Eradication of Helicobacter pylori and prevention of recurrence of duodenal ulcer: a randomized, double-blind, multi-centre trial of omeprazole with or without clarithromycin.

BACKGROUND: Antimicrobial treatment for Helicobacter pylori eradication is currently recommended for all patients with duodenal ulcer disease, but consensus on the best treatment is lacking. METHODS: Patients with active duodenal ulcer and H. pylori were enrolled in a double-blind, randomized, placebo-controlled multi-centre study. Patients received omeprazole 40 mg daily for 28 days and either clarithromycin 500 mg t.d.s. or placebo t.d.s. for the first 14 days. Patients underwent endoscopy before starting treatment, at 2 weeks, immediately after stopping treatment if unhealed at 2 weeks, and at 1, 6 and 12 months after the end of treatment, or at the recurrence of symptoms. Eradication of H. pylori, duodenal ulcer healing and ulcer recurrence were measured. RESULTS: One-hundred and fifty-four patients were recruited and randomized to omeprazole plus clarithromycin (n = 74) or to omeprazole plus placebo (n = 80). One month after treatment, H. pylori was eradicated in 57 of 69 (83%; 95% CI: 72-91%) patients receiving omeprazole plus clarithromycin, compared with 1 of 75 (1%; 95% CI: 0-7%) receiving omeprazole alone (P < 0.001). In patients receiving omeprazole plus clarithromycin the ulcer healed at 2 weeks in 83% (95% CI: 71-91%) and at 4 weeks in 100% (95% CI: 95-100%), compared with 77% (95% CI: 66-86%) and 97% (95% CI: 91-100%) in those given omeprazole plus placebo (N.S.). Ulcers recurred at 12 months in 6% (95% CI: 1-16%) of patients given omeprazole plus clarithromycin, compared with 76% (95% CI: 63-86%) of patients given omeprazole plus placebo (P < 0.001). The incidence of side-effects was similar in both treatment groups (38% with clarithromycin dual therapy and 29% with omeprazole plus placebo; P = 0.304). Ninety per cent of patients took at least 90% of their prescribed medication. CONCLUSIONS: Omeprazole plus clarithromycin dual therapy eradicated H. pylori in 83% of patients with duodenal ulcer and significantly decreased 12-month recurrence from 76% to 6%.

Rectocolectomy with anal conservation in inflammatory colitis.

Eleven patients with inflammatory colitis underwent total colectomy and rectal excision with conservation of the anus. This is a lesser procedure than proctocolectomy and achieves total extirpation of diseased large-bowel mucosa.

A new technique for excision of recurrent anastomotic strictures of the rectum.

A previously unreported method of resection of anastomotic strictures of the rectum using a circular stapling device is described. The use of the technique in two cases of recurrent anastomotic stricture is reported. Neither patient has had further stricture formation during the follow-up period.

Gastrojejunostomy: a simple method of treatment of gastric volvulus.

Ten patients treated for gastric volvulus over eleven years are reviewed. Nine were treated successfully by gastrojejunostomy. The advantages of this simple procedure are discussed. Changes occurring in the position of the pylorus may predispose to this condition.

Large gallstones may pass spontaneously.

We report two cases in which gallstones greater than 1 cm in diameter passed spontaneously from the common bile duct into the duodenum. The possibility of spontaneous passage should be borne in mind in the management of patients with common duct stones.

Gynaecomastia associated with cimetidine.

Gynaecomastia has occurred unilaterally or bilaterally in five out of 25 male duodenal ulcer patients after more than four months treatment with cimetidine 1.6 g daily. All elected to continue treatment to 12 months and their breast enlargement regressed rapidly and disappeared after stopping treatment. During treatment all patients were found to have normal concentrations of plasma testosterone and oestradiol, and serum prolactin was normal in the two patients measured. Excision biopsy of the subareolar tissue in one patient revealed histology typical of the florid stage of gynaecomastia. Blockade of androgen-responsive receptors receptors in the target organ appears to be the most likely mechanism involved.

Influence of a meal on the absorption of cimetidine. A new histamine H2-receptor antagonist.

Absorption of an oral dose of 300 mg of Cimetidine was studied after an overnight fast in six healthy male volunteers on three separate occasions, 20 min before, during, and 2 h after a standard breakfast. Compared to the doses taken before and after the meal, the dose taken with the meal showed a significant delay in the time taken to reach therapeutic blood concentrations of the drug with no reduction in the period of time during which this concentration was maintained. We, therefore, suggest that the drug should be taken with a meal to achieve optimal acid inhibition in the interdigestive period.

Effect of metiamide on basal and stimulated serum cholecystokinin levels in duodenal ulcer patients.

Serum cholecystokinin (CCK) levels were measured in 10 patients with chronic duodenal ulcers, fasting and at intervals after two standard tests meals (300 ml of 40 mmol/1 phenylalanine solution), one given before and one during H2-receptor blockade with metiamide (200 mg four times a day). Fasting serum CCK levels were lower in all patients during treatment with metiamide (the mean level falling from 306-0 +/- 102-0 (SEM) to 82-1 +/- 23-6 pg/ml after treatment (p less than 0-01)). In contrast, peak serum CCK levels after the meal were not significantly different (7400 +/- 1141 pg/ml before treatment and 7569 +/- 1293 pg/ml on metiamide). We conclude that in duodenal ulcer patients CCK secretion under basal condtions may be in part dependent on stimulation of the small intestinal mucosa by gastric acid, but that, after an amino acid meal, gastric acid secretion is less important in determining the amount of CCK released.

Anorectal Crohn's disease.

Four hundred and twenty-three patients with Crohn's disease have been reviewed, 48 of whom had isolated anorectal involvement--an incidence of 11.4 per cent. These patients were compared with 48 randomly selected and sex-matched cases who presented with isolated ileocolic disease. The age of the anorectal patients (53.6 +/- 18 years) was greater than that of the controls (34.2 +/- 12 years). The duration of follow-up was 6.0 +/- 4 years and 12.6 +/- 8 years respectively. Rectal bleeding, diarrhoea and perianal disease were more common in the anorectal group. Twenty-two patients (46 per cent) with anorectal disease and 40 (83 per cent) in the ileocolic group underwent definitive surgery. There were 4 (18 per cent) postoperative deaths in the anorectal group and none among the controls. The incidence of recurrence was lower among the anorectal patients (21 per cent) compared with the ileocolic group (40 per cent). However, the estimated probability of recurrence, based on the duration of follow-up, the number of deaths during follow-up and the actual incidence of recurrence, is similar in both groups.

Glucose and insulin levels in duodenal ulcer disease before and after surgery.

Glucose and insulin responses to a standardized test meal in patients with chronic duodenal ulceration were measured pre-operatively and again post-operatively. An abnormal pre-operative glucose tolerance contributes to an even more deranged post-operative glucose tolerance. However, following administration of an alpha-glucosidase inhibitor, Acarbose, these post-operative abnormalities are markedly attenuated.

[Endoscopic treatment of oesophageal sténosis using Celestin prosthesis (author's transl)]. / Traitement endoscopique des sténoses oesophagiennes par prothèse de Célestin.

The Celestin pulsion tube introduced by endoscopy seems to constitute a satisfactory method of dealing with oesophageal strictures, both malignant and benign. The site and histology of the tumour, as well as the diameter of the remaining lumen are determined by an initial endoscopic examination. The Eder-Puestow guide wire, essential to safe dilatation and intubation, may be introduced in various ways depending upon the size, length and nature of the stenosis: it may be threaded through the lumen with a fiberoscope under radiological control, or after drilling with laser. Subsequent dilatation may be carried out with olive-shaped metal dialtors, stepped plastic dilators of laminaria, depending upon the degree of fibrosis and the risks of fissuration. A final diameter of 17 mm is advisable. The pulsion tube, with its soft anti-migration skirt, is positioned using an introducer mounted on a semi-rigid mandrin or sliding over a fiberoscope. Its position must be checked at three-monthly intervals. The authors have used this method in 115 patients, 24 of whom had benign lesions and 91 malignant lesions. Among the latter, 23 had been irradiated, 7 were post-anatomotic and 61 had never been treated. There were 5 cases of mediatinitis and one of haemorrhage. Eleven tight strictures, wich had resisted dilatation with metal olive yieled laminaria. The longest follow-ups are of 19 months for malignant stenose and 40 months for benign stenoses. The main indications are malignant stenoses, irrespective of whether they have been irradiated or not, and peptic stenoses in inopereable patients. The procedure restores normal oral feeding, thereby avoiding the need for gastrostomy or jejunostomy.