BACKGROUND: In vitro omega-3-fatty acids (Eicosapen) are bacteriostatic to Helicobacter pylori and have a variety of immuno-modulating effects. AIM: To investigate the efficacy and tolerability of eicosapen (E) as an antibiotic-sparing component of a triple H. pylori eradication regimen in non-ulcer dyspepsia patients in a randomized, double-blind trial. METHODS:Non-ulcer dyspepsia patients (n=199), with a normal upper endoscopy and a positive (13)C-urea breath test (UBT) were randomly assigned to either pantoprazole, clarithromycin and metronidazole (PCM) or pantoprazole, clarithromycin and eicosapen (PCE) for 7 days. Four weeks after treatment, H. pylori eradication was determined by UBT. Symptoms were followed up to 16 months. RESULTS: In the intention-to-treat population, PCM eradicated infection in 78% but PCE was successful in only 34% (P < 0.001). Symptomatic improvement occurred in both groups, and was not related to H. pylori eradication. CONCLUSION:Eicosapen is unlikely to be useful in H. pylori eradication regimens.
RCT Entities:
BACKGROUND: In vitro omega-3-fatty acids (Eicosapen) are bacteriostatic to Helicobacter pylori and have a variety of immuno-modulating effects. AIM: To investigate the efficacy and tolerability of eicosapen (E) as an antibiotic-sparing component of a triple H. pylori eradication regimen in non-ulcer dyspepsiapatients in a randomized, double-blind trial. METHODS:Non-ulcer dyspepsiapatients (n=199), with a normal upper endoscopy and a positive (13)C-urea breath test (UBT) were randomly assigned to either pantoprazole, clarithromycin and metronidazole (PCM) or pantoprazole, clarithromycin and eicosapen (PCE) for 7 days. Four weeks after treatment, H. pylori eradication was determined by UBT. Symptoms were followed up to 16 months. RESULTS: In the intention-to-treat population, PCM eradicated infection in 78% but PCE was successful in only 34% (P < 0.001). Symptomatic improvement occurred in both groups, and was not related to H. pylori eradication. CONCLUSION:Eicosapen is unlikely to be useful in H. pylori eradication regimens.