Effectiveness of 7-Day and 14-Day Moxifloxacin-Dexlansoprazole Based Triple Therapy and Probiotic Supplement for Helicobacter Pylori Eradication in Thai Patients with Non-Ulcer Dyspepsia: A Double-Blind Randomized Placebo-Controlled Study

Abstract

<br /> <strong><span style="font-size: small;">Background: </span></strong><em><span style="font-family: Times New Roman,Times New Roman; font-size: small;"><span style="font-family: Times New Roman,Times New Roman; font-size: small;">Helicobacter pylori (H. pylori) </span></span></em><span style="font-family: Times New Roman,Times New Roman; font-size: small;"><span style="font-family: Times New Roman,Times New Roman; font-size: small;">is important cause of peptic ulcer and gastric cancer. Moxifloxacin is </span></span><span style="font-family: Times New Roman,Times New Roman; font-size: small;"><span style="font-family: Times New Roman,Times New Roman; font-size: small;">effective antibiotic for treatment for </span></span><em><span style="font-family: Times New Roman,Times New Roman; font-size: small;"><span style="font-family: Times New Roman,Times New Roman; font-size: small;">H. pylori. </span></span></em><span style="font-family: Times New Roman,Times New Roman; font-size: small;"><span style="font-family: Times New Roman,Times New Roman; font-size: small;">However, there were limited studies as first line therapy. Probiotics had been shown to decrease therapy-related side-effect and increase eradication rate. Aim of this study was to evaluate the efficacy of moxifloxacin-dexlansoprazole based triple therapy with probiotic for </span></span><em><span style="font-family: Times New Roman,Times New Roman; font-size: small;"><span style="font-family: Times New Roman,Times New Roman; font-size: small;">H. pylori </span></span></em><span style="font-family: Times New Roman,Times New Roman; font-size: small;"><span style="font-family: Times New Roman,Times New Roman; font-size: small;">treatment in Thailand. </span></span><strong><span style="font-size: small;">Methods: </span></strong><span style="font-family: Times New Roman,Times New Roman; font-size: small;"><span style="font-family: Times New Roman,Times New Roman; font-size: small;">Patients with </span></span><em><span style="font-family: Times New Roman,Times New Roman; font-size: small;"><span style="font-family: Times New Roman,Times New Roman; font-size: small;">H. pylori </span></span></em><span style="font-family: Times New Roman,Times New Roman; font-size: small;"><span style="font-family: Times New Roman,Times New Roman; font-size: small;">infected gastritis were randomized to receive 7- or 14-day moxifloxacin-dexlansoprazole based triple therapy with probiotic or placebo. Regimen consisted of 60 mg dexlansoprazole twice daily, 400mg moxifloxacin once daily, 1g clarithromycin MR once daily. Probiotic used in this study was 282.5mg </span></span><em><span style="font-family: Times New Roman,Times New Roman; font-size: small;"><span style="font-family: Times New Roman,Times New Roman; font-size: small;">Saccharomyces boulardii (S. boulardii) </span></span></em><span style="font-family: Times New Roman,Times New Roman; font-size: small;"><span style="font-family: Times New Roman,Times New Roman; font-size: small;">in capsule prescribed twice daily. </span></span><em><span style="font-family: Times New Roman,Times New Roman; font-size: small;"><span style="font-family: Times New Roman,Times New Roman; font-size: small;">CYP2C19 </span></span></em><span style="font-family: Times New Roman,Times New Roman; font-size: small;"><span style="font-family: Times New Roman,Times New Roman; font-size: small;">genotyping, antibiotic susceptibility tests, and CagA genotyping were also done. Successful eradication was defined as a negative 13C-urea breath test at least 4 weeks after treatment. </span></span><strong><span style="font-size: small;">Results: </span></strong><span style="font-family: Times New Roman,Times New Roman; font-size: small;"><span style="font-family: Times New Roman,Times New Roman; font-size: small;">Total of 108 subjects was enrolled (27 each to 7-and 14-day regimens with probiotic or placebo). Antibiotic susceptibility tests showed 29% fluoroquinolone, 19% metronidazole and 4% clarithromycin resistance. </span></span><em><span style="font-family: Times New Roman,Times New Roman; font-size: small;"><span style="font-family: Times New Roman,Times New Roman; font-size: small;">CYP2C19 </span></span></em><span style="font-family: Times New Roman,Times New Roman; font-size: small;"><span style="font-family: Times New Roman,Times New Roman; font-size: small;">genotyping demonstrated 43%, 47% and 11% were rapid, intermediate and poor metabolizers, respectively. CagA genes were positive in all patients. Eradication rates of 7-day and 14-day regimens with probiotic were 100%, and 93% respectively. There were no significant differences between eradication rate of 7-day and 14-day regimen with or without probiotics. Regarding side-effects, incidence of nausea, abdominal discomfort, bitter taste, and diarrhea were significantly lower in regimen with probiotic group compared with placebo(7.4%vs. 22.2%; p=0.028, 0.00%vs.14.8%; p=0.003, 35.2%vs.70.4%; p=0.0002, and 0.00%vs.9.3%; p=0.028, respectively). </span></span><strong><span style="font-size: small;">Conclusions: </span></strong><span style="font-family: Times New Roman,Times New Roman; font-size: small;"><span style="font-family: Times New Roman,Times New Roman; font-size: small;">7-day moxifloxacin-dexlansoprazole therapy plus S. boulardii provide an reliable cure rate of H. pylori in non-ulcer dyspeptic patients in Thailand, independent of </span></span><em><span style="font-family: Times New Roman,Times New Roman; font-size: small;"><span style="font-family: Times New Roman,Times New Roman; font-size: small;">CYP2C19 </span></span></em><span style="font-family: Times New Roman,Times New Roman; font-size: small;"><span style="font-family: Times New Roman,Times New Roman; font-size: small;">genotype. Probiotic adding also decreased side effects during the treatment. </span></span>