Efficacy of a Modified Sequential Therapy Including Bismuth Subcitrate as First-Line Therapy to Eradicate Helicobacter pylori in a Turkish Population

• Published in: Helicobacter (Cambridge, Mass.) Vol. 17; no. 6; pp. 486 - 490
• Main Authors: Uygun, Ahmet, OZEL, A. Melih, Sivri, Bulent, Polat, Zulfikar, Genç, Halil, Sakin, Yusuf Serdar, Çelebi, Gürkan, Uygur-Bayramiçli, Oya, Erçin, Cemal Nuri, Kadayifçi, Abdurrahman, Emer, Ozdes, Gunal, Armagan, Bagci, Sait
• Format: Journal Article
• Language: English
• Published: England Blackwell Publishing Ltd 01-12-2012
• Subjects: Adult; Age; Amoxicillin; Anti-Bacterial Agents - administration & dosage; Anti-Bacterial Agents - adverse effects; bismuth; Breath Tests; Diarrhea; Drug Therapy, Combination - adverse effects; Drug Therapy, Combination - methods; Female; Fever; Hand; Helicobacter Infections - drug therapy; Helicobacter pylori; Humans; Infection; Male; Metronidazole; Middle Aged; modified treatment; Nausea; Organometallic Compounds - administration & dosage; Organometallic Compounds - adverse effects; Pain; Prospective Studies; sequential therapy; Sex; Side effects; Tablets; Tetracyclines; Treatment Outcome; Turkey; Urea; Urea - analysis; Vagina; Vomiting; Turkey
• ISSN: 1083-4389; 1523-5378
• DOI: 10.1111/j.1523-5378.2012.00989.x

Background
Eradication rates of Helicobacter pylori with standard triple therapy are not satisfactory. Sequential therapy is an alternative method to overcome this problem.
Objectives
The aim of this study was to assess efficacy of a modified sequential therapy with the addition of a bismuth preparation, as first‐line treatment in the eradication of H. pylori infection.
Materials and Methods
One hundred and forty‐two H. pylori‐positive patients were included in the study. Patients were given a 14‐day sequential therapy program consisting of pantoprazole, 40 mg (b.i.d. for 14 days); colloidal bismuth subcitrate, 300 mg 4 (two tablets before breakfast and dinner, for 14 days); amoxicillin, 1 g (b.i.d.for the first 7 days); tetracycline, 500 mg (q.i.d. for the second 7 days); and metronidazole, 500 mg (t.i.d. for the second 7 days). Eradication was tested by urea breath test (UBT) 6 weeks after completion of treatment.
Results
Of the 142 patients included, 131 completed the study. “Per‐protocol” and “intention‐to‐treat” analyses revealed high eradication rates in this group (92.0–95% CI, 87.2–96.8%, and 81.0–95% CI, 74.5–87.4%, respectively). There was no relation to sex and age with this modified sequential therapy. Compliance was satisfactory (11 patients – four women and seven men were unavailable for follow‐up), and side effects were minimal (six patients had to stop treatment – metronidazole‐related facial swelling and numbness on the face and hands in two patients; tetracycline‐related fever and epigastric pain and nausea and vomiting in two patients; and amoxicillin‐related diarrhea and vaginal discharge in two patients). These side effects were reversible and resolved after the cessation of the related medication.
Conclusions
This 14‐day modified sequential treatment, including bismuth, achieves a significantly high eradication rates in patients with H. pylori infection, with five satisfactory patient compliance and minor side effects.