[Peptic ulcer disease and Helicobacter pylori. A comparative study of two different three-drug regimens]

Helicobacter pylori (H. pylori) is now known to be strongly associated with gastritis type B, duodenal ulcer, gastric ulcer and perhaps gastric cancer. To cure peptic ulcer disease has become reality. This prospective study included 60 patients, 41 male and 19 females, with long history of peptic ulcer disease (1 - 41 yr, mean 16.5 yr), diagnosed with active duodenal ulcer (50) or gastric ulcer (10) during endoscopy of the upper gastrointestinal tract. After a positive CLO test and histologic confirmation as well as positive culture of H. pylori from the antral mucosa, patients were treated with conventional anti-ulcer therapy. After ulcers were healed (usually in 4 - 6 weeks) patients were randomized to take one of two regimens: 1) colloid bismuth sub-citrate 120 mg, four times a day for 28 days, metronidazole 400 mg, three times a day for 10 days and tetracyclin (DMT) 250 mg, four times a day for 14 days, 2) De-Nol 120 mg, four times a day for 28 days, metronidazole 400 mg, three times a day for 10 days and ampicillin 500 mg, four times a day for 14 days (DMA). Careful monitoring of compliance, symptoms, side effects, H. pylori status and ulcer recurrence by endoscopy was performed at one, two, six and 12 months after completion of triple therapy. Duodenal ulcer recurred in all six patients, that remained H. pylori positive (10%). Eradication of H. pylori was achieved in all patients (30) treated with DMT, and they remained H. pylori negative throughout the 12 months follow-up period. The compliance to the treatment regimens was excellent (<95%). Side effects were frequent (38%), but mild in most cases, mainly soft stool and nausea. One patient had to discontinue the treatment. Re-infection rate was 2% (one patient) during the 12 months follow-up period. A triple therapy with DMT was 100% effective in eradicating H. pylori and statistically superior (p = 0.0105) to DMA at 12 months follow-up. No ulcer recurrence occured in H. pylori negative patients. The importance of persistent and marked symptomatic improvement observed in this study as compared to conventional maintenance treatment has not been emphasized enough in the recent debates on ulcer treatment modalities. The ultimate benefit of H. pylori eradication in peptic ulcer disease should be evaluated by long term follow up studies..