Are guidelines followed in Helicobacter pylori diagnosis and therapy? An inquiry among gastroenterologists, referring physicians and patients in Munich.

BACKGROUND AND STUDY AIMS: Attempts to standardize Helicobacter pylori (Hp) diagnosis and therapy have led to the publication of guidelines by various national gastroenterological societies in Europe and the USA. However, little information is available either regarding the compliance of gastroenterologists and referring physicians with these guidelines, or regarding the patients' perspective. PATIENTS AND METHODS: A retrospective analysis was conducted of all outpatient upper gastrointestinal endoscopy reports for a one-month period in eleven different centers (two university hospitals and nine private practice gastroenterology offices) with a total of 24 gastroenterologists. Endoscopy reports from patients wit the indications of reflux, diarrhea, and tumors were excluded. Diagnoses and treatment recommendations given by gastroenterologists were recorded. Questionnaires concerning Hp diagnosis, treatment indications and performance, and follow-up were sent to referring physicians and patients. RESULTS: A total of 772 endoscopy reports were included in the study; analyzable questionnaires were returned by 287 referring physicians (47%) and by 265 patients (59%). Gastroenterologists recommended Hp eradication in all ulcers and in 29% of gastritis/nonulcer dyspepsia (NUD) cases. Referring physicians thought that 94% of ulcers should be treated by Hp eradication, which was also considered to be an absolute and relative indication in NUD by 15% and 53% of the referring physicians, respectively. Among the patients who replied, 52% had received Hp eradication regimens; ulcers were found in 22% of the total patient group. Check-up examinations after Hp therapy were considered necessary by 75% of the referring physicians, but only 22% of the responding patients actually underwent some form of check-up (upper gastrointestinal endoscopy in 91%). CONCLUSIONS: Gastroenterologists and (to a somewhat lesser extent) referring physician appear to be following the current guidelines for Hp treatment. As expected, two thirds of referring physicians consider NUD to be absolute or relative indication for Hp eradication. Check-up examinations are apparently being performed less frequently than recommended.

Comparison of omeprazole, metronidazole and clarithromycin with omeprazole/amoxicillin dual-therapy for the cure of Helicobacter pylori infection.

In this randomized, multicenter trial, we evaluated the effectiveness and side effect profile of a modified omeprazole-based triple therapy to cure Helicobacter pylori infection. The control group consisted of patients treated with standard dual therapy comprising omeprazole and amoxicillin. One hundred and fifty-seven H. pylori infected patients with duodenal ulcers were randomly assigned to receive either a combination of omeprazole 10 mg, clarithromycin 250 mg and metronidazole 400 mg (OCM) given three times daily for 10 days (n = 81), or a combination of omeprazole 20 mg and amoxicillin 1 g (OA) given twice daily for 14 days (n = 76). Prior to treatment and after 2 and 6 weeks, gastric biopsies from the antrum and corpus were obtained for histology and H. pylori culture. H. pylori infection was cured in 97.4% after OCM and in 65.8% after OA in the per-protocol analysis (p < 0.001) (intention-to-treat analysis: 93.4% and 63.2%, respectively). H. pylori was successfully cultured in 122 patients (77%). The overall rate of metronidazole resistance was 19.7% (24/122), no primary resistance to clarithromycin or amoxicillin was found. In the OCM group, all patients infected with metronidazole-sensitive H. pylori strains (n = 51) and those infected with strains of unknown susceptibility to metronidazole (n = 14) were cured (100%), while 77% (10/13) of those harboring metronidazole-resistant strains were cured of the infection (p = 0.36). Side effects leading to premature termination of treatment occurred in 2.5% of the patients in the OCM group and in 1.4% of the OA group. We conclude that combined treatment with omeprazole, clarithromycin and a higher dose of metronidazole is highly effective in curing H. pylori infection, and that this regimen remains very effective in the presence of metronidazole-resistant strains.

Double-blind trial of omeprazole and amoxicillin in the cure of Helicobacter pylori infection in gastric ulcer patients. The Ulcer Study Group, Germany.

BACKGROUND: Our aim was to investigate the efficacy of omeprazole and amoxicillin in curing Helicobacter pylori infection in gastric ulcer patients. METHODS: In a double-blind trial 185 H. pylori-positive gastric ulcer patients were prospectively randomized to receive 40 mg omeprazole twice daily and either 750 mg amoxicillin three times daily or 750 mg amoxicillin placebo three times daily on days 1-14, followed by 20 mg omeprazole daily on days 15-56. RESULTS: Twenty-seven patients were excluded because of lack of compliance or missed follow-up examinations; one patient receiving amoxicillin discontinued treatment owing to side effects. On an intention-to-treat basis, omeprazole/amoxicillin led to cure of H. pylori infection in 67.1% (47 of 70) of patients not using non-steroidal anti-inflammatory drugs (NSAIDs)/aspirin (ASA) and in 46.7% (14 of 30) of those taking NSAIDs/ASA (P < 0.05). With the omeprazole/placebo regimen, H. pylori infection was cured in 8.8% (no NSAIDs), and 0% (NSAIDs). CONCLUSIONS: The use of NSAIDs/ASA may limit the efficacy of omeprazole/amoxicillin in curing H. pylori infection in gastric ulcer patients.

Severity of Helicobacter pylori gastritis predicts duodenal ulcer recurrence.

BACKGROUND: Helicobacter pylori gastritis is suggested to be the underlying condition leading to duodenal ulcer disease. The aim of the study was to investigate the relationship between chronic active H. pylori gastritis and the risk of duodenal ulcer (DU) recurrence. METHODS: One hundred and eighty-eight patients were followed up with regard to the evolution of their H. pylori gastritis after they had received antibacterial or acid-suppressing treatment for their DU. Four weeks, 1 year, and 2 years after treatment and in the case of DU recurrence several morphologic indicators of gastritis were studied histologically in the antrum and corpus. RESULTS: In patients who were cured of H. pylori infection a significant and long-lasting regression of all gastritis variables were observed. patients with persistent H. pylori infection after antibacterial treatment showed only a temporary regression of all gastritis variables. In the overall group of patients who received acid-suppressive therapy there was no change in gastritis. However, in the subgroup of patients who received omeprazole monotherapy, no change in the antrum but a statistically significant increase of gastritis in the corpus was observed. The grade of antral gastritis at the end of treatment was significantly and positively correlated with the risk of DU recurrence and was independent of the kind of pretreatment (18.5% recurrences in grade-2 versus 86% in grade-4 gastritis). CONCLUSIONS: The data show that the grade of gastritis is an important risk factor for duodenal ulcer recurrence. Cure of H. pylori infection is associated with healing of chronic H. pylori-associated gastritis. These data lend considerable support to the hypothesis that H. pylori gastritis is the most important factor among those leading to duodenal ulcer disease.

Cure of gastric ulcer disease after cure of Helicobacter pylori infection--German Gastric Ulcer Study.

BACKGROUND: Helicobacter pylori infection is associated with gastric ulcer disease in about 75% of cases. OBJECTIVE: The aim of this study was to determine whether H. pylori eradication reduces gastric ulcer relapse rates. DESIGN: The study was randomized, controlled, multicentric and investigator blinded, and was conducted at three university hospitals, two teaching hospitals, and by six practising gastroenterologists. METHODS: During a period of 1 year 152 patients with gastric ulcers were randomly assigned to one of two treatment regimens: omeprazole 20 mg daily in the morning for 8 weeks (74 patients), or bismuth subsalicylate 600 mg three times daily for 8 weeks combined with 500 mg amoxicillin twice daily and 1000 mg tinidazole twice daily for the first 10 days (triple therapy) (78 patients). Follow-up examinations were performed 6, 12 and 18 months after treatment and whenever ulcer symptoms occurred. RESULTS: Of the 152 randomized patients five were excluded because of gastric cancer, 10 missed follow-up examinations and seven receiving triple therapy terminated treatment because of side effects. Of the remaining 130 patients, five of 69 (7.2%) in the omeprazole and six of 61 (9.8%) in the triple group were H. pylori negative. After 8 weeks' therapy, the gastric ulcer was healed in 85.9% (omeprazole) and in 81.8% triple) in H. pylori-positive patients, and in 80% (omeprazole) and 16.7% (triple) in H. pylori-negatives. H. pylori was eradicated in 8.1% of the patients who received omeprazole monotherapy and in 78.2% receiving triple therapy, and in 8.1% and 69.4% in an intention-to-treat analysis. The subsequent relapse rates during a follow-up period of 12 months were 50% in the omeprazole group and 4% in the triple group. Gastric ulcer relapse was observed in 49% of patients who were H. pylori positive and in 2% who were H. pylori negative after treatment. CONCLUSION: The data show that the presence of H. pylori is an important predictor of gastric ulcer relapse and that eradication of H. pylori may heal gastric ulcer disease.

Recurrence of duodenal ulcers during five years of follow-up after cure of Helicobacter pylori infection.

BACKGROUND: Chronic Helicobacter pylori-associated gastritis is now widely accepted as one of the most important pathogenic factors in duodenal ulcer disease. However, little is known about for how long patients remain free of duodenal ulcer relapses after H. pylori infection has been cured. In the present study, we investigated remission time during a 5-year follow-up period after anti-H. pylori treatment. METHODS: The patients were randomly allocated to treatment with either a combination of 3 x 600 mg bismuth subsalicylate and 2 x 1000 mg amoxycillin or 3 x 600 mg bismuth subsalicylate monotherapy. Endoscopy, including histological and microbiological examination of biopsies, was performed 4 weeks after termination of treatment and after 1 and 2 years. During the third, fourth and fifth years of the follow-up period, patients were monitored twice a year for symptoms compatible with ulcer relapse and for their use of anti-ulcer medication. Endoscopic and histological examinations were carried out whenever symptoms occurred. RESULTS: Of 56 evaluated patients, 47 showed healing of ulcers after bismuth subsalicylate plus amoxycillin compared with 44 of 57 after bismuth subsalicylate monotherapy. H. pylori infection was cured in 52% (29 of 56) of the patients after combined therapy and in 4% (2 of 57) after the monotherapy. The cumulative duodenal ulcer relapse rates after 5 years were 38% (18 of 47) after the combined therapy and 75% (33 of 44) after the monotherapy. In patients who were cured of H. pylori infection, the cumulative duodenal ulcer relapse rate after 5 years was 9.7% (3 of 31), compared with 81.7% (49 of 60) in those patients who remained H. pylori-positive after treatment (P < 0.001). In two of the three patients who suffered duodenal ulcer relapse after being cured of H. pylori infection, H. pylori was present again at the time of relapse. CONCLUSION: The data suggest that curing H. pylori infection results in long-term cure of duodenal ulcer disease and that duodenal ulcer relapses in successfully treated patients are most often associated with H. pylori reinfection.

Double-blind trial of omeprazole and amoxicillin to cure Helicobacter pylori infection in patients with duodenal ulcers.

BACKGROUND/AIMS: Anti-Helicobacter pylori treatment with combinations of omeprazole and amoxicillin is a promising treatment option. The aim of this study was to investigate whether a daily omeprazole dose of 120 mg combined with amoxicillin would cure H. pylori infection at a rate comparable with that achieved with "triple therapy." METHODS: In a double-blind, randomized, controlled, and multicenter trial in Germany, 270 patients with an H. pylori-associated duodenal ulcer were treated with 40 mg omeprazole three times a day and 750 mg amoxicillin three times a day for the first 14 days (n = 139) followed by 20 mg omeprazole once daily until day 42 or with omeprazole plus 750 mg amoxicillin placebo three times a day for the same time period (n = 131). RESULTS: Cure rates of H. pylori infection were 91% in the omeprazole plus amoxicillin group, 0% in the omeprazole plus placebo group, and 89% and 0%, respectively, performing an intention-to-treat analysis. Cure of H. pylori infection in patients pretreated with omeprazole was only 58% compared with 95% in patients who were not. The cumulative 12-month relapse rates were 11.3% and 44% in the treatment groups and 1.6% in H. pylori-negative and 49% in H. pylori-positive patients. CONCLUSIONS: The combination of 120 mg omeprazole daily and 2.25 g amoxicillin daily with its H. pylori cure rate of around 90% is one of the best tolerated and most effective treatment regimens.

Two-year follow-up of duodenal ulcer patients treated with omeprazole and amoxicillin.

The present study evaluated the time in remission during a 2-year follow-up after eradication of Helicobacter pylori (HP) in patients with an HP-associated duodenal ulcer (DU). HP was eradicated by combined treatment with high-dose omeprazole (2 x 40 mg) and amoxicillin (2 x 1,000 mg; n = 27) administered for 10 days (OME + AMX); alternatively, patients were treated with omeprazole monotherapy (OME) using the same dosage (n = 25). During the 2-year follow-up period endoscopy including histological examination was performed after 1 and 2 years or whenever symptoms compatible with ulcer relapse occurred. HP eradication was achieved in 82% of the OME + AMX group, but in 0% of the OME group. The cumulative DU relapse rates were 0% after 1 year and 7% after 2 years in 22 patients who became HP-negative. Both HP-negative patients who relapsed in the 2nd year of follow-up were HP-positive again at the time of relapse. Of the 5 patients who were not eradicated after OME + AMX therapy, 2 relapsed within the 1st year (40%) and another 2 within the 2nd year (80%). In the OME group the cumulative relapse rates within 1 and 2 years of follow-up were 52 and 76%, respectively. The results further confirm that eradication of HP with combined OME + AMX treatment leads to a distinct decrease in DU relapse rates and thus may cure DU disease. Long-term eradication with combined OME + AMX treatment is possible, and the rate of reinfection with HP is low (4.5%/year).

Long-term follow-up after eradication of Helicobacter pylori with a combination of omeprazole and amoxycillin.

Early studies have suggested that omeprazole may facilitate the eradication of Helicobacter pylori. Sixty patients with duodenal ulcer and H. pylori colonization were randomly assigned to receive either omeprazole monotherapy (n = 30) or combination therapy with omeprazole and amoxycillin (n = 30) for a total duration of 6 weeks. Four patients receiving monotherapy and three receiving combination therapy had to be withdrawn from the study. All (100%) duodenal ulcers healed in patients receiving combination therapy, and 25 out of 26 (96%) healed in the group receiving monotherapy. H. pylori was eradicated in 22 out of 27 (82%) patients receiving combination therapy; only two ulcer relapses (9%) occurred within 18 months in these 22 patients. Of the five patients who remained H. pylori-positive after combination therapy, two relapsed during the 18-month follow-up. In the monotherapy group, all patients remained H. pylori-positive after treatment, and duodenal ulcer relapsed in 16 out of 25 (64%) patients within the median follow-up of 18 months. Adverse events were not reported in the group treated with combination therapy; one patient receiving monotherapy reported severe headache. These results lend further support to existing data that H. pylori eradication prevents duodenal ulcer relapse and show that combination therapy with omeprazole and amoxycillin is effective and well tolerated.

Bioptic microbiology in the differential diagnosis of enterocolitis.

Parameters in the differential diagnosis of enterocolitis have been poorly evident for many years. Development and profitable employment of endoscopic instruments were the first step towards advancing the diagnostic facilities in inflammatory bowel disease. The microbiologic examination of mucosal biopsies creates a new diagnostic dimension, and it distinctly seems to increase the diagnostic sensitivity for pathogens. Within fifteen months 152 patients admitted to the gastroenterologic unit with acute, or symptoms of exacerbated, bowel disease were examined for the aetiologic agents. Compared with former reports, idiopathic inflammatory bowel disease (IIBD) such as Crohn's disease (32.2%) and ulcerative colitis (18.4%) were decreased. Infectious colitis (22.3%), mostly Campylobacter or Yersinia infections, was, sometimes exclusively, diagnosed by bioptic microbiology, non-classifiable forms of colitis (21.7%), and rare forms (5.4%) were diagnosed more often. It proved to be important that IIBD was frequently superinfected by Campylobacter, Yersinia and Chlamydia, and the differential diagnosis was complicated, since these microorganisms can mimic IIBD. The results suggest that coloileoscopy combined with bioptic microbiologic investigation additional to faecal samples should include a search for Campylobacter and Yersinia. It appears indispensable that the final diagnosis "Crohn's disease" or "ulcerative colitis" should be confirmed by sequential coloileoscopy and microbiologic examination.

Angiodysplasia in the colon and rectum. Endoscopic morphology, localisation and frequency.

In a prospective study, the occurrence of angiodysplasia was investigated by total colonoscopy in 1938 patients. Angiodysplasia was found in 59 patients, i.e. 3%. 12 out of 59 patients were admitted for acute or chronic peranal hemorrhage or anemia. 47 out of 59 patients were asymptomatic. The site of the lesions was as follows: cecum 37%, ascending colon 17%, transverse colon 7%, descending colon 7%, sigmoid colon 18% and rectum 14%. Histological confirmation was obtained in 15 out of 37 biopsies. The endoscopic appearance was variable, most of the vascular dilatations being smaller than 5 mm (n = 47), with a homogeneous (n = 35) or inhomogeneous (n = 24) structure and a regular (n = 34) or irregular (n = 25) border. The lesions were single (n = 34) as well as multiple (n = 25), they were usually flat (n = 54), seldom slightly prominent (n = 5). Concomitant pathological findings in the bowel were diagnosed in 33 out of 59 patients: diverticula in 32%, adenomas in 24% and carcinomas in 8.5%. Right hemicolectomy for bleeding angiodysplasia is indicated only if endoscopic therapy has failed and other colorectal sources of bleeding, and especially angiodysplasia in the left colon and rectum have been excluded by endoscopy or angiography.

Ergotamine-induced colitis.

We report on a 45-year-old woman with ulcerative colitis of the rectum that arose after the use of up to 6 suppositories of a preparation containing ergotamine daily over a period of 6 years. On the basis of a review of the literature the clinical, endoscopic and histological features of the ergotamine-induced colitis are characterized.

[Duodenal polyps. Incidence, histologic substrate and significance]. / Duodenalpolypen. Häufigkeit, histologisches Substrat und Bedeutung.

378 duodenal polyps were identified by endoscopic biopsy since 1973 in the course of more than 25,000 oesophago-gastro-duodenoscopies, corresponding to an incidence rate of 1.5%. Heterotopias of the gastric mucosa and so-called inflammatory polyps were most frequent (35.7% and 35.2%, respectively), followed by hyperplasia of Brunner's glands (6.9%), lipid islets (2.9%) and lymphatic hyperplasia (1.8%). Histologically there was no correlate to the endoscopic findings. Hence, non-neoplastic polyps account for about 90% of duodenal polyps; they are harmless and generally produce no (or only minor) signs or symptoms. Clinically relevant polyps besides the primary and secondary malignant processes are the adenomas of the colon type (6.9%) and Peutz-Jeghers polyps (1.3%). Since these two may occur in gastrointestinal polyposis, "top-and-tail endoscopy" must be performed. The rate of complications of 15% in endoscopic loopectomy in the duodenum is clearly higher than that in the stomach and colon.

[Fungus colonization in colitis]. / Pilzbesiedlung bei Kolitiden.

Fungal cultures, unstained smears and histological assessment of endoscopically obtained particles from ulcers in rectum, colon or terminal ileum were obtained in a prospective study of possible fungal infection in 78 patients with colitis of various aetiologies (Crohn's disease - 46; ulcerative colitis - 21; infectious colitis - 5; ischaemic colitis - 2; radiation colitis - 1; non-classifiable colitis - 3). Positive fungal culture was obtained in 13 patients (16.7%). The germ count was low (2--8 colonies per biopsy piece). The demonstrated fungi were almost exclusively Candida or Torulopsis. The potentially pathogenic mycelia phase of the fungi were never seen, either histologically or in unstained preparations. Stool specimens, obtained at the same time, were examined in 54 patients: positive cultures were obtained in 14 (25.9%). Only rarely were there concordance of positive fungal findings in both ulcer particles and faeces. It is concluded that (1) there is little danger of secondary fungal infection in colitis of various aetiologies; (2) positive faecal fungal culture is apparently of no pathogenic significance if the germ count is less than 10(6) per gram stool; (3) in the lower as well as the upper gastro-intestinal tract pathogenic fungal infection can be demonstrated only by endoscopy and biopsy.