Antacid Tablets Research Articles

Low-Dose Antacids versus 400 mg Cimetidine Twice Daily for Reflux Oesophagitis

Ninety-one patients with reflux oesophagitis were randomly allocated to treatment with one chewable antacid tablet (acid-neutralizing capacity, 30 mmol) four times daily, 400 mg cimetidine twice daily, or placebo. The study was double-blind, with a double-dummy technique. Endoscopy was performed before inclusion and after 8 weeks' treatment. Symptoms were recorded on diary cards and on visual analogue scales. Statistically significant healing of oesophagitis was achieved in all three treatment groups, but none of the active regimens were significantly superior to placebo. Symptoms were significantly reduced with both cimetidine and antacids compared with placebo. Patients taking antacids consumed significantly less extra antacids for pain relief and had significantly better global assessment score than patients taking cimetidine during the first and second half of the study, respectively. In conclusion, neither cimetidine nor antacids were significantly superior to placebo in healing of reflux oesophagitis. Both the active regimens were superior to placebo for symptomatic relief.

Suppression of nocturnal acid secretion with famotidine accelerates gastric ulcer healing

Although nocturnal acid secretion has been emphasized in the pathophysiology and treatment of duodenal ulcer, its importance in gastric ulcer disease has been questioned. To explore this area, this multicenter U.S. trial compared the effect of a once-daily nighttime dose of H2-receptor antagonist with placebo on the healing of gastric ulcer and relief of associated symptoms. One hundred fifty-seven patients with endoscopically verified benign gastric ulcers were randomized in a double-blind fashion to either famotidine (40 mg at bedtime) or placebo. Antacid tablets were allowed as needed. The healing rates for famotidine were 45%, 66%, and 78% at weeks 4, 6, and 8, respectively. In comparison, placebo healing rates were 39%, 44%, and 64%. These differences were statistically significant in favor of famotidine at weeks 6 (p ≤ 0.01) and 8 (p ≤ 0.05), as well as in a life-table analysis (p ≤ 0.05). Nocturnal famotidine was also significantly better than placebo with respect to time to complete relief of pain and to the percentage of patients with complete relief of pain. No concomitant factor (including ulcer size, ulcer location, smoking history, or regular alcohol use) affected healing rates in this study. Famotidine was well-tolerated and no serious clinical or laboratory adverse effects were judged to be related to this dosing regimen of famotidine. In conclusion, suppression of nocturnal acid secretion with famotidine (40 mg at bedtime) was more effective than placebo in promoting the healing of acute benign gastric ulcer and its associated symptoms. The results of this study suggest that suppression of nocturnal acid secretion alone is as effective as “around the clock” acid suppression in the healing of benign gastric ulcer.

Randomized, double-blind comparison of famotidine with ranitidine in treatment of acute, benign gastric ulcer disease

A multicenter, double-blind, randomized controlled trial comparing the efficacy and safety of famotidine with ranitidine in the treatment of acute, benign gastric ulcer disease was coupled with a community-based gastric ulcer disease registry. One hundred ninety-five patients with endoscopically documented gastric ulcer disease were enrolled in the trial and randomly allocated to treatment with either famotidine 40 mg at bedtime or ranitidine 150 mg twice a day. Healing rates were similar in both groups: at four weeks 49% vs 48%, at six weeks 71% vs 69%, and at eight weeks 83% vs 81% for famotidine and for ranitidine, respectively. Pain relief, antacid tablet use, and adverse experiences were also similar in the two groups. Only 25% of patients entered in the gastric ulcer registry were enrolled in the trial. Given that patients with more severe or complicated gastric ulcer disease should be excluded from controlled trials of new drugs, the screening criteria used in the present study be excluded from findings being representative of a quarter of the patients seen in these practices. Therefore, coupling a patient registry with a clinical trial helps determine the applicability of its results. Famotidine 40 mg at bedtime is an effective and well-tolerated treatment of acute, benign gastric ulcer disease and is comparable in efficacy and safety to ranitidine 150 mg twice a day.

Symptom relief and duodenal ulcer healing with omeprazole or cimetidine

In a double-blind parallel-group study, 98 patients with symptomatic duodenal ulcer received omeprazole 20 mg o.m. and 91 cimetidine 800 mg nocte for 2 or, if then not healed, 4 weeks. After 2 weeks the healing rates on an intention-to-treat basis were: for omeprazole 62% and for cimetidine 33% (P less than 0.001), and at 4 weeks 85% and 61%, respectively (P less than 0.001). The proportions symptom-free at 2 weeks were 83% of the omeprazole and 63% of the cimetidine-group (P less than 0.01) and at 4 weeks 84% and 72% (P = 0.01). Patients receiving omeprazole took fewer antacid tablets than those receiving cimetidine. Patient tolerance of both drugs was similar and good. In the treatment of duodenal ulcer, omeprazole 20 mg o.m. gives faster symptom relief than cimetidine 800 mg nocte, as well as healing a greater proportion of ulcers within 2 and 4 weeks.

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.

Chewable cimetidine versus chewable antacid in dyspepsia: Which provides faster pain relief?

A randomized double-blind antacid-controlled study was carried out to investigate the speed of onset of relief from dyspeptic pain with a novel, chewable formulation of cimetidine in 80 patients with persistent dyspepsia. Inclusion and exclusion criteria were chosen to identify patients with an acid-related dyspeptic complex. After the ingestion of either 1 chewable cimetidine (200 mg) tablet or a chewable antacid tablet identical in appearance, dyspeptic pain was recorded by each patient every 10 minutes over a 1-hour period. The times for some improvement and for total disappearance of the pain were noted, as was the appearance of the next attack of dyspepsia. For both treatments, the median times for some improvement were less than 20 minutes and for total pain relief were less than 45 minutes. There was no statistically significant difference between treatments. The duration of pain relief was variable, but 13% of patients who had received antacid reported another attack of dyspepsia in less than 5 hours compared to none of the cimetidine-treated patients.

Symptomatic Effect of a Low-Dose Antacid Regimen in Reflux Oesophagitis

The symptomatic effect of a 2-week low-dose antacid tablet regimen was assessed in a prospective, double-blind, randomized, placebo-controlled, crossover trial in 47 patients with endoscopically verified reflux oesophagitis. During treatment with antacid there were lower global symptomatic scores (p less than 0.05), less acid regurgitation (p less than 0.05), and fewer days (p less than 0.01) and nights (p less than 0.05) with heartburn than during placebo therapy. Also, significantly more patients preferred antacid than placebo treatment (p less than 0.05). Thus, a low-dose antacid tablet regimen relieves symptoms significantly better than placebo in patients with reflux oesophagitis.

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 Evaluation of Several Direct Compression Sugars II

The formulation efficiency of several sucrose based direct compression vehicles has been evaluated. The effect of compression force on various fundamental tablet properties has been investigated.It has been observed that even chemically similar matrices may show differences in formulation efficiencies if there are subtile changes in the structure of the particles.A simple method for evaluating acid neutralizing efficiency of antacid tablets, particularly when aging is concern, has been presented.

Ranitidine Therapy for Gastroesophageal Reflux Disease

In a multicenter, double-blind trial, 284 patients with gastroesophageal reflux disease were evaluated before, during, and after six weeks of treatment with either placebo or ranitidine (150 mg twice daily). Randomization resulted in two comparable patient groups. Ranitidine treatment was significantly more effective than placebo treatment in decreasing the frequency and the severity of heartburn during both daytime and nighttime assessment periods. There was a significant correlation between improvement in heartburn symptoms and decrease in antacid consumption; hence, patients receiving ranitidine consumed significantly fewer antacid tablets. Among patients with endoscopic esophagitis at baseline, the overall change in endoscopic classification after six weeks of therapy was significantly better for the ranitidine-treated patients. The ranitidine-treated group had less evidence of erosions and ulcerations as well as greater healing. There were no differences between the groups with respect to changes in esophageal mucosal sensitivity to acid perfusion or changes in histologic grading of esophageal mucosal biopsy specimens. The ranitidine safety profile was similar to that of previous studies. We conclude that, in patients with gastroesophageal reflux disease, ranitidine therapy, 150 mg twice daily, markedly reduced the heartburn symptoms of reflux disease and significantly improved the endoscopic appearance of the esophageal mucosa.

Treatment of Acute Duodenal Ulcer — a Swedish Multicenter Study

Medical ulcer therapy focuses on enhancing mucosal defence mechanisms or reducing intraluminal acidity. In this Swedish multicenter, randomized double-blind study these two principles were compared in the treatment of acute duodenal ulcerations. Sucralfate (Andapsin 1g X 4) or cimetidine (Tagamet 400mg X 2), together with antacid tablets (Novalucol), were supplied to patients with acute ulcerations in the pyloric ring or duodenal bulb. Endoscopy was performed at inclusion, after four weeks and in some patients also after eight weeks. Besides healing rate, symptoms and antacid intake, smoking and side effects were recorded on a special protocol. 371 patients from 15 centers completed the trial. At inclusion the patient groups did not differ in any essential aspect. At four weeks 71% of 177 patients on sucralfate and 77% of 194 on cimetidine were healed. The corresponding figures for eight weeks were 86% (suc) and 92% (cim). The difference is not significant, the 95% confidence interval for the difference in ulcer healing efficacy of sucralfate compared with cimetidine at eight weeks was -12% to +5%. Antacid intake and symptoms decreased rapidly and equally in both groups. Side effects related to the treatments were uncommon. It is concluded that sucralfate and cimetidine, representing two different principles in medical ulcer treatment, are both very effective and compare well in the short term treatment of acute duodenal ulcer.

Gastrointestinal absorption of aluminium from single doses of aluminium containing antacids in man

Ten subjects with normal renal function were given different single doses of aluminium containing antacids (1, 4, or 8 tablets). The antacid tablets (aluminium content 244 mg tablet-1) were chewed and swallowed either with water, with orange juice, or with citric acid solution. There was a marked increase in serum concentration of aluminium when the antacids was ingested with citric acid (P less than 0.001) or with orange juice (P less than 0.05). When antacids were taken with water, a slight, but significant increase in serum aluminium concentration was seen with 4, but not with 1 or with 8 tablets. Following all doses of antacid, a significant increase in 24 h urinary excretion of aluminium was seen. The estimated absorption of aluminium was 8 and 50 times higher when antacids were taken with orange juice or with citric acid, respectively, than when taken with water. Thus, measurable quantities of aluminium are absorbed from single oral doses of antacids. The absorption is substantially enhanced by concomitant ingestion of citric acid.

Treatment of active duodenal ulcers with famotidine: A double-blind comparison with ranitidine

In a double-blind multicenter trial, 100 patients with active duodenal ulcer were treated with a single nocturnal dose of famotidine 40 mg or ranitidine 300 mg. Antacid tablets were allowed as additional treatment if needed for pain relief. Endoscopy was repeated after two weeks, and again after four weeks if the ulcer had not healed earlier. Two patients in the famotidine group were withdrawn from the study because of non-compliance with the protocol. After two weeks, ulcers in 64 percent of the patients receiving famotidine and 46 percent of the patients receiving ranitidine were healed (p = 0.072). After four weeks, healing rates were 94 percent (famotidine) and 90 percent (ranitidine). Pain relief was rapid in either treatment group, with a tendency for better response during the day in the famotidine group. Mean antacid consumption during the first week was 3.0 tablets (34.5 mmol) in the famotidine group and 4.1 tablets (47.2 mmol) in the ranitidine group. Famotidine provides excellent healing and relief of symptoms in patients with duodenal ulcer disease.

Mineral-metabolic side effects of low-dose antacids.

Mineral-metabolic side effects of a low dose of a conventional Al-Mg antacid were examined in 10 healthy volunteers, who were given one antacid tablet after the 3 main meals and at bedtime (buffering capacity, 120 mmol/day) for 4 weeks. Compared with the pre-medication state, the following changes of statistical significance occurred during antacid ingestion: increase in urinary excretion of magnesium, calcium, and aluminum; decrease in urinary excretion of phosphate; increase in maximal renal phosphate reabsorption (Tm PO4/GFR); and increase in serum concentration of aluminum. Most of the changes were normalized 3-4 days after cessation of antacid medication. There was no change in intestinal absorption of calcium. The fact that even this low dose of antacids can provoke measurable changes in mineral metabolism, including aluminum absorption, is noteworthy, although we did not see any clinical symptoms from the biochemical changes.

The use of antisera (‘Serocytol’) in the management of gastritis: a double-blind clinical assessment versus placebo

A double-blind, placebo-controlled study was carried out in 40 out-patients with endoscopically confirmed hypertrophic or erosive gastritis, without ulcer, to assess the effectiveness and tolerance of treatment with equine antisera (antidiencephalon and anti-stomach tissue). Patients were assigned at random to receive a single dose in suppository form on 2 days a week for 6 weeks of both antisera (anti-diencephalon on Days 1 and 4, anti-stomach tissue on Days 2 and 5) or placebo (saline solution). No other anti-ulcer treatment was allowed except standard antacid tablets, the consumption of which was recorded and used as an evaluation parameter. Endoscopy, haematology and haematochemistry were performed before and after treatment; symptoms (daytime and night-time pain, heartburn and dyspepsia) and possible adverse reactions were scored 0 to 4 in order of increasing severity before treatment and after 1, 2, 4 and 6 weeks. Five patients in the placebo group had to be withdrawn from the trial at the second week because of therapeutic failure. This proportion was significantly in favour of the antisera group, as was the proportion of patients endoscopically healed and the extent and rate of symptomatic improvement. Concomitant antacid consumption rapidly and significantly decreased in the antisera but not in the placebo group. Signs of intolerance were not observed with either treatment, nor were there any significant alterations in haematology or haematochemistry. In particular, the immune titre of patients did not increase after treatment, thus indicating that the administered heterologous proteins did not elicit an immunization of the patients against horse protein.(ABSTRACT TRUNCATED AT 250 WORDS)

A 'Supersalivation Syndrome'

To the Editor.— For about ten years I have had an esophageal reflux syndrome characterized by recurrent epigastric distress, "heartburn," and awakening at night with sour regurgitation and rather severe epigastric pain. The pain, also sometimes present in the lower retrosternal area, feels like a spasm. What has been striking, however, is the remarkable, exuberant outpouring of saliva that occurs with the pain. They go together when the pain is more severe; milder pains may not be associated with the salivary hyperfunction. When it occurs, the salivary outpouring forces almost continuous swallowing and at times is itself more disconcerting than the pain. The epigastric and lower retrosternal pain is relieved by sitting up and drinking hot water or by sucking on an antacid tablet. Even the severe pain is relieved in a few minutes, although a vague residual discomfort may persist for up to 30 minutes. All the symptoms are

A Double-Blind Endoscopic Study with De-Nol® Tablets and Cimetidine for Duodenal Ulcer

In a double-blind, double-dummy comparison of short-term ulcer healing, involving 50 patients treated with either De-Nol tablets (four times daily) or cimetidine tablets (400 mg, twice daily), no statistical difference in healing rates was observed after 8 weeks' treatment. There was, however, a numerical trend in favour of De-Nol (De-Nol, 100% healed; cimetidine, 88% healed). Statistical significance in favour of De-Nol was observed, however, in the reduction of antacid tablet consumption and relief of ulcer pain. No unwanted side effects were observed with either drug. This trial indicates that De-Nol and cimetidine are equally effective and useful in the short-term treatment of duodenal ulcer.

Treatment of Gastric Ulcer with Ranitidine

Forty-eight patients with endoscopically proven gastric ulcer were treated either with ranitidine tablets, 150 mg twice daily, or with placebo tablets under double-blind conditions. Three patients were for various reasons excluded from the study. After 6 weeks' treatment a second endoscopy was performed. The ulcer had healed in 22 (88%) of the 25 patients who had received ranitidine tablets and in 4 (20%) of the 20 patients who had received placebo tablets. The difference was statistically significant (p < 0.002). The number of days and nights with pain attacks and the number of antacid tablets consumed were significantly (p < 0.002) lower in the patient group treated with ranitidine. The 3 patients with non-healed ulcer after treatment with ranitidine had their ulcers healed after a further 6 weeks' treatment with ranitidine, and of the 16 patients with non-healed ulcer after treatment with placebo tablets, 13 had their ulcers healed after 6 weeks' open treatment with ranitidine, 150mg twice daily. No serious side effects that could be ascribed to treatment occurred during the study.

The effect of flavour on acceptability of antacid tablets.

One hundred healthy volunteers recorded their subjective impressions of taste, mouth feel, after-taste and preference, after receiving in turn two tablets of each of four commonly-used antacids. The subjects remained unaware of the appearance of name of the products. The orange flavoured tablets, Asilone Orange, were shown to have a more acceptable taste, mouth feel and after-taste than three other commonly used antacids, Gaviscon, Altacite Plus, and Aluminium Hydroxide B.P., and these differences were highly significant (P less than 0.0001). Furthermore, 93% of cases expressed a willingness to take the orange flavoured tablets again, on a long term basis if necessary.

Gas chromatographic determination of oxazepam from tablets and micro capsules in urine

AbstractThree new and two commercially available sugar matrices were comparatively evaluated for several fundamental properties of direct compression powder systems. These properties included: particle size distribution, powder flow (determined by a recording powder flow meter), bulk density and moisture content. The matrices studied were Dipac, Nutab, and California and Hawaiian (C & H) Products A, B, and C. These matrices were formulated into chewable ascorbic acid, multivitamin, and antacid tablets, and analyzed for: weight uniformity, thickness, diameter, hardness, disintegration, resistance to impact stress, friability, dissolution and effect due to aging.The data obtained showed that the new products (C & H products) were comparable, and in some cases, even superior to the commercially available ones.