scholarly journals Sequential, concomitant and hybrid first-line therapies for Helicobacter pylori eradication: a prospective randomized study

2014 ◽  
Vol 63 (5) ◽  
pp. 748-752 ◽  
Author(s):  
Vincenzo De Francesco ◽  
Cesare Hassan ◽  
Lorenzo Ridola ◽  
Floriana Giorgio ◽  
Enzo Ierardi ◽  
...  
Keyword(s):  
Helicobacter Pylori ◽  
Randomized Study ◽  
Sequential Therapy ◽  
Concomitant Therapy ◽  
First Line ◽  
Helicobacter Pylori Eradication ◽  
Intention To Treat ◽  
H Pylori ◽  
To Receive ◽  
Treat Analysis

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.

scholarly journals Sequential Therapy for First-Line Helicobacter pylori Eradication: 10- or 14-Day Regimen?

2019 ◽  
Vol 28 (1) ◽  
pp. 11-14 ◽  
Author(s):  
Angelo Zullo ◽  
Giulia Fiorini ◽  
Giuseppe Scaccianoce ◽  
Piero Portincasa ◽  
Vincenzo De Francesco ◽  
...  
Keyword(s):  
Helicobacter Pylori ◽  
Previous Treatment ◽  
Sequential Therapy ◽  
Bacterial Eradication ◽  
First Line ◽  
Open Label ◽  
Intention To Treat ◽  
First Line Therapy ◽  
13C Urea Breath Test ◽  
H Pylori

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.

scholarly journals Ten-day bismuth-containing quadruple therapy versus 7-day proton pump inhibitor-clarithromycin containing triple therapy as first-line empirical therapy for the Helicobacter pylori infection in Korea: a randomized open-label trial

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Young-Il Kim ◽  
Jong Yeul Lee ◽  
Chan Gyoo Kim ◽  
Boram Park ◽  
Jin Young Park ◽  
...  
Keyword(s):  
Helicobacter Pylori ◽  
Line Treatment ◽  
First Line ◽  
Open Label ◽  
Quadruple Therapy ◽  
Intention To Treat ◽  
Open Label Trial ◽  
H Pylori ◽  
Treat Analysis ◽  
First Line Treatment

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.

scholarly journals Randomized Controlled Trial Comparing 7-Day Triple, 10-Day Sequential, and 7-Day Concomitant Therapies for Helicobacter pylori Infection

2014 ◽  
Vol 58 (10) ◽  
pp. 5936-5942 ◽  
Author(s):  
Ping-I Hsu ◽  
Deng-Chyang Wu ◽  
Wen-Chi Chen ◽  
Hui-Hwa Tseng ◽  
Hsien-Chung Yu ◽  
...  
Keyword(s):  
Helicobacter Pylori ◽  
Triple Therapy ◽  
Controlled Trial ◽  
Sequential Therapy ◽  
Controlled Study ◽  
Concomitant Therapy ◽  
Content Type ◽  
Intention To Treat ◽  
Standard Triple Therapy ◽  
H Pylori

ABSTRACTWith the rising prevalence of antimicrobial resistance, the failure rate of the standard triple therapy forHelicobacter pyloriinfection is increasing. Sequential therapy and concomitant therapy have been recommended to replace standard triple therapy forH. pylorieradication in regions with high clarithromycin resistance. The aim of this prospective, randomized, and controlled study was to simultaneously assess the efficacies of 10-day sequential and 7-day concomitant therapies versus a 7-day standard triple therapy for treatingH. pyloriinfection. ConsecutiveH. pylori-infected subjects were randomly assigned to a 7-day standard triple therapy (pantoprazole, clarithromycin, and amoxicillin for 7 days), a 10-day sequential therapy (pantoprazole and amoxicillin for 5 days, followed by pantoprazole, clarithromycin, and metronidazole for a further 5 days), or a 7-day quadruple therapy (pantoprazole, clarithromycin, amoxicillin, and metronidazole for 7 days).H. pyloristatus was confirmed 6 weeks after therapy. Three hundred sevenH. pylori-infected participants were randomized to receive triple (n= 103), sequential (n= 102), or concomitant (n= 102) therapies. The eradication rates by an intention-to-treat analysis in the three treatment groups were 81.6% (95% confidence interval [CI], 74.1% to 89.0%), 89.2% (95% CI, 83.2% to 95.2%), and 94.1% (95% CI, 89.5% to 98.7%). The seven-day concomitant therapy had a higher eradication rate than did the 7-day triple therapy (difference, 12.5%; 95% CI, 3.7% to 21.3%). There were no significant differences in the eradication rates between the sequential and standard triple therapies. All three treatments exhibited similar frequencies of adverse events (8.7%, 8.8%, and 13.7%, respectively) and drug compliance (99.0%, 98.0%, and 100.0%, respectively). In conclusion, the seven-day concomitant therapy is superior to the 7-day standard triple therapy forH. pylorieradication. Additionally, it is less complex than the 10-day sequential therapy because the drugs are not changed halfway through the treatment course. (This study has been registered atClinicalTrials.govunder registration no. NCT1769365.)

scholarly journals Helicobacter pylori eradication using tetracycline and furazolidone versus amoxicillin and azithromycin in lansoprazole based triple therapy: an open randomized clinical trial

2005 ◽  
Vol 42 (2) ◽  
pp. 111-115 ◽  
Author(s):  
Laura Cidrão Frota ◽  
Maria do Perpétuo Socorro Saldanha da Cunha ◽  
Carlos René Lima Luz ◽  
Antonio Haroldo de Araujo-Filho ◽  
Luciano A. S. Frota ◽  
...  
Keyword(s):  
Helicobacter Pylori ◽  
Triple Therapy ◽  
Protocol Analysis ◽  
Urea Breath Test ◽  
Test Results ◽  
Suitable Alternative ◽  
Helicobacter Pylori Eradication ◽  
Helicobacter Pylori Treatment ◽  
H Pylori ◽  
To Receive

BACKGROUND: Optimal anti-Helicobacter pylori treatment has not yet been established. AIM: To evaluate H. pylori eradication using tetracycline and furazolidone versus amoxicillin and azithromycin in lansoprazole based triple therapy in northeastern of Brazil. PATIENTS AND METHODS: One hundred and four patients with H. pylori infection, as determined by rapid urease testing and histology, were randomly assigned to receive either: lansoprazole (30 mg q.d.), tetracycline (500 mg q.i.d.), and furazolidone (200 mg t.i.d.) for 7 days (LTF; n = 52); or lansoprazole (30 mg b.i.d.) and amoxicillin (1 g b.i.d.) for 1 week, plus azithromycin (500 mg q.d.) for the first 3 days (LAAz; n = 52). H. pylori eradication was assessed 3 months following completion of therapy by means of rapid urease testing, histology and a 14C-urea breath test. RESULTS: H. pylori eradication was achieved in 46 of 52 (88.4%, 95% CI: 77.5%-95.1%) patients in LTF group and in 14 of 52 (26.9%, 95% CI: 16.2%-40,1%) patients in LAAz group. On a per-protocol analysis, eradication rates were 91.8% (95% CI: 81.4%-97.3%) and 28.5% (95% CI: 17.2%-42.3%), respectively in LTF and LAAz groups. CONCLUSION: The LAAz regimen yielded unacceptably low eradication rates. On the other hand, the LTF scheme represents a suitable alternative for H. pylori eradication.

scholarly journals A 14-Day Course of Triple Therapy is Superior to a 10-Day Course for the Eradication ofHelicobacter pylori: A Canadian Study Conducted in a ‘Real World’ Setting

2015 ◽  
Vol 29 (8) ◽  
pp. e7-e10 ◽  
Author(s):  
Yen-I Chen ◽  
Carlo A Fallone
Keyword(s):  
Triple Therapy ◽  
Eradication Rate ◽  
Day Treatment ◽  
Office Visit ◽  
First Line ◽  
Intention To Treat ◽  
Treatment Naïve ◽  
Gastric Biopsies ◽  
H Pylori ◽  
Treat Analysis

BACKGROUND: SuccessfulHelicobacter pylorieradication with the traditional seven-day course of proton pump inhibitor (PPI) triple therapy is declining. Prolonging therapy to either 10 or 14 days is associated with better eradications rates.OBJECTIVE: To compare the effectiveness of 14-day course of triple therapy versus a 10-day course in the treatment ofH pyloriin Canada.METHODS: Consecutive treatment-naive patients with clinical indications forH pylorieradication underwent either a 10-day course or a 14-day course of traditional PPI triple therapy depending on the date of the office visit (an odd date received the 10-day course, whereas an even date received the 14-day treatment).H pylorieradication was ascertained via urea breath test or gastric biopsies performed ≥4 weeks after completion of therapy. Analyses were by both intention to treat and per-protocol.RESULTS: A total of 83 patients were included in the study (31 in the 10-day group and 52 in the 14-day group). In the intention-to-treat analysis, eradication rates were 82.7% (95% CI 70% to 92%) versus 45.2% (95% CI 27% to 64%), favouring the 14-day treatment (P<0.001). Similarly, in the per-protocol analysis, eradication rates were 91.5% (95% CI 80% to 98%) versus 63.6% (95% CI 41% to 83%), favouring the 14-day arm (P=0.01). Adverse events and compliance were not significantly different between the two groups.CONCLUSION: A 14-day course of standard PPI triple therapy was superior to a shorter-duration therapy and should be included as a first-line regimen forH pylorieradication in Canada. The 10-day course of treatment did not achieve an acceptable eradication rate and should no longer be used in this country.

scholarly journals European Registry on Helicobacter pylori Management: single-capsule bismuth quadruple therapy is effective in real-world clinical practice

2020 ◽  
pp. 205064062097261
Author(s):  
Olga P Nyssen ◽  
Angeles Perez-Aisa ◽  
Manuel Castro-Fernandez ◽  
Rinaldo Pellicano ◽  
Jose M. Huguet ◽  
...  
Keyword(s):  
Helicobacter Pylori ◽  
Clinical Practice ◽  
Proton Pump Inhibitor ◽  
Proton Pump ◽  
Real World ◽  
Case Report Form ◽  
First Line ◽  
Quadruple Therapy ◽  
Intention To Treat ◽  
H Pylori

Background There has been resurgence in the use of bismuth quadruple therapy (proton pump inhibitor, bismuth, tetracycline and metronidazole) for treating Helicobacter pylori infection thanks to a three-in-one single-capsule formulation. Objective To evaluate the effectiveness and safety of the single-capsule bismuth quadruple therapy. Methods Data were collected in a multicentre, prospective registry of the clinical practice of gastroenterologists on the management of H. pylori infection, where patients were registered at the Asociación Española de Gastroenterología REDCap database on an electronic case report form until January 2020. Effectiveness by modified intention-to-treat and per-protocol as well as multivariable analysis were performed. Independent factors evaluated were: age, gender, indication, compliance, proton pump inhibitor dose and treatment line. Results Finally, 2100 patients were prescribed single-capsule bismuth quadruple therapy following the technical sheet (i.e. three capsules every 6 hours for 10 days). The majority of these patients were naive (64%), with an average age of 50 years, 64% women and 16% with peptic ulcer. An overall modified intention-to-treat effectiveness of 92% was achieved. Eradication was over 90% in first-line treatment (95% modified intention-to-treat, n = 1166), and this was maintained as a rescue therapy, both in second (89% modified intention-to-treat, n = 375) and subsequent lines of therapy (third to sixth line: 92% modified intention-to-treat, n = 236). Compliance was the factor most closely associated with treatment effectiveness. Adverse events were generally mild to moderate, and 3% of patients reported a severe adverse event, leading to discontinuation of treatment in 1.7% of cases. Conclusions Single-capsule bismuth quadruple therapy achieved H. pylori eradication in approximately 90% of patients in real-world clinical practice, both as a first-line and rescue treatment, with good compliance and a favourable safety profile.

Sequential therapy versus standard triple-drug therapy for Helicobacter pylori eradication: a prospective randomized study

2013 ◽  
Vol 69 (9) ◽  
pp. 1709-1715 ◽  
Author(s):  
Hassan Seddik ◽  
Samir Ahid ◽  
Tarek El Adioui ◽  
Fatim-Zohra El Hamdi ◽  
Mohammed Hassar ◽  
...  
Keyword(s):  
Helicobacter Pylori ◽  
Drug Therapy ◽  
Randomized Study ◽  
Sequential Therapy ◽  
Prospective Randomized Study ◽  
Helicobacter Pylori Eradication
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