scholarly journals Standard Triple Therapy versus Sequential Therapy inHelicobacter pyloriEradication: A Double-Blind, Randomized, and Controlled Trial

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.

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.


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.)


2020 ◽  
Vol 92 (8) ◽  
pp. 52-59
Author(s):  
S. R. Abdulkhakov ◽  
D. S. Bordin ◽  
R. A. Abdulkhakov ◽  
D. D. Safina ◽  
A. R. Gizdatullina ◽  
...  

Background. As part of an observational multicenter prospective study European Registry on the management of Helicobacter pylori infection, conducted on the initiative of the European H. pylori and Microbiota Study Group, the compliance of clinical practice in the management of patients with Helicobacter pylori infection in Kazan with clinical guidelines was assessed. Materials and methods. The data of 437 patients included into the register by clinical sites in Kazan in 20132019 were analyzed. The methods used for the initial diagnosis of H. pylori infection and eradication control were evaluated. The frequency of various eradication therapy regimens prescription was analyzed in 379 cases. Data regarding the effectiveness of eradication therapy was analyzed in 173 patients. Results. The rapid urease test (44.2% of cases) and cytology/histology (60% of cases) were most often used for the initial diagnosis of H. pylori infection; however non-invasive methods such as 13C-urea breath (9.2%), serology (6.2%), H. pylori stool antigen test (2.3%) were less common. In 21.7% of patients two methods of H. pylori detection were used for primary diagnosis. The control test to evaluate the effectiveness of eradication therapy at the recommended timepoint was performed in 46.2% of patients. 13C-urea breath test (31.7%), stool PCR/stool antigen test (28.7%), rapid urease test (22.3%), cytology/histology (26.2% of cases) prevailed in the assessment of eradication rate. Standard triple therapy, including proton pump inhibitor, clarithromycin and amoxicillin was most commonly prescribed as first-line therapy (64.6% of cases). The duration of eradication therapy was 14 days in the majority of cases with pantoprazole as the most common proton pump inhibitor in standard triple therapy regimens (84.8%). The efficacy of 14-day standard triple therapy (mITT) was 87.0%. Conclusion. The results indicate a high frequency of non-invasive methods use for assessing the effectiveness of eradication therapy; however, the overall rate of eradication efficacy assessment is low, limiting the possibility of analyzing the eradication results. The effectiveness of the most common 14-day standard triple first-line therapy in Kazan doesnt reach the recommended 90% eradication level. This could be explained by high rate of pantoprazole use, which is not an optimal proton pump inhibitor in eradication therapy regimens.


2018 ◽  
Vol 90 (2) ◽  
pp. 35-42 ◽  
Author(s):  
D S Bordin ◽  
Yu V Embutnieks ◽  
L G Vologzhanina ◽  
T A Il'chishina ◽  
I N Voinovan ◽  
...  

On behalf of the scientific Committee and researchers Hp-EuReg European Registry on the management of Helicobacter pylori infection («Hp-EuReg») - a multicenter prospective observational study initiated by the European Helicobacter and Microbiota Study Group, conducted in 27 European countries in order to evaluate the real clinical practice of diagnosis and treatment of H. pylori and its comparison with international recommendations. Materials and methods. The analysis of 2360 patients entered in the register by the Russian centres of «Hp-EuReg» in 2013-2017, who were underwent 1st line eradication therapy. Results. The most common methods of primary diagnosis of H. pylori are histological (37.7%), rapid urease test (29.2%) and serology (29.7%). The duration of eradication therapy in 9.4% of cases was 7 days, in 65.3% - 10 days, and in 25.3% - 14 days. To control the effectiveness of treatment, H. pylori antigen in feces (31.3%), urea breath test (23.4%) and histological method (23.3%) were used. In 3.6% cases was used serology by mistake. In 17.3% of patients control was not carried out. The effectiveness of triple therapy with a PPI, amoxicillin, clarithromycin (per protocol) was 67.6%, with 7-day course, 81.1% at 10-day and 86.7% at 14-day course. Еradication rate of triple therapy with addition of bismuth (per protocol) reached 90,6% in the group receiving 10-day scheme and 93.6% in the group receiving the 14-day treatment. Conclusion. Significant deviations of clinical practice from expert recommendations, most pronounced at the stage of monitoring the effectiveness of therapy, were noted. The suboptimal efficacy of triple therapy is shown.


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.


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