Application of a semi‐automatic, intensive follow‐up for improving efficacy and adherence of Helicobacter pylori eradication therapy: A randomized controlled trial

Abstract

A complete understanding and good adherence are crucial for successful Helicobacter pylori eradication. Proper frequency of reminders might be helpful to both doctors and patients to maintain adherence during treatment. The study was to evaluate the influence of an intensive follow‐up system based on a clinical database on H. pylori eradication therapy. A total of 196 eligible patients were equally and randomly divided into an intensive follow‐up group and a control group. Both groups were administered bismuth‐containing quadruple therapy for 14 days. Patients in the intensive follow‐up group were informed of pre‐treatment, including the duration and potential adverse events. Subsequently, they received telephone follow‐ups on days 3 and 14 and 3 days before the urea breath test (UBT). The time points were automatically reminded by a follow‐up system in the established clinical database. The control group was only informed of pre‐treatment information. UBT was performed 4 weeks after treatment in both groups to assess the presence of H. pylori. The eradication rate, patient compliance, and adverse events were calculated and compared. The H. pylori eradication rates of the intensive follow‐up and control groups were 94.7% (90/95, 95% CI: 90%–99%) and 92.9% (78/84, 95% CI: 87%–98%), respectively, by PP analysis (p = 0.601), and 91.8% (90/98, 95% CI: 86%–97%) and 81.6% (80/98, 95% CI: 74%–89%) by ITT analysis (p = 0.035). Adverse events occurred in 9 intensive follow‐up group patients and 12 in the control group. Adherence was 96.9% (95/98) in the intensive follow‐up group and 85.7% (84/98) in the control group. Semi‐automatic intensive follow‐up contributed to a higher eradication rate and adherence to H. pylori treatment.

Effect of enhanced patient instructions onHelicobacter pylorieradication: A systematic review and meta‐analysis of randomized controlled trials

“…Two studies 21,24 provided sufficient data for allocation concealment and were judged as low risk, while others were judged as unclear risk. Regarding blinding, 3 studies 20,22,24 described methods for single blinding, one study 27 was open trial (non‐blind), and the remaining 5 studies 21,23,25,26,28 were judged as unclear risk due to insufficient information. With respect to attrition bias, one study conducted by Ma et al 28 was judged as high risk of bias due to the unbalanced proportion of missing data, and all the remaining studies were judged as low risk of bias.…”

“…A total of 8 studies 20,22‐28 (involving 1 875 patients) reported data on H . pylori eradication rate.…”

“…Due to the complexity and long duration of current H . pylori eradication regimens, which may affect patient compliance, increasing clinical studies 20‐28 have attempted to use these EPI methods to improve H . pylori eradication rate.…”

“…Regarding H. pylori eradication regimen, 4 studies used standard triple therapy, [20][21][22][23] and 5 studies used bismuth-quadruple therapy. [24][25][26][27][28] The duration of eradication regimen ranged from 10 days to 14 days.…”

“…Primary outcome: H. pylori eradication rate3.4.1 | Overall resultsA total of 8 studies20,[22][23][24][25][26][27][28] (involving 1 875 patients) reported data on H. pylori eradication rate. Based on the data analyzed by ITT analysis, the eradication rate in the EPI group was higher than RPI group F I G U R E 1 PRISMA flowchart of study selection process.…”