Duodenal ulcer healing with four antacid tablets daily

In a double-blind, randomized, multicenter trial in 80 consecutive outpatients with endoscopically verified duodenal ulcer, we have tested the ulcer-healing efficacy of a quite low dose of antacids, given only four times daily. The patients received one chewable aluminum-magnesium-antacid tablet (buffering capacity, 30 mmol/tablet) or placebo 1 h after meals and at bedtime. Re-endoscopy after 4 weeks of treatment showed healed ulcer in 28 of 38 patients (74%) in the antacid group, compared with 11 of 38 patients (29%) in the placebo group (p less than 0.001). The number of days and nights with ulcer pain was significantly less in the antacid group than in the placebo group during the treatment period. Thus, only four antacid tablets a day, with a total buffering capacity of 120 mmol/day, significantly promote duodenal ulcer healing and pain relief.     

Antacids in the Treatment of Duodenal Ulcer

ABSTRACT Fifty patients with endoscopically proven pyloric-prepyloric ulcers (PU/PPU) and 50 with duodenal ulcers (DU) completed a six-week double-blind clinical trial initially comprising 124 patients. The antacid-treated patients received 10 ml of an antacid suspension seven times a day (buffering 367.5 mmol acid). Healing rate after three weeks of treatment was 74% in the antacid and 42% in the placebo group (p<0.01). After six weeks the corresponding figures were 96 and 68% (p<0.001). Regarding the PU/PPU and DU subgroups we found significant differences compared to placebo in the PU/PPU group only. Antacids caused a significantly faster and more perceptible pain relief than placebo. We found no significant correlation between ulcer healing and smoking habits. Regression analyses showed that, besides antacids, ulcer size and peak acid output influenced the healing rate significantly.     

Antacid Treatment of Duodenal Ulcer

ABSTRACT. Becker U, Lindorff K, Andersen C, Ranløv PJ (Department of Internal Medicine B, Central Hospital, Hillerød, Denmark). Antacid treatment of duodenal ulcer. Acta Med Scand 1987; 221:95–101. Sixty-seven consecutive outpatients with endoscopically verified duodenal ulcer were randomised to a double-blind treatment with either 10 ml of an antacid suspension (buffering capacity 85 mmol/10 ml, packed in single dosage pads) 1 and 3 h after each meal and at bedtime or cimetidine 400 mg b.i.d. The double-dummy technique was employed. Endoscopy was performed after 4 weeks treatment and, if the ulcer had not healed, after 8 weeks treatment. When ulcer healing had occurred, the patient entered a 1 year follow-up study. The cumulative healing rates after 4 and 8 weeks treatment were 83 and 97% vs. 69 and 94% in the antacid and cimetidine groups respectively. No significant differences were observed between the treatment groups regarding ulcer healing, symptom relief or compliance. Adverse reactions were few and only 3 (9%) patients in the antacid group had to discontinue the treatment due to diarrhoea. Of the cimetidine treated patients, 61% had symptomatic relapse during the 1 year follow-up compared to 71% of the antacid treated patients. There were no significant differences in recurrence rate or time to relapse. The moderate dose antacid treatment used here is efficient, well tolerated, safe, convenient and is a good alternative treatment of the duodenal ulcer patient.     

Healing of benign gastric ulcer with low-dose antacids and fiber diet

A randomized, double-blind, placebo-controlled trial was conducted to determine the efficacy of a low-dose aluminum-magnesium antacid regimen (Link one tablet q.i.d.) (total neutralizing capacity 120 mmol HCl/day) in combination with a high- or a low-fiber diet in ulcer healing and relief of symptoms in patients with benign gastric ulcer. After 6 wk, the ulcer healed in 28 (67%) of the 42 patients treated with antacids compared with 11 (25%) of the 44 patients treated with placebo (p less than 0.001). Antacids were also significantly more effective than placebo in the relief of symptoms. The dietary treatment did not significantly influence ulcer healing or ulcer symptoms. Constipation was more frequently seen with the low- than with the high-fiber diet (p less than 0.01). No significant side effects from antacids were recorded.     

Factors affecting the healing rate of duodenal and pyloric ulcers with low-dose antacid treatment.

In 80 patients with duodenal ulcer, the effects of various factors--symptoms, endoscopic findings, and peak acid output (PAO)--on the healing rate were studied during eight weeks of outpatient therapy with low-dose antacid (neutralising capacity less than 50 mmol HCl/d). Fifty-six per cent of the ulcers healed. The following unfavourable factors were found to cause a significant delay in ulcer healing: a long duration of pain in the last ulcer relapse and the present period of ulcer pain, smoking, stenosis of the duodenal bulb, and a high PAO. Multiple regression analysis showed that three factors (duration of the present ulcer pain, smoking, and stenosis of the duodenum) had a significant influence on healing rate. According to the results obtained with this method, the patients with no or only one unfavourable factor (n = 35) had the best healing rate: 80%, compared with patients who had two (n = 31) or three (n = 14) unfavourable factors. The healing rate of the latter two groups was 41% and 28%, respectively (p less than 0.001). A prognostic score based on these three factors represents the severity of duodenal-ulcer disease with regard to the healing process under placebo-like doses of antacid.     

Cimetidine vs placebo in duodenal ulcer therapy

We studied the healing efficacy of cimetidine or placebo in 23 endoscopically proven duodenal ulcer outpatients in a randomized, controlled, prospective, double-blind trial. There were 11 patients in the cimetidine (1200 mg daily) treatment group and 12 patients in the placebo-treated group. No antacid was allowed, but a placebo antacid with no neutralizing capacity was given as needed for pain. The incidence of complete endoscopic healing at 2, 4, and 6 weeks was 54%, 63%, and 72% in the cimetidine-treated patients and 8%, 50%, and 67% in the placebo-treated patients. There was a statistically significant difference (P<0.05) in complete duodenal ulcer healing between both treatment groups after 2 weeks of therapy, but there was no significant difference at the 4- and 6-week observation periods. The incidence of complete pain relief at 2 and 4 weeks was 64% and 82% in the cimetidine-treated patients and 67% and 75% in the placebo-treated patients. At 6 weeks of treatment there was no increase in the number of patients with complete pain relief in either group. There was no significant difference between the two groups in the incidence of ulcer pain relief at any of the three observation periods. Duodenal ulcer healing rates and duodenal ulcer pain relief were compared at 2, 4, and 6 weeks. There was no statistical association between ulcer healing and complete pain relief in the placebo treatment group at the 2-week evaluation period, but there was statistical association (P<0.05) in the cimetidine treatment group at 2 weeks and both treatment groups at the 4- and 6-week evaluation periods. The results of this study demonstrate that in duodenal ulcer outpatients treated for 6 weeks: (1) cimetidine increases the incidence of duodenal ulcer healing during the first 2 weeks of treatment; (2) more than 50% of duodenal ulcers will spontaneously heal during a 4 to 6-week observation period which is not statistically modified by cimetidine treatment; (3) the complete relief of duodenal ulcer pain is not influenced by treatment with cimetidine when compared to placebo.     

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.     

Low-dose antacids or cimetidine for duodenal ulcer?

In a double-blind, randomized, multicenter trial 150 consecutive outpatients with endoscopically verified duodenal ulcer were treated with either a low-dose antacid regimen (1 tablet q.i.d.; acid-neutralizing capacity, 120 mmol/day), or cimetidine (800 mg nocte). After 4 wk of treatment control gastroscopy showed ulcer healing in 54 of 76 patients (71.1%) in the antacid group, as compared with 58 of 74 patients (78.4%) in the cimetidine-treated group. The difference in healing rate of 7.3% (95% confidence interval, -6.5% to +21.1%) was not statistically significant. The symptomatic effect, measured as number of days and nights with ulcer pain, was also quite similar in the two treatment groups. However, the number of days with pain was significantly lower in the first week of treatment in the antacid group (p less than 0.01). Thus, the efficacy of a low-dose antacid tablet regimen approximated that of cimetidine (800 mg nocte) in the treatment of duodenal ulcer patients.     

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.     

A double-blind study of trimipramine in the treatment of active duodenal ulceration

Thirty-six patients with endoscopically proven active duodenal ulcers entered a randomized double-blind trial. Five patients were excluded or lost to follow-up. Fifteen patients received 50 mg trimipramine at night and 16 patients received placebo. Endoscopy at 4 weeks showed ulcer healing in 11 patients (73%) receiving trimipramine and in 6 patients (38%) receiving placebo. Three patients were withdrawn at this stage, and the remainder were followed up for a further 4 weeks while receiving antacids only for symptomatic relief. At final endoscopy after 8 weeks, no further healing had occurred in the trimipramine group, whereas one further patient in the placebo group showed ulcer healing. The frequency and severity of night pain and waking were reduced and antacid consumption was lower int he trimipramine group, but initial drowsiness was greater. Trimipramine appears to be of some value in the treatment of duodenal ulceration.     

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 low-dose antacids

The aim of the present investigation was to compare the efficacy of a low-dose antacid (Maalox 70, 280 mmol/day) with that of the H2-receptor antagonist cimetidine (Tagamet, 200 mg three times daily and 400 mg/day) after 14 and 28 days in the treatment of duodenal ulcer. The prospective multicentre study included 171 patients with endoscopically confirmed duodenal ulcers. The patients were randomly assigned to the treatment groups with antacid containing Mg and Al hydroxide (M)(4 X 70 mmol/day; n = 86) or to the group receiving cimetidine (T) (1000 mg/day; n = 85). The two treatment groups were matched for age, sex, drinking and smoking habits, and drug use. Endoscopic examinations were carried out before the start of treatment and 14 days later. If the ulcer was still present at this time, the second endoscopic examination was done after a further 14 days. Endoscopically, the ulcer had healed at 14 days in 38.8% (M) and in 34.9% (T) and at 28 days in 80.0% (M) and 74.7% (T), respectively. The healing rate did not differ significantly between the two treatment groups. Complaints, measured as percentage of days per week with upper abdominal pain, were significantly reduced in both groups. No significant differences were found between the two treatment groups with regard to pain relief or side effects. Treatment had to be abandoned in one patient receiving antacid because of diarrhoea and in one patient receiving cimetidine because of the absence of any response.(ABSTRACT TRUNCATED AT 250 WORDS)     

Antacid provides better restoration of glandular structures within the gastric ulcer scar than omeprazole.

Mucosa of healed gastric ulcers displays histological abnormalities that are possibly the basis of ulcer recurrence. The influence of antacid and omeprazole treatment was studied on the quality of ulcer healing. Sixty four rats with gastric cryoulcers were treated daily either with placebo, antacid, omeprazole, or antacid plus omeprazole. Ulcer size was measured three times per week with a novel video endoscopic method. Prostaglandin generation (day 6), cell proliferation (day 8 and 15), height and cell composition of ulcer margin (day 8), and mucosal scar (day 15) were quantitatively assessed. Antacid, omeprazole, and antacid plus omeprazole significantly accelerated ulcer healing predominantly during days 3-8. Compared with placebo, the height of ulcer margin and mucosal ulcer scar was significantly increased in antacid (+7 and +9% respectively) and significantly decreased in omeprazole (-33 and -22% respectively) and antacid plus omeprazole (-26 and -18% respectively) treated rats. The number of bromodeoxyuridine labelled cells (+42%, day 8), epithelial cell mass (+42%, day 15), and the ratios of epithelial cells/connective tissue (+73%, day 15) and epithelial cells/gland lumen (+100%, day 15) were significantly increased in antacid treated rats. In conclusion, both antacid and omeprazole accelerate ulcer healing but antacid provides a better quality of healing. This advantage is lost by cotreatment with omeprazole.     

Antacid and placebo produced similar pain relief in duodenal ulcer patients.

The effectiveness of antacid and placebo in relieving single episodes of spontaneous duodenal ulcer pain were compared in two double blind, controlled, randomized trials. The trials compared the effects on ulcer pain of individual doses of a liquid antacid and placebo, rather than the effects of therapeutic regimens with antacid or placebo. Thirty patients were studied. There were no significant differences between antacid and placebo in time to onset, degree, or duration of pain relief. These results suggest that factors other than gastric acid neutralization are important in acute relief of spontaneous duodenal ulcer pain.     

Famotidine versus cimetidine in the treatment of acute duodenal ulcer. Double-blind, randomized clinical trial comparing nocturnal administration of 40 mg famotidine to 800 mg cimetidine

The efficacy of famotidine, a potent new long-acting H2 receptor antagonist, was compared with cimetidine in 78 patients with endoscopically proven acute duodenal ulcers. Additional antacid self-medication was allowed if needed for relief of pain. Thirty-nine patients were allocated to each group, receiving a nocturnal oral dose of either 40 mg famotidine or 800 mg cimetidine. Patients were reassessed by endoscopy at 2, 4 and 6 weeks if ulcer healing had not occurred at the respective earlier control date. A diary was kept to record the duration and intensity of day and night pain and the amount of antacids ingested. After 2 and 4 weeks of treatment healing rates were not significantly different for either group (famotidine 31 and 95%, cimetidine 23 and 85%, respectively). Pain relief was rapid in both treatment groups with a tendency for better response of nighttime pain in famotidine-treated patients. Antacid consumption was not different in either group. Famotidine appears to be an effective treatment for acute duodenal ulcer. Compared to cimetidine, healing rates and relief of pain are not significantly different.     

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.     

A multicenter, double-blind, randomized, placebo-controlled comparison of nocturnal and twice-a-day famotidine in the treatment of active duodenal ulcer disease

The efficacy and safety of famotidine, a potent new long-acting H2-receptor antagonist, was compared with placebo in a multicenter, double-blind, randomized, placebo-controlled study in the United States. A total of 384 patients with endoscopically proven acute duodenal ulcer disease were enrolled. Patients received either famotidine or a placebo. The patients receiving famotidine were treated with one of three dose regimens, 40 mg h.s., 40 mg b.i.d., or 20 mg b.i.d. Patients were reassessed by endoscopy at 2, 4, and 8 wk if ulcer healing had not occurred sooner. A diary was kept to record the duration and intensity of the day and night pain and the amount of Gelusil antacid (Parke-Davis, Morris Plains, N.J.) ingested. Three hundred sixty-three patients met the evaluation criteria. The results revealed a 4-wk healing rate of 70%, 75%, 67%, and 31% for the famotidine 40 mg h.s., 40 mg b.i.d., 20 mg b.i.d., and placebo groups, respectively. The 8-wk healing rates for the same respective groups were 83%, 82%, 82%, 45%. Ulcer pain and antacid consumption occurred less often in the famotidine groups. The clinical and laboratory safety profile of the famotidine groups was similar to that of the placebo group. Famotidine appears to be an effective and safe once-a-day therapy for the treatment of acute duodenal ulcer disease. The recommended dosage is 40 mg h.s.     

Conventional versus on-demand therapy for duodenal ulcer: results of a controlled therapeutic trial

To compare the efficacy of conventional versus on-demand (symptomatic) treatment of duodenal ulcer, 81 patients were randomized into two groups. Group A (n = 40) patients were treated with ranitidine 150 mg twice daily until complete ulcer healing was achieved. Group B (n = 41) received a similar dose of ranitidine until complete relief of pain was achieved, irrespective of ulcer healing. Recurrence of ulcer in group A was treated with a full course of treatment until complete healing of the ulcer was achieved again, whereas, in group B, treatment was given only until pain recurrence was symptomatically controlled. Endoscopic examination was performed each month. Analysis of the results at 8 wk and 28 wk showed that 1) ulcer healing in group A was significantly superior to that in group B up to 24 wk, but at 28 wk the difference was no longer statistically significant (95% vs 70%), 2) the number of painful days were similar in the two groups, 3) group A patients took treatment for a significantly longer period than those in group B, 4) the cost of treatment per patient in group A was significantly greater than that in group B, 5) the recurrence rate assessed in patients followed for 28 wk after complete ulcer healing was similar in the two groups, and 6) the ulcer-related complications were not significantly different in the two groups. These findings indicate that, although on-demand treatment results in slower ulcer healing, it is not associated with an increase in the duration of pain and incidence of complications. A major advantage of this approach was a significant reduction in the cost of treatment. It is concluded that on-demand treatment is an attractive alternative therapeutic approach in the management of duodenal ulcer disease.     

Comparison of colloidal bismuth subcitrate tablets and liquid in duodenal ulcer healing

A double-blind trial using 51 outpatients was aimed at comparing the effectiveness of colloidal bismuth subcitrate (C.B.S.) in tablet and liquid form in the healing of duodenal ulcer. Criteria of entry included endoscopically proven duodenal ulcer, duration of symptoms greater than 4 weeks, and the absence of other major systemic disease. Patients were given either C.B.S. tablets (1 four times daily) or C.B.S. liquid (5 ml four times daily) for 4 weeks. Ulcer symptoms and their relief were recorded by patients, along with data on cigarette, alcohol, and drug intake. Endoscopy was performed after 4 weeks to assess healing. By 4 weeks, 18 of 26 patients taking tablets (69%) and 19 out of 25 patients taking liquid (76%), had healed (p = 0.82). Symptomatic improvement was similar with both tablets and liquid. Smoking and analgesic ingestion did not influence healing rate. We conclude that C.B.S. tablets and liquid are equally effective in healing duodenal ulcer.     

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.