Long-term low-dose antacid versus cimetidine therapy in the treatment of duodenal ulcer recurrence

The effect of cimetidine (400 mg at night) and of low-dose antacid (400 mg of aluminum hydroxide plus 400 mg of magnesium hydroxide four times a day) given alone or in combination was assessed in a double-blind double-dummy endoscopic trial on prevention of duodenal ulcer (DU). Seventy-five outpatients with healed DU were followed up clinically for 1 year and were checked endoscopically after 6 and 12 months of therapy or in case of symptomatic relapse. After 6 and 12 months, 25% and 41%, respectively, of patients treated with cimetidine alone experienced a relapse, compared with 42% and 54% of those treated with antacid alone and 25% and 43% of patients treated with the combination therapy. The differences are not statistically significant. No relevant side effects were observed in patients of any group. It is concluded that long-term prophylactic treatment of DU with low-dose antacid is as safe and effective as cimetidine treatment, whereas a combination of the two drugs does not achieve a therapeutic gain.     

Relapse rates of duodenal ulcer healed with concentrated antacid or cimetidine

The incidence of duodenal ulcer relapse after initial therapy with concentrated aluminium-magnesium hydroxide (Maalox 70) or cimetidine (Tagamet) was investigated in a one-year follow-up study. 92.3% (24 out of 26) of the antacid patients and 76.2% (16 out of 21) of the cimetidine patients relapsed. The difference is not statistically significant. With respect to the pattern of onset of relapses, no difference was seen between the two groups. 33% of the recurrent lesions following treatment with antacids and 25% of those following cimetidine therapy were asymptomatic. This difference too is not significant. The results permit the conclusion that the mode of pharmaceutical therapy of ulcers (buffering of gastric acid by way of an antacid or inhibition of acid secretion by an H2-blocker) has no bearing on the further course of the ulcer disease.     

A multicenter, randomized, double-blind study comparing famotidine with cimetidine in the treatment of active duodenal ulcer disease

The efficacy and safety of famotidine (40 mg at night), a new potent H2-receptor antagonist, has been studied in 119 patients by four investigators in four Spanish hospitals in a randomized double-blind comparative study with cimetidine (800 mg at night). Antacid tablets were allowed as additional treatment, if needed for pain relief. There were no significant differences between the groups in baseline characteristics, including duodenal ulcer size. Efficacy parameters included daytime and nocturnal symptom relief and duodenal ulcer healing, documented by endoscopy, and defined as complete reepithelization of the ulcer crater. Endoscopy was performed at baseline and after 4 and 6 weeks of treatment. One hundred and five patients fulfilled the evaluation criteria (51 patients in the famotidine group and 54 in the cimetidine group). After 4 weeks, in 91.6% of the patients receiving famotidine and 82.3% of the patients receiving cimetidine ulcers were healed. After 6 weeks, healing rates were 96% (famotidine) and 85.1% (cimetidine) (p = 0.056). Pain relief was rapid in both treatment groups, with a tendency to better response during the day in the famotidine group. The intake of antacids, as well as the clinical and laboratory safety profile were similar for both groups.     

Very-low dose antacid in treatment of duodenal ulcer

Antacid (AA) in a very low dose (88 mmol/day) was compared to the standard 800-mg dose of cimetidine in healing duodenal ulcers. The influence of sex, age, symptom duration at entry, night pain, smoking, coffee consumption, and alcohol on ulcer healing was studied. The antacid was given in two different schedules: group I--20 ml 1 hr after breakfast and at bedtime; group II--10 ml 1 hr after breakfast and lunch and 20 ml at bedtime. Cimetidine (group III) was given in two divided doses: 400 mg 1 hr after breakfast and 400 mg at bedtime. Endoscopic control was performed after four weeks and, if necessary, after eight weeks of treatment. The healing rate after four weeks of treatment was, respectively, for groups I, II, and III, 45.5%, 55.8%, and 69.4% (group I = group II, and group III different from groups I and II). After eight weeks of treatment the healing rate was 61.5%, 80.8%, and 88.0% for groups I, II, and III, respectively (group II = group III, and group I different from groups II and III). Except for group I, smoking did not influence healing rate. Age, sex, symptoms at entry, night pain, and coffee consumption did not influence the treatment results. The authors concluded that the very low dose of magaldrate (88 mmol/day), when administered in three divided doses (10 ml after breakfast and lunch and 20 ml at bedtime) for eight weeks was as effective as 800 mg of cimetidine (400 mg twice a day) in healing duodenal ulcer.     

Treatment of duodenal ulcer with antacid and sulpiride. A double-blind controlled study.

The effect of aluminum-magnesium hydroxide tablets (800 mg seven times per day) and that of sulpiride, a hypothalamic neurolaptic, were studied in 101 patients with duodenal ulcer in a double-blind controlled 4-wk trial. Significantly more of the patients treated with antacid, sulpiride, or antacid-sulpiride combination showed a greater than 50% reduction in ulcer size than did the patients treated with placebo. However, only in the antacid- and antacid-sulpiride-treated groups did the ulcer, with and without residual inflammation, disappear statistically more often than in the placebo-treated group. Furthermore, only in the antacid-sulpiride-treated group did complete healing, with no trace of inflammation, occur statistically more often than in the placebo-treated group. Disappearance of ulcer pain was likewise statistically more frequent in the antacid-sulpiride group than in the placebo-treated group. Antacid therapy with aluminum-magnesium hydroxide tablets appears to accelerate the rate of ulcer healing. Sulpiride appears to have a minor but definite synergism with antacids. Cigarette smoking affected ulcer healing adversely; on the other hand, factors favorable to healing were the early onset age of ulcer symptoms and acid hypersecretion. Male patients also healed more favorably than females.     

Efficacy of ranitidine and cimetidine in the treatment of gastric or duodenal ulcer resistant to an initial treatment with cimetidine. Multicenter controlled therapeutic trial

In a controlled clinical trial conducted in 28 centers, 354 ambulatory patients with a cimetidine-resistant duodenal or gastric ulcer (at least six weeks of treatment at a dose of 1 g/day) confirmed by endoscopy were allocated at random to either ranitidine or cimetidine treatment: 166 patients received cimetidine (1.6 g/day in 4 oral doses), and 188, ranitidine (0.3 g/day in 2 oral doses). The two groups differed significantly with regard to sex and history of gastrointestinal hemorrhage but not with regard to age, weight, history of peptic disease, history of perforated ulcer, duodenal/gastric ulcer ratio, number of smokers and alcohol consumers. The criterion of effectiveness was endoscopic healing of the ulcer after six weeks of treatment; in case of doubt, vital staining with methyl blue was performed. A significant difference was observed between the results of the two treatments in the duodenal group (p less than 0.05) but not in the gastric group, the healing rates being respectively 71 p. 100 and 65 p. 100 with ranitidine, and 59 p. 100 and 44 p. 100 with cimetidine. Twelve patients developed side-effects with a highly significant difference between the two groups: 11 patients under cimetidine and one patient under ranitidine (p less than 0.001). These results show the effectiveness of ranitidine as a complementary treatment in cimetidine-resistant peptic ulcers of duodenal location.     

Pirenzepine and cimetidine in the treatment of duodenal ulcer

The efficacy of pirenzepin--of anticholinergic effect--and the H2-receptor blocking cimetidine has been studied in duodenal ulcer with random, double blind fashion. Recurrence examinations were carried out 6 and 12 months following the treatment. 50 patients were given pirenzepin and 50 cimetidine. The average age of the patients was 44.5 and 43.8 years respectively. Of them 60 (24 + 36) were men and 40 (26 + 14) women. At the start, 6 weeks following the start 6 and 12 months after the finishing of the treatment gastroscopy was performed. In the course of the six-week-long treatment 38 (76%) of the pirenzepin taking patients and 36 (72%) of the cimetidine taking patients recovered. No significant difference was found between the efficacy of the both treatments. In the respect of the half and one year recurrence, no significant difference was observed between the two patient groups. Ten of the patients taking pirenzepin and 4 of those taking cimetidine complained of side effects. Dryness of mouth, visual disturbance in the former group and constipation in the latter one. On the basis of the examinations both secretion inhibitors were found equally suitable for the therapy of duodenal ulcer.     

Parietal cell vagotomy or cimetidine maintenance therapy for duodenal ulcer? A prospective controlled trial

In a prospective controlled trial 86 duodenal ulcer patients with symptoms severe enough to indicate surgery were randomized to a full-dose cimetidine course followed by maintenance therapy for 1 year or parietal cell vagotomy (PCV). The average follow-up period was 57 months. In the group assigned to medical therapy 62% of the patients were free of symptoms during maintenance therapy, and 12% remained well during the follow-up period. Operation was later performed in 35%, whereas 53% had symptomatic recurrence demanding medical treatment regularly. After PCV no patient died, and there were no serious sequelae. The overall recurrence rate was 17%; after treatment of failures 9% continued to have dyspepsia. Since nearly 3/4 of the patients were free of symptoms after PCV, operation seems to be the method of choice in patients with a severe history and fast recurrence after medical therapy. However, the aged and those at high risk of surgery may benefit from cimetidine maintenance therapy.     

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.     

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.     

Comparison of ranitidine and high-dose antacid in the treatment of prepyloric or duodenal ulcer. A double-blind controlled trial

One hundred and nineteen patients with endoscopically confirmed prepyloric (n = 59) or duodenal (n = 60) ulcer were stratified for ulcer location before entering a randomized double-blind trial comparing ranitidine (150 mg twice daily) and a potent liquid antacid (Novaluzid; 10 ml seven times daily, with a neutralizing capacity of 600 mmol H+). Fifty-four patients with prepyloric (26 receiving ranitidine) and 53 patients with duodenal ulcer (28 receiving ranitidine) completed the trial in accordance with the protocol. The 4 and 6 weeks' healing rates for prepyloric ulcers were 54%, 68%, and 61%, versus 69%, 79%, and 74% for the ranitidine, the antacid, and whole groups, respectively. For duodenal ulcers these figures were 89%, 84%, and 87%, versus 100%, 96%, and 98% for the ranitidine, antacid, and whole groups, respectively. Differences in healing rates between treatments were statistically insignificant within strata for ulcer type, but healing rates for prepyloric ulcers were significantly lower than for duodenal ulcers (p less than 0.002). A significant early pain relief was found in all groups, and side effects, including diarrhoea, were rare. In conclusion, these two ulcer treatment modalities appear to be equally effective in the short term. In addition, the data emphasize the need for proper stratification of prepyloric and duodenal ulcers in clinical trials of ulcer healing.     

Final report on the United States Multicenter Trial comparing ranitidine to cimetidine as maintenance therapy following healing of duodenal ulcer

Patients with recently healed duodenal ulcers were enrolled at 14 participating centers in a 12-month study comparing the effectiveness of ranitidine and cimetidine, two H2-receptor blockers, for maintenance therapy. Patients were randomly assigned to take bedtime doses of 150 mg of ranitidine (n = 60) or 400 mg of cimetidine (n = 66). Endoscopic examinations were scheduled at baseline and after 4, 8, and 12 months of therapy, or when symptoms compatible with active ulcer disease developed. Life-table analysis indicated a relapse rate of 16% for the ranitidine subjects and 43% for the cimetidine subjects during the 12-month period (p = 0.01). Therapy was discontinued in one ranitidine subject and two cimetidine subjects for adverse events considered drug-related. There were no drug-related laboratory abnormalities in either treatment group. No significant drug-related adverse effects were seen with either drug during this 1-year trial. At the doses prescribed, ranitidine was superior to cimetidine as maintenance therapy in duodenal ulcer disease.     

Low-dose cimetidine in the acute treatment of duodenal ulcer. Comparison of a single nocturnal dose regimen with a twice daily regimen

A 0.5 g daily dose of cimetidine was as effective as a 1 g dose in the acute treatment of duodenal ulcer patients in Hong Kong. The aims of the present study were, first, to determine whether low-dose cimetidine treatment was as effective as standard doses in acute duodenal ulcer treatment of patients in Singapore, and second, to compare a single nocturnal dosage regimen with a twice daily regimen. In this single centre, double-blind, controlled trial, 282 patients with endoscopically proven duodenal ulcer were randomized to receive four weeks' treatment with cimetidine using one of three dosage regimens: (A) 800 mg at night; (B) 400 mg at night; or (C) 400 mg twice daily. Two hundred and forty-seven patients were evaluated. The incidences of healing at four weeks were: (A) 40/80 (50%), (B) 39/88 (44%); and (C) 48/79 (61%); (B vs C: P less than 0.05; A vs C: NS; 95% confidence limits: -5% to 27%; A vs B: NS, 95% confidence limits: -6% to 21%). Of 183 patients who had antral biopsies taken, 176 (96%) had histological gastritis, while 167 (91%) were positive for Helicobacter-like organisms. The occurrence of gastritis or Helicobacter-like organisms had no influence on ulcer healing. A 400 mg dose of cimetidine is therefore suboptimal for the treatment of duodenal ulcer in patients in Singapore. A single nocturnal dosage regimen may be less effective than a twice daily regimen.     

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.