AIM: The aim of this study was to compare the half-dose and full-dose triple therapy regimens for Helicobacter pylori (Hp) eradication in patients with end-stage renal disease. BACKGROUND: H. Pylori is one the most important causes of dyspepsia in patients with end-stage renal disease (ESRD). PATIENTS AND METHODS: Sixty-six patients with ESRD were enrolled in the study with Hp infection and peptic disease with a need of Hp eradication. Patients were randomly assigned to full-dose (A=35 patients) or half-dose group (B=31 patients). Patients received clarithromycin 500 mg, amoxicillin 1000 mg and omeprazole 20 mg twice daily in group A and clarithromycin 250 mg and amoxicillin 500 mg twice daily and omeprazole 20 mg once daily in group B for two weeks. Patients provided stool samples 4 weeks of completing study to assess the success of Hp eradication by Hp-specific stool antigen. Finally, the rate of eradication and complications were compared between two groups. RESULTS: The successful Hp eradication was achieved in 26 patients (74%) in group A and in 22 patients (74%) in group B. The difference between 2 groups was not statistically significant (p=0.973) (per protocol analysis). CONCLUSION: Half-dose triple-therapy with clarithromycin, amoxicillin and omeprazole is as effective as full-dose triple-therapy to eradicate the Hp in patients with ESRD. According to lower toxicity level, complications and cost in half-dose regimen in this subset of patients, this protocol is advised.
RCT Entities:
AIM: The aim of this study was to compare the half-dose and full-dose triple therapy regimens for Helicobacter pylori (Hp) eradication in patients with end-stage renal disease. BACKGROUND:H. Pylori is one the most important causes of dyspepsia in patients with end-stage renal disease (ESRD). PATIENTS AND METHODS: Sixty-six patients with ESRD were enrolled in the study with Hp infection and peptic disease with a need of Hp eradication. Patients were randomly assigned to full-dose (A=35 patients) or half-dose group (B=31 patients). Patients received clarithromycin 500 mg, amoxicillin 1000 mg and omeprazole 20 mg twice daily in group A and clarithromycin 250 mg and amoxicillin 500 mg twice daily and omeprazole 20 mg once daily in group B for two weeks. Patients provided stool samples 4 weeks of completing study to assess the success of Hp eradication by Hp-specific stool antigen. Finally, the rate of eradication and complications were compared between two groups. RESULTS: The successful Hp eradication was achieved in 26 patients (74%) in group A and in 22 patients (74%) in group B. The difference between 2 groups was not statistically significant (p=0.973) (per protocol analysis). CONCLUSION: Half-dose triple-therapy with clarithromycin, amoxicillin and omeprazole is as effective as full-dose triple-therapy to eradicate the Hp in patients with ESRD. According to lower toxicity level, complications and cost in half-dose regimen in this subset of patients, this protocol is advised.
Authors: F Luzza; M Imeneo; M Maletta; I Mantelli; D Tancre; G Merando; L Biancone; F Pallone Journal: Nephrol Dial Transplant Date: 1996-01 Impact factor: 5.992
Authors: U Gladziwa; G Haase; S Handt; J Riehl; H Wietholtz; K V Dakshinamurty; W M Glöckner; H G Sieberth Journal: Nephrol Dial Transplant Date: 1993 Impact factor: 5.992