Dino Vaira, MD; Angelo Zullo, MD; Nimish Vakil, MD
Potential Financial Conflicts of Interest: Consultancies: N. Vakil (Altana Pharma [now Nicomed]). Stock ownership or options (other than mutual funds): D. Vaira (Meridian Bioscience). Grants received: N. Vakil (Altana Pharma [now Nicomed]).
Vaira D., Zullo A., Vakil N.; Ethical Considerations of Comparing Sequential and Traditional Anti–Helicobacter pylori Therapy. Ann Intern Med. 2007;147:435-436. doi: 10.7326/0003-4819-147-6-200709180-00023
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Published: Ann Intern Med. 2007;147(6):435-436.
There are several misstatements in Drs. Graham and Yamaoka's letter. There was no sponsor for our study, and triple therapy is a legacy therapy solely in a fantasy world. Triple therapy was recently reaffirmed by an international consensus group as the principal therapy to be used worldwide and by U.S. and Japanese guidelines (1–3). It is, therefore, an appropriate control group for any new therapy. Our study began in 2003, when it was uncertain whether sequential therapy was truly effective in large cohorts. A fundamental question remained unanswered until now: Was sequential therapy the answer to clarithromycin resistance? An expert international consensus group reviewed the data on sequential therapy in 2005 and concluded that it was promising but that more data were needed, particularly with regard to clarithromycin resistance (1). Because there were no safety issues with either treatment in our study and because the consensus group felt that more data were needed, it was imperative that we continue the trial. We have already demonstrated that triple-drug therapy with levofloxacin is an effective salvage therapy for patients in whom sequential therapy fails (4). Therefore, a perfectly satisfactory alternative therapy of proven efficacy was available for patients with treatment failure; data on those patients will be reported elsewhere.
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