BLEEDING PEPTIC ULCER, NONSTEROIDAL ANTIINFLAMMATORY DRUGS AND HELICOBACTER PYLORI INFECTION – A PROSPECTIVE, CONTROLLED, RANDOMIZED STUDY
Abstract
Background. The explanation of peptic ulcer etiology has changed significantly in the past decade after the clarification of the significance of Helicobacter pylori infection.
Aim. To evaluate the effectiveness of Helicobacter pylori eradication in patients with hemorrhaging peptic ulcer and patients with peptic ulcer without complications.
Study ethics. The study was approved in 1998 by the Medical Ethics Committee of the Republic of Slovenia (No. 90/09/98).
Type of study. Prospective, controlled and randomized study, carried out between 1998–2000.
Patients and methods. The study included 80 patients (50 male and 30 female, av.age 57.5 years, SD ± 17.1, range 22– 80) in which endoscopy confirmed hemorrhage from peptic ulcer of stomach or duodenum and Helicobacter pylori infection. In all cases endoscopic hemostasis was performed: injection sclerotherapy with diluted adrenalin 1:10,000 and 1% polidocanol or argon plasma coagulation. The control group was made up of 80 patients (50 male and 30 female, av.age 56.8 years, SD ± 16.8, range 19–80) with peptic ulcer of stomach or duodenum and Helicobacter pylori infection. Infection was confirmed by a rapid urease test and histologic investigation of the gastric mucosa. In all cases the recommended drug combinations were used in the treatment of the infection: a proton pump inhibitor, omeprazol (4 weeks), and combination of antibiotics, claritromycin and metronidazole or with regard to the antibiogram (1 week). The therapeutic success was ascertained endoscopically four weeks after inclusion in the study. Infection eradication was confirmed by the rapid urease test and histologic investigation of the gastric mucosa.
Results. Four weeks after inclusion in the study the success of infection eradication was 92.5% in the study group, in the control group it was 91.3% (p > 0.05). In 6 patients (7.5%, 6/ 80) from the study group and in 7 (8.8%, 7/80) from the control group we introduced a replacement treatment for the infection. Final treatment of the infection according to the antibiogram was required in two patients (2/80, 2.5%) from the study group and in 3 (3/80, 3.8%) from the control group. Control endoscopy showed the peptic ulcer had healed in 71/ 80 patients (88.8%) from the study group and in 68/80 patients (85%) from the control group (p > 0.05). Endoscopic investigation performed one year after inclusion in the study revealed a recurrence of Helicobacter pylori infection in 4 patients (5%, 4/80) from the study group and in 5 (6.3%, 5/80) from the control group (p > 0.05). Of these 9 patients we found peptic ulcer recurrence in only one patient (1.3%, 1/80) from the study group and in one (1.3%, 1/80) from the control group. Both patients has used preparations of acetylsalycilic acid prior to endoscopic investigation.
Conclusions. The findings of our study confirm that during the observed period of time, one year, the reinfection rate with Helicobacter pylori was 5.6%. In this period we did not observed rebleeding due to peptic ulcer and only two patients had a recurrence of ulcer disease.
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