A comparison between omeprazole-based triple therapy and bismuth-based triple therapy for the treatment of Helicobacter pylori infection: a prospective randomized 1-yr follow-up study.

OBJECTIVES: To compare the efficacy and side effects of standard bismuth triple therapy with those of omeprazole-based triple therapy in patients with Helicobacter pylori infection and duodenal ulcer disease. METHODS: One hundred patients were prospectively recruited and randomized to receive either bismuth subnitrate 75 mg q.i.d., oxytetracycline 500 mg q.i.d., and metronidazole 400 mg b.i.d. (regimen BTM), or omeprazole 20 mg b.i.d., amoxicillin 750 mg b.i.d., and metronidazole 400 mg b.i.d. (regimen OAM), both for 14 days. Upper endoscopy (with antral biopsy specimens for microbiology and antral and corpus biopsy specimens for histology) was performed before treatment, after 2 months, and again 1 yr after treatment. Serum samples for serology (IgG) were taken. Patients with in vitro metronidazole-resistant (M-R) H. pylori strains were excluded. In a nonrandomized study, 41 patients with M-R strains were given either BTM or OAM. RESULTS: According to intention-to-treat analysis, H. pylori cure rates were 91% and 96% with BTM and OAM, respectively (p = 0.45). In the BTM group, the mean total side effect score was higher (p < 0.001), and more severe side effects were reported (32% vs. 4%, p < 0.001). In the nonrandomized group of patients with M-R strains, H. pylori cure rates were 88% and 67% with BTM and OAM, respectively. All of the successfully treated patients were still H. pylori-negative after 1 yr. CONCLUSIONS: Both treatment regimens were highly effective in curing H. pylori infection in patients with metronidazole-sensitive strains. Omeprazole-based triple therapy was tolerated better than standard bismuth-based triple therapy.

A double-blind placebo-controlled trial with loperamide in irritable bowel syndrome.

BACKGROUND: Loperamide has a relaxing effect on localized and segmental large-bowel spasms. On the basis of previously observed effects on pain and stool habits in patients with diarrhoea, the present trial intended to examine the regulating effect in an unselected cohort of patients with the irritable bowel syndrome (IBS). The symptoms in IBS are dependent on variations in motility initiated by different mechanisms. Therefore, when examining the effect of treatment, characterization of the patient material is important. METHODS: Ninety patients were included in this prospective double-blind trial comparing loperamide with placebo over 5 weeks. The two groups were characterized and compared with healthy controls (n = 33), matched by age and sex. Demographic, clinical, and biochemical data were recorded. RESULTS: Clinical variables and social and personal relationships were similar for the loperamide group (n = 35), the placebo group ( n = 34), the dropouts (n = 21), and controls. Somatic diseases and mental disturbances were increased in the patients compared with the controls. Throughout the 5 weeks of treatment an improved stool consistency (32%), reduced defecation frequency (36%), and reduced intensity of pain (30%) were found in the loperamide group. An increase in nightly pain was observed in the loperamide group. CONCLUSIONS: This trial lends support to a multifactorial aetiology in IBS. Treatment must be individualized with regard to both the effect and the risk of constipation and abdominal pain. The trial shows a benefit of loperamide in an unselected cohort of IBS patients with regard to stool frequency, stool consistency, and the overall pain intensity, but with increased abdominal pain during the night. It should be recommended that the patients take the medication in divided daily doses.