Efficacy of two different dosage regimens of omeprazole, amoxycillin and metronidazole for the cure of Helicobacter pylori infection.

BACKGROUND: While addition of metronidazole to the omeprazole-amoxycillin combination has been shown to be advantageous, the optimal dosage and drug distribution of the antimicrobials has not been sufficiently evaluated. AIM: To investigate the efficacy of two different regimens of omeprazole, amoxycillin and metronidazole for the cure of Helicobacter pylori infection. METHODS: Two hundred and fifty-five patients with H. pylori associated duodenal ulcers were randomly treated with either a 1-week regimen of omeprazole 20 mg b.d., amoxycillin 1000 mg b.d. and metronidazole 800 mg b.d. (OAM b.d.) or a combination of omeprazole 40 mg o.d., amoxycillin 500 mg t.d.s. and metronidazole 400 mg t.d.s. (OAM t.d.s.). All patients subsequently received omeprazole 20 mg o.d. for an additional 3 weeks. H. pylori status was assessed by histology and 13C-UBT prior to treatment and 8 weeks after randomization. Additional biopsies were obtained for H. pylori culture to determine primary and secondary resistance to metronidazole by agar dilution. RESULTS: Two hundred and thirty-seven patients were included in the intention-to-treat analysis and 198 patients in the per protocol analysis. With intention-to-treat analysis, the cure rate was 77% after treatment with OAM b.d. (95% CI, 69%-85%) and 76% after OAM t. d.s. therapy (95% CI, 67%-83%). Ulcer healing (intention-to-treat analysis) was documented in 95% of patients in the OAM b.d. group (n=122) and in 97% of patients in the OAM t.d.s. group (n=115). Adverse events were reported in 26 (20%) and in 18 (14%) patients in the OAM b.d. and OAM t.d.s. groups, respectively. None resulted in discontinuation of treatment. Overall primary resistance of H. pylori against metronidazole was found in 22 of 116 strains (19%). CONCLUSIONS: The combination of omeprazole, amoxycillin and metronidazole achieves about an 80% cure rate of H. pylori infection even in active ulcers. The total daily dose, and the choice of twice or three times daily dosing does not seem critical with this regimen.

The GU-MACH study: the effect of 1-week omeprazole triple therapy on Helicobacter pylori infection in patients with gastric ulcer.

AIMS: To study the efficacy of omeprazole triple therapy in the eradication of Helicobacter pylori in patients with active gastric ulcer, and to assess healing and relapse of gastric ulcer. METHODS: A double-blind, randomized study was carried out in 18 centres in Germany, Hungary and Poland. Patients (n = 160) with gastric ulcer and a positive H. pylori screening test were randomized to a 7-day twice daily treatment with omeprazole 20 mg, clarithromycin 500 mg and amoxycillin 1000 mg (OAC) or omeprazole 20 mg, clarithromycin 250 mg and metronidazole 400 mg (OMC), or with omeprazole 20 mg once daily (O). After completion of this 1-week treatment, patients were treated with omeprazole until healing (maximum 12 weeks), and followed for 6 months. H. pylori was assessed by urea breath test (UBT) and histology. RESULTS: Eradication rates ITT were OAC 79% (95% CI: 65-90%), OMC 86% (95% CI: 73-94%) and O 4% (95% CI: 0-14%). Eradication rates PP were OAC 83% (95% CI: 68-93%), OMC 93% (95% CI: 80-98%) and O 3% (95% CI: 0-13%). Gastric ulcer relapses occurred in 5, 0 and 11 patients in the groups, respectively. CONCLUSIONS: The results from the study demonstrate that OMC and OAC 1-week regimens are safe and effective for eradication of H. pylori in gastric ulcer patients, and that ulcer relapse is infrequent after successful eradication.

Performance of a rapid whole blood test for Helicobacter pylori in primary care: a German multicenter study.

BACKGROUND: Serological rapid whole-blood tests for the detection of H. pylori are presently being promoted for use in primary care. We conducted a multi-center study to investigate the diagnostic accuracy of the Boehringer Mannheim Helicobacter pylori test (BM test), which is identical with the Cortecs Helisal test. PATIENTS AND METHODS: A previous diagnosis of H. pylori, a history of peptic ulcer diseases, or proton-pump inhibitor, bismuth or antibiotic use during the preceding month were exclusion criteria. The BM test was performed prior to endoscopy by 7 primary care physicians, 5 practicing gastroenterologists, or a single physician in the university hospital outpatient service. During endoscopy, antral and corpus biopsies were obtained for histology and rapid urease testing (RUT). H. pylori positivity was defined by histology and/or RUT as reference methods. H. pylori IgG-ELISA was performed additionally. RESULTS: Of the 203 patients included, 151 were H. pylori-positive by reference methods (74.4%). The overall accuracy of the BM test was 77.3%. Eight BM tests were indeterminate, and in the other 195 patients the test performed as follows: sensitivity 80.3%, specificity 81.3%, positive predictive value 92.9%, negative predictive value 57.4%. Using IgG-ELISA as reference, the BM test performance was similar. It also did not differ substantially among the three groups of physicians involved. CONCLUSIONS: We found the performance of the BM test to be insufficiently accurate, as both over- and underdiagnosis of H. pylori infection were not infrequent. This test needs to be improved before its use in primary care can be recommended.

[Valine and branched-chain amino acids in the treatment of hepatic encephalopathy]. / Valin und verzweigtkettige Aminosäuren in der Behandlung der hepatischen Enzephalopathie.

We studied the effects of infusion of a liver adapted amino acid solution (Amino-Mel hepa: Group A) versus a liver adapted amino acid solution plus L-valine (Amino-Mel hepa + L-valine: Group B) in 30 patients with decompensated liver cirrhosis with coma. Each 15 patients were randomly allocated to the group A and B, respectively. Both regimens included the infusion of glucose and fat, further supplementation of vitamins and trace elements in addition to the amino acid solution. The results of this study show that in patients with advanced stage of hepatic coma a valine increased supply of branched chain amino acids neither influences the course of the disease nor the death rate. The prognosis of patients with this disease is mainly determined by liver function and accompanying complications.

Clinical studies on zinc in chronic liver diseases.

Zinc is essential to numerous metabolic processes in the organism, multiform symptoms being found especially in deficiencies. In addition to nutritional factors, diseases such as cirrhosis of the liver. Crohn's disease and chronic renal diseases are relevant in this context. In the present work, serum zinc levels were investigated in 109 patients with various chronic liver diseases. The lowest serum zinc concentrations were seen in patients with decompensated hepatic cirrhosis with coma. Patients with decompensated alcoholic cirrhosis had lower zinc levels as subjects with nonalcoholic cirrhosis. None of the groups exhibited a significant change in serum zinc levels during the treatment period. Laboratory data (such as transaminases, thromboplastin time, alkaline phosphatase, total proteins) did not correlate with the serum zinc concentrations. The concentration of plasma ammonia, however, appeared to be inversely related to the serum zinc levels. Thus, patients with coma had maximum ammonia and minimum zinc levels.

[Planned reoperation following perforation of peptic ulcer with a simple suture. A differentiated treatment concept]. / Die planmässige Reoperation nach Perforation eines Ulcus pepticum mit einfacher Ubernähung. Ein differenziertes Behandlungskonzept.

Even after perforation of chronic peptic ulcer with simple closure, patients continue to be in danger for additional complications of the ulcer ailment. Postoperative conditions of patients with perforated ulcer were analysed for a period of ten years. Classical indications for re-operation were recorded from 60 per cent. A differentiated concept for treatment of ulcer perforation is presented in this paper.