scholarly journals A Randomized Controlled Trial Comparing Sequential with Triple Therapy forHelicobacter pyloriin an Aboriginal Community in the Canadian North

2013 ◽  
Vol 27 (12) ◽  
pp. 701-706 ◽  
Author(s):  
Amy L Morse ◽  
Karen J Goodman ◽  
Rachel Munday ◽  
Hsiu-Ju Chang ◽  
John Morse ◽  
...  

BACKGROUND:Helicobacter pyloriinfection occurs more frequently in Arctic Aboriginal settings than elsewhere in North America and Europe. Research aimed at reducing health risks fromH pyloriinfection has been conducted in the Aboriginal community of Aklavik, Northwest Territories.OBJECTIVE: To compare the effectiveness of the Canadian standard therapy with an alternative therapy for eliminatingH pyloriinfection in Aklavik.METHODS: Treatment-naiveH pylori-positive individuals were randomly assigned to a 10-day regimen (oral twice-daily doses) with rabeprazole (20 mg): standard triple therapy (proton pump inhibitor, added clarithromycin [500 mg] and amoxicillin [1 g] [PPI-CA]); sequential therapy (ST) added amoxicillin (1 g) on days 1 to 5, and metronidazole (500 mg) and clarithromycin (500 mg) on days 6 to 10. Participants with clarithromycin-resistantH pyloriwere randomly assigned to ST or quadruple therapy. Treatment effectiveness was estimated as per cent (95% CI) with a negative urea breath test at least 10 weeks after treatment.RESULTS: Of 104 (53 PPI-CA, 51 ST) randomized participants, 89 (49 PPI-CA, 40 ST) had post-treatment results. Per-protocol treatment effectiveness was 59% (95% CI 45% to 73%) for PPI-CA and 73% (95% CI 58% to 87%) for ST. Based on intention to treat, effectiveness was 55% (95% CI 41% to 69%) for PPI-CA and 57% (95% CI 43% to 71%) for ST. Of 77 participants (43 PPI-CA, 34 ST) with 100% adherence, effectiveness was 63% (95% CI 43% to 82%) for PPI-CA and 81% (95% CI 63% to 99%) for ST.CONCLUSIONS: While additional evidence is needed to confirm that ST is more effective for Arctic Aboriginal communities than the Canadian standardH pyloritreatment, these results show standard PPI-CA treatment to be inadequate for communities such as Aklavik.

2015 ◽  
Vol 2015 ◽  
pp. 1-5 ◽  
Author(s):  
Jaime Natan Eisig ◽  
Tomás Navarro-Rodriguez ◽  
Ana Cristina Sá Teixeira ◽  
Fernando Marcuz Silva ◽  
Rejane Mattar ◽  
...  

Aim. To compare 10-day standard triple therapy versus sequential therapy as first-line treatment in patients infected withH. pylori.Methods. One hundredH. pyloripositive 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, or13C-urea breath test.Results. In intention to treat (ITT) analysis, the rate ofH. pylorieradication 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 ofH. pylorieradication 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 eradicatingHelicobacter pyloripatients. This study was registered under Clinical Trials with numberISRCTN62400496.


2014 ◽  
Vol 58 (10) ◽  
pp. 5936-5942 ◽  
Author(s):  
Ping-I Hsu ◽  
Deng-Chyang Wu ◽  
Wen-Chi Chen ◽  
Hui-Hwa Tseng ◽  
Hsien-Chung Yu ◽  
...  

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.)


2011 ◽  
Vol 25 (6) ◽  
pp. 315-318 ◽  
Author(s):  
R Urgesi ◽  
G Pelecca ◽  
R Cianci ◽  
A Masini ◽  
C Zampaletta ◽  
...  

BACKGROUND: Clarithromycin resistance has decreased the eradication rates ofHelicobacter pylori.AIMS: To determine whether a 10-day course of sequential therapy (ST) is more effective at eradicatingH pyloriinfection than triple therapy (TT) in the first or second line, and to assess side effects and compliance with therapy.METHODS: One hundred sixty treatment-naive and 40 non-treatment-naive patients who were positive forH pyloriinfection by13C-urea breath test or endoscopy were enrolled. Eighty of 160 patients underwent TT, while 80 of 160 underwent ST with omeprazole (20 mg) plus amoxicillin (1 g) twice/day for five days, followed by omeprazole (20 mg) with tinidazole (500 mg) twice/day and clarithromycin (500 mg) twice/day for five consecutive days.H pylorieradication was evaluated by13C-urea breath test no sooner than four weeks after the end of treatment.RESULTS: Eradication was achieved in 59 of 80 treatment-naive patients treated with TT (74%), in 74 of 80 patients treated with ST (93%), and in 38 of 40 non-treatment-naive patients (95%). Eradication rates in treatment-naive patients with ST were statistically significantly higher than TT (92.5% versus 73.7%; P=0.0015; OR 4.39 [95% CI 1.66 to 11.58]). Mild adverse effects were reported for both regimens.CONCLUSIONS: ST appears to be a well-tolerated, promising therapy; however, randomized controlled trials with larger and more diverse sample populations are needed before it can be recommended as a first-line treatment.


2015 ◽  
Vol 29 (8) ◽  
pp. e7-e10 ◽  
Author(s):  
Yen-I Chen ◽  
Carlo A Fallone

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.


2020 ◽  
Vol 13 ◽  
pp. 175628482092730
Author(s):  
Chieh-Chang Chen ◽  
Jiing-Chyuan Luo ◽  
Yu-Jen Fang ◽  
Ji-Yuh Lee ◽  
Chia-Chi Kuo ◽  
...  

Background: Whether adjunctive N-acetylcysteine (NAC) may improve the efficacy of triple therapy in the first-line treatment of Helicobacter pylori infection remains unknown. Our aim was to compare the efficacy of 14-day triple therapy with or without NAC for the first-line treatment of H. pylori. Material and methods: Between 1 January 2014 and 30 June 2018, 680 patients with H. pylori infection naïve to treatment were enrolled in this multicenter, open-label, randomized trial. Patients were randomly assigned to receive triple therapy with NAC [NAC-T14, dexlansoprazole 60 mg four times daily (q.d.); amoxicillin 1 g twice daily (b.i.d.), clarithromycin 500 mg b.i.d., NAC 600 mg b.i.d.] for 14 days, or triple therapy alone (T14, dexlansoprazole 60 mg q.d.; amoxicillin 1 g b.i.d., clarithromycin 500 mg b.i.d.) for 14 days. Our primary outcome was the eradication rates by intention to treat (ITT). Antibiotic resistance and CYP2C19 gene polymorphism were determined. Results: The ITT analysis demonstrated H. pylori eradication rates in NAC-T14 and T14 were 81.7% [276/338, 95% confidence interval (CI): 77.5–85.8%] and 84.3% (285/338, 95% CI 80.4–88.2%), respectively. In 646 participants who adhered to their assigned therapy, the eradication rates were 85.7% and 88.0% with NAC-T14 and T14 therapies, respectively. There were no differences in compliance or adverse effects. The eradication rates in subjects with clarithromycin-resistant, amoxicillin-resistant, or either clarithromycin/amoxicillin resistant strains were 45.2%, 57.9%, and 52.2%, respectively, for NAC-T14, and were 66.7%, 76.9%, and 70.0%, respectively, for T14. The efficacy of NAC-T14 and T14 was not affected by CYP2C19 polymorphism. Conclusion: Add-on NAC to triple therapy was not superior to triple therapy alone for first-line H. pylori eradication [ClinicalTrials.gov identifier: NCT02249546].


2016 ◽  
Vol 2016 ◽  
pp. 1-7 ◽  
Author(s):  
WonGun Kwack ◽  
YunJeong Lim ◽  
ChiYeon Lim ◽  
David Y. Graham

Objective. The eradication rate ofHelicobacter pylori(H. pylori) following standard triple therapy has declined over the past few decades. This study has determined whether high dose dual therapy (PPI and amoxicillin) is adequate for eradicatingH. pyloriin Korea.Methods. This was an open-labeled study ofH. pyloriinfected treatment-naive patients. Subjects received dual therapy for 14 days: ilaprazole 40 mg tablets given twice a day and amoxicillin 750 mg tablets given 4 times a day. At the end of the therapy, the subjects visited the clinic to confirm compliance and monitor for any side effects. Subjects visited again after 4–6 weeks to confirmH. pyloristatus through a urea breath test.Results.The cure rate ofH. pyloriwas 79.3% (23 of 29) (95% confidence interval: 61.6–90.2) in the intention-to-treat analysis and 82.1% (23 of 28) in the per-protocol analysis. Compliance rates were high (96.6%) and side effects were minimal and tolerable.Conclusion.A high dose of ilaprazole + amoxicillin was ineffective as the first-line therapy for eradicatingH. pyloriin Korea. Future studies should focus on intragastric pH measurements and assess amoxicillin resistance.


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