Third Time is a Charm: Chase H. pylori from the Stomach
Third Time is a Charm: Chase H. pylori from the Stomach
Abstract & Commentary
By Joseph E. Scherger, MD, MPH
Synopsis: A study group in Greece used 3 consecutive different regimens to achieve a 98% eradication rate among 540 patients not lost to follow-up. The success of each individual regimen was about 70%.
Source: Rokkas T, et al. Cumulative H. pylori eradication rates in clinical practice by adopting first and second-line regimens proposed by the Maastricht III consensus and a third-line empirical regimen. Am J Gastroenterol 2009;104:21-25.
Helicobacter pylori infection of the stomach is the leading cause of gastric and duodenal ulcers, chronic gastritis, and gastric cancer. There are many regimens to attempt eradication of the organism, and all consist of a proton-pump inhibitor and various antimicrobial combinations. None of the regimens achieve greater than 80% eradication rates alone. In 2005, The European Helicobacter Study Group published a Consensus Report (Maastricht III) recommending 2 consecutive regimens to achieve a higher eradication rate.1 If the 2 regimens failed, a gastric biopsy and culture is recommended. A study group in Athens, Greece, led by Rokkas, feeling that the invasive testing was expensive and impractical, studied whether a third empiric regimen would achieve greater eradication results.
A total of 540 consecutive patients with H. pylori demonstrated by endoscopy were treated and followed. There was no control group in this cohort study. All were symptomatic or expressed a strong desire to eradicate H. pylori. Patients younger than age 18, type 1 diabetics, and patients with cancer or major hepatic, cardiorespiratory, or renal disease were excluded. Successful eradication of H. pylori was measured using urea breath testing 4-8 weeks after treatment.
The first regimen consisted of omeprazole 20 mg twice daily, amoxicillin 1000 mg twice daily, and clarithromycin 500 mg twice daily for 10 days. After this first regimen, 380 patients had their H. pylori successfully eradicated and 40 patients withdrew from treatment, resulting in a 76% per-protocol success rate and a 70% intention-to-treat success rate. A total of 120 patients had a treatment failure and remained in the study for the second regimen.
Following the Maastricht III Consensus Report guidelines, the second regimen consisted of omeprazole 20 mg twice daily, bismuth subcitrate 300 mg four times daily, metronidazole 500 mg three times daily, and tetracycline 500 mg twice daily for 10 days. Eighty-three of these patients had successful eradication and 7 patients withdrew, resulting in a 73% per-protocol success rate and a 69% intention-to-treat success rate. Thirty patients (6% of the original group) had a treatment failure after the 2 regimens and remained in the study for a third regimen rather than undergo gastric biopsy.
The third regimen chosen by the study group consisted of omeprazole 20 mg twice daily, amoxicillin 1000 mg twice daily, and levofloxacin 500 mg twice daily for 10 days. The authors received no financial support for this study. Twenty-one of the 30 H. pylori-positive patients had successful eradication with the third regimen and none withdrew from treatment, resulting in 70% per-protocol and intention-to-treat success rates. Overall, 98% of the patients had a per-protocol success rate with 3 regimens and a 90% intention-to-treat success rate.
Commentary
Eradicating H. pylori from the stomach of our symptomatic patients is one of the most frustrating and challenging treatments in adult medicine. If at first you do not succeed, try again, has become standard therapy. In this study, the combination of 2 successive treatment regimens resulted in only 6% of the original group remaining positive and still in treatment. Nine percent of patients withdrew from the first or second treatment regimen, giving an 85% intention-to-treat success rate for 2 consecutive regimens. This study shows that adding a third treatment regimen, and using levofloxacin with it, results in another level of success.
The take home message for me from this study is that 3 regimens may be reasonable for some H. pylori-positive patients before going to gastric biopsy and culture. Each regimen has about a 70% success rate. Combining these 70% success rates in consecutive therapy will get the overall success rate over 90% in patients that remain in treatment. A third regimen drives that success rate up to 98%. That is about as good as it can get. Unfortunately, there was no long-term follow-up of these patients and I wonder how many are H. pylori-positive after 1 or 2 years. We know that H. pylori is normal gastric flora for many people around the world. Therein lies the great challenge for continuity of care and we still have much to learn about the pathophysiology of H. pylori and gastroduodenal disease.
Reference
1. Malfertheiner P, et al. Current concepts in the management of Helicobacter pylori infection: The Maastricht III Consensus Report. Gut 2007;56:772-781.
A study group in Greece used 3 consecutive different regimens to achieve a 98% eradication rate among 540 patients not lost to follow-up. The success of each individual regimen was about 70%.Subscribe Now for Access
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