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Clinical Studies
Major North American Study of Eradication Treatment of Helicobacter pylori in Duodenal Ulcer Patients ...
Bismuth-Based Quadruple Therapy Using a Single Capsule of Bismuth Biskalcitrate, Metronidazole, and Tetracycline Given with Omeprazole Versus Omeprazole, Amoxicillin, and Clarithromycin for Eradication of Helicobacter pylori in Duodenal Ulcer Patients.
A Prospective, Randomized, Multicenter, North American Trial
Loren Laine, Richard Hunt, Hala El-Zimaity, Bich Nguyen, Michael Osato, Jean Spénard
Am J Gastroenterol 2003; 98:562-567.
Overcoming Antimicrobial Resistance
"However, OBMT [omeprazole, bismuth biskalcitrate, metronidazole, and tetracycline] provided markedly better rates of eradication in strains with clarithromycin resistance because the eradication rate with OAC [omeprazole, amoxicillin and clarithromycin] was less than 25% in this group."
"In contrast, eradication rates for OBMT [omeprazole, bismuth biskalcitrate, metronidazole, and tetracycline] and OAC [omeprazole, amoxicillin and clarithromycin] in metronidazole susceptible and metronidazole resistant strains were not significantly different and were over 80%."
Compliance and Safety
"Compliance was comparable in the two study groups: 91% of patients in the OBMT group [omeprazole, bismuth biskalcitrate, metronidazole, and tetracycline] and 94% of patients in the OAC group [omeprazole, amoxicillin and clarithromycin] took at least 75% of their study medications."
"The most common adverse events were of a GI nature. Diarrhea was the most common adverse event and was nearly twice as frequent in the OAC group [omeprazole, amoxicillin and clarithromycin]."
* bismuth biskalcitrate 140 mg, metronidazole 125 mg, tetracycline 125 mg given
as 3 capsules q.i.d. plus omeprazole 20 mg b.i.d.
** omeprazole 20 mg, amoxicillin 1000 mg, clarithromycin 500 mg, all b.i.d.
First-Line Treatment
"Thus, this OBMT quadruple therapy [omeprazole, bismuth biskalcitrate, metronidazole, and tetracycline] with the single-triple capsule can be considered as a first-line regimen or treatment of H. pylori infection."
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