Context: Helicobacter pylori (H pylori) is strongly associated with the development of gastritis, duodenal and gastric ulcers, gastric mucosa-associated lymphoid tissue (MALT) lymphomas and gastric carcinoma. Emerging antibiotic resistance and patients' poor compliance with modern therapies have resulted in increasing eradication failure.
Objectives: The current trial was conducted to evaluate the efficacy of current quadruple and phytomedicine-based therapies for the eradication of H pylori infection and relief of its associated symptoms in Pakistan.
Design: The study was a randomized, controlled, multicenter clinical trial. Setting • The study was conducted in high-risk areas of Pakistan, including at Shifa-Ul-Mulk Memorial Hospital in Karachi, at Bahawalpur Victoria Hospital in Bahawalpur, and at Nawaz Salik Hospital in Rawalpindi.
Participants: The study enrolled 210 patients who tested positive for H pylori, 118 males and 92 females.
Intervention: Participants were divided into 2 groups according to treatment regimens. One group of participants received quadruple therapy-20 mg of omeprazole, 1g of amoxicillin, 500 mg of metronidazole, and 400 mg of bismuth compound-that was prescribed for 7 d, and another group received an alternate, phytomedicine-based, quadruple formulation-500 mg of Pylorex Plus-that was prescribed for 15 d.
Outcome measures: The eradication rate for H pylori was the primary outcome measure. Eradication was considered to be achieved on the basis of a negative C-urea breath test (UBT) and a negative stool antigen test for H pylori (HpSAg) at 4 wk after the end of treatment. The secondary outcome measure was the improvement in the clinical features as assessed by dyspepsia scores.
Results: In an intention-to-treat (ITT) analysis, the study found that H pylori was eradicated in 56 of the 90 participants in the quadruple therapy group who completed the study (62.2%) and in 48 of the 86 participants in the Pylorex Plus group who completed the study (55.8%). Therefore, Pylorex Plus had an eradication rate comparable with quadruple therapy. However, Pylorex Plus had significantly reduced gastrointestinal (GI) symptoms at the second wk and at 1 mo after treatment, both for participants in whom H pylori was eradicated and for those in whom it was not eradicated. The quadruple therapy group also showed reduced GI symptoms at the second wk and at 1 mo after treatment, but that result occurred only for those participants in whom H pylori was eradicated, and no significant improvement was observed for participants in whom it was not eradicated.
Conclusions: Current quadruple and alternate therapies yielded poor eradication rates (<70%), but the latter produced marked symptomatic improvement, both for participants in whom H pylori was eradicated and for those in whom it was not eradicated, pointing out its potential use with patients with functional dyspepsia (FD) who are both positive and negative for H pylori.