A Comparative Study of Modified ginger Quadruple Therapy and Standard Concomitant Therapy for Helicobacter Pylori Infection in Banpong Hospital: A Randomized Controlled Trial

Abstract

Background: Eradication rates for Helicobacter pylori (H.pylori) with a standard triple therapy have declined globally including in Thailand due to the rising prevalence of antimicrobial resistance. Concomitant therapy has been recommended to replace standard triple therapy for H. pylori eradication in regions with high clarithromycin resistance but the concomitant therapy increases therapy-related side–effects. Ginger has been shown to eradiacate H. pylori infection and decrease dyspepsia symptom. So, we conducted the study to compare eradication rates between 10–day modified ginger quadruple therapy to 10–day standard concomitant therapy which is another alternative first-line H. pylori treatment option in Thailand.

          Objective: This study was aimed to compare the H.pylori eradication rates between 10–day modified ginger quadruple therapy and 10–day standard concomitant therapy.

Methods: Patients who underwent upper gastrointestinal endoscopy at Banpong Hospital from  March 1, 2020 to March 31, 2021 were included. The patients who had active H.pylori infection (n=161) were enrolled and randomized (1:1) into either 10–day modified ginger quadruple therapy (omeprazole 20 mg b.i.d., amoxicillin 1000 mg b.i.d., and clarithromycin 500 mg b.i.d., ginger 1000 mg (t.i.d.) or 10–day standard concomitant therapy (omeprazole 20 mg b.i.d., amoxicillin 1000 mg b.i.d., and clarithromycin 500 mg b.i.d., metronidazole 400 mg t.i.d.). Stool antigen tests were performed for evaluation of H. pylori eradication at least 4 weeks after treatment. Eradication rates, side effects, patient compliance, and improvement of pain symptoms of dyspepsia were recorded.

          Results: Total 161 H. pylori-infected participants were randomized to receive 10–day modified ginger quadruple therapy (n=80) or 10–day standard concomitant therapy (n=81)  The eradication rates were 96.3% and 96.3 % respectively (p > .999). Bitter taste was the most commonly reported adverse effect in both groups (25% in the 10-day modified ginger quadruple therapy vs. 35.8% in the 10–day standard concomitant therapy; p = .045). 10-day standard concomitant therapy experienced major adverse events from nausea of two patients (2.5%), bitter taste of five patients (6.2%), and dizziness of three patients (3.7%). 10–day modified ginger quadruple therapy experienced major adverse events from fatigue of one patient (1.3%). Other side effects were not significantly different between 2 groups. Of total 64 patients diagnosed with dyspepsia, 44 were treated with 10–day modified ginger quadruple therapy and the remaining 20 were treated with 10–day standard concomitant therapy. In the 10–day modified ginger quadruple therapy group, postprandial fullness, early satiety, epigastrium paining, and epigastrium burning were showed to have a statistically significant improvement (p = .003, p = .001, p = .001, p = .017 respectively) In the group treated with 10-day standard concomitant therapy, postprandial fullness and epigastrium paining had

a statistically significant improvement (p = .039, p = .008 respectively). The symptoms of early satiety and epigastrium burning also had some improvement, but this was not statistically significant (p = .068, p = .180 respectively). However, when comparing 10–day modified ginger quadruple therapy and 10–day standard concomitant therapy, there was no difference in treatment efficacy in patients with dyspepsia with postprandial fullness, early satiety, epigastrium. paining, and epigastrium burning.

          Conclusion: The efficacy of H. pylori eradaication of 10-day modified ginger quadruple therapy is not inferior to that of 10–day standard concomitant therapy. There was no difference in effectiveness for the treatment of dyspepsia between the two regimens. The advantages of 10–day modified ginger quadruple therapy were fewer bitter tastes and absence of severe adverse effect, i.e. , nausea and dizziness.