A randomized controlled trial of an enhanced patient compliance program for Helicobacter pylori therapy.

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Abstract
HELICOBACTER PYLORI plays a major role in peptic ulcer disease. Clinical data have demonstrated that eradication of H pylori significantly reduces gastric and duodenal ulcer recurrence rates.1,2 The role of H pylori in nonulcer dyspepsia remains controversial owing to the lack of well-designed clinical trials addressing this issue.3,4 Although practice guidelines5 have been developed for the treatment of peptic ulcer disease, with an emphasis on eradicating H pylori, there is no consensus regarding the optimal regimen for patients with H pylori infection. Two weeks of triple therapy consisting of a bismuth compound (bismuth subsalicylate), metronidazole, and tetracycline hydrochloride (BMT) appears to produce consistent, high eradication rates and has been viewed as one of the preferred H pylori regimens.6 (The treatment of active duodenal ulcers using bismuth subsalicylate, tetracycline, and metronidazole is patented and commercially available in a compliance kit [Helidac Therapy; Procter & Gamble Pharmaceuticals Inc, Cincinnati, Ohio]. Helidac Therapy is indicated for use in conjunction with a histamine2 antagonist.) However, many clinicians are discouraged by the frequency of adverse effects and the complexity of the dosing schedule. Graham et al7 investigated the factors influencing the efficacy of bismuth-based triple therapy and found that H pylori organisms were eradicated in 96% of the patients who took 60% or more of their medications but in only 69% of the patients who took less than 60% of their medications. If medication adherence could be enhanced, the clinical effectiveness of bismuth-based triple therapy might be increased. (In this article, we use adherence and compliance interchangeably, although we recognize that compliance may be interpreted as placing the patient in a passive role, whereas adherence emphasizes a patient's active role in working with a health provider on achieving a common goal.)