AIM: To establish a triple therapy regimen for Helicobacter pylori eradication in patients with chronic renal insufficiency. METHODS:Eighty-eight patients with chronic renal insufficiency andH. pylori infection were evenly randomized into two groups receiving 1-week lansoprazole, 30 mg, clarithromycin, 500 mg, and either amoxicillin, 750 mg, or metronidazole, 500 mg, twice daily. The adverse events and compliance with triple therapy were reviewed at the week 1 visit. Patients provided stool samples at week 6 to assess the success of H. pylori eradication by H. pylori-specific stool antigen. The serum creatinine levels were monitored at enrollment, at weeks 1, 2 and 6 and on any unscheduled visit after triple therapy. RESULTS: The success of H. pylori eradication was higher in the lansoprazole-clarithromycin-metronidazole group than in the lansoprazole-clarithromycin-amoxicillin group (intention-to-treat analysis: 84% vs. 66%, P < 0.05: per protocol analysis: 93% vs. 76%, P < 0.05). Complete drug compliance was also better in the lansoprazole-clarithromycin-metronidazole group than in the lansoprazole-clarithromycin-amoxicillin group (77% vs. 52%, P < 0.05). Patients in the lansoprazole-clarithromycin-metronidazole group had a lower risk of acute renal failure than those in the lansoprazole-clarithromycin-amoxicillin group (2% vs. 18%, P < 0.05; relative risk, 0.128, 95% confidence interval, 0.016-0.979). CONCLUSIONS: Triple therapy with metronidazole and clarithromycin, but not amoxicillin, can be used for H. pylori eradication in patients with chronic renal insufficiency, because it is more effective, well tolerated and less likely to cause deterioration of renal function.
RCT Entities:
AIM: To establish a triple therapy regimen for Helicobacter pylori eradication in patients with chronic renal insufficiency. METHODS: Eighty-eight patients with chronic renal insufficiency and H. pyloriinfection were evenly randomized into two groups receiving 1-week lansoprazole, 30 mg, clarithromycin, 500 mg, and either amoxicillin, 750 mg, or metronidazole, 500 mg, twice daily. The adverse events and compliance with triple therapy were reviewed at the week 1 visit. Patients provided stool samples at week 6 to assess the success of H. pylori eradication by H. pylori-specific stool antigen. The serum creatinine levels were monitored at enrollment, at weeks 1, 2 and 6 and on any unscheduled visit after triple therapy. RESULTS: The success of H. pylori eradication was higher in the lansoprazole-clarithromycin-metronidazole group than in the lansoprazole-clarithromycin-amoxicillin group (intention-to-treat analysis: 84% vs. 66%, P < 0.05: per protocol analysis: 93% vs. 76%, P < 0.05). Complete drug compliance was also better in the lansoprazole-clarithromycin-metronidazole group than in the lansoprazole-clarithromycin-amoxicillin group (77% vs. 52%, P < 0.05). Patients in the lansoprazole-clarithromycin-metronidazole group had a lower risk of acute renal failure than those in the lansoprazole-clarithromycin-amoxicillin group (2% vs. 18%, P < 0.05; relative risk, 0.128, 95% confidence interval, 0.016-0.979). CONCLUSIONS: Triple therapy with metronidazole and clarithromycin, but not amoxicillin, can be used for H. pylori eradication in patients with chronic renal insufficiency, because it is more effective, well tolerated and less likely to cause deterioration of renal function.