[Diagnostic value of alginate test in gastroesophageal reflux disease].

AIM OF STUDY: To evaluate the diagnostic accuracy of single dose of gaviscon (the alginates test) in detecting gastroesophageal reflux disease (GERD) in patients with heartburn symptoms. MATERIAL AND METHODS: 123 patients (male 46, female 77, age 43.6 +/- 15.5 years) with symptoms suggestive of GERD were investigated. Symptom response to the alginates test compared in GERD positive and GERD negative patients according traditional diagnostic criteria of GERD (upper endoscopy, 24-hr pH-monitoring, esophageal manometry, response to treatment with PPIs). RESULTS: Of 91 (78.9%) patients with positive alginates test, 87 were classified as GERD positive and 4 as GERD negative. Of 32 (26%) patients with negative alginates test, 29 were GERD negative and 3 GERD positive. The results providing a sensitivity of alginates test of 96.7% and a specificity of 87.7%. CONCLUSIONS: The alginates test is sensitive and specific for diagnosing GERD in patients with typical GERD symptoms.

Symptomatic response to GERDOFF® in patients with gastro-esophageal reflux disease and poor response to alginates: an exploratory, post-market, open-label study.

BACKGROUND/AIMS: A novel medical device based on hyaluronic acid, chondroitin sulphate plus aluminum hydroxide (GERDOFF®, melt-in-mouth tablets) showed efficacy in reducing GER-related symptoms. This exploratory, open-label study evaluated symptomatic effects of a 14-day treatment with GERDOFF® in GERD patients. MATERIALS AND METHODS: GERD Impact Scale (GIS) questionnaire was filled at baseline visit, after 7 and 14 days of treatment; patients' Global Satisfaction was evaluated at the final visit. Primary endpoint was the reduction of heartburn episodes per week; secondary endpoints were GERD-related symptoms, patients' satisfaction, and safety. RESULTS: Forty patients were included, 22 were on stable therapy with proton pump inhibitor (PPI). Compared to baseline, the days with heartburn episodes and the GIS score progressively decreased during the first (p<0.0001) and the second week of treatment (p<0.0001). Heartburn episodes per week (p<0.0001) and the GIS score (p<0.0001) decreased in the first and the last 7 days of 14-day treatment and did not differ between patients on and off PPI. The treatment was safe and well-tolerated, and it was rated as very good (46.2%) or good (43.6%) on the satisfaction questionnaire. CONCLUSION: GERDOFF® could effectively treat GER symptoms in patients not responding to PPI or alginate-based formulation. ISRCTN_15143752.

Formulation of intelligent tablets with an antacid effect.

Matrix systems with a local antacid effect were produced in this study. Aluminium hydroxide and magnesium trisilicate in constant concentrations were used as active agents. Eudragit E PO was applied as a matrix former and sodium bicarbonate as a disintegrant (third antacid component), in different ratios. Their effects on the properties of the tablets were studied. Such formulated systems must be insoluble if the pH of the stomach is less acidic, but a rapid disintegration must occur if necessary. It can be concluded that Eudragit E PO in appropriate composition can ensure tablets with pH-dependent disintegration. Its binding effect allows tablet making from the elastic active component. The liberation of antacid materials from this system is controlled. If the pH reached 2.5, the erosion of the tablet was reduced. In contrast with expectations, the application of poorly compressible and effervescent sodium bicarbonate increased the time for disintegration of the tablets, because of its extended alkalizing effect around the tablet. This system with this acrylic component is appropriate to produce a controlled-release local antacid preparation.

Determination of bioavailable fluoride from sepiolite by "in vivo" digestibility assays.

This work presents a study of the bioavailability and distribution of fluoride in tissues of animals (Wistar rats) which were fed with a poultry feeding that contains sepiolite as an additive. The determination of fluoride concentration was carried out by potentiometric measurements using a fluoride selective electrode. The quantification was done using the standard addition method with enough accuracy and precision in all the assays. The results demonstrate that fluoride present in sepiolite is not bioavailable. The digestion process does not extract all the fluoride from sepiolite, so sepiolite can be use in poultry feedings without any risk. These studies have contributed to the discussions at EU level about extraction procedures and F(-) determination in feed material of mineral origin.

Potassium citrate decreases urine calcium excretion in patients with hypocitraturic calcium oxalate nephrolithiasis.

Two previous studies (<10 patients each) have demonstrated that alkali therapy may reduce urine calcium excretion in patients with calcium oxalate nephrolithiasis. The hypothesized mechanisms are (1) a decrease in bone turnover due to systemic alkalinization by the medications; (2) binding of calcium by citrate in the gastrointestinal tract; (3) direct effects on TRPV5 activity in the distal tubule. We performed a retrospective review of patients on potassium citrate therapy to evaluate the effects of this medication on urinary calcium excretion. A retrospective review was performed of a metabolic stone database at a tertiary care academic hospital. Patients were identified with a history of calcium oxalate nephrolithiasis and hypocitraturia who were on potassium citrate therapy for a minimum of 3 months. 24-h urine composition was assessed prior to the initiation of potassium citrate therapy and after 3 months of therapy. Patients received 30-60 mEq potassium citrate by mouth daily. Inclusion criterion was a change in urine potassium of 20 mEq/day or greater, which suggests compliance with potassium citrate therapy. Paired t test was used to compare therapeutic effect. Twenty-two patients were evaluated. Mean age was 58.8 years (SD 14.0), mean BMI was 29.6 kg/m(2) (SD 5.9), and gender prevalence was 36.4% female:63.6% male. Mean pre-treatment 24-h urine values were as follows: citrate 280.0 mg/day, potassium 58.7 mEq/day, calcium 216.0 mg/day, pH 5.87. Potassium citrate therapy was associated with statistically significant changes in each of these parameters-citrate increased to 548.4 mg/day (p < 0.0001), potassium increased to 94.1 mEq/day (p < 0.0001), calcium decreased to 156.5 mg/day (p = 0.04), pH increased to 6.47 (p = 0.001). Urine sodium excretion was not different pre- and post-therapy (175 mEq/day pre-therapy versus 201 mEq/day post-therapy, p = NS). Urinary calcium excretion decreased by a mean of 60 mg/day on potassium citrate therapy-a nearly 30 % decrease in urine calcium excretion. These data lend support to the hypothesis that alkali therapy reduces urine calcium excretion.

15 (R)-15-methyl prostaglandin E2 does not prevent gastrointestinal bleeding in seriously ill patients.

A prospective, randomized trial was designed to compare the relative efficacy of 15 (R)-15-methyl prostaglandin E2 with antacid (usually Mylanta II) in 46 patients admitted to a respiratory-surgical intensive care unit. Bleeding was assessed by a modification of the Hemoccult slide test. Three of 22 patients in the antacid group bled, and 12 of 24 patients in the prostaglandin group bled, for a highly significant difference (p = 0.008). Patients in whom prophylaxis failed tended to have a greater number of risk factors. Other prostaglandin analogues that do not require conversion from an inactive to an active form, may be more useful than the agent we studied. Based on currently available data, the hourly titration of the gastric juice to a pH of greater than 3.5 remains the preferred method of prophylaxis for acute bleeding from the stomach in seriously ill patients.

Comparison of an intravenous bolus of famotidine and Mylanta II for the control of gastric pH in critically ill patients.

The effects of the intravenous bolus administration of famotidine versus the administration of Mylanta II liquid every 2 hours on the pH of the gastric antrum, body, and fundus for 24 hours were compared in 10 critically ill patients admitted to the intensive care unit with isolated cranial trauma. Patients received 30 mL of Mylanta II every 2 hours via nasogastric tube for 24 hours, followed by administration of 20 mg of intravenous bolus famotidine every 12 hours for the subsequent 24-hour period. pH of the gastric antrum, body, and fundus was monitored continuously using a three antimony pH electrode/nasogastric tube assembly. Gastric pH data were analyzed for the percentage of time pH was less than 4 and median pH for the antrum, body, and fundus for each 24-hour period. The percentage of time pH was less than 4 was significantly less in the antrum and body of the stomach during famotidine therapy (8.9% +/- 3.6% and 24.9% +/- 6.9%, respectively) compared with Mylanta II (39.1% +/- 6.7% and 57.6% +/- 8.5%, respectively, both p < 0.005), but was not significantly different in the fundus (famotidine: 25.3% +/- 7.8%; Mylanta II: 28.3% +/- 6.5%). Median gastric pH for 24 hours was significantly greater in the antrum and body of the stomach during famotidine therapy (7.8 +/- 0.2 and 6.8 +/- 0.6, respectively) compared with Mylanta II (4.5 +/- 0.6 and 3.7 +/- 0.9, respectively, p < 0.005 and p < 0.01, respectively), but was not significantly different in the fundus (famotidine: 5.9 +/- 0.8; Mylanta II: 5.4 +/- 0.7). The data indicate that an intravenous bolus of famotidine every 12 hours is more effective than Mylanta II liquid every 2 hours administered via a nasogastric tube in maintaining gastric pH above 4 in critically ill patients. Famotidine produces a uniform increase in gastric pH throughout the stomach, whereas Mylanta II controls only proximal gastric pH, probably related to fundic pooling of antacid in the supine position.

Prospective randomized study of viscous lidocaine versus benzocaine in a GI cocktail for dyspepsia.

We hypothesized that Benzocaine (Hurricaine) would work as quickly and effectively as viscous Lidocaine in this preparation. This was a prospective randomized, single-blinded comparison between Benzocaine and Lidocaine as the topical anesthetic in a gastrointestinal (GI) cocktail. Patients 18 years or older were approached for participation when a GI cocktail was ordered by the Emergency Physician. Patients were randomized to equivalent doses of either Benzocaine or viscous Lidocaine in addition to 30 cc of Maalox and 10 cc of Donnatal. Assessment using a visual analog pain scale occurred at time intervals of 0, 5, 15, and 30 min. Eighty-two patients were enrolled (44 to Benzocaine, 38 to viscous Lidocaine), with each group having a statistically significant improvement in pain (p < 0.001). There were no statistical differences between the Benzocaine and viscous Lidocaine groups in terms of the relief of symptoms at each of the assessment times. There were no adverse outcomes in either group.

Bismuth subsalicylate as filler particle for an experimental epoxy-based root canal sealer

AIM: To evaluate the influence of bismuth subsalicylate addition in different concentrations on theproperties ofan experimental epoxy-based root canal sealer. METHODS: Bismuth subsalicylate in 20%, 40%, 60%, 80%, 100% and 120 wt% was added tothe sealer. Flow, film thickness, working time, setting time, dimensional change, sorption, solubility and cytotoxicity were evaluated according to ISO standard. Data were statistically analyzed by one-way ANOVA and Tukey'stest with a significance level of 5% for all tests. RESULTS:The flow, working and setting times significantly decreased withincreasing particle concentration. The film thickness, dimensional change, water sorption and solubility values significantly increased with higher particle amount. The results for cytotoxicity showed no statistically significant differences among the particle proportions. CONCLUSIONS: The results suggest that the addition up to 80% wt of bismuth subsalicylate appears to be a promising filler particle to root canal sealer development.

In vitro release--in vivo microbiological and toxicological studies on ketoconazole lipid granules.

In some multidrug therapy programs, ketoconazole (KTZ) may be administered with some antacids that could modify its dissolution rate and reduce its absorption, thus leading to therapeutic failures. The primary aim of this study was to evaluate the influence of Compritol HD5 ATO and Compritol 888 ATO on this interaction in comparison with commercial KTZ tablets. The second aim was to prepare lipid granules of KTZ that could be an alternative to the commercial formulation. Therefore, six KTZ sustained-release granules were prepared with different lipid concentrations, because they were found to be more suitable than tablets that are dissolved only in gastric medium. The results confirmed that the dissolution rate of KTZ granules was significantly reduced in the presence of antacids. The ideal formulation was selected as granules including 5% of Compritol lipids in relation to the suitability of the target profile. Therapeutic effects of orally administered, ideal KTZ granule formulations, and commercial tablets were evaluated in vivo by the experimental model of murine vulvo-vaginal candidiasis (VVC) with and without antacids. It was found that formulations were very effective on VVC, and the therapeutic effect decreased significantly in the presence of antacids. Histopathological studies were carried out for vagina, stomach, and liver tissues and hepatoxicity was also examined. The levels of reduced glutathione (GSH) were measured to assess the oxidative stress induced by KTZ and function of the liver. It was observed that orally administered formulations of KTZ were successful in treating candidiasis in mice without irritancy in stomach. However, liver tissues were damaged. The decreased GSH levels indicated toxicity in our study. This study suggested that in vitro release and in vivo microbiological-toxicological properties of KTZ were affected by antacids and drug-excipient interactions. Lipid granules of KTZ prepared with Compritol 888 ATO could be proposed as a new KTZ solid dosage form with optimum dissolution and therapeutic characteristics.

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.

A morphological comparison of radicular dentin following root planing and treatment with citric acid or tetracycline HCl.

The conditioning of root surfaces with saturated solutions of citric acid or tetracycline is unpredictable in facilitating new attachment, perhaps due to the low pH of these solutions which may be denaturing the organic matrix of the root as well as demineralizing the surface. The purpose of the present study was to compare the effects of a saturated solution of citric acid (pH = 1) with that of a 0.5% solution of tetracycline HCl (pH = 3.2) on radicular dentin with regard to the removal of the smear layer, exposure of dentinal tubule openings, and demineralization of the peritubular dentin. 10 bovine incisors were used in this study. The crowns and apical 1/3 of the root were resected and the resulting root segments were then frozen in icy freon. The cementum was fractured off of the root to produce a fracture-exposed, non-instrumented dentin surface. This fracture-exposed dentin surface was divided into 4 specimens, the 1st being a fracture-exposed, non-instrumented dentin control specimen (FE). After removal of the (FE) specimen from the root segment, the remainder of the fracture-exposed dentin surface was thoroughly root planed and then subdivided into the 3 remaining specimens. One of these specimens served as the root planed dentin surface (RP); another specimen (CA) was immersed in saturated citric acid (pH = 1) for 5 min and then washed in water for 5 min; the final specimen (T) was immersed in a 0.5 mg/ml solution of tetracycline HCl for 5 min and rinsed in water for 5 min.(ABSTRACT TRUNCATED AT 250 WORDS)

A graded combination regimen for maintenance of gastric pH above 3.5 in critically ill patients.

Prophylaxis of acute upper gastrointestinal bleeding by control of gastric pH has been widely advocated for intensive care patients. H2-blockers and antacids have been used and demonstrated to be incompletely effective at maintaining gastric pH above 4. A study of 100 patients measured the efficacy of two-hourly gastric pH measurement and titrated therapy consisting of five levels: 1. no therapy 2. ranitidine 50 mg 8 hourly intravenously 3. ranitidine plus Mylanta 30 ml 2 hourly by nasogastric tube 4. ranitidine plus Mylanta 60 ml 2 hourly and 5. ranitidine 100 mg 8 hourly intravenously plus Mylanta II 60 ml 2 hourly. The level of treatment required by proportions of the total study group were (1) 15%, (2) 71%, (3) 96%, (4) 100%. Head-injured and intubated patients generally fell in the more resistant group while patients having had major elective surgery required lower levels of therapy. If control of gastric pH is to be uniformly achieved, a technique of titrated therapy based on gastric pH measurements is supported as cheaper and more effective than other standardised treatment regimens.

Antacid versus cimetidine in preventing acute gastrointestinal bleeding. A randomized trial in 75 critically ill patients.

Over a 15-month period, 75 critically ill patients at risk of acute gastrointestinal bleeding were randomized into two groups: one group (38 patients) received the H2-blocker cimetidine intravenously at an initial dosage of 300 mg every six hours, and the other group (37 patients) received antacid (Mylanta II) through a nasogastric tube at an intial dosage of 30 ml every hour. Gastric pH was measured hourly and titrated above 3.5. Upper-gastrointestinal-tract bleeding occurred in seven of 38 cimetidine-treated patients but in none of 37 antacid-treated patients (P less than 0.01). When antacid titration was added to the cimetidine regimen in four of seven patients with bleeding, all four stopped bleeding. Renal failure, sepsis, peritonitis, hypotension, respiratory failure, jaundice, multiple trauma, and major operative procedures were associated with an increased incidence of bleeding. Cimetidine does not adequately protect seriously ill patients from acute upper-gastrointestinal-tract bleeding. Antacid is better for this purpose.

Healing of duodenal ulcer with an antacid regimen.

To determine whether a large-dose antacid regimen is effective in promoting healing of duodenal ulcer, 74 patients with endoscopically proved duodenal ulcer completed a 28-day double-blind clinical trial comparing such a regimen with an inert placebo. The ulcer healed completely in 28 of the 36 antacid-treated as compared to 17 of the 38 placebo-treated patients (P less than 0.005). The antacid regimen was not more effective than placebo in relieving ulcer symptoms. Presence or absence of symptoms during the fourth treatment week was a poor predictor of presence or absence of an ulcer crater. Ulcers of placebo-treated patients who smoked cigarettes were less likely to heal than those of nonsmokers (P = 0.03). Except for mild diarrhea, no side effects of the antacid regimen were observed. We conclude that a large-dose antacid regimen hastens the healing of duodenal ulcer.

Relief of duodenal ulcer sysmptons by oral metiamide.

Thirty patients with symptoms of duodenal ulceration were treated for five to eight weeks in a double-blind trial with either metiamide 1 g daily by mouth or a placebo. In the 15 patients receiving metiamide there were significant reductions in nocturnal pain and antacid consumption. Daytime pain was diminished. The results suggest that histamine H2-receptor antagonists are likely to be useful in the medical management of the symptoms of duodenal ulceration.

Effect of magnesium hydroxide on the absorption of tolfenamic and mefenamic acids.

The effect of various antacids on the absorption of tolfenamic and mefenamic acids has been investigated in three separate crossover studies, each consisting of four phases. Single doses of magnesium hydroxide (85 mg, 425 mg and 1700 mg) or of water (150 ml) were given by mouth to 6 healthy volunteers immediately after tolfenamic acid 400 mg (Study 1), and, using an identical study design, after mefenamic acid 500 mg (Study 3). In Study 2 sodium bicarbonate 1 g, aluminium hydroxide 1 g, an antacid preparation containing both aluminium and magnesium hydroxides, or water alone were ingested with tolfenamic acid 400 mg. Plasma concentrations of tolfenamic and mefenamic acids and their cumulative excretion in urine were determined up to 24 h. Magnesium hydroxide greatly accelerated, in a dose-dependent manner the absorption of both tolfenamic and mefenamic acids. The peak times in plasma were shortened by about 1 h by 425 mg and 1700 mg magnesium hydroxide, and the peak plasma concentrations of both fenamates were elevated up to 3-fold. The area under the plasma concentration-time curve between 0 and 1 h of tolfenamic acid was increased up to 7-fold and that of mefenamic acid up to 3-fold. The total bioavailability of tolfenamic and mefenamic acids was only slightly increased. Aluminium hydroxide alone and in combination with magnesium hydroxide significantly retarded the absorption and lowered the peak plasma concentration of tolfenamic acid. Sodium bicarbonate had no significant effect on its absorption. The interaction with magnesium hydroxide leads to higher and earlier peak plasma concentrations of the fenamates.(ABSTRACT TRUNCATED AT 250 WORDS)