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Running head: COMPARISON OF TREATMENT REGIMENS FOR H. PYLORI
Comparison of Treatment Regimens for H. pylori
Dana Redmond
University of Mary
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COMPARISON OF TREATMENT REGIMENS FOR H. PYLORI
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Comparison of Treatment Regimens for H. pylori
Author: Dana Redmond
Date: June 10, 2016
Clinical Scenario:
A 42 year old female presents to the clinic for a follow up visit after having epigastric pain for
one week which she describes as a gnawing pain. She has been taking OTC antacids which has
helped, but the pain is still present. She also states that she has been smoking more cigarettes
because she has been stressed out. You decided at the previous visit to obtain some diagnostic
tests. As you are reviewing the results, you see that her urea breath test has confirmed
Helicobacter pylori. You would like to start this patient on a therapy regimen to treat the H.
pylori infection.
PICO Question:
In adult patients who have Helicobacter pylori is the sequential therapy regimen more effective
than the standard triple therapy regimen in eliminating the infection?
Articles:
Eisig, J. N., Navarro-Rodriguez, T., Teixeira, A. S., Silva, F. M., Mattar, R., Chinzon, D., &
Barbuti, R. C. (2015). Standard triple therapy versus sequential therapy in helicobacter
pylori eradication: A double-blind, randomized, and controlled trial. Gastroenterology
Research & Practice, 20151-5 5p. doi:10.1155/2015/818043
Kate, V., Kalayarasan, R., & Ananthakrishnan, N. (2013). Sequential therapy versus standard
triple-drug therapy for helicobacter pylori eradication: A systematic review of recent
evidence. Drugs, 73(8), 815-824 10p. doi:10.1007/s40265-013-0053-z
Summary and Appraisal of Key Evidence:
Eisig et al. (2015) conducted a randomized, double blind controlled trial to compare a ten day
standard triple therapy versus sequential therapy as first-line treatment in patients infected with
H. pylori. One hundred H. pylori positive patients who had peptic ulcer disease or chronic
gastritis were randomized to receive either standard triple treatment which consisted of
lansoprazole 30 mg, clarithromycin 500 mg, and amoxicillin 1 gram twice daily for 10 days, or
sequential therapy which consisted of lansoprazole 30 mg, amoxicillin and placebo 1 gram twice
daily for the first five days, followed by lansoprazole 30 mg, clarithromycin 500 mg, and
tinidazole 500 mg twice daily for the remaining five days. The findings from this study suggests
that sequential therapy has not proven to be superior over triple therapy in eradicating H. pylori
infection. There was no significant difference in the elimination rate between patients with
chronic gastritis and those with peptic ulcer disease. Additionally, the study suggests that triple
COMPARISON OF TREATMENT REGIMENS FOR H. PYLORI
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therapy is still a good first-line regimen to treat H. pylori because the regimen has satisfactory
eradication rates, low cost, and is less complex for the patient.
One of the strengths is the randomized, double blind controlled trial is rated a level II in the level
of evidence pyramid and has low risk of bias. An independent researcher prepared the pill boxes
containing the medications and placebo making them indistinguishable from the active medicine.
The weakness of this study was that it was performed in Brazil and H. pylori resistance to
antibiotics is still relatively low. Eisig et al (2015) suggests that variation in resistance can
influence the efficacy of H. pylori therapeutic regimens. More research needs to be done to
assess if H. pylori has a tendency to increase its resistance to clarithromycin.
Kate, Kalayarasan, & Ananthakrishnan (2013) conducted a systematic review of seventeen
randomized controlled trials (RCT’S) worldwide that compared the sequential and standard triple
therapy in patients with documented H. pylori infection. The most frequently used sequential
therapy in this review consists of a proton pump inhibitor (PPI) and amoxicillin for the first five
days followed by a PPI, clarithromycin and metronidazole or tinidazole or amoxicillin for the
following five days. The standard triple therapy that was used consisted of a PPI, clarithromycin
and amoxicillin or metronidazole. Of the seventeen RCT’s included in this analysis, twelve
reported better eradication rates with the sequential therapy, four did not find a significance
between the two regimens, and one reported a better eradication rate with the standard triple
therapy. Additionally, this review had assessed the compliance rate between the two regimens.
Sixteen out of the seventeen trials reported that sequential therapy was not associated with a poor
compliance rate. Overall, the majority of the RCT’s have shown superior eradication rates with
sequential therapy.
This review is rated a level I in the level of evidence pyramid, has low risk of bias, and included
a large number of worldwide RCT’s. There were several limitations of the trials that were
included in the systematic review. The sequential therapy regimen and the duration of the
standard triple therapy were not uniform. Additionally, antibiotic susceptibility tests were only
performed in three of the trials. Kate et al (2013) suggests that sequential therapy has shown
good efficacy, however further trials need to be completed to assess its superiority over existing
regimens before recommending sequential therapy as the first line of treatment for H. pylori
infection.
Clinical Bottom Line:
There have been multiple treatment regimens that have been studied in numerous randomized
clinical trials to eradicate H. pylori infection. Unfortunately, the best treatment has not been
found due to ever changing antibiotic resistance. The choice of antibiotic will vary from country
to country because of this resistance. As for now, more studies need to be done here in the U.S.
to determine whether sequential therapy is superior to the standard triple drug therapy. Health
care providers need to be aware that as antibiotic resistance increases, we may see a change in
how H. pylori is treated in the future.
COMPARISON OF TREATMENT REGIMENS FOR H. PYLORI
References
Eisig, J. N., Navarro-Rodriguez, T., Teixeira, A. S., Silva, F. M., Mattar, R., Chinzon, D., &
Barbuti, R. C. (2015). Standard triple therapy versus sequential therapy in helicobacter
pylori eradication: A double-blind, randomized, and controlled trial. Gastroenterology
Research & Practice, 20151-5 5p. doi:10.1155/2015/818043
Kate, V., Kalayarasan, R., & Ananthakrishnan, N. (2013). Sequential therapy versus standard
triple-drug therapy for helicobacter pylori eradication: A systematic review of recent
evidence. Drugs, 73(8), 815-824 10p. doi:10.1007/s40265-013-0053-z
4