A Randomized Controlled Trial of an Enhanced Patient Compliance Program for Helicobacter pylori Therapy

Abstract

Objectives:To determine whether an enhanced compliance program (ECP) improves patient compliance with bismuth subsalicylate, metronidazole, and tetracycline hydrochloride (BMT) triple therapy for the treatment of Helicobacter pylori infection and to identify factors that affect compliance with therapy.Design: A randomized controlled trial conducted in 4 staff-model health centers 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 therapy 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 pharmacist, along with a medication calendar and a minipillbox, as well as a follow-up telephone call after initiation of therapy. Compliance was assessed by a pill count, and factors affecting adherence to the regimen were identified by patients' reports.Results: There was no statistically significant difference between the 2 groups in the number of patients taking more than 60% of the medications (89% of the control group vs 95% of the ECP group; PϾ.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 group; PϽ.01). An intention-to-treat analysis confirmed these results. The most frequently reported adverse effect was gastrointestinal intolerance. Other factors reported to affect compliance included the frequency of dosing and the number of pills.Conclusions: These findings suggest that although adverse effects were common, most patients were able to complete 60% or more of the 2-week regimen. An ECP further improved the percentage of medications taken.

The Patients’ Adherence and Adverse Drug Reactions (ADRs) which are Caused by Helicobacter Pylori Eradication Regimens

“…This phenomenon is called as 'white-coat adherence' [14,15] and a randomized controlled trial demonstrated that the techniques such as a received medication counseling (written and oral) from a pharmacist, as well as a telephone call follow-up after the initiation of the therapy, increased the number of patients who took more than 90% of the medications; we performed both the pharmacist counseling and the telephone call follow-up for evaluating the patients' compliance. This could be the major source of the motivation for the greater compliance rate of our study [16]. In the randomized study, to evaluate the efficacy of the H. pylori eradication regimes, 90% of the patients used 100% of the prescribed medications correctly, and it seemed that the results of this study were similar to those of our study [17].…”

“…In Lee et al's study, 36% of the patients had experienced a gastrointestinal intolerance, which included nausea, vomiting, diarrhoea, stomach cramps, and constipation; taste disturbance was the more frequent GI ADR, as in our study [16]. This bothering effect of metronidazole can be explained as the reason for the noncompliance to the regimens.…”

The impact of medication regimen factors on adherence to chronic treatment: a review of literature

“…Lee and colleagues conducted a randomized controlled trial (RCT) to determine whether compliance differed between standard care and a program of enhanced compliance care (Lee et al 1999). They found that although the intervention and control group did not differ, adherence varied by the frequency of dosing and the total number of pills.…”

Helicobacter pylori: Evidence-Based Review with a Focus on Immigrant Populations

“…It has been shown that approximately10% of patients fail to take more than 60 % 78 The most commonly cited reason for medication noncompliance is gastrointestinal intolerance. This has implications with regards to H. pylori eradication rates.…”