors of resistance. Between 2007 and 2014, consecutive patients undergoing gastroscopy withH. pyloriculture and susceptibility testing at our institution following at least two treatment failures were retrospectively identified. Antibiotic susceptibilities were recorded and linked to the demographic data. A total of 1,042 patients were identified, including 739 (70.9%) males, aged 39.3 ± 18.9 years. Resistance to clarithromycin, metronidazole, and levofloxacin was found in 57.2%, 64.4%, and 5.1% of isolates, respectively. Dual resistance to clarithromycin and metronidazole was seen in 39.9%. Over the study period, clarithromycin resistance increased annually in a linear manner (odds ratio [OR], 1.09; 95% confidence interval [CI], 1.03 to 1.14;P< 0.01), levofloxacin resistance decreased annually (OR, 0.78; 95% CI, 0.61 to 0.92;P< 0.01), and metronidazole resistance was nonlinear. Age was an independent predictor of resistance to all antibiotics. Time elapsed predicted resistance for clarithromycin and levofloxacin and dual resistance for clarithromycin-metronidazole. Secondary resistance ofH. pylorito clarithromycin and metronidazole remains high. The low secondary resistance to levofloxacin makes it an attractive treatment option in our region for patients following two failed eradication attempts.

scholarly journals Antofloxacin, a novel fluoroquinolone, as a component of bismuth quadruple therapy for Helicobacter pylori eradication: a prospective, open-label, randomized trial

2020 ◽  
Author(s):  
He Xiaojian ◽  
Wang Wen ◽  
Li Dazhou ◽  
Liu Gang ◽  
Jiang Chuanshen
Keyword(s):  
Helicobacter Pylori ◽  
Eradication Rate ◽  
Group Versus ◽  
Chinese Patients ◽  
Antibiotics Resistance ◽  
Once Daily ◽  
Quadruple Therapy ◽  
H Pylori ◽  
Colloidal Bismuth ◽  
Alcohol Drinker

Abstract Background Currently, the eradication rate of Helicobacter pylori ( H. pylori ) is markedly decreasing due to some antibiotics resistance, including clarithromycin, metronidazole, and levofloxacin. So, there is a considerable interest in evaluating new antibiotic combinations and regimens. Antofloxacin is a novel fluoroquinolone with broad-spectrum antibacterial activity against Gram-negative bacilli including H. pylori . This study is designed to evaluate the efficacy, safety and tolerability of 14-day antofloxacin-based bismuth quadruple therapy as a treatment regimen in Chinese patients with H. pylori infection. Methods We recruited 290 adult patients with H. pylori infection through upper endoscopy and histologic examination. Patients were randomly assigned to receive either antofloxacin-based bismuth quadruple therapy (ACLA therapy, antofloxacin 200 mg once daily, colloidal bismuth pectin 200 mg three times a day, lansoprazole 30 mg twice daily, and amoxicillin 1 g twice daily) for 14 days; or levofloxacin-based bismuth quadruple therapy (LCLA therapy, levofloxacin 500 mg once daily, colloidal bismuth pectin 200 mg three times a day, lansoprazole 30 mg twice daily, and amoxicillin 1 g twice daily) for 14 days. Eradication was assessed by 13 C-urea breath test after six-week treatment, the primary endpoint was the eradication rate by intention-to-treat (ITT) and per-protocol (PP) analyses. Results Allocated to ACLA were 145 (66F/70M, 42.1±12.8 years, 19.3% smokers, 13.1% alcohol drinker) and 145 (64F/81M, 41.1±12.2 years, 17.9% smokers, 12.4% alcohol drinker) patients to LCLA. 13 patients were lost to follow-up and 3 patients took < 80% of treatment drugs. The resistant rates for amoxicillin, levofloxacin and antofloxaci were 4.1% (12/290), 30.3% (44/145) and 0% (0/145), respectively. The ITT analysis showed eradication rates were 93.8% (136/145) in the ACLA group versus 86.2% (125/145) in the LCLA group ( p =0.031). The PP analysis showed eradication rates were 97.8% (136/139) in the ACLA group versus 92.6% (125/135) in the LCLA group ( p =0.000). The ACLA therapy exhibited lower rates of overall adverse events than LCLA therapy (33.8% vs. 42.0%), but the difference was not statistically significant ( p =0. 159). Conclusion Antofloxacin-based bismuth quadruple therapy might be considered as an alternative for the eradication of H. pylori treatment, since it attained a successful eradication rate of 90% which was superior than levofloxacin-based bismuth quadruple therapy. Both regimens were well tolerated and safe.

scholarly journals Comparison of combination of probiotic and standard therapy compared to standard therapy on eradication of Helicobacter pylori infection in children

2016 ◽  
Vol 50 (1) ◽  
pp. 38
Author(s):  
Fransisca Theresia Aryani ◽  
Agus Firmansyah ◽  
Abdul Latief
Keyword(s):  
Helicobacter Pylori ◽  
Treatment Group ◽  
Side Effects ◽  
Standard Therapy ◽  
Eradication Rate ◽  
Controlled Trial ◽  
Control Group ◽  
Double Blind ◽  
Cancer Management ◽  
H Pylori

Background Helicobacter pylori (H. pylori) infection is thought to be the etiology of chronic gastritis, peptic ulcer, and risk factor for gastric cancer. Management of H. pylori infection in children is associated with several problems such as compliance to therapy, untolerated side effects, and antibiotic resistance. Probiotic is reported to give beneficial effect in the management of H. pylori infection and there is no study yet on the effect of probiotic in eradication of H. pylori infection in Indonesian children.Objectives To study the effect of additional probiotic in the standard therapy on the rate of H. pylori infection eradication in children and its side effect.Methods This was a double blind randomized controlled trial performed in 23 children with H. pylori infection at Kampung Melayu and Rawa Bunga District. The diagnosis was determined based on Helicobacter pylori stool antigen test (HpSA). Subjects were randomly assigned to either receive receive amoxiycilin, clarithromycin, omeprazole, and probiotic (2 x 109 cfu of Lactobacillus acidophilus La5 and Bifidobacterium lactis Bb12) or amoxicillin, clarithromycin, omeprazole dan placebo (maltodextrin). HpSA examination was evaluated again after 2 weeks of therapy.Results Two of 13 subjects in the treatment group and 6 of 10 subjects in the control group experienced side effects. Eradication rate in the treatment group is higher than the control group (13/13 vs 7/10) but the correlation between additional probiotic with the eradication rate of H. pylori is not statistically significant.Conclusions Probiotic can reduce the incidence of side effects due to antibiotic used in H. pylori eradication (2/13 vs 6/10, p < 0.012). [Paediatr Indones. 2010;50:38-41].

scholarly journals High dose PPI-amoxicillin dual therapy for the treatment of Helicobacter pylori infection: a systematic review with meta-analysis

2020 ◽  
Vol 13 ◽  
pp. 175628482093711
Author(s):  
Yang-Jie Zhu ◽  
Yi Zhang ◽  
Ting-Yi Wang ◽  
Jing-Tao Zhao ◽  
Zhe Zhao ◽  
...  
Keyword(s):  
Helicobacter Pylori ◽  
Adverse Events ◽  
Eradication Rate ◽  
Meta Analysis ◽  
Dual Therapy ◽  
Controlled Trials ◽  
High Dose ◽  
First Line ◽  
Quadruple Therapy ◽  
H Pylori

Background: Helicobacter pylori resistance to amoxicillin remains rare in many regions. Proton pump inhibitor-amoxicillin-containing high dose dual therapy (HDDT) has been proposed to treat H. pylori infection. We aimed to assess the effectiveness and safety of PPI-amoxicillin HDDT for treatment of H. pylori infection in comparison with other regimens. Methods: Databases, including PubMed, Embase, and the Cochrane Register of Controlled Trials, were searched to find relevant publications. Randomized controlled trials comparing HDDT with control regimens for H. pylori eradication in adult patients were included. The primary outcome was eradication rate by intention-to-treat analysis. Adverse events were analyzed as second outcome. Results: A total of 15 trials with 3818 patients qualified for inclusion. The eradication rate of HDDT was neither significantly inferior nor superior to the recommended regimens such as triple therapy, bismuth quadruple therapy, and non-bismuth quadruple therapy [relative risk (RR): 1.00, 95% confidence interval (CI): 0.96–1.05, p = 0.870]. This finding was robust through subgroup analyses and sensitivity analyses. Trial sequential analysis showed that HDDT was equivalent to control regimens, and further similar trials were unlikely to alter the conclusions of this analysis. The frequency of adverse events was significantly lower in HDDT group (RR: 0.48, 95% CI: 0.37–0.64, p < 0.001). Conclusion: HDDT was equivalent to recommended first-line or rescue regimens with fewer adverse effects. The evidence from this meta-analysis supports the use of HDDT as first-line or rescue treatment for H. pylori infection. Trial registration: PROSPERO CRD42019133002

scholarly journals Efficacy of quadruple regimen with polaprezinc for gastric Helicobacter pylori infection eradication: protocol for a single-centre, single-blind, non-inferiority, randomised clinical trial

BMJ Open ◽  
2020 ◽  
Vol 10 (11) ◽  
pp. e037182
Author(s):  
Dingkun Wu ◽  
Zhen Sun ◽  
Tingyuan Li ◽  
Qinwen Tan ◽  
Yue Sun ◽  
...  
Keyword(s):  
Helicobacter Pylori ◽  
Controlled Trial ◽  
Potassium Citrate ◽  
Cancer Center ◽  
Control Group ◽  
Gastrointestinal Microbiota ◽  
Single Centre ◽  
Quadruple Therapy ◽  
H Pylori ◽  
Single Blind

IntroductionHelicobacter pylori (H. pylori) is the most well-known risk factor for gastric cancer. At present, H. pylori shows varying levels of resistance to different treatments, leading to a lower rate of H. pylori eradication. The aim of this study is to evaluate the efficacy of polaprezinc-containing quadruple therapy (PQT) for the eradication of H. pylori infection and, thus, to provide more evidence to inform the clinical treatment of H. pylori infection in China.Methods and analysisThis is a single-centre, single-blind, non-inferiority, randomised controlled trial, enrolling 158 patients with H. pylori infection. Patients are randomised (1:1) to the two groups for a 14-day therapy. Treatment group: PQT (esomeprazole 20 mg, amoxicillin 1 g, clarithromycin 500 mg, polaprezinc 75 mg) two times per day; control group: bismuth-containing quadruple therapy (esomeprazole 20 mg, amoxicillin 1 g, clarithromycin 500 mg, bismuth potassium citrate 220 mg) two times per day. The primary outcome is the rate of H. pylori eradication. Secondary outcomes are the incidence of adverse events and the gastrointestinal microbiota distribution. The 16S ribosomal RNA (16S rRNA) next-generation sequencing (NGS) is used to evaluate the effect of two different therapies on the distribution of the gastrointestinal microbiota.Ethics and disseminationThis study was approved by the Ethics Committee of Sichuan Cancer Center & Hospital (No. SCCHEC-02-2019-015). Any amendment to the research protocol will be submitted for ethical approval. All participants must provide informed consent. On completion, the results of the study will be published in the appropriate peer-reviewed journal.Trial registration numberChiCTR1900025800; preresults.

scholarly journals Cost-Effectiveness, Efficacy, and Safety Analysis of Tailored Therapy in Patients with Helicobacter pylori Infection

2021 ◽  
Vol 10 (12) ◽  
pp. 2619
Author(s):  
A Reum Choe ◽  
Ki-Nam Shim ◽  
Yehyun Park ◽  
Eun-Mi Song ◽  
Chung Hyun Tae ◽  
...  
Keyword(s):  
Helicobacter Pylori ◽  
Antibiotic Resistance ◽  
Cost Effectiveness ◽  
Eradication Rate ◽  
Empirical Therapy ◽  
Medical Costs ◽  
First Line ◽  
Tailored Therapy ◽  
Total Treatment ◽  
H Pylori

Recently in Korea, where triple therapy is accepted as the first-line Helicobacter pylori (H. pylori) eradication treatment, antibiotic resistance to clarithromycin has increased considerably, resulting in eradication rates of less than 80%. We investigated the efficacy of tailored therapy after a clarithromycin resistance test compared with empirical therapy for H. pylori eradication. The cost-effectiveness of H. pylori eradication success was evaluated according to the average medical cost per patient. A total of 364 patients were enrolled in the study. The first-line H. pylori eradication rate was significantly higher in patients who received tailored therapy than in those who received empirical therapy. The total medical costs for the tailored and empirical groups were 46,374 Won and 53,528 Won. The total treatment period for each ultimately successful eradication in the tailored group was 79.8 ± 2.8 days, which is shorter than that of the empirical group (99.2 ± 7.4 days). The rate of eradication-related adverse events for the tailored group and empirical group was 12.9% and 14.8%, respectively. Tailored therapy could be a useful option to achieve a higher successful eradication rate, shorter treatment periods, and lower medical costs than empirical therapy in the era of increasing antibiotic resistance.

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