Bismuth-based quadruple therapy using a single capsule of bismuth biskalcitrate, metronidazole, and tetracycline given with omeprazole versus omeprazole, amoxicillin, and clarithromycin for eradication of helicobacter pylori in duodenal ulcer patients: a prospective, randomized, multicenter, nort... (original) (raw)
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2017
Aim: To evaluate the efficacy and tolerability of replacing tetracycline with high dose of amoxicillin in bismuth-based quadruple therapy for H.pylori eradication. Methods: This randomized, open label clinical trial study was performed on 228 patients with H.pylori infection and duodenal ulcer without the history of previous H.pylori treatment. Patients were randomly divided into two groups. Group one received metronidazole 500mg, bismuth subcitrate 240mg and amoxicillin 1000mg, all three times a day and omeprazole 20 mg twice a day (amoxicillin group)for14 days. The second group received metronidazole 500mg three times a day and bismuth subcitrate240mg and tetracycline HCL 500mg both four times a day and omeprazole 20 mg twice a day (tetracycline group), for 14 days. Evaluation for compliance and drugs side effects were done after two weeks. Eight weeks after treatment, H.pylori eradication rate was assessed by c13-urease breath test. Results: Two hundred twenty-eight patients were enrolled. There was no statistically significant demographic difference between two groups. Amoxicillin containing regimen achieved higher Eradication rate: 105 of 110 ,95.51% (95%CI 91.5% to 99.3%) and 88 of 105, 83.8% (95% CI 76.7% to 90.8%) by per-protocol analysis (p-value=0.005) and 92.9%(95%CI 88.1% to 97.6%) and 76.5% (95% CI 68.7% to 84.2%) by intention-totreat (p-value=0.001) for amoxicillin and tetracycline groups, respectively. Adverse events were statistically more significant higher in Tetracycline group (65.2%) amoxicillin group (43.4%) (P value = 0.001). Conclusion: Bismuth based quadruple therapy included high dose of amoxicillin and metronidazole has an acceptable H. pylori infection eradication rate with good tolerance in patients with duodenal ulcer. This can overcome treatment resistance in areas with high prevalence of metronidazole and clarithromycin resistance DOI dx.
PLOS ONE
To evaluate the efficacy and tolerability of tetracycline vs. high-dose amoxicillin in bismuthbased quadruple therapy for Helicobacter pylori(H. pylori) eradication. Methods This randomized, open-label clinical trial included 228 patients with H.pylori infection and duodenal ulcer without a history of H.pylori treatment. Patients were randomly divided into two groups. The amoxicillin group received metronidazole 500mg, bismuth subcitrate 240mg, and amoxicillin 1000mg, all three times a day, plus omeprazole 20 mg twice a day, for 14 days. The tetracycline group received metronidazole 500mg three times a day; bismuth subcitrate240mg and tetracycline HCl 500mg, both four times a day; and omeprazole 20 mg twice a day, for 14 days. Evaluation for compliance and drug-relatedadverse effects were evaluated at the end of two weeks. Eight weeks after the end of treatment, the rate of H.pylori eradication was assessed by the C 13 urease breath test. Results There were no significant demographic differences between the two groups. Eradication rate was higher with the amoxicillin-containing regimen than the tetracycline-containing regimen: 105/110 (95.51%; 95% confidence interval, 91.5%-99.3%) vs. 88/105 (83.8%; 95% CI, 76.7%-90.8%) by per-protocol analysis (p = 0.005) and 92.9% (95%CI, 88.1%-97.6%) vs. 76.5% (95%CI, 68.7%-84.2%) by intention-to-treat analysis (ITT, p = 0.001).
Alimentary Pharmacology and Therapeutics, 2003
Background: The high prevalence of Helicobacter pylori resistance to metronidazole demands treatments more effective than standard bismuth-based triple therapy against these strains. Aim: To evaluate the H. pylori eradication rate in both metronidazole-sensitive and -resistant strains following quadruple therapy using single-triple capsules of bismuth biskalcitrate, metronidazole and tetracycline, given with omeprazole. Methods: One hundred and seventy valid patients with duodenal ulcer, gastric ulcer or non-ulcer dyspepsia were treated in eight centres located in five countries. H. pylori was confirmed at baseline using 13 C-urea breath test, histology and ⁄ or culture. Patients received three single-triple capsules q.i.d. and omeprazole, 20 mg b.d., for 10 days. Each capsule contained bismuth biskalcitrate, 140 mg (as 40 mg Bi 2 O 3 equivalent), metronidazole, 125 mg, and tetracycline, 125 mg. 13 C-Urea breath test was repeated at least 4 and 8 weeks post-treatment. Results: Overall eradication rates were 93% (158 ⁄ 170) by modified intention-to-treat analysis and 97% (142 ⁄ 146) by per protocol analysis. Eradication rates were 93% (40 ⁄ 43) and 95% (38 ⁄ 40) for strains resistant to metronidazole and 95% (82 ⁄ 86) and 99% (75 ⁄ 76) for strains sensitive to metronidazole by modified intention-to-treat and per protocol analysis, respectively. Conclusion: This omeprazole-bismuth biskalcitratemetronidazole-tetracycline 10-day regimen is a very effective and well-tolerated treatment, which overcomes metronidazole resistance.
Helicobacter, 1996
Background.Eradication of Helicobacter pylori provides potential cure in the majority of patients with peptic ulcer disease, and eradication rates of more than 90% have been reported, using omeprazole in combination with two antimicrobials. The choice of antimicrobials, dose regimen and duration of treatment have varied between studies, however, and an optimal treatment still has to be established.Materials and Methods.We conducted an international, randomized, double-blind, placebo-controlled study involving more than 100 patients in each of six treatment groups in 43 hospital gastrointestinal units in Canada, Germany, Ireland, Sweden, and the United Kingdom. Patients (n=787) with proved duodenal ulcer disease were randomized to treatment twice daily for 1 week with omeprazole, 20 mg (O), plus either placebo (P) or combinations of two of the following anti-microbials: amoxicillin, 1 gm (A), clarithromycin, 250 or 500 mg (C250, C500), or metronidazole, 400 mg (M). Eradication of H. pylori was evaluated by 13C-UBT, performed before and 4 weeks after treatment cessation.Results.The eradication rates for the all-patients-treated analysis were 96%. OAC500; 95%, OMC250; 90%, OMC500; 84%, OAC250; 79%, OAM; and 1%, OP. OAC500 and OMC250 achieved eradication rates with lower 95% confidence interval limits exceeding 90%. All regimens were well-tolerated, 96% of patients complied with their dose regimen, and 2.3% of the patients discontinued treatment owing to adverse events.Conclusions.Omeprazole triple therapies given twice daily for 1 week produce high eradication rates, are well-tolerated, and are associated with high patient compliance. The two most effective therapies were those combining omeprazole, 20 mg, with either amoxicillin, 1 gm, plus clarithromycin, 500 mg, or metronidazole, 400 mg, plus clarithromycin, 250 mg, all given twice daily.
Medical Science Monitor International Medical Journal of Experimental and Clinical Research, 2002
Background: The object of the study was to study the efficacy and safety of furazolidone and tetracycline compared to metronidazole and amoxicillin in an omeprazole based triple therapy in a prospective randomized-blind-clinical trial. Material/Methods: Patients with endoscopically verified active duodenal ulcer disease in the presence of Helicobacter pylori infection were eligible to enter the study. Endoscopy was performed a day before and 6-8 weeks after the cessation of treatment. H. pylori status was assessed by histologic examination (Giemsa stain) of biopsy specimens were taken from the antrum and corpus. H. pylori eradication was defined as absence in histology of the biopsy specimens at the second endoscopy. Ulcer healing was considered as decrease in ulcer size to less than 20% of its primary size. Patients were randomly assigned to receive omeprazole 20 mg, amoxicillin 1000 mg and metronidazole 500 mg (OAM group) or omeprazole 20 mg, tetracycline 500 mg and furazolidone 200 mg (OTF group). All medications were taken twice daily, for 2 weeks. Results: Out of 111 patients enrolled in the study, 108 completed a course of treatment and underwent a follow-up endoscopy, with 54 patients in each group. H. pylori eradication was achieved in 52 patients (96.3%-95% CI: 91.27-100) in OTF group and 45 patients (83.3%-95% CI: 73.35-93.25) in OAM group (P=0.015). Our study showed the superiority of OTF vs. OAM regimen with a 13% increment in eradication rate, with only occasional severe side effect. Conclusions: In conclusion OTF regimen is a safe, cheaper and effective alternative for OTF regimen and we recommend it to be used especially in developing countries.
Alimentary Pharmacology & Therapeutics, 2007
To compare the efficacy, safety and tolerability of an omeprazole/amoxycillin (OA) dual therapy Helicobacter pylori eradication regimen with an omeprazole/amoxycillin/metronidazole (OAM) triple therapy regimen. Methods: In this double-blind trial, conducted in 19 hospitals, 119 patients with symptomatic duodenal ulcer disease were randomized to receive either 14 days treatment with omeprazole 40 mg daily, amoxycillin 500 mg t.d.s. and placebo followed by a further 1 4 days' treatment with omeprazole 20 mg daily ( n = 59) or 14 days treatment with omeprazole 4 0 mg daily, amoxycillin 500 mg t.d.s., and metronidazole 400 mg t.d.s., followed by a further 14 days' treatment with omeprazole 20 mg daily ( n = 60). H. pylori status was assessed by 13C-urea breath test at entry and at 4 weeks post-treatment. Results: H. pylori infection was eradicated in 46% of the OA treated patients and in 92 % of the OAM treated patients, a mean difference of 46% (P < 0.0001, 95% CI for the difference: + 30 to + 62). In only one patient was the duodenal ulcer not endoscopically healed after 4 weeks of treatment (OA 100%; OAM 98 % healed). There were no significant differences in speed of symptom relief or improvement in symptoms between the two groups. Both regimens were well tolerated, with 96 % of patients completing the course, and only one patient withdrawing due to an adverse event. The only side-effect with a significantly higher incidence in the OAM group was diarrhoea, which occurred in 36 % of patients compared to 1 6 % of patients in the OA group (P < 0.05). Conclusions : A regimen consisting of omeprazole 40 mg daily, amoxyciUin 500 mg t.d.s. and metronidazole 400 mg t.d.s. for 1 4 days gives an appreciably higher H. pylori eradication rate than omeprazole and amoxycillin alone, with acceptable tolerability.
Clinical Gastroenterology and Hepatology, 2013
Background & Aims: We assessed the efficacy and safety of 4 bismuth-containing quadruple regimens as empiric therapies for Helicobacter pylori infections in patients that did not respond to previous treatment. Methods: We performed a prospective single-center study of 424 patients with H pylori infection not eradicated by previous therapies. Patients were randomly assigned to groups given lansoprazole (30 mg, twice daily) and bismuth potassium citrate (220 mg, twice daily), along with 500 mg tetracycline and 400 mg metronidazole 4 times daily (LBTM), 500 mg tetracycline and 100 mg furazolidone 3 times daily (LBTF), 1000 mg amoxicillin 3 times and 500 mg tetracycline 4 times daily (LBAT), or 1000 mg amoxicillin and 100 mg furazolidone 3 times daily (LBAF). Eradication was assessed by 13 C-urea breath test. Antimicrobial susceptibility was assessed in 188 patients by the agar dilution method. Results: Per-protocol rates of H pylori eradication were >90% for all regimens: 93.1% for LBTM (95% confidence interval [CI], 88.1%-98.0%), 96.1% for LBTF (95% CI, 92.4%−99.8%), 94.6% for LBAT (95% CI, 90.0%-99.2%), and 99.0% for LBAF (95% CI, 97.0%−100%). Intention to treat response rates were 87.9% for LBTM (95% CI, 81.7%-94.0%), 91.7% for LBTF (95% CI, LBAT 87.1%−96.3%), 83.8% for LBAT (95% CI, 76.8%-90.9%), and 95.2% for LBAF (95% CI, 91.1%−99.3%). Significantly more patients had infections eradicated by furazolidone-containing regimens than non-furazolidone regimens (P=.01). Side effects occurred in 33.6% subjects and significantly more frequently in the LBTM group than the other 3 groups (vs LBTF, P=0.006; vs LBAT, P=0.003; vs LBAF, P=0.02). Metronidazole resistance was 96.8%; no isolates were resistant to amoxicillin, tetracycline, or furazolidone. Conclusions: Four bismuth-containing quadruple therapies achieved >90% eradication of H pylori in patients who did not respond to previous treatment, including patients with metronidazole resistance. For patients allergic to penicillin, tetracycline and either metronidazole-or furazolidone-containing regimens are recommended.ClincialTrials.gov number, NCT01668927.