title: Phytomedicine-based and Quadruple Therapies in Helicobacter pylori Infection: A Comparative, Randomized Trial.
abstract: BACKGROUND
  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.
  
  
  OBJECTIVE
  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.
  
  
  METHODS
  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.
  
  
  METHODS
  The study enrolled 210 patients who tested positive for H pylori, 118 males and 92 females.
  
  
  METHODS
  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.
  
  
  METHODS
  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.
authors: Hafiz Muhammad
authors: HM
authors: Asif
authors: Syed Faisal
authors: SF
authors: Zaidi
authors: Toshiro
authors: T
authors: Sugiyama
authors: Naveed
authors: N
authors: Akhtar
authors: Khan
authors: K
authors: Usmanghani
mesh_terms: D000293:Adolescent; D000328:Adult; D000658:Amoxicillin / Q000008:administration & dosage / Q000009:adverse effects; D000900:Anti-Bacterial Agents / Q000008:administration & dosage* / Q000009:adverse effects; D000897:Anti-Ulcer Agents / Q000008:administration & dosage* / Q000009:adverse effects; D001729:Bismuth / Q000008:administration & dosage / Q000009:adverse effects; D004359:Drug Therapy, Combination; D005260:Female; D005767:Gastrointestinal Diseases / Q000188:drug therapy* / Q000382:microbiology*; D016481:Helicobacter Infections / Q000188:drug therapy*; D016480:Helicobacter pylori / Q000302:isolation & purification*; D006801:Humans; D008297:Male; D008795:Metronidazole / Q000008:administration & dosage / Q000009:adverse effects; D008875:Middle Aged; D009853:Omeprazole / Q000008:administration & dosage / Q000009:adverse effects; D008517:Phytotherapy / Q000379:methods*; D010936:Plant Extracts / Q000008:administration & dosage* / Q000009:adverse effects; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000900:Anti-Bacterial Agents; D000897:Anti-Ulcer Agents; D010936:Plant Extracts; D008795:Metronidazole; D000658:Amoxicillin; D009853:Omeprazole; D001729:Bismuth