Quadruple and Phytomedicine-based Therapies in Helicobacter pylori Infection: A Randomized Comparative Trial

Abstract

Purpose:Helicobacter pylori is strongly associated with the development of gastrointestinal disorders. Emerging antibiotic resistance of modern therapies has created a major problem, particularly in developing countries. A clinical trial was conducted to evaluate the efficacy of current quadruple and phytomedicine-based (mixture of anti-H. pylori components) therapies for the eradication of H. pylori infection and the relief of symptoms in the high H. pylori-prevalence country of Pakistan. Methods: One hundred seventy-six H. pylori-positive patients (males: 97; females: 79; mean age: 36±12 years) were enrolled in this study and divided into two groups according to treatment regimens. Quadruple therapy with omeprazole (20 mg bid), amoxicillin (1 g bid), metronidazole (500 mg bid), and bismuth compound (400 mg bid) was prescribed for 7 days, and phytomedicine-based formulation (pylorex plus 500 mg tablet contains 150 mg Curcuma longa rhizomes, 150 mg Mallotus phillipenensis fruits powder, 100 mg Glycyrrhiza glabra roots, and 100 mg Zingiber officinale rhizomes) twice daily was prescribed for 15 days. C13 urea breath and stool antigen (HpSAg) tests were performed at baseline and after treatment. The gastrointestinal (GI) symptoms (abdominal pain, regurgitation, heartburn, indigestion and flatulence, nausea, vomiting and belching) were evaluated by questioners, using a scoring system (absent: 0, mild: 1, moderate: 2, severe: 3). Results:H. pylori was eradicated in 56 out of 90 patients (62.2%) by quadruple therapy and in 48 out of 86 patients (55.8%) by pylorex plus therapy. The eradication rate of pylorex plus therapy was comparable to that of quadruple therapy. However, pylorex plus therapy have significantly ameliorated GI symptoms not only in H. pylori-eradicated patients from baseline (median 8; IQR 6-10) to 1 month after treatment (median 3; IQR 2-6), but also in non-eradicated patients from baseline (median 9; IQR 7-10) to 1 month after treatment (median 4; IQR 2-6). Whereas, quadruple therapy only relieved GI symptoms in H. pylori-eradicated patients from baseline (median 9; IQR 6-10) to 1 month after treatment (median 4; IQR 3-7), while lesser improvement in non-eradicated patients from baseline (median 9; IQR 6-10) to 1 month after treatment (median 8; IQR 5-10). Conclusion: Current quadruple and alternate therapies yielded poor eradication rates (<70%) in a developing country, but the later produced marked symptomatic improvement in both H. pylori-eradicated and non-eradicated patients, which might also be promising in functional dyspepsia by dual effects.