Serum fasting gastrin levels after short-term treatment with cimetidine in patients with duodenal ulcer.

The behaviour of serum gastrin fasting levels was studied in 39 randomized patients with proven duodenal ulcer, 21 receiving cimetidine (1 g/day) and 18 placebo for 28 days. No significant variations of gastrin fasting values were found, but in four patients given cimetidine a relevant increase was observed at the end of the treatment. One out of 6 patients, previously treated with placebo, showed a marked increase of fasting gastrin levels after a second trial of cimetidine. No increase of G-17 was observed in the patients showing fasting hypergastrinemia after cimetidine. The present study seems to confirm some previous observations and it seems to suggest the possibility that in some patients cimetidine could induce hypergastrinemia.     

Omeprazole vs. ranitidine in short-term treatment of Helicobacter pylori positive duodenal ulcer patients.

Forty-three patients with active duodenal ulcer and Helicobacter pylori positivity in gastric antrum were randomly assigned to either omeprazole treatment (20 mg once a day) or ranitidine treatment (300 mg once a day) for 28 days. Re-evaluation of the patients (clinical and endoscopic examination and assessments for H pylori detection) was repeated after 2 weeks and at the end of the treatment. Healing rates in the omeprazole group were 40% after 2 weeks and 90% after 4 weeks, in the ranitidine group ulcer healing was recorded in 20% of patients after 2 weeks and in 80% after 4 weeks. Differences between treatments at 2 and 4 weeks were not statistically significant. Clinical response (disappearance of ulcer-related symptoms) was better in the omeprazole group at 2 weeks (p less than 0.05) but not at 4 weeks. At the end of the trial H pylori positivity in gastric antrum disappeared in 95% of the patients treated with omeprazole and in 5% of the patients who received ranitidine (p less than 0.001). The results confirm the effectiveness of omeprazole in short-term treatment of duodenal ulcer and re-emphasize the powerful activity of the drug on H pylori infection.     

Chief cell mass after short-term ranitidine treatment for duodenal ulcer.

The chief cell mass and the parietal cell mass were evaluated in endoscopically obtained biopsy specimens of fundic mucosa from 15 duodenal ulcer patients before and after ranitidine treatment. Patients were given ranitidine, 300 mg/day, for 8 weeks. Chief cell mass and parietal cell mass were expressed respectively by a "zymogenous index" (ZI) and a "parietal index" (PI), obtained by multiplying the number of cells per mm2 by the thickness of the glandular layer. From the results of this study it would appear that, in patients with duodenal ulcer, treatment with ranitidine at a dose of 300 mg/day for 8 weeks results in a significant increase in parietal cell mass and a decrease in chief cess mass.     

Medium-dose antacids versus cimetidine in the short-term treatment of duodenal ulcer

Seventy-eight patients with endoscopically proven duodenal ulcer were randomly allocated to be treated with a medium dose of liquid aluminum-magnesium antacid (75 ml in five daily doses) or cimetidine (400 mg twice daily) for 4 weeks in a prospective double-blind, double-dummy study. Healing rates at completion of trial were 66.7% in the cimetidine-treated group and 71.8% in the antacid group (p, ns). Both treatments were equally effective in relieving ulcer symptoms. Among the patient variables considered, only cigarette smoking was found to have a significant negative effect on ulcer healing. These results indicate that medium doses of antacids are as effective as cimetidine in the short-term treatment of duodenal ulcer.     

Fiber diet and antacids in the short-term treatment of duodenal ulcer

Eighty patients with active duodenal ulcer were randomized to a diet poor or rich in fiber for a treatment period of 4 weeks. In addition, all patients received one antacid tablet (Link, 1.1 g) four times a day (total neutralizing capacity, 120 mmol HCl/day). The ulcer healed in 27 (67.5%) of the 40 patients in the high-fiber group, compared with in 24 (60%) of the 40 patients in the low-fiber group (p less than 0.5). Ulcer symptoms did not differ significantly between groups during the 4-week treatment period. No serious side effects were recorded. Constipation, the most frequently registered side effect, was seen in 11 (27.5%) of the patients in the low-fiber group, compared within 4 (10%) in the high-fiber group (chi-square = 4.0; p less than 0.05). Patients with unhealed ulcer after 4 weeks' treatment received ranitidine instead of antacids. While they were receiving ranitidine treatment, no significant differences in healing rates were seen between the two dietary groups.     

Gastric acid secretion and plasma gastrin during short-term treatment with omeprazole and ranitidine in duodenal ulcer patients.

The aim of this study was to evaluate changes in peptic acid secretion, and in fasting and meal-stimulated plasma gastrin levels after a 7-day course of omeprazole 30 mg/day or ranitidine 300 mg/day, administered in accordance with a randomized, double-blind, double-dummy protocol. Ten duodenal ulcer patients were studied. Their acid and pepsin output was determined prior to and after treatment. Plasma gastrin levels were also determined under basal conditions on day 7 of treatment, and 24 hours after the last administration of the drug. With regard to acid output, omeprazole resulted in a 98% reduction in BAO and an 80% reduction in PAO, both significantly greater than those achieved with ranitidine (BAO 50%, PAO 25%). No significant changes in pepsin secretion were observed. The increase in fasting plasma gastrin observed after ranitidine and omeprazole was 86% and 242%, respectively, on day 7, and 13% and 103% twenty-four hours after final dose. Increases in meal-stimulated plasma gastrin were, respectively, 126% and 125% on day 7 and 8 after omeprazole, whereas the increase with ranitidine was 62% only on day 7 of treatment, with subsequent normalization. In addition to confirming the well-known effect of omeprazole on the physiology of gastric secretion, our data show that administration of therapeutic doses of traditional H2-antagonists is accompanied by a secondary hypergastrinemia, which is rapidly reversible after discontinuation of therapy.     

Dose-range finding study with the proton pump inhibitor pantoprazole in acute duodenal ulcer patients.

Pantoprazole is a newly developed benzimidazole derivative with strong inhibitory actions on gastric acid secretion by blocking H(+)-K(+)-ATPase. This randomized double-blind multicenter trial investigated the efficacy of 20 mg, 40 mg and 80 mg pantoprazole o.m. on ulcer healing and symptomatic relief in 219 out-patients with endoscopically assessed acute duodenal ulcer. After 2 weeks complete ulcer healing was achieved in 58%, 89% and 82% of the patients with 20 mg, 40 mg and 80 mg pantoprazole o.m., respectively. After 4 weeks, corresponding figures were 93%, 99% and 100%; the difference of the healing rates between the 20 mg and 40 mg groups at 2 weeks was statistically significant (p < 0.0001). A rapid pain relief was achieved in all treatment groups: 72% of the 20 mg group, 89% of the 40 mg group, and 84% of the 80 mg group were pain-free after 2 weeks. The difference between 20 mg and 40 mg was statistically significant (p < 0.05). Pantoprazole was well tolerated. Adverse events occurred in 13 patients; headache, skin alterations, and diarrhea were reported most frequently. Severity and frequency of adverse events did not reveal any dose-dependence. In conclusion, pantoprazole provides fast healing of acute duodenal ulcer as well as rapid improvement of ulcer symptoms. For further clinical trials in peptic ulcer disease a daily dose of pantoprazole 40 mg o.m. is recommended.     

Cimetidine or propantheline combined with antacid therapy for short-term treatment of duodenal ulcer

Seventy-one patients with duodenal ulcer disease completed a 3-to 6-week controlled randomized trial in which cimetidine (1 g daily) was compared with an optimally effective dose of propantheline. Both groups had free access to an antacid suspension. There were no significant differences between the groups concerning ulcer healing, relief of ulcer symptoms, antacid consumption, or patient compliance. After 3 weeks of treatment, endoscopic examination revealed complete ulcer healing in 63% of the cimetidine and 47% of the propantheline treated patients. The corresponding figures after 6 weeks were 94% and 86%, respectively. After 12 weeks, ulcer recurrence was confirmed in 26% of the cimetidine-and 23% of the propantheline-treated patients. Except for the absence of anticholinergic adverse reactions, no significant advantages could be confirmed, for combined cimetidine and antacid treatment.     

Invasive candidiasis does not complicate short-term cimetidine treatment of duodenal ulcer

The purpose of this study was to record the frequency of invasive candidiasis of duodenal ulcer and to determine whether or not it is enhanced by cimetidine treatment. Our multicenter prospective trial involved 99 patients with endoscopically proven duodenal ulcer who were undergoing a 4- or 8-week cimetidine (800 mg/day) treatment program. At the endoscopic examination, performed before and after the 4- or 8-week treatment, three biopsy samples were taken from the ulcer edge or from the healed tissue. Ulcer infiltration by Candida was presumed by the presence of mycetes in stained tissue samples. Healing rate was 76% at 4 weeks and 89.9% at 8 weeks. Candida infiltration was not seen in any biopsy specimen. Short-term treatment with cimetidine does not promote invasion of mycetes into the duodenal ulcer lesion.     

Double blind controlled trial with oxmetidine and cimetidine in the short-term treatment of duodenal ulcer

Clinical efficacy and safety of oxmetidine (400 mg b.i.d.), a new potent specific H2-receptor antagonist, and cimetidine (1 g/day) were compared in a double-blind randomized trial of 4 weeks duration that involved 39 outpatients with endoscopically proven active duodenal ulcer. The disappearance of the ulcer crater leading to complete reepithelization of the bulbs or to the presence of erosions occurred in 17 out of 19 (89.6%) patients treated with oxmetidine, and in 13 out of 20 (65.0%) patients treated with cimetidine (n.s.). Ulcer symptoms and antacid consumption were not different in two groups. No side effects or significant haematological or biochemical abnormalities were found. Both drugs failed to evoke significant changes in the basal levels of prolactin (PRL) and gonadotropins. The higher, though not significant, percentage of healing obtained with oxmetidine had no clinical relevance and needs to be demonstrated in a larger number of patients.     

Omeprazole vs. ranitidine in the short-term treatment of duodenal ulcer: an Italian multicenter study

A double-blind, double-dummy, randomized Italian multicenter trial was carried out to compare the efficacy and safety of omeprazole 20 mg in the morning and ranitidine 150 mg b.i.d. in short-term treatment of acute duodenal ulcer. One hundred and twenty-one patients (61 in the omeprazole and 60 in the ranitidine group) with endoscopically proven active duodenal ulcer, completed the study. The healing rates after 2, 4 and 6 weeks were 66, 97 and 100%, respectively, with omeprazole and 53, 85 and 92%, respectively, with ranitidine. The difference was statistically significant (p less than 0.05) at weeks 4 and 6. Night and day pain were markedly reduced during both treatments, as also antacid consumption. Both drugs were well tolerated, and the adverse events were infrequent and moderate. In our experience, omeprazole 20 mg once daily seems to be superior to ranitidine 150 mg b.i.d. in the short-term treatment of duodenal ulcer.     

Cholecystokinin-like activity in the duodenal mucosa of duodenal ulcer patients.

Cholecystokinin-like activity in the duodenal mucosa was measured by the bioassay method described by Ljungberg to elucidate its significance in 14 duodenal ulcer patients as well as in 13 normal subjects with no evidence of gastrointestinal diseases. The stage of duodenal ulceration was determined endoscopically according to the criterion of the Japanese Gastroenterological Endoscopic Society. The cholecystokinin-like activity in the duodenal mucosa of duodenal ulcer patients in active stage 1, which was considered as an early stage of active open duodenal ulceration, did not differ statistically from that of normal subjects, whereas that of duodenal ulcer patients in active stage 2 began to show a significant increase (p less than 0.05), and the cholecystokinin-like activity in the duodenal mucosa of duodenal ulcer patients in healing stage 1 or healing stage 2 was significantly higher than that in normal subjects (p less than 0.01). The cholecystokinin-like activity in the duodenal mucosa of duodenal ulcer patients in the scarring stage, however, returned to the normal range. It is concluded that cholecystokinin may act physiologically in the cure of duodenal ulcer.     

Maintenance treatment of duodenal ulcer patients with a single bedtime dose of cimetidine.

Fifty-eight patients with endoscopically verified duodenal ulcers were treated with cimetidine, 1 g/day, for 6--10 weeks. The ulcers healed in 52 out of the 54 patients completing the treatment (96.3%). Forty-seven of the patients with healed ulcer were randomly allocated to 1 year of maintenance treatment, 23 patients with cimetidine, 400 mg at night, and 24 patients with placebo tablets. In the cimetidine-treated group 2 out of the 20 patients (10%) completing the trial had recurrence of ulceration, whereas 16 out of the 23 patients (70%) completing the placebo treatment had ulcer recurrence (p less than 0.001). The drug was well tolerated and, except for a marked increase in serum transaminases in three patients, no serious side effects were seen.     

Enprostil and cimetidine: comparative efficacy and safety in patients with duodenal ulcer

The safety and efficacy of enprostil, 35 micrograms twice daily, and of cimetidine, 400 mg twice daily, in the treatment of duodenal ulcers were compared in a randomized, double-blind, parallel, multiclinic study. Endoscopy was performed before treatment and at 2-week intervals for 6 weeks or until the ulcer healed. Patients recorded their drug compliance, antacid use, ulcer symptoms, and adverse experiences daily. One hundred and six patients entered the trial, of which 104 were eligible for the initial endoscopy analysis. Base-line characteristics were similar in the two treatment groups. The cumulative healing rates in the enprostil group were 56%, 86%, and 92% at 2, 4, and 6 weeks, respectively, and those in the cimetidine group were 53%, 84%, and 90% (NS). The healing rates for nonsmokers at 6 weeks were 96% in the enprostil group and 97% in the cimetidine group, which were significantly greater than those for smokers--88% and 81%, respectively. There were no significant differences in the duration, severity, or frequency of daytime or nighttime pain between the groups. Seventeen of the enprostil patients (32%) reported 21 adverse experiences during the trial, and 20 of the cimetidine patients (39%) reported 23 adverse experiences. No patients withdrew because of adverse experiences. The two drugs were similarly safe and effective in the treatment of duodenal ulcer.     

哌仑西平治疗十二指肠球部溃疡远期疗效及复发的观察

目的　观察哌仑西平治疗十二指肠球部溃疡的远期疗效及复发情况。方法　 63例经胃镜明确诊断十二指肠球部溃疡的患者随机分为A、B、C 3组 ,分别以哌仑西平、雷尼替丁及哌仑西平加雷尼替丁进行为期 4周的短期治疗 ,然后对各组经胃镜检查确定为治愈的患者定期随访一年 ,最后由胃镜检查了解溃疡复发情况。结果　A组 (哌仑西平 )和C组 (哌仑西平加雷尼替丁 )复发率分别为 3 6 4%和 3 3 3 % ,明显低于B组 (雷尼替丁的 81 8% ) ,统计学上有显著差异 (P <0 0 5 )。结论　用哌仑西平治疗十二指肠球部溃疡能降低停药后的溃疡复发率。     

Histamine and duodenal ulcer: effect of omeprazole on gastric histamine in patients with duodenal ulcer.

Gastric mucosal concentrations of histamine and of its metabolic enzyme, histamine methyltransferase activity, were measured in patients with duodenal ulcer disease and patients with an apparently normal stomach and duodenum. Patients with duodenal ulcer had significantly less (p less than 0.05) mucosal histamine (median 204 nmol/g) than control subjects (median 252 nmol/g). There was no significant difference between the two groups in their histamine methyltransferase activity values. Omeprazole therapy did not significantly change mucosal histamine (+23%), histamine methyltransferase activity (+5%), histamine release before (+5%) or during (+7%) pentagastrin infusion. It significantly decreased acid secretion during pentagastrin stimulation (median -73%, p less than 0.001). Omeprazole, like cimetidine, does not stop histamine release during pentagastrin stimulation.