Amoxicillin plus omeprazole versus triple therapy for eradication of Helicobacter pylori in duodenal ulcer disease: a prospective, randomized, and controlled study.

Treatment with amoxicillin and omeprazole resulted in encouraging Helicobacter pylori eradication rates in pilot studies that included medium term follow up. These results were evaluated in a prospective, randomised and controlled study. Forty patients with active duodenal ulcer disease and H pylori colonisation of the gastric mucosa were randomly assigned to receive either omeprazole (20 mg twice daily) and amoxicillin suspension (500 mg four times daily) for two weeks (group I) or bismuth subsalicylate (600 mg three times daily), metronidazole (400 mg three times daily), tetracycline (500 mg three times daily), and ranitidine (300 mg in the evening) for two weeks (group II). Study medication was followed in both groups by a four week treatment course with 300 mg ranitidine up to the final examination. One patient from each group was lost to follow up. H pylori was eradicated in 78.9% of group I and 84.2% of group II (p = 1.00). All ulcers in patients on omeprazole plus amoxicillin healed but in the triple treatment group four patients had residual peptic lesions after six weeks (ulcer healing rate: 78.9%, p = 0.11). Complete pain relief occurred after a median duration of 1 day in group I and of 6 days in group II (p = 0.03). There were no major complications in either group but minor side effects were more frequently recorded in patients on triple therapy (63.2% v 15.8%, p < 0.01). In conclusion, two weeks of treatment with omeprazole plus amoxicillin is as good as triple therapy plus ranitidine in eradicating H pylori but seems better with regard to safety, pain relief, and ulcer healing. Thus, amoxicillin plus omeprazole should be recommended as the treatment of choice in eradicating H pylori in patients with duodenal ulcer disease.

[Oral triple therapy for eradication of Helicobacter pylori in duodenal ulcer disease]. / Orale Tripeltherapie zur Helicobacter-pylori-Eradikation bei duodenaler Ulkuskrankheit.

25 patients with Helicobacter pylori-associated active duodenal ulcer disease (bleeding: n = 5, penetrating: n = 1, stenosis of the bulb: n = 4, frequent ulcer relapse: n = 18) were treated with 3 x 600 mg bismuth subsalicylate (BSS), 3 x 400 mg metronidazole and 3 x 500 mg tetracycline in addition to 300 mg ranitidine. 23 out of 25 patients (92%) proved to be Helicobacter pylori-negative four weeks after cessation of study medication as judged from negative urease test, specific culture and histology after modified Giemsa staining. 24/25 ulcers (96%) had healed after six weeks. In one patient on NSAIDs a small duodenal ulcer was detected on the final endoscopic examination despite successful Helicobacter pylori eradication. Twelve out of 25 (48%) patients complained side effects that did not lead to discontinuation of therapy. In conclusion, oral triple therapy with BSS, metronidazole and tetracycline is highly effective in Helicobacter pylori eradication, but there was a rather high rate of more or less serious side effects, diminishing the attractiveness of this therapeutic regimen.

Omeprazole plus amoxicillin: efficacy of various treatment regimens to eradicate Helicobacter pylori.

In five subsequent open clinical studies, 180 patients with Helicobacter pylori (HP)-associated ulcer disease (n = 163) or severe functional dyspepsia (n = 17) requiring therapy were treated with either 40 mg omeprazole plus 4 x 500 mg amoxicillin suspension for 1 wk (group I, n = 35), 2 x 40 mg omeprazole plus 4 x 500 mg amoxicillin for 1 wk (group II, n = 50), 2 x 20 mg omeprazole plus 4 x 500 mg amoxicillin for 2 wk (group III, n = 62), 2 x 20 mg omeprazole (day 1-14) and 4 x 500 mg amoxicillin (day 8-14) (group IV, n = 22) or with 2 x 20 mg omeprazole for 2 wk (group V, n = 11). The HP eradication rates determined with a biopsy urease test, microscopy of a mucosal smear, specific culture, and histology after modified GIEMSA staining in the 5th wk after discontinuation of study medication were 61.3% in group I, 61.7% in group II, 82.8% in group III, 28.6% in group IV, and 0% in group V. Apart from clinical insignificant pharyngeal paresthesias (n = 6), nine patients (5.7%) with combined therapy complained of important side effects (stomatitis: n = 3, diarrhea: n = 3, allergic exanthema: n = 3) that led to termination of amoxicillin treatment in four cases (2.5%). We conclude that omeprazole-enhanced amoxicillin antibiosis is a simple and effective approach to the eradication of HP colonization.

[Is Helicobacter pylori gastritis a macroscopic diagnosis?]. / Ist die Helicobacter-pylori-Gastritis eine makroskopische Diagnose?

In a prospective study, gastroscopy and biopsies from the gastric antrum and body were undertaken in 100 consecutive patients (67 women, 33 men; mean age 58.6 [11-90] years) with unknown Helicobacter pylori status. None had been on any bacteria-suppressing drugs. Main indications for gastroscopy were upper abdominal pain, dyspepsia, emesis and anaemia of unknown cause. The macroscopic criteria for the diagnosis of H. pylori gastritis were the presence of at least one of the following signs: (1) chronic antral erosions; (2) goose-pimple-like appearance of the antral mucosa; (3) spotty erythema in the antrum; (4) complex changes of the antral mucosa with both bizarre reddening and pale areas; and (5) increased areolar markings and diffuse or fine-spotty erythema in the mucosa of the body of the stomach. Four biopsies each from the antrum and body were examined with the urease quick-test, microscopically as smears, specific culture and histology as reference methods. 60 patients had H. pylori gastritis, recognized macroscopically in 59 (sensitivity 98.3%). A false-positive diagnosis was made in 10 of 40 H. pylori-negative patients (specificity 75%). The positive predictive value of macroscopic diagnosis was 85.5%, the negative predictive value 96.8%.

Two weeks treatment with amoxicillin/omeprazole for eradication of Helicobacter pylori.

In an open study, 62 patients with Helicobacter pylori-associated ulcer disease or functional dyspepsia were treated for two weeks with 2 x 20 mg omeprazole preprandially and 4 x 500 mg amoxicillin suspension one hour before meals and at night. 57 patients (active ulcer disease: n = 53, functional dyspepsia: n = 4) completed the study without contravening the protocol. The rate of eradication of the bacteria at least 4 weeks after cessation of study medication was 82.5% (47/57 patients). Three patients experienced side effects during the treatment period (stomatitis, self-limiting diarrhea, allergic exanthema). In one case allergic exanthema led to discontinuation of therapy. 11 patients with H. pylori-associated ulcer disease received 2 x 20 mg omeprazole for two weeks. In this group no eradication of bacteria was observed.

[Short-term therapy with high dosage omeprazole and amoxicillin for Helicobacter pylori eradication. A pilot study]. / Kurzzeittherapie mit hochdosiertem Omeprazol und Amoxicillin zur Helicobacter-pylori-Eradikation. Eine Pilotstudie.

In an open study, 50 patients with Helicobacter pylori-associated ulcer disease or severe functional dyspepsia were treated over one week with 2 x 40 mg omeprazole in the morning and evening preprandially and 4 x 500 mg amoxicillin suspension one hour before meals and at night. Fourty-seven patients (ulcer disease: n = 40, functional dyspepsia: n = 7) completed the study without contravening the protocol. The proportion of Helicobacter pylori eradication four weeks after cessation of study medication was 61.7% (29/47 patients) as judged from negative biopsy urease test, specific culture and histology after modified Giemsa staining. Three patients experienced side effects (stomatitis, self-limiting diarrhea, allergic exanthema).

[Diagnosis of Helicobacter pylori colonization of the gastric mucosa. A prospective comparative study of direct test methods and validation of a new urease test]. / Diagnostik der Helicobacter-pylori-Kolonisation der Magenschleimhaut. Eine prospektive Vergleichsstudie direkter Nachweisverfahren und Validierung eines neuen Urease-Tests.

A prospective study including 119 patients submitted for routine endoscopy of the upper gastrointestinal tract was initiated to compare three commercial biopsy urease tests with regard to sensitivity and specificity in detecting Helicobacter pylori colonization of the gastric mucosa and their reaction velocity. Specific culture, microscopy after staining with methylene-blue, histologic search after modified Giemsa staining and the combined results of culture and histology ("true standard") served as reference methods. The sensitivity and specificity of all three tests were high: Angass urease test 92.0%/97.7%, Telen-Quick test 94.7%/100%, CLO-test 94.7%/100% (analysis of one antrum and one body biopsy in a single test kit). Telen-Quick and CLO-tests reacted faster than the Angass urease test, but a period of 24 hours was necessary for all three tests to detect "true negatives". Histology and microscopy were reliable reference methods concerning sensitivity and specificity, while culture was characterized by inferior sensitivity (78.6%) and high specificity (100%).

[Ciprofloxacin-omeprazole combination therapy for eradication of Helicobacter pylori]. / Ciprofloxacin-Omeprazol-Kombinationstherapie zur Eradikation von Helicobacter pylori.

20 H. pylori-positive patients with gastric or duodenal ulcer disease (n = 16, one with proof of gastric cancer obtained by histology) or severe non-ulcer dyspepsia (n = 4) were entered in a pilot study to examine the effect of a combination of omeprazole (40 mg) before breakfast and ciprofloxacin (2 x 500 mg) 1 hour after meals for 1 week to treat Helicobacter pylori (Hp). The eradication rate was 15% (3 out of 20 patients) 4 weeks after therapy. Ulcer healing occurred in 2 of 3 patients having eradication and 9 of 11 control patients with positive H. pylori urease test and/or culture 4 weeks after treatment. Despite some good theoretical background, this drug combination is inefficient to eradicate H. pylori and cannot be recommended for routine clinical practice. No major side effects of the therapy-regimen were observed.

Effect of "stacking" on the resolving power of ultrathin-layer two-dimensional gel electrophoresis.

The resolving power of two-dimensional ultrathin-layer polyacrylamide gel electrophoresis with and without "stacking" was investigated. Side-by-side analysis shows that the use of a properly adjusted upper gel improves the resolution and reproducibility of this sensitive analytical method. The effects of various detergents (Nonidet-P40, Zwittergent, urea) on the ultrathin-layer polyacrylamide gel electrophoresis were also investigated. For this case, whole cell proteins of Pseudomonas aeruginosa and Staphylococcus aureus treated with different detergents were electrofocused in the presence of the same detergents.