scholarly journals Fourteen-Day Sequential Therapy Containing Rabeprazole Versus 10 And 14-Day Concomitant Therapy in The First Line Treatment of Helicobacter Pylori Infection: A Randomized, Open-Label Clinical Trial

Author(s):  
Hassan Seddik ◽  
Hanae Boutallaka ◽  
Sanaa Berrag ◽  
Samir Mrabti ◽  
Khaoula Loubaris ◽  
...  

Abstract Aims:To compare an optimized sequential therapy to 10 and 14-day non-Bismuth quadruple therapies currently recommended, in terms of efficacy, incidence of adverse effects and cost.Patients and methods:This open-label prospective study randomized patients with confirmed Helicobacter pylori (H.Pylori) infection to 3 groups (1:1:1): The first group received quadruple therapy of twice-daily (bid) Omeprazole 20mg, Amoxicillin 1g, Clarithromycin 500mg and Metronidazole 500mg for 10days (QT-10), the second group received a 14 day quadruple therapy following the same regimen (QT-14), and the third received an optimized sequential therapy consisting on a bid Rabeprazole 20 mg plus amoxicillin 1g for 7 days, followed by bid Rabeprazole 20 mg, clarithromycin 500 mg and metronidazole 500mg for the next 7 days (OST-14). Adverse events (AEs) were recorded throughout the study, and the H.Pylori eradication rate was determined 4 to 6 weeks after treatment using the 13C urea breath test.Results:In intention to treat analysis, eradication rate was 85,5%, 91,8% and 95,4% respectively in QT-10, QT-14 and OST-14 groups (p=0,03). In the per protocol analysis, the eradication rate was significantly higher in the OST- 14 group compared to the QT-14 and QT-10 groups (98,1%, 94,4% and 89,5% respectively, p=0,02).The overall incidence of AEs was significantly lower in the OST-14 group (p=0,01). Furthermore, the OST-14 was the most cost-effective among the three groups.Conclusion:14-day optimized sequential therapy is a safe and effective alternative that allows a higher eradication rate compared to 10 and 14-days quadruple therapies while causing less adverse effects and allowing a gain in term of cost.

Antibiotics ◽  
2022 ◽  
Vol 11 (1) ◽  
pp. 78
Author(s):  
Giuseppe Losurdo ◽  
Ilaria Lacavalla ◽  
Francesco Russo ◽  
Giuseppe Riezzo ◽  
Irene Vita Brescia ◽  
...  

The eradication of Helicobacter pylori (H. pylori) may be difficult due to antibiotic resistance. Indeed, after one failure, a second-line therapy is needed and a bismuth containing quadruple therapy (BQT) with a three-in-one capsule formulation is becoming very popular. Therefore, we aimed to evaluate effectiveness and safety of BQT as a second-line therapy. We recruited consecutive patients with one therapy failure. For ten days patients received the three-in-one BQT Pylera® therapy, in combination with a proton-pump inhibitor (PPI), decided at the choice of the investigator, at full dose bid. The eradication rate was calculated by intention-to-treat (ITT) and per-protocol (PP)analyses and 95% confidence intervals (CI) were calculated. Seventy-three patients were recruited, 41 females and 32 males (mean age 53.0±13.1 years). Fifty-five patients failed triple therapy with amoxicillin and clarithromycin and the remaining 18 received sequential therapy. Seventy-two patients consumed at least 90% of the capsules, while only one did not complete the therapy due to adverse events (nausea and diarrhea). By ITT analysis, BQT was successful in 62 subjects (eradication rate 84.9%, 95%CI 76.7–93.1%). By PP analysis, the eradication rate was 86.1% (95%CI 78.1–94.1%).Adverse events were observed in 14 subjects (20.5%).In conclusion, our report confirmed that BQT is effective as an empiric second-line regimen.


2019 ◽  
Vol 28 (1) ◽  
pp. 11-14 ◽  
Author(s):  
Angelo Zullo ◽  
Giulia Fiorini ◽  
Giuseppe Scaccianoce ◽  
Piero Portincasa ◽  
Vincenzo De Francesco ◽  
...  

Background & Aim: Standard 10-day sequential therapy is advised as first-line therapy for Helicobacter pylori (H. pylori) eradication by current Italian guidelines. Some data suggested that a 14-day regimen may achieve higher eradication rates. This study compared the efficacy of sequential therapy administered for either 10- or 14-days.Methods: This prospective, multicenter, open-label study enrolled patients with H. pylori infection without previous treatment. Patients were receiving a sequential therapy for either 10 or 14 days with esomeprazole 40 mg and amoxicillin 1 g (5 or 7 days) followed by esomeprazole 40 mg, clarithromycin 500 mg and tinidazole 500 mg (5 or 7 days), all given twice daily. Bacterial eradication was checked using 13C-urea breath test. Eradication cure rates were calculated at both Intention-to-treat (ITT) and per-protocol (PP) analyses.Results: A total of 291 patients were enrolled, including 146 patients in 10-day and 145 in the 14-day regimen. The eradication rates were 87% (95% CI = 81.5-92.4) and 90.3% (95% CI = 85.5-95.1) at ITT analysis with the 10- and 14-day regimen, respectively, and 92.7% (95% CI = 88.3-97) and 97% (95% CI = 94.2-99.9) at PP analysis (p =0.37). Among patients, who earlier had interrupted therapy, bacterial eradication was achieved in 8 out of 9 who completed the first therapy phase and performed at least ≥3 days of triple therapy in the second phase.Conclusion: This study found that both 10- and 14-day sequential therapies achieved a high eradication rate for first-line H. pylori therapy in clinical practice.


2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Young-Il Kim ◽  
Jong Yeul Lee ◽  
Chan Gyoo Kim ◽  
Boram Park ◽  
Jin Young Park ◽  
...  

Abstract Background This randomized, open-label trial aimed to compare the efficacy of 10-day bismuth-containing quadruple therapy (BQT) with 7-day proton-pump inhibitor-clarithromycin containing standard triple therapy (STT) as an empirical first-line Helicobacter pylori therapy. Methods Participants with H. pylori infection were randomly assigned to either 10-day BQT (daily doses of bismuth 300 mg, four times; lansoprazole 30 mg, twice; metronidazole 500 mg, three times; and tetracycline 500 mg, four times) or 7-day STT (lansoprazole 30 mg; amoxicillin 1,000 mg; and clarithromycin 500 mg; each given twice daily). Participants who failed initial therapy were crossed over to the alternative treatment regimen. Primary outcome was the eradication rates of first-line treatment by intention-to-treat analysis. Results Study participants (n = 352) were randomized to receive either 10-day BQT (n = 175) or 7-day STT (n = 177). The BQT-group achieved a significantly higher eradication rate than the STT-group in the intention-to-treat analysis (74.3% vs 57.1%, respectively; P = 0.001), modified intention-to-analysis (87.2% [130/149] vs 68.7% [101/147], respectively; P < 0.001) and per-protocol analysis (92.9% [105/113] vs 70.1% [94/134], respectively; P < 0.001). Although there was no serious adverse event, the compliance was lower with BQT than STT as a higher proportion of participants in the BQT-group discontinued therapy because of adverse events than those in the STT-group (23.1% vs 9.1%, respectively; P = 0.001) Conclusions Ten-day BQT had higher eradication rates compared to that of the 7-day STT as an empirical first-line treatment for H. pylori eradication in Korea. Trial registration: ClinicalTrials.gov, NCT02557932. Registered 23 September 2015, https://clinicaltrials.gov/ct2/show/NCT02557932?term=NCT02557932&draw=2&rank=1.


2019 ◽  
pp. 28-32
Author(s):  
Van Huy Tran

Background and aims: Efficacy with substitution of tetracycline with amoxicillin, an antibiotics having a very low resistance rate and a high tolerability, in bismuth quadruple therapy (BQT) have not been studied in Vietnam. Our study aimed to evaluate the efficacy and tolerability of modified BQT vs. standard BQT for first-line Helicobacter pylori eradication. Patients and methods: This is a randomized, prospective study. 120 patients with H.pylori positive-chronic gastritis were randomly divided into two groups. The RBMA group containing rabeprazole 20 mg, bismuth subsalicylic 524mg, metronidazole 500mg, amoxicillin 1000mg, all 2 times a day, for 14 days. The RBMT group received rabeprazole, bismuth subsalicylic, metronidazole and tetracycline. Evaluation for compliance and drug-related side effects were evaluated at the end of two weeks. 4-6 weeks after the end of treatment, the H.pylori eradication rate was determined by the C13urease breath test. Results: Eradication rate was not statistically significative different between the RBMA and the RBMT: 91.2%; 95% confidence interval, 78.2% - 96.7%) vs. 90%; 95% CI, 81.6% - 96.3%) by per-protocol analysis (p = 0.42) and 86.7% (95%CI, 75.84% - 93.09%) vs. 75% (95%CI, 62.1% - 85.3%) by intention-to-treat analysis (ITT, p = 0.06). Adverse effects were significant higher in the RBMT group than in the RBMA group (48.3% vs. 26.7%; p = 0.071) and rate of good compliance was significantly higher in RBMA group than in RBMT group (p < 0.05). Conclusion: The modified BQT including rabeprazole, bismuth, metronidazole and amoxicillin achieved a fairly high rate of H.pylori infection eradication with a higher compliance and lower rate of adverse effects compared to the BQT in patients with chronic gastritis. Further studies need to conduct to confirm this new regimens as a first-line therapy in our country. Key words: Modified bismuth quadruple therapy, BQT, Helicobacter pylori eradication


2012 ◽  
Vol 2012 ◽  
pp. 1-8 ◽  
Author(s):  
M. Gasparetto ◽  
M. Pescarin ◽  
G. Guariso

Background. Though Helicobacter pylori (HP) infections have progressively declined throughout most of the industrialized countries, a gradual increase in failure of HP eradication treatments is observed. Aim. To critically review evidence on the efficacy of the therapeutic availabilities for HP eradication, as yet. Methods. A selection of Clinical Trials, Systematic Reviews and Meta-analyses within the time period 2010–2012, was performed through a Medline search. Previous references were included when basically supporting the first selection. Results. An increasing rise in HP resistance rates for antimicrobial agents is currently observed. Further causes of HP treatment failure include polymorphisms of the CYP 2C19, an increased body mass index (BMI), smoking, poor compliance and re-infections. Alternative recent approaches to standard triple therapy have been attempted to increase the eradication rate, including bismuth-containing quadruple therapy, non-bismuth containing quadruple therapy, sequential therapy and levofloxacin-containing regimens. Conclusions. The main current aims should be the maintenance of a high eradication rate (>85%) of HP and the prevention of any increase in antimicrobial resistance. In the next future, the perspective of a tailored therapy could optimize eradication regimens within the different countries.


Digestion ◽  
2019 ◽  
Vol 101 (6) ◽  
pp. 743-751 ◽  
Author(s):  
Takahisa Furuta ◽  
Mihoko Yamade ◽  
Takuma Kagami ◽  
Takahiro Uotani ◽  
Takahiro Suzuki ◽  
...  

<b><i>Backgrounds/Aims:</i></b> Vonoprazan (VPZ) is the first clinically available potassium competitive acid blocker. This class of agents provides faster and more potent acid inhibition than proton pump inhibitors. Most strains of <i>Helicobacter pylori</i> are sensitive to amoxicillin. We hypothesized that dual therapy with VPZ and amoxicillin would provide the sufficient eradication rate for <i>H. pylori</i> infection. To evaluate this, we compared the eradication rate by the dual VPZ/amoxicillin therapy with that by the standard triple VPZ/amoxicillin/clarithromycin therapy. <b><i>Methods:</i></b> Non-inferiority of the eradication rate of <i>H. pylori</i> by the dual therapy with VPZ 20 mg twice daily (bid) and amoxicillin 500 mg 3 times daily (tid) for 1 week to that by the triple therapy with VPZ 20 mg bid, amoxicillin 750 mg bid and clarithromycin 200 mg bid for 1 week was retrospectively studied. Propensity score matching was performed to improve comparability between 2 regimen groups. Successful eradication was diagnosed using the [<sup>13</sup>C]-urea breath test at 1–2 months after the end of eradication therapy. <b><i>Results:</i></b> The intention-to-treat analysis demonstrated that the eradication rate by the dual therapy (92.9%; 95% CI 82.7–98.0%, 52/56) was not inferior to that of the triple therapy (91.9%; 95% CI 80.4–97.0%, 51/56; OR 1.275, 95% CI 0.324–5.017%, <i>p</i> = 0.728). There were no statistically significant differences in incidences of adverse events between 2 regimens. <b><i>Conclusion:</i></b> VPZ-based dual therapy (VPZ 20 mg bid and amoxicillin 500 mg tid for 1 week) provides an acceptable eradication rate of <i>H. pylori</i> infection without the need for second antimicrobial agents, such as clarithromycin.


2018 ◽  
Vol 10 (4) ◽  
pp. 242-248 ◽  
Author(s):  
Eskandar Hajiani ◽  
Pezhman Alavinejad ◽  
Nahid Avandi ◽  
Abdol Rahim Masjedizadeh ◽  
Ali Akbar Shayesteh

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.


2020 ◽  
Author(s):  
Marouf Muhammad Alhalabi ◽  
Mohammed Waleed Alassi ◽  
Khaled Cheha

Abstract Background: The eradication rate of Helicobacter Pylori infection with standard triple therapy either clarithromycin or levofloxacin has declined due to antimicrobial resistance. The aim of this research was to estimate the eradication rate of bismuth quadruple and levofloxacin concomitant regimens as empirical first-line regimens in a referral hospital in Syria.Settings and Design: an open‑label parallel blind randomized controlled trial.Methods: Researchers randomly assigned naïve patients with H pylori infection with a 1:1 ratio into two groups. We give group A (bismuth subsalicylate 524 mg four times a day, and doxycycline 100 mg tinidazole 500 mg and esomeprazole 20 mg, each twice daily for 14 days). We give group B (levofloxacin 500 mg every day, tinidazole 500 mg, amoxicillin 1000 mg and esomeprazole 20 mg each twice daily for 14 days). Researchers used a computer program to generate randomized numbers. We concealed the sequence in an opaque envelope until the intervention was assigned. medical laboratory doctors were blinded to treatment allocation. Statistical analysis: chi-square test for categorical variables, t-test for continuous data.Results: Researchers allocated seventy-eight patients. Thirty-eight patients completed the follow‑up in bismuth regimen, and thirty-nine patients in concomitant levofloxacin. Thirty patients in the bismuth regimen were cured, the eradication rate was 78.94% according to per-protocol analysis, and 76.92% according to intention‑to‑treat analysis. While in concomitant levofloxacin thirty-two patients were cured, the eradication rate was 82.05% according to intention‑to‑treat analysis (P = 0.780). Researchers didn’t report serious adverse events in both groups. Odds ratio with 95% confidence interval according to the intention‑to‑treat analysis was 1.371 [0.454-4.146]. While the odds ratio with a 95% confidence interval according to per-protocol analysis was 1.22 [0.394-3.774].Conclusions: Both treatment regimens had acceptable eradication rates. Researchers suggest using both regimens as empirical first-line therapy in treating Helicobacter Pylori gastric infection in the Syrian population. No serious adverse events were recorded.Trial registration: Researchers This study was registered as a standard randomized clinical trial (Clinicaltrial.gov, identifier‑NCT04348786, date:29-January-2020, https://clinicaltrials.gov/ct2/show/NCT04348786).


2014 ◽  
Vol 63 (5) ◽  
pp. 748-752 ◽  
Author(s):  
Vincenzo De Francesco ◽  
Cesare Hassan ◽  
Lorenzo Ridola ◽  
Floriana Giorgio ◽  
Enzo Ierardi ◽  
...  

Helicobacter pylori eradication remains a challenge for physicians. Sequential, concomitant and the hybrid regimens have been proposed as novel, more effective therapies. We compare the efficacy of these therapies. Dyspeptic patients referred for upper endoscopy with H. pylori infection were enrolled. Patients were randomized to receive: (a) sequential therapy – 20 mg omeprazole and 1 g amoxicillin for 5 days, followed by 20 mg omeprazole, 500 mg clarithromycin and 500 mg tinidazole for the successive 5 days; (b) concomitant therapy – 20 mg omeprazole, 1 g amoxicillin, 500 mg clarithromycin and 500 mg tinidazole for either 5 days (5 day concomitant) or 14 days (14 day concomitant); or (c) hybrid therapy – 20 mg omeprazole and 1 g amoxicillin for 7 days, followed by 20 mg omeprazole, 1 g amoxicillin, 500 mg clarithromycin and 500 mg tinidazole for the successive 7 days. All drugs were given twice daily. Bacterial eradication was checked by using a [13C]urea breath test. In ‘intention-to-treat’ analysis, sequential therapy achieved the highest eradication rate, which was higher than that of 5 day concomitant therapy (90  vs 78.1 %; P = 0.02). The success rate did not statistically differ among the sequential and either 14 day concomitant (90  vs 86.3 %; P = not significant) or hybrid therapies (90  vs 82.7 %; P = not significant). The 10 day sequential, 14 day concomitant and 14 day hybrid therapies, but not the 5 day concomitant regimen, achieved similarly high eradication rates. The lower therapeutic cost coupled with the lower number of tablets needed would favour the sequential therapy as the first-line H. pylori treatment in clinical practice.


2015 ◽  
Vol 2015 ◽  
pp. 1-6 ◽  
Author(s):  
Guang-Hong Jheng ◽  
I-Chen Wu ◽  
Hsiang-Yao Shih ◽  
Meng-Chieh Wu ◽  
Fu-Chen Kuo ◽  
...  

The bismuth-based quadruple regimen has been applied inHelicobacter pylorirescue therapy worldwide. The non-bismuth-based quadruple therapy or “concomitant therapy” is an alternative option in first-line eradication but has not been used in second-line therapy. Discovering a valid regimen for rescue therapy in bismuth-unavailable countries is important. We conducted a randomized controlled trial to compare the efficacies of the standard quadruple therapy and a modified concomitant regimen. One hundred and twenty-four patients were randomly assigned into two groups: RBTM (rabeprozole 20 mg bid., bismuth subcitrate 120 mg qid, tetracycline 500 mg qid, and metronidazole 250 mg qid) and RATM (rabeprozole 20 mg bid., amoxicillin 1 g bid., tetracycline 500 mg qid, and metronidazole 250 mg qid) for 10 days. The eradication rate of the RBTM and RATM regimen was 92.1% and 90.2%, respectively, in intention-to-treat analysis. Patients in both groups had good compliance (~96%). The overall incidence of adverse events was higher in the RATM group (42.6% versus 22.2%,P=0.02), but only seven patients (11.5%) experienced grades 2-3 events. In conclusion, both regimens had good efficacy, compliance, and acceptable side effects. The 10-day RATM treatment could be an alternative rescue therapy in bismuth-unavailable countries.


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