Comparison of Treatment Regimens for H. pylori

Running head: comparison of treatment regimens for H. pylori

Comparison of Treatment Regimens for H. pylori

Dana Redmond

University of Mary

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 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.

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