A Comparison between 10-day and 12-day Concomitant Regimens for Helicobacter Pylori Eradication: A Randomized Clinical Trial.

BACKGROUND Helicobacter pylori (H. pylori) infection is one of the most common bacterial infections worldwide, which is associated with peptic ulcer disease and gastric cancer. In this study, we compared the efficacy of 10-day versus 12-day concomitant therapy as the first-line treatment for H. pylo...

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Publicado en:Middle East Journal of Digestive Diseases Vol. 12; no. 2; pp. 106 - 111
Autores principales: Bari, Zohreh, Fakheri, Hafez, Taghvaei, Tarang, Yaghoobi, Mohammad
Formato: research tables/charts randomized controlled trial Journal Article
Publicado: Iranian Association of Gastroenterology & Hepatology 2020
Acceso en línea:Ver este registro en EBSCOhost
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      pub: Iranian Association of Gastroenterology & Hepatology
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        10.34172/mejdd.2020.169
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        atl: A Comparison between 10-day and 12-day Concomitant Regimens for Helicobacter Pylori Eradication: A Randomized Clinical Trial.
      aug:
        au:
          Bari, Zohreh
          Fakheri, Hafez
          Taghvaei, Tarang
          Yaghoobi, Mohammad
        affil: Gut and Liver Research Center, Mazandaran University of Medical Sciences, Sari, Iran
      sug:
        subj:
          Helicobacter Infections Drug Therapy
          Time Factors
          Treatment Outcomes
          Human
          Randomized Controlled Trials
          Iran
          Peptic Ulcer Drug Therapy
          Pantoprazole Sodium Administration and Dosage
          Amoxicillin Administration and Dosage
          Clarithromycin Administration and Dosage
          Metronidazole Administration and Dosage
          Breath Tests Methods
          Descriptive Statistics
          Confidence Intervals
          Comparative Studies
      ab: BACKGROUND Helicobacter pylori (H. pylori) infection is one of the most common bacterial infections worldwide, which is associated with peptic ulcer disease and gastric cancer. In this study, we compared the efficacy of 10-day versus 12-day concomitant therapy as the first-line treatment for H. pylori eradication in Iran. METHODS 218 patients with peptic ulcer disease and naïve H. pylori infection, were randomly divided into two groups to receive either 10-day or 12-day concomitant regimens, composed of pantoprazole 40 mg, amoxicillin 1000 mg, clarithromycin 500 mg, and metronidazole 500 mg, all given twice daily. Eight weeks after treatment, H. pylori eradication was assessed by 14C- urea breath test. The trial was registered in the Iranian Registry of Clinical Trials (code: IRCT20170521034070N2). RESULTS 212 patients completed the study. According to the intention to treat analysis, the eradication rates were 83.6% (95% CI: 76.6-90.5) and 88.8% (95% CI: 82.8-94.7) in 10-day and 12-day concomitant therapy groups, respectively (p = 0.24). Per-protocol eradication rates were 85.9% (95% CI: 79.3--92.4) and 92.6% (95% CI: 87.6--97.5), respectively (p = 0.19). The rates of severe side effects were not statistically different between the two groups (3.6% vs. 8.1%; p = 0.428). CONCLUSION 12-day concomitant therapy could achieve ideal eradication rates by both intention to treat and perprotocol analyses. In order to reduce the cost of drugs and the rate of adverse effects of therapy, among 10-day and 12day regimens, 12-day concomitant therapy seems to be a good alternative to 14-day concomitant therapy that has been suggested by international guidelines.
      pubtype: Academic Journal
      doctype:
        research
        tables/charts
        randomized controlled trial
        Journal Article
      ougenre: Article
    language: English
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