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Biomedical subjects

R J Bailey

Publications and source records attributed to R J Bailey.

At least 37 records · Page 2Linked to original sources

Twice daily nizatidine or ranitidine is superior to once daily dosing in elevating 24 h intragastric pH in patients with duodenal ulcer disease.

The present study was performed in six asymptomatic patients with a history of resistant duodenal ulcers in whom 24 h intragastric pH, gastric juice pepsin and PGE2 concentrations, as well as serum gastrin concentrations, were measured. We wanted to compare the effects on these parameters of a single night time (q.h.s.) dose of nizatidine 300 mg (N1), nizatidine 300 mg b.i.d. (N2), ranitidine 300 mg q.h.s. (R1) or ranitidine 300 mg b.i.d. (R2) compared with placebo (P). During the night (22.00-08.00 h), all treatments gave a higher mean pH than P, but during the day (08.00-22.00 h) the mean pH was higher than P only for patients administered R2 and N2. Doubling the dose of nizatidine (N2 vs N1) or ranitidine (R2 vs R1) increased the mean daytime pH, but had no effect on night time pH. The daytime pepsin concentration was unaffected by H2-receptor antagonists, while night time pepsin was lower with R1 and R2, but not with N1 or N2. The night time gastrin concentration was unaffected by H2-receptor antagonists; doubling the dose of the H2-receptor antagonist (R2 vs R1 and N2 vs N1) increased daytime gastrin concentration. During the night, each treatment increased PGE2 concentration by at least six-fold compared with P. Thus, where it is therapeutically indicated to achieve greater suppression of acid secretion, doubling the total daily dose by dosing with twice daily versus once daily night time nizatidine or ranitidine is efficacious.

Adult↗

Mesalazine (Mesasal/Claversal) 1.5 g b.d. vs. placebo in the maintenance of remission of patients with Crohn's disease.

UNLABELLED: INVESTIGATORS: This multicentre study was conducted by 29 principal investigators in 11 countries. AIMS: To compare the safety and efficacy of oral mesalazine (Mesasal/Claversal, 5-ASA) 1.5 g b.d. in comparison with placebo in the maintenance of remission in 286 patients with Crohn's disease. MATERIALS AND METHODS: Patients had to score less than 150 in their Crohn's Disease Activity Index (CDAI), and had to have had one period of clinical activity (CDAI > 150) within 18 months of the study start. Patients were randomized to receive 5-ASA 1.5 g b.d. daily or matching placebo for 12 months. Study visits were scheduled for months 1, 3, 6, 9 and 12, or when symptoms suggested a relapse of the disease. Relapse was defined as a CDAI score greater than 150, with at least a 60-point increase from the baseline index score. None of the patients used glucocorticoids or immunosuppressants during the trial. RESULTS: In the first group, 207 patients with Crohn's colitis or ileocolitis were randomized: there were 101 females and 106 males, in age range 18-71 years. A total of 106 patients (51 in the 5-ASA group and 55 in the placebo group) were withdrawn from the study due to adverse events, insufficient therapeutic effect, or for other reasons. This left 101 patients (51 in the 5-ASA group and 50 in the placebo group) who completed the 12-month trial. In the second group, 79 patients with Crohn's ileitis were randomized to treatment. There were 53 females and 26 males, age range 18-66 years. A total of 41 patients (19 in the 5-ASA group and 22 in the placebo group) were withdrawn from the study. This left 38 patients (17 in the 5-ASA group and 21 in the placebo group) who completed the 12-month trial. The primary efficacy variable was the CDAI. A protocol-eligible analysis and an intent-to-treat analysis were performed. No statistical differences were noted between the two analyses. In patients with Crohn's colitis or ileocolitis, or in those with ileitis, no statistically significant differences were noted with respect to the relapse rates between the 5-ASA and the placebo treatment groups. Adverse events in the gastrointestinal system were the most frequently reported in both treatment groups. Many of the events such as diarrhoea or abdominal pain are symptoms of Crohn's disease. The majority of the events reported were mild or moderate in severity. In neither study was the prevalence of adverse events or the proportion of drop-outs different between patients in the treatment or in the placebo groups. The site of the Crohn's disease had no effect on the frequency of adverse events. CONCLUSION: The relapse rates of Crohn's disease were similar for up to 12 months in both the 5-ASA 1.5 g b.d. and the placebo treatment groups.

Adult↗

Pneumocystis carinii pneumonia complicating methotrexate treatment of primary sclerosing cholangitis.

The etiology of primary sclerosing cholangitis, a chronic progressive cholestatic liver disease, is poorly understood. Treatment with oral methotrexate may improve patient symptoms, liver biochemistry, and hepatic histology. This report describes a severe life-threatening complication of methotrexate therapy in primary sclerosing cholangitis--the development of Pneumocystis carinii pneumonia. The reported cases of methotrexate-associated P. carinii pneumonia in the literature are reviewed. With the increasing use of methotrexate in chronic inflammatory disorders, physicians should be aware of this potentially lethal complication.

Adult↗

The Canadian Multicenter Double-blind Randomized Controlled Trial of ursodeoxycholic acid in primary biliary cirrhosis.

Ursodeoxycholic acid, a dihydroxyl bile acid normally present in human beings in minimal amounts, becomes incorporated into the bile salt pool when taken orally. In cholestasis, bile acids are retained in the liver and are hepatotoxic. Ursodeoxycholic acid is the least-known hepatotoxic bile acid, has choleretic properties and is reported to benefit patients with chronic cholestasis. In a nationwide Canadian controlled trial, 222 patients with primary biliary cirrhosis were treated with ursodeoxycholic acid (14 mg/kg/body wt/day) or placebo for 24 mo. Only patients with a diagnosis confirmed by liver biopsy and serum positive for antimitochondrial antibodies were enrolled; 88% were symptomatic on entry. The primary outcome measure was percent change in total serum bilirubin from baseline to final follow-up. Treated patients (111) and controls (111) were comparable with regard to age, gender, biochemical parameters and liver histological condition. Although treatment was not associated with any improvement in symptoms, ursodeoxycholic acid therapy caused the bilirubin to fall significantly within the first 3 mo of therapy (p < 0.001). Significant falls in serum alkaline phosphatase, aminotransferases, cholesterol and IgM levels were also noted in the treated group. Improvement in some histological features was observed but there was no difference between the groups in the number of patients who reached the endpoints of death or liver transplantation. Ursodeoxycholic acid, given to patients with primary biliary cirrhosis, leads to an improvement in serum markers of cholestasis. A larger sample size is needed to determine whether ursodeoxycholic acid therapy has a beneficial effect on the survival of patients with primary biliary cirrhosis.

Adult↗

Postshunt myelopathy.

Postshunt myelopathy is a rare, severely debilitating syndrome complicating portosystemic shunts that is characterized by spastic paraparesis. In this report we describe a 39-year-old woman with alcoholic liver disease and postshunt myelopathy resulting in an inability to walk. The syndrome did not become manifest until eight years after construction of a side-to-side portacaval shunt. This case is compared with reported literature on the subject.

Adult↗

Small-bowel lipoma: an uncommon cause of obstruction.

Small-bowel tumours are an uncommon cause of small-bowel obstruction. The symptoms are unusually nonspecific and intermittent. Contrast studies of the small bowel are the best means of delineating the lesion. The authors present a case in which obstruction was treated with small-bowel resection, and they give a brief account of the occurrence of small-bowel tumours in a major teaching hospital.

Aged↗

Arbaprostil [15(R)-15-methyl prostaglandin E2] in a single nighttime dose of either 50 or 100 micrograms in acute duodenal ulcer.

To determine the efficacy of single nighttime doses of arbaprostil [15(R)-15-methyl prostaglandin E2], 50 or 100 micrograms for 4 wk, a double-blind randomized placebo-controlled multiclinic trial was undertaken. Success was defined as complete healing of the ulcer documented by endoscopy. Fifty-one of 64 patients enrolled were considered evaluable. Ulcer healing was documented in 64.3%, 85.7%, and 31.2% of the 100-micrograms arbaprostil, 50-micrograms arbaprostil, and placebo treatment groups (p value vs. placebo = 0.003 and 0.002, respectively). No difference in side effects or changes in laboratory parameters were found between the treatment groups except that diarrhea, usually mild, was found more often in the 100-micrograms arbaprostil group (60.0%) than in the 50-micrograms arbaprostil (31.8%) or placebo groups (23.5%) (p value 100 micrograms arbaprostil vs. placebo = 0.02). A single nighttime administration of arbaprostil seems to be a safe and efficacious agent for the treatment of acute duodenal ulcer.

Adult↗

Omeprazole (20 mg daily) versus cimetidine (1200 mg daily) in duodenal ulcer healing and pain relief.

We conducted a double-blind, randomized, parallel group study in 169 patients with acute duodenal ulcers to compare omeprazole, 20 mg daily, with cimetidine, 600 mg twice daily. After 2 wk, 58% of the omeprazole-treated patients and 46% of the cimetidine-treated patients were completely healed (p = 0.056). After 4 and 6 wk 84% and 88% healed with omeprazole, and 80% and 89% healed with cimetidine (p = NS). After 2 wk, pain was completely gone in 62% of the omeprazole-treated patients versus 46% of the cimetidine-treated patients (p = 0.04). Clinical or laboratory adverse events were reported in 6 (7%) of the omeprazole-treated patients and 11 (13%) of the cimetidine-treated patients (p = NS). An adverse event caused withdrawal of 1 patient on omeprazole (anxiety and depression) and 2 patients on cimetidine (diarrhea and fall in hemoglobin). We conclude that omeprazole (20 mg daily) resulted in a trend toward more rapid ulcer healing compared with a relatively high dose of cimetidine (600 mg b.i.d.), and was preferred by patients for relief of ulcer pain.

Adult↗

Noncardiac side-effects of long-term oral amiodarone in the elderly.

Amiodarone is a powerful anti-arrhythmic drug. However, its use is somewhat limited by side-effects. No study examining side-effects specifically in elderly patients exists. We have reviewed noncardiac side-effects in 61 elderly patients on long-term oral amiodarone treatment (follow-up 3-66 months). The most troublesome side-effect was hypothyroidism (nine patients, 15%). No cases of frank hyperthyroidism were seen. Elevation of aspartate transaminase (AST) was common (16 patients, 26%), but generally mild and transient. Photosensitivity occurred in six patients (10%). Corneal deposits were common but gave rise to symptoms in only one patient. Two patients reported tremor. Hypothyroidism appeared to be more common and photosensitivity less common than in previously reported series in younger adults. Possible reasons for this are discussed. It is our policy to continue to prescribe amiodarone to elderly patients, regulate monitoring for adverse effects is however mandatory.

Administration, Oral↗

Comparative study of cimetidine and Mylanta II in the 6-week treatment of gastric ulcer.

The efficacy of antacid in the treatment of benign gastric ulcer is less well established than in the treatment of duodenal ulcer. The objective of this study was to monitor ulcer healing and symptom relief in 38 patients with gastric ulceration treated for 6 weeks with cimetidine (Tagamet) 300 mg q.i.d. or an aluminum-magnesium containing antacid (Mylanta II) 10 ml q.i.d. (acid neutralizing capacity 203.2 mEq/day). The study was single-blind; the study physicians and those providing endoscopic assessments were not aware of the patients' treatment. Entered into the study were 19 male and 19 female patients ranging in age from 17 to 70 years, with a mean age of 52 years. None of the patients had taken cimetidine in the previous month, and none abused alcohol or nonsteroidal anti-inflammatory agents, but two-thirds of the patients were smokers. Five patients in the antacid group withdrew for numerous reasons including continued pain, noncompliance, and side effects. All patients in the cimetidine group completed the study, and no side effects were noted. There was no difference between the antacid- and the cimetidine-treated patients in the relief of symptoms. There was a significant difference in the 6-week ulcer healing between the groups, with 14/19 (74%) healed in the cimetidine group compared with only 6/14 (43%) healed in the antacid group (p less than 0.025). Thus, Mylanta II, 10 ml four times daily, is comparable to cimetidine 300 mg q.i.d. in the symptomatic relief of benign gastric ulceration, but ulcer healing was superior using cimetidine.

Adolescent↗

Ranitidine versus cimetidine in the management of acute upper gastrointestinal tract bleeding.

Ranitidine and cimetidine were compared with respect to their effect on preventing the continuation or recurrence of acute upper gastrointestinal bleeding secondary to peptic ulcer disease. Fifty patients were randomly allocated to treatment with either ranitidine or with cimetidine. The two groups were comparable for age, sex, and severity of hemorrhage. There was no statistically significant difference in outcome between the groups when assessing need for surgery, total number of units in blood required, days in hospital, incidence of rebleeding, or deaths. However, there was a trend in favor of ranitidine: only one ranitidine-treated patient went to operation versus four of the cimetidine group. In addition, the number of rebleeds was higher in the cimetidine group (14) compared to the ranitidine group (1). Two patients in each group died. Therefore, ranitidine appears to be comparable to cimetidine in the management of patients with acute upper gastrointestinal tract bleeding. However, this study did not include a placebo group, and thus the generalized use of H2-receptor blockers in all patients with acute upper gastrointestinal tract bleeding has not been proven.

Acute Disease↗

Oesophageal function in cirrhotic patients undergoing injection sclerotherapy for oesophageal varices.

Oesophageal function has been studied in three groups of cirrhotic patients: those without varices, those with varices and those with varices treated by injection sclerotherapy. Using the Honeywell Model 31 oesophageal motility probe and the Ingold combined stomach pH electrode, measurements were made of the lower oesophageal sphincter (LES) pressure and length, swallowing responses, reflux and clearance of acid. The presence of varices was associated with an increase in LES length and reduced lower oesophageal contraction pressure during swallowing and some failure of sphincter relaxation during swallowing. Sclerotherapy was associated with a reduction in the maximum LES pressure both at rest and during swallowing, and an impairment of acid clearance, but postural reflux of acid was not observed in any patient.

Deglutition↗

H2-receptor antagonists and antacids in the prevention of acute gastrointestinal haemorrhage in fulminant hepatic failure. Two controlled trials.

In two controlled trials, involving 75 patients, on the prevention of bleeding from gastric erosions in fulminant hepatic failure, antacids given four-hourly had no significant effect. Only 35% of intragastric pH recordings taken at two-hourly intervals in the treated group were maintained above 5 with the doses used, whereas this could be consistently achieved with the histamine H2-receptor antagonists, metiamide and cimetidine. In the group receiving these drugs only 1 patient out of 26 bled, compared with 13 (54%) of the controls, a highly significant difference. Blood-transfusion requirements were significantly less in those treated with H2-receptor antagonists.

Antacids↗