A United States multicentre trial of dual and proton pump inhibitor‐based triple therapies for Helicobacter pylori

Abstract

Background: One‐week proton pump inhibitor‐based triple therapies are very popular in the US despite limited US data documenting efficacy. We assessed 1‐week proton pump inhibitor triple therapies for Helicobacter pylori, and compared them to dual antibiotic therapies (to assess benefit of omeprazole) and to omeprazole–amoxycillin (to assess benefit of clarithro‐ mycin) in a large, randomized, US multicentre study. Methods: Healthy subjects who were H. pylori‐positive by rapid serological test and 13C‐urea breath test were randomly assigned to (i) omeprazole (O) 20 mg b.d. + amoxycillin (A) 1 g t.d.s. for 14 days (OA); (ii) A 1 g b.d. + clarithromycin (C) 500 mg b.d. for 7 days (AC); (iii) C 250 mg b.d. + metronidazole (M) 500 mg b.d. for 7 days (CM); (iv) O 20 mg b.d. + C 250 mg b.d. + M 500 mg b.d. for 7 days (MOC); or (v) O 20 mg b.d. + C 500 mg b.d. + A 1 g b.d. for 7 days (OAC). Repeat breath tests were done at 6 weeks to assess H. pylori status. Results: Three hundred and two H. pylori‐positive subjects at 25 centres received medication. Intention‐to‐treat cure rate was significantly higher for OAC (82%) than for MOC (67%), CM (59%), AC (18%) or OA (58%). Per‐protocol cure rates were 85% for OAC and 75% for MOC. Discontinuation of therapy due to a side‐effect occurred in 0–3% of each study group. Conclusions: One‐week twice‐daily triple therapy with omeprazole, amoxycillin and clarithromycin provides the best rate of eradication of the five regimens studied. However, treatment in the US for 7 days may be unable to achieve eradication rates of ≥ 90% with proton pump inhibitor‐based triple therapy.

Helicobacter pylori treatment in the era of increasing antibiotic resistance

“…As shown in figure 2, treatment success fails to reach even 80% in most studies in the southern and central European countries of France, Italy, Spain and Turkey, populations which, as the Maastricht III report noted, tend to have a high prevalence (∼18.5%) of clarithromycin resistance (figure 2). Similar poor results were obtained in the more recent large US trials of triple regimens 68 77 89–91. Using meta-regression methods described previously,7 92 we observed treatment success for the more commonly used ‘legacy triple therapy’ to be ∼8.1% lower than treatment success for the combination using metronidazole in place of amoxicillin in recent years (95% CI 2.2% to 14.0%).…”

Treatment of Helicobacter pylori in surgical practice: A randomised trial of triple versus quadruple therapy in a rural district general hospital

“…Triple therapies are the mainstay of current treatment but resistance to clarithromycin is reducing its effectiveness. In the presence of resistance to clarithromycin, some studies have shown eradication rate below 80% and even as low as 25%-61% with standard triple therapy containing clarithromycin, amoxycillin and a proton-pump inhibitor [7][8][9][10][11] . Clarithromycin resistance is also increasing in our region [12,13] .…”

Helicobacter Pylori

“…Numerous large European trials have reported an eradication rate with one-week triple therapy of >85% [44,46]. Unfortunately, currently available studies conducted in the United States have not reproduced the encouraging observations made in Europe [29,47]. As such, the report of the recent Digestive Health Initiative International Update Conference on Helicobacter pylori recently recommended that therapy be given for 14 days in the United States [43].…”

“…Side effects are most often associated with clarithromycin. They include altered taste, nau- [29,30]. PPI or RBC-based triple therapies (Table 2) are effective in eradicating H. pylori infection, and are reasonably well tolerated by patients [31].…”