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

Objectives: To determine whether an enhanced compliance program (ECP) impro ves patient compliance with bismuth subsalicylate, metronidazole, and tetra cycline hydrochloride (BMT) triple therapy for the treatment of Helicobacte r pylori infection and to identify factors that affect compliance with ther apy. Design: A randomized controlled trial conducted in 4 staff-model health cen ters of a health maintenance organization in Massachusetts. Patients and Methods: A total of 125 patients 18 years of age or older with peptic ulcer disease or dyspepsia whose clinicians prescribed BMT triple t herapy for 14 days were randomized to a control group or to the ECP group. The ECP group received medication counseling (written and oral) from a phar macist, along with a medication calendar and a minipillbox, as well as a fo llow-up telephone call after initiation of therapy. Compliance was assessed by a pill count, and factors affecting adherence to the regimen were ident ified by patients' reports. Results: There was no statistically significant difference between the 2 gr oups in the number of patients taking more than 60% of the medications (89% of the control group vs 95% of the ECP group; P>.30). However, there was a statistically significant difference in the number of patients taking more than 90% of the medications (67% of the control group vs 89% of the ECP gr oup; P<.01). An intention-to-treat analysis confirmed these results. The mo st frequently reported adverse effect was gastrointestinal intolerance. Oth er factors reported to affect compliance included the frequency of dosing a nd the number of pills. Conclusions: These findings suggest that although adverse effects were comm on, most patients were able to complete 60% or more of the 2-week regimen. An ECP further improved the percentage of medications taken.