Efficacy and tolerability of fourteen-day sequential quadruple regimen: pantoprazole, bismuth, amoxicillin, metronidazole and or furazolidone as first-line therapy for eradication of Helicobacter pylori: a randomized, double-blind clinical trial (original) (raw)
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Lokman Hekim Health Sciences, 2021
Introduction: To determine the Helicobacter pylori (H. pylori) eradication rates with a quadruple treatment regimen consisted of pantoprazole, bismuth subcitrate, metronidazole, and amoxicillin for 14 days in a country with high metronidazole and clarithromycin resistance rates. Methods: All patients were prescribed 14-day quadruple therapy (pantoprazole 40 mg twice daily, bismuth subcitrate 600 mg 2 × 1, amoxicillin 1 g twice daily, and Metronidazole 500 mg three times a day, for 14 days). The success rates of eradication treatment were investigated with stool H. pylori antigen test performed 2 months after eradication. Results: Among 132 H. pylori-infected treatment-naive patients, 8 (6.0%) patients could not complete the study due to adverse events or lost from the follow up. Among 124 patients who completed the study, 10 patients presented with a positive result on stool H. pylori antigen testing at 8 th week, while in remaining 114 cases, the test result was negative. In intention to treat analysis, the eradication rate was determined as 86.4% (95% confidence interval [CI]=81.2%-92.3%), while in per-protocol analysis, the eradication rate was 91.9% (95% CI=88.2%-96.1%). Discussion and Conclusion: With low adverse events and high compliance rates, this treatment modality should be kept in mind for H. pylori eradication especially in regions with high clarithromycin resistance.
The Journal of antimicrobial chemotherapy, 2015
Helicobacter pylori eradication remains a challenge. Non-bismuth-based quadruple regimens (NBQR) have shown high eradication rates (ER) elsewhere that need to be locally confirmed. The objective of this study was to compare the first-line ER of a hybrid therapy (20 mg of omeprazole twice daily and 1 g of amoxicillin twice daily for 10 days, adding 500 mg of clarithromycin twice daily and 500 mg of metronidazole every 8 h for the last 5 days; OA-OACM) with that of a 10 day concomitant regimen consisting of taking all four drugs twice daily every day (including 500 mg of metronidazole every 12 h; OACM). A 10 day arm with standard triple therapy (OAC; 20 mg of omeprazole/12 h, 1 g of amoxicillin/12 h and 500 mg of clarithromycin/12 h) was included. Three hundred consecutive patients were randomized (1: 2: 2) into one of the three following regimens: (i) OAC (60); (ii) OA-OACM (120); and (iii) OACM (120). Eradication was generally confirmed by a [(13)C]urea breath test at least 4 weeks ...
Gastroenterology Research and Practice, 2015
Aim. To compare 10-day standard triple therapy versus sequential therapy as first-line treatment in patients infected with H. pylori. Methods. One hundred H. pylori positive patients (diagnosed by rapid urease test and histology), with average age of 47.2, M/F = 28/72, were randomized to receive either standard triple treatment (TT) as follows: lansoprazole 30 mg, clarithromycin 500 mg, and amoxicillin 1 g, b.i.d. for ten days, or sequential treatment (ST) as follows: lansoprazole 30 mg, amoxicillin and placebo 1.0 g b.i.d for the first five days, followed by lansoprazole 30 mg, clarithromycin 500 mg, and tinidazole 500 mg b.i.d, for the remaining five days. Eradication rates were determined 60 days after treatment by urease, histology, or 13 C-urea breath test. Results. In intention to treat (ITT) analysis, the rate of H. pylori eradication in the TT and ST groups was the same for both regimens as follows: 86% (43/50), 95% CI 93,3 to 73.4%. In Per protocol (PP) analysis, the rate of H. pylori eradication in the TT and ST groups was 87.8% (43/49), 95% CI 94,5 to 75.3% and 89.6% (43/48), 95% CI 95,8 to 77.3%, respectively. Conclusions. In Brazil, standard triple therapy is as equally effective as sequential therapy in eradicating Helicobacter pylori patients. This study was registered under Clinical Trials with number ISRCTN62400496.
Indian Journal of Gastroenterology, 2019
Introduction Resistance to commonly used antibiotics against Helicobacter pylori (H. pylori) is increasing rapidly leading to lower success of traditional triple therapy to eradicate H. pylori infection. So, search for a new regimen as the first-line therapy of H. pylori infection is needed. Aim In this study, we compared the efficacy of 14-day concomitant therapy and 14-day triple therapy for the eradication of H. pylori infection. Method In this open-labeled prospective trial, patients with H. pylori infection were randomized to concomitant therapy (pantoprazole 80 mg, amoxicillin 2000 mg, clarithromycin 1000 mg, and metronidazole 1000 mg daily in divided doses) and triple therapy (pantoprazole 80 mg, amoxicillin 2000 mg, and clarithromycin 1000 mg daily in divided doses). Duration of treatment was 14 days. Gastric biopsy was done 10-12 weeks after completion of therapy to confirm H. pylori eradication. Result The eradication rate achieved with the concomitant therapy was significantly greater than that obtained with the triple therapy. Per-protocol eradication rates of concomitant and triple therapy were 77% and 58.3% (p = 0.028), respectively. Intention-to-treat eradication rates of concomitant and triple therapy were 70.1% and 49.3% (p = 0.013), respectively. Both the treatment regimens were well tolerated. Conclusion Although the rate of eradication of H. pylori infection with concomitant therapy was higher than that with triple therapy, the rate of concomitant therapy was still less than expected.
Annals of internal medicine
Antimicrobial resistance has decreased eradication rates for Helicobacter pylori infection worldwide. To determine whether sequential treatment eradicates H. pylori infection better than standard triple-drug therapy for adults with dyspepsia or peptic ulcers. Randomized, double-blind, placebo-controlled trial. Two Italian hospitals between September 2003 and April 2006. 300 patients with dyspepsia or peptic ulcers. (13)C-urea breath test, upper endoscopy, histologic evaluation, rapid urease test, bacterial culture, and assessment of antibiotic resistance. A 10-day sequential regimen (40 mg of pantoprazole, 1 g of amoxicillin, and placebo, each administered twice daily for the first 5 days, followed by 40 mg of pantoprazole, 500 mg of clarithromycin, and 500 mg of tinidazole, each administered twice daily for the remaining 5 days) or standard 10-day therapy (40 mg of pantoprazole, 500 mg of clarithromycin, and 1 g of amoxicillin, each administered twice daily). The eradication rate a...
Treatments with bismuth-containing quadruple therapy (QT), sequential therapy (ST), or concomitant therapy (CT) have been proposed as empirical first-line regimens for Helicobacter pylori. We compared the efficacy and tolerability of 10 days bismuth-containing quadruple QT, 10 days ST, and 10 days CT with as first-line treatments for H. pylori in a randomized crossover study. The subjects were randomly divided into three groups. The first 130 patients were treated with rabeprazole, bismuth potassium citrate, metronidazole, and tetracycline for 10 days. The second 130 patients in the sequential group were treated with rabeprazole and amoxicillin for 5 days, and then rabeprazole, clarithromycin, and metronidazole for an additional 5 days. The last 130 patients in the concomitant group were treated with rabeprazole, amoxicillin, clarithromycin, and metronidazole for 10 days. H. pylori eradication was confirmed by urea breath test at 6 weeks. The primary outcome was eradication rates of first-line treatment by intention to treat and per protocol (PP) analyzes. There was no difference between the average ages and the male/female ratio of the groups. The PP analysis was performed on 121, 119, and 118 patients in the QT, ST, and CT groups, respectively. In the PP analysis, the successful eradication 94.2% (114/121), 95.0% (113/119), and 95.8% (113/118) the QT, ST, and CT groups, respectively. There was no significant difference among the three groups (p = 0.86). 10 days QT, ST, and CT are highly effective as empirical first-line therapies for H. pylori in the region with high clarithromycin resistance.
International Journal of Advanced Research
To compare the efficacy of levofloxacin based and clarithromycin based sequential therapies for eradication of Helicobacter pylori infection. Methods: From january 2017 to december 2018, 260 patients with H. pylori infection randomly received 14 d of levofloxacin-based sequential therapy (LEVO-ST group, n = 130) or clarithromycin-based sequential therapy (CLA-ST group, n = 130).H.pylori infection was defined on the basis of either histologic evidence of H. pylori by modified Giemsa staining; or a positive rapid urease test by gastric mucosal biopsy. Successful eradication therapy for H.pylori infection was defined as a negative 13-Carbon-urea breath test four weeks after the end of eradication treatment.Compliance was defined as good when drug intake was at least 90%. H. Pylori eradication rates, patient compliance with drug treatment, adverse events, and factors influencing the efficacy of eradicationtherapy were evaluated. Results: The eradication rates by intention-to-treatanalysis were 89% (116/130; 95%ci: 86.2%-95.4%)in the levo-st group and 86% (112/130; 95%ci:65.8%-77.4%) in the cla-st group (p = 0.450). Theeradication rates by per-protocol analysis were 91%(114/124) 95%ci: 89.1%-98.1%) in the LEVO-ST groupand 87% (106/122; 95%ci: 69.4%-81.8%) in the CLA-ST group (p = 0.227). Compliance was 100% in bothgroups. The adverse event rates were 17.6 % (22/125) and 28.6% (35/122) in the LEVO-ST and CLA-ST group,respectively (p = 0.038). Most of the adverse eventswere mildto-moderate in intensity; there was none serious enough to cause discontinuation of treatmentin either group. Conclusion: The 14-d levofloxacin-based sequential therapy has high efficacy for H. pylori eradication effective. Moreover, it showed excellent patient compliance and safety compared to the 14-d clarithromycin-based sequential therapy.
Helicobacter, 2012
Background: Eradication rates of Helicobacter pylori with standard triple therapy are not satisfactory. Sequential therapy is an alternative method to overcome this problem. Objectives: The aim of this study was to assess efficacy of a modified sequential therapy with the addition of a bismuth preparation, as first-line treatment in the eradication of H. pylori infection. Materials and Methods: One hundred and forty-two H. pylori-positive patients were included in the study. Patients were given a 14-day sequential therapy program consisting of pantoprazole, 40 mg (b.i.d. for 14 days); colloidal bismuth subcitrate, 300 mg 4 (two tablets before breakfast and dinner, for 14 days); amoxicillin, 1 g (b.i.d.for the first 7 days); tetracycline, 500 mg (q.i.d. for the second 7 days); and metronidazole, 500 mg (t.i.d. for the second 7 days). Eradication was tested by urea breath test (UBT) 6 weeks after completion of treatment. Results: Of the 142 patients included, 131 completed the study. "Per-protocol" and "intention-to-treat" analyses revealed high eradication rates in this group (92.0-95% CI, 87.2-96.8%, and 81.0-95% CI, 74.5-87.4%, respectively). There was no relation to sex and age with this modified sequential therapy. Compliance was satisfactory (11 patientsfour women and seven men were unavailable for follow-up), and side effects were minimal (six patients had to stop treatmentmetronidazole-related facial swelling and numbness on the face and hands in two patients; tetracycline-related fever and epigastric pain and nausea and vomiting in two patients; and amoxicillin-related diarrhea and vaginal discharge in two patients). These side effects were reversible and resolved after the cessation of the related medication. Conclusions: This 14-day modified sequential treatment, including bismuth, achieves a significantly high eradication rates in patients with H. pylori infection, with five satisfactory patient compliance and minor side effects.
Clinical Drug Investigation, 2001
Objective: Helicobacter pylori plays a pivotal role in gastroduodenal disease. Ranitidine bismuth citrate (RBC)-based triple therapies for a period of 7 days have proven to be an effective treatment for H. pylori. The aim of this study was to compare the eradication efficacy and tolerability profile of a 7-day course of RBC plus clarithromycin and amoxicillin, RBC plus clarithromycin, and omeprazole plus clarithromycin and amoxicillin. Design: Prospective, randomised, double-blind, multicentre study. Methods: A total of 154 H. pylori-positive patients with dyspeptic symptoms were randomised to RBC 400mg twice daily (bid) plus clarithromycin 500mg bid and amoxicillin 1g bid (RBCCA group, n = 53); RBC 400mg bid plus clarithromycin 500mg bid (RBCC group, n = 52); or omeprazole 20mg bid plus clarithromycin 500mg bid and amoxicillin 1g bid (OCA group, n = 49) administered for 7 days. H. pylori infection was initially detected on an antral biopsy by the rapid urease test and confirmed by 13 C-urea breath test. H. pylori status was assessed by 13 C-urea breath test at least 28 days after the end of treatment. Results: There were no statistically significant differences in eradication rates per intention-to-treat (ITT) analysis (n = 149) and per protocol (PP) analysis (n = 135) among the three regimens. Eradication rates per ITT were 82.6% [95% confidence interval (CI), 69.2 to 92%] for RBCCA; 82% (95% CI, 68.7 to 91.9%) for RBCC; and 72.3% (95% CI, 57.7 to 85.6%) for OCA. The corresponding figures for the PP analysis were 85.1% (95% CI, 71.1 to 93.1%), 83% (95% CI, 68.7 to 91.9%), and 73.2% (95% CI, 56.8 to 85.2%), respectively. All regimens were well tolerated. Adverse events occurred in 59 (38%) of the 154 patients and included minor gastrointestinal symptoms and neurological complaints (anxiety, insomnia and headache).