bluuebunny/crossref_metadata_2025_split huggingface dataset:
Can higher doses of an H2‐receptor antagonist accelerate duodenal ulcer healing?
Authors: PAGE M. C. , LACEY L. A. , MILLS J. G. , WOOD J. R. 
Published: July 2010

SUMMARYDrugs that inhibit gastric acid secretion heal duodenal ulcers at a rate that correlates with the ability of individual treatment regimens to decrease 24‐h intragastric acidity. As current therapeutic regimens of ranitidine decrease 24‐h intragastric acidity submaximally, higher dosages may expedite duodenal ulcer healing. To test this hypothesis a randomized, double‐blind clinical trial was conducted in 245 patients with duodenal ulcer to compare the effects of standard dose (300 mg nocte) and highdose (300 mg q.d.s.) ranitidine. Patients were assessed after 2 weeks of treatment and, if unhealed, after a further 2 weeks of therapy. The therapeutic gain in ulcer healing at the 2‐week endoscopy of the higher dose over the lower dose of ranitidine was 22% (68%vs 46%, P < 0.001). The cumulative ulcer healing rates at the 4‐week endoscopy were 88% and 92% for the standard and high‐dose ranitidine groups, respectively (N.S.). By 2 weeks, 61% of patients treated with standard ranitidine therapy and 79% of those receiving 300 mg ranitidine q.d.s. were pain‐free (P < 0.01). A further 2 weeks of therapy enabled 88% and 97% of patients (N.S.) to become pain‐free on these two regimens, respectively. The drug regimens were equally well tolerated. Thus higher‐dose ranitidine can significantly accelerate the healing of duodenal ulcer with improvement in pain relief.
Effects of cisapride on ano‐rectal sphincter function
Authors: ENCK P. , ARPING H. G. , ENGEL S. , BIELEFELDT K. , ERCKENBRECHT J. F. 
Published: July 2010

SUMMARYTo investigate the effects of cisapride, a motility‐inducing agent, on anorectal sphincter functions, standard manometry was performed in 10 healthy male volunteers after 5 days on a 20‐mg dose of cisapride in a placebo‐controlled double‐blind randomized crossover fashion. All subjects kept stool diaries during the experiment. Cisapride significantly increased stool frequency by adding soft and liquid stools; in addition, anal resting pressure was reduced with cisapride in seven of the 10 subjects; mean resting pressure decreased by 16%, while all other measurements were not altered. This suggests that cisapride may act directly on the smooth muscle of the internal anal sphincter. It also supports the view that enhanced defaecation in chronic constipation induced by cisapride may not be achieved by propulsive motor activity in the colon but also by a decreased anal sphincter tone.
Acute treatment of benign gastric ulcer with once‐daily bedtime dosing of cimetidine compared with placebo
Authors: FRANK W. O. , YOUNG M. D. , PALMER R. , ROCKHOLD F. , KARLSTADT R. , MOUNCE W. , O'CONNELL S. 
Published: July 2010

SUMMARYThis multicentre, double‐blind study evaluated the efficacy of cimetidine 800 mg nocte compared to placebo for ulcer healing and pain relief in patients with endoscopically confirmed, benign gastric ulcers treated for up to 8 weeks. Cimetidine accelerated ulcer healing throughout the study. More cimetidine‐treated patients (35 of 82, 43%) than placebotreated patients (26 of 79, 33%) had healed ulcers after 4 weeks of therapy. Similarly, after 6 and 8 weeks of treatment, cimetidine continued to have superior healing rates, 76% (59 of 78, P= 0.02) and 91% (69 of 76, P= 0.02) heal rates for cimitidine recipients compared with 58% (42 of 73) and 74% (52 of 70) for placebo. For every week of the study except the second, a greater proportion of cimetidine‐treated patients were free of daytime and night‐time pain than placebo‐treated patients; the differences were statistically significant for night‐time pain. Adverse reaction profiles were similar for the cimetidine and placebo groups. In conclusion, cimetidine 800 mg nocte was comparably safe and significantly more effective than placebo in accelerating healing and relieving pain in the treatment of acute, benign gastric ulcer.
Coated oral 5‐aminosalicylic acid versus placebo in maintaining remission of inactive Crohn's disease
Authors:   INTERNATIONAL MESALAZINE STUDY GROUP
Published: July 2010

SUMMARYA randomized, double‐blind, placebo‐controlled multicentre study was undertaken to evaluate the safety and efficacy of coated, oral 5‐aminosalicylic acid (Mesasal/Claversal; 5‐ASA) in maintaining remission of inactive Crohn's disease for up to 12 months. A total of 248 patients were entered from eight countries, of which 206 adhered to the protocol and were included in the analysis. The patients had Crohn's disease for an average of 5 years, with their disease clinically inactive for at least 1 month prior to entry into the study, and for an average of over 12 months previously. Thirty per cent of patients had had a previous resection, 16% of patients had been treated with sulphasalazine, while none of those analysed received glucocorticosteroids. Treatment consisted of 500 mg 5‐ASA t.d.s. or placebo. ‘Relapse’was defined as the first occurrence of Best's Crohn's Disease Activity Index > 150, which had increased 60 points from the pre‐trial index. The cumulative life‐table relapse estimate was lower in 5‐ASA patients compared to placebo (22.4% us 36.2%, respectively, Log rank test P = 0.0395). The 12‐month relapse estimate in the 5‐ASA group was also lower in patients with ileal disease (8.3% for 5‐ASA and 31.0% for placebo, P = 0.0535) and in patients with previous bowel resections (14.2% us 47.0%, P = 0.0436). The incidence of side‐effects was similar in both treatment groups. It is concluded that 5‐ASA was significantly superior to placebo in preventing relapse of Crohn's disease; this effect was most apparent in patients with disease restricted to the ileum and in patients with previous bowel resection. 5‐ASA was well‐tolerated, as demonstrated by a low incidence of adverse events.
Colonic transit in man is slowed by ondansetron (GR38032F), a selective 5‐hydroxytryptamine receptor (type 3) antagonist
Authors: GORE S. , GILMORE I. T. , HAIGH C. G. , BROWNLESS S. M. , STOCKDALE H. , MORRIS A. I. 
Published: July 2010

SUMMARYOndansetron (GR38032F) is a selective antagonist of 5‐hydroxytryptamine (5‐HT) type 3 receptors. This randomized, doubleblind, cross‐over study was undertaken to evaluate and compare the effect of ondansetron with placebo on gastrointestinal transit in 10 healthy male volunteers. There were no significant differences between the effects of placebo and ondansetron on gastric emptying or mouth‐to‐caecum transit time. However, significant differences in mean whole‐gut transit time were observed, that is 54.8 h with ondansetron and 32.1 h with placebo. Therefore, 5‐HT3 receptors may be involved in the regulation of colonic transit and ondansetron may prove useful as an anti‐diarrhoeal agent.
A comparison of two doses of nizatidine versus placebo in the treatment of reflux oesophagitis
Authors: QUIK R. F. P. , COOPER M. J. , GLEESON M. , HENTSCHEL E. , SCHUETZE K. , KINGSTON R. D. , MITCHELL M. 
Published: July 2010

SUMMARYThree‐hundred and twenty‐five patients with endoscopically verified oesophagitis entered a double‐blind, randomized multicentre study that compared 300 mg nizatidine b.d., 300 mg nocte and placebo. The 6‐ and 12‐week treatment responses were studied. Healing was defined as complete epithelialization of all oesophageal lesions. The healing rates were 40% in the 300 mg nizatidine b.d. group, 30% in the 300 mg nocte group and 26% in the placebo group at 6 weeks. The corresponding figures after 12 weeks of treatment were 50%, 44% and 34%, respectively. The healing rates were significantly different (P< 0.05) between the high‐dose nizatidine group and placebo only, both at 6 and 12 weeks. Despite a trend at both 6 and 12 weeks in favour of 300 mg nizatidine nocte compared to placebo, this was not significantly different. The most important factor for the outcome, apart from the treatment group, was the pre‐entry severity of oesophagitis. The differences observed between treatment groups in healing rates, symptomatic relief, and antacid consumption appear to result mainly from the patients with
Single intravenous administration of the H+, K+‐ATPase inhibitor BY 1023/SK&F 96022—inhibition of pentagastrin‐stimulated gastric acid secretion and pharmacokinetics in man
Authors: SIMON B. , MÜLLER P. , BLIESATH H. , LÜHMANN R. , HARTMANN M. , HUBER R. , WURST W. 
Published: July 2010

SUMMARYThe effects of the H+, K+‐ATPase inhibitor BY 1023/SK&F 96022 on pentagastrin‐stimulated acid secretion have been studied in healthy male volunteers (n= 12). The gastric acid response to submaximal pentagastrin‐stimulation (0.6 μg/h/kg b.w.) was dose‐dependently inhibited. A single dose of 5 mg decreased acid output by 22% while after 60 mg and 80 mg secretion was almost completely abolished.A good dose linearity was observed for AUC (0, >) and Cmax over the dose range from 5 to 80 mg. Elimination half‐life, total clearance and volume of distribution of the parent compound were independent of the dose.The drug was well tolerated up to the highest dose of 80 mg. No clinically relevant influence was found on either laboratory screen or cardiovascular parameters.
Omeprazole in the treatment of peptic ulcers resistant to H2‐receptor antagonist
Authors: GUERREIRO A. S. , NEVES B. C. , QUINA M. G. 
Published: July 2010

SUMMARYThirty patients with peptic ulcers resistant to at least 8 weeks of continuous therapy with full‐dose H2‐receptor antagonists alone or followed by other anti‐ulcer drugs, were treated with the gastric proton pump inhibitor omeprazole (40 mg), administered orally once daily for up to 8 weeks. The study design was non‐comparative and open; healing was verified by endoscopy. After only 2 weeks of treatment, 21 out of 23 (91%) duodenal ulcer patients were healed, as well as 2 out of 2 patients with both duodenal and gastric ulcer and 1 out of 3 patients with prepyloric ulcer. After 4 weeks, all duodenal ulcers, 1 out of 2 gastric ulcers and 2 out of 3 pre‐pyloric ulcers were healed. A further month of therapy healed the gastric ulcer to give an overall healing rate of 97% and leaving only one patient (pre‐pyloric ulcer) unhealed at the end of the study.Of 19 patients suffering ulcer symptoms at entry, only two patients reported any symptoms at 2 weeks and one of these (who remained unhealed) continued to have symptoms throughout the study. One patient reported mild asthenia; otherwise, no clinical or biochemical side‐effects were recorded. It is concluded that omeprazole is highly effective in healing refractory peptic ulcers.
Effect of repeated oral administration of BY 1023/SK&F 96022 – a new substituted benzimidazole derivative – on pentagastrin‐stimulated gastric acid secretion and pharmacokinetics in man
Authors: SIMON B. , MÜLLER P. , MARINIS E. , LÜHMANN R. , HUBER R. , HARTMANN R. , WURST W. 
Published: July 2010

SUMMARYPentagastrin stimulated gastric secretion was measured in 12 healthy male subjects after repeated once daily oral administration of 20 and 40 mg BY 1023/SK&F 96022 – a new substituted benzimidazole derivative.Twenty milligrams inhibited acid output compared with placebo by 24% (2.5–3.5 h) and 26% (24.5–25.5 h) after the first oral intake. Inhibition increased to 56% and 50%, respectively, after the seventh oral dose. Forty milligrams inhibited acid output by a mean of 51% (2.5 to 3.5 h) and 52% (24.5–25.5) after the first oral intake. After the seventh dose mean inhibition rose to 85% and 66%, respectively.
Effect of mefenamic acid on bowel transit time in healthy adult volunteers
Authors: RASHID M. U. , BATEMAN D. N. 
Published: July 2010

SUMMARYThe effect of mefenamic acid on bowel transit time was investigated. Seven healthy adult male subjects of age 39 ± 2.4 years (mean ± S.E.M.) received placebo or mefenamic acid (500 mg t.d.s) orally in randomized order for five days, with a 7‐day washout between studies. On the third morning after starting the drug they had a meal containing Redi‐Brek and baked beans with radio‐opaque markers. Small bowel transit time was measured using breath hydrogen, and whole gut transit time was measured using radio‐opaque markers. The small bowel transit times were 160 min (median) with placebo and 50 min with mefenamic acid (P< 0.05). The percentages of appearance of marker in stool within 24 h were 24.9 ± 11.8 (mean± S.E.M.) with placebo and 48.9±11.7 with mefenamic acid (P< 0.05). The times of appearance of twenty‐fifth marker in stool were 41.0±4.4h with placebo and 26.9±3.2h with mefenamic acid (P< 0.05). The total weights of faeces in 72 h were 500.9±96.2 g with placebo and 657.1 ± 118.8 g with mefenamic acid (P< 0.05). Mefenamic acid in therapeutic doses (500 mg t.d.s.) accelerated bowel transit time in healthy subjects.
Combined gastric and oesophageal 24‐hour pH monitoring and oesophageal manometry in patients with reflux disease, resistant to treatment with omeprazole.
Authors: KLINKENBERG‐KNOL E. C. , MEUWISSEN S. G. M. 
Published: July 2010

SUMMARYCombined oesophageal and gastric 24‐hour pH monitoring and oesophageal manometry were performed in 19 patients with resistant reflux oesophagitis after short‐term therapy with omeprazole (40 to 60 mg daily) or during maintenance treatment with omeprazole (20 to 80 mg daily). Omeprazole's effects on acidity were analysed as well as any possible influence on oesophageal motility. A pH in the stomach of below 4 was present during considerable periods of time (in 27 of 29 measurements), particularly during the night. As a consequence, pathological gastro‐oesophageal reflux occurred, particularly in the supine period. Insuficiency of the lower oesophageal sphincter was present in all but one patient; decreased or virtually absent motility of the oesophagus was found in 63 % of the patients. Combined intragastric and intra‐oesophageal pH monitoring, with oesophageal manometry, may contribute to the management of patients with reflux disease resistant to treatment with omeprazole. The present study emphasizes the need to individualize therapy in patients with refractory gastro‐ oesophageal reflux disease.
Pharmacokinetics of a 5‐aminosalicylic acid enteric‐coated tablet in patients with Crohn's disease or ulcerative colitis and in healthy volunteers
Authors: NORLANDER B. , GOTTHARD R. , STRÖM M. 
Published: July 2010

SUMMARYAn Eudragit‐L coated oral 5‐aminosalicylic acid (5‐ASA; mesalazine) product (Mesasal), has been formulated to deliver 5‐ASA to the distal small bowel and colon for the treatment of inflammatory bowel disease. The purpose of this study was to compare the pharmacokinetic profile of this drug between two patient groups, with either inflamed small or large bowel and with volunteers.Two carefully selected patient groups (one with nine patients suffering from Crohn's disease restricted to the small intestine, and one with ten patients suffering from total ulcerative colitis) and a group of ten volunteers received two 250 mg Mesasal tablets in the morning, on a fasting stomach. Plasma 5‐ASA and acetyl‐5‐ASA concentrations were followed for 48 h, and urine and faecal excretion for 72 h. There was a great variation in most pharmacokinetic parameters within each group. Numerically, however, the data suggests a somewhat higher systemic absorption in patients with Crohn's disease than in healthy volunteers or patients with ulcerative colitis. The location of the inflammatory process might have some influence on the pharmacokinetics of 5‐ASA in inflammatory bowel disease.
Topical and systemic availability of 5‐amino‐salicylate: comparisons of three controlled release preparations in man
Authors: CHRISTENSEN L. A. , FALLINGBORG J. , ABILDGAARD K. , JACOBSEN B. A. , SANCHEZ G. , HANSEN S. H. , BONDESEN S. , HVIDBERG E. F. , RASMUSSEN S. NØRBY 
Published: July 2010

SUMMARYThe bioavailability of three pure 5‐aminosalicylic (5‐ASA) preparations (Asacol, Claversal, and Pentasa) was studied in 8 ileostomy patients and 12 normal subjects after 6 days of treatment with 2000 mg 5‐ASA. The local bioavailability, reflected by the 5‐ASA concentration was thereby measured at two clinically relevant areas of the gut: at the entrance to, and the exit from the colon. Estimates of the systemic bioavailability were obtained from the urinary excretions and the plasma values of 5‐ASA and Acetyl‐5‐ASA (Ac‐5‐ASA) during the three regimens. The three preparations studied are designed to release 5‐ASA at different levels in the intestine, but there was no significant difference in the 5‐ASA concentrations in the ileostomy effluents (Asacol 1.8 mmol/L, Claversal 3.4 mmol/L, Pentasa 2.0 mmol/L, median values). However, we found a smaller urinary excretion of 5‐ASA and Ac‐5‐ASA (5.2%vs Claversal 27.9% and Pentasa 23.0%, median values of ingested daily dose) and a lower concentration of Ac‐5‐ASA in the ileostomy effluents after Asacol treatment (0.8 mmol/L, median value) which indicates a more distal release from this preparation compared with Claversal (2.4 mmol/L, median value) and Pentasa (5.5 mmol/L, median value). In normal subjects a higher faecal water concentration of 5‐ASA was found after Asacol (9.8 mmol/L, median value) compared with Claversal (5.0 mmol/L, median value), whereas no difference between the faecal water concentrations of Ac‐5‐ASA was found (Asacol 21.5 mmol/L, Claversal 21.6 mmol/L, median values). This can be explained by a larger systemic absorption of 5‐ASA from Claversal, and accordingly Claversal treatment resulted in the largest urinary excretion of 5‐ASA and Ac‐5‐ ASA (43.7% us Asacol 35.6% and Pentasa 31.6 %, median values of ingested daily dose). The high Ac‐5‐ASA concentration in the ileostomy effluents and in the faeces after Pentasa, and the low plasma values, indicate a slow 5‐ASA release from this preparation throughout the small and large intestine. The results of the study indicate that Asacol is released in the distal part of the small intestine, that Pentasa is gradually released in the small and large intestine, and that Claversal shows an intermediate release pattern.
Prospective evaluation of omeprazole treatment in reflux oesophagitis refractory to H2‐receptor antagonists
Authors: KOOP H. , HOTZ J. , POMMER G. , KLEIN M. , ARNOLD R. 
Published: July 2010

SUMMARYThe efficacy of omeprazole therapy (40 mg daily) in H2‐blocker refractory severe reflux oesophagitis (Grade II‐IV; Savary and Miller classification) was investigated in 61 patients. Mean duration of reflux disease and preceding H2‐antagonist treatment were 4.3 years and 15 months, respectively. Healing rates at 4, 8 and 12 weeks were 48%, 80% and 92%, respectively. There was a correlation between severity of oesophagitis and duration of omeprazole therapy necessary for healing. Three patients (5%) required higher dosages than 40 mg for healing. Symptomatic responses paralleled healing. It is concluded that omeprazole is a highly effective drug for severe reflux oesophagitis not responding to H2‐blocker treatment and that 40 mg daily is the optimal dose.
The effect of intravenous doxofylline or aminophylline on gastric secretion in duodenal ulcer patients
Authors: LAZZARONI M. , GROSSI E. , PORRO G. BIANCHI 
Published: July 2010

SUMMARYThe aim of this study was to compare the effects upon gastric secretion of therapeutic doses of aminophylline, with doxofylline, a new xanthine derivative proposed for the treatment of chronic asthma.Twelve patients with endoscopically‐proven healed duodenal ulcer were studied twice under double‐blind conditions in cross‐over experiments. In a 1‐hour infusion, six patients received either 240 mg aminophylline i.v. or 200 mg doxofylline i.v., and six received either 240 mg aminophylline i.v. or 400 mg doxofylline i.v.Compared with basal gastric secretion, for the hour after the infusion 240 mg aminophylline i.v. stimulated gastric acid output by a mean 213% (P< 0.01) and mean pepsin output by 129% (P< 0.01). Intravenous doxofylline did not stimulate a significant increase of either acid or pepsin output (200 mg: acid output + 4%, pepsin output + 10%; 400 mg: acid output + 25%, pepsin output + 27%).These findings suggest that doxofylline, unlike aminophylline, has a low secretagogue activity and it may be more suitable for asthmatic patients with peptic ulcer disease.
Helicobacter pylori infection treated with a tripotassium dicitrato bismuthate and metronidazole combination
Authors: WEIL J. , BELL G. D. , POWELL K. , MORDEN A. , HARRISON G. , GANT P. W. , JONES P. H. , TROWELL J. E. 
Published: July 2010

SUMMARYSeventy‐two patients with H. pylori infection in their antral mucosa took part in the study. Forty‐three received metronidazole 400 mg t.d.s. for two weeks, plus De‐Nol tabs 2 b.d. for four weeks, and the remaining 29 patients received metronidazole 400 mg t.d.s. for two weeks plus De‐Nol liquid 5 ml q.d.s. for four weeks. Seven of 57 H. pylori isolates were found to have pre‐treatment metronidazole resistance. Success, in terms of eradication of H. pylori, was assessed using a one‐month post‐treatment 14C urea breath test.Successful eradication of H. pylori was achieved in 72% and 79%, respectively, of the metronidazole/De‐Nol tablet and metronidazole/De‐Nol liquid groups. These figures increased to 87% and 84%, respectively, if the patients whose organisms were known to be metronidazole‐sensitive were considered in isolation. H. pylori was successfully eradicated in only one of seven patients with a metronidazole‐resistant organism.
Controlled study of the effects of intravenous famotidine on intragastric pH in bleeding peptic ulcers
Authors: FULLARTON G. M. , MACDONALD A. M. , MANN S. G. , McCOLL K. E. L. 
Published: July 2010

SUMMARYAs blood coagulation and platelet aggregation are abolished at pH < 5.4 the failure of antisecretory drugs to promote haemostasis in bleeding peptic ulcers may reflect inadequate pH control. This study examined the ability of famotidine, a potent, long‐acting H2 blocker to maintain intragastric pH above 5.4 in patients presenting with bleeding peptic ulcers. Twenty patients with acute upper gastrointestinal haemorrhage confirmed endoscopically to be related to peptic ulceration (17 duodenal, 3 gastric ulcers), were entered into the study within 24 h of presentation. Each patient was randomly allocated to receive either intravenous famotidine (n= 10) administered as a 10 mg bolus followed by a constant infusion of 3.2 mg/h or similarly administered placebo (n= 10). All patients remained fasted over the 22‐h study period. Their median intragastric pH values ranged from 6.8 to 7.9 (median 7.1) in the famotidine group and from 1.1 to 6.9 (median 1.6) in the placebo group (P < 0.001). Over this same period intragastric pH was > 6 for 64%‐100% (median 98%) of the recording time in the famotidine group compared with 0%‐93% (median 13%) in the placebo group (P < 0.001).We conclude that intravenous famotidine can maintain intragastric pH > 6 in fasting patients with acute upper gastro‐intestinal bleeding from peptic ulceration. This provides a rational basis for further studies assessing its clinical efficacy in such patients.
Short report: a double‐blind placebo‐controlled trial of omeprazole on characteristics of gastric emptying in healthy subjects
Authors: RASMUSSEN L. , ØTER‐JØRGENSEN E. , QVIST N. , KRAGLUND K. , HOVENDAL C. , PEDERSEN S. A. 
Published: July 2010

SUMMARYThe aim of the study was to investigate a possible effect of omeprazole on the characteristics of the gastric emptying of liquid and solid in healthy subjects. The study was performed as a double‐blind crossover study and the gastric emptying studies were performed after 10 days of treatment with placebo or omeprazole 40 mg o.m. Omeprazole was without effect on the characteristics of liquid emptying or the lag phase of solid. It does, however, decrease the emptying rate of solid as the omeprazole group had a median half‐time duration of the linear emptying period which had twice the duration of the corresponding figure in the placebo group.