simethicone and Dyspepsia

A simethicone, activated charcoal and magnesium oxide combination (Carbosymag(®)) has been used for almost 20 years in functional dyspepsia, but there is limited scientific evidence of efficacy.. We evaluated the efficacy of Carbosymag(®) in 18- to 49-year-old patients with functional dyspepsia.. A total of 276 dyspeptic patients consulting a general practitioner and meeting the Rome III criteria were included in this prospective placebo-controlled study. Variations in overall and individual dyspeptic symptoms were evaluated after 1 month of treatment.. At the end of the treatment period, overall dyspeptic symptom intensity was significantly lower in the Carbosymag(®) group (P=0.01). The intensity of post-prandial fullness, epigastric pain, epigastric burning and abdominal bloating was significantly reduced in the Carbosymag(®) group relative to the placebo group (P<0.05). The number need to treat to induce a 70-% decrease in overall dyspeptic symptoms by Carbosymag(®) was 7 (IC 95%: 4-32).. A simethicone, activated charcoal and magnesium oxide combination (Carbosymag(®)) was significantly more effective than a placebo on overall symptom intensity in dyspeptic patients consulting a general practitioner.

Topics: Adult; Antacids; Antidotes; Antifoaming Agents; Charcoal; Double-Blind Method; Drug Combinations; Dyspepsia; Female; General Practice; Humans; Magnesium Oxide; Male; Prospective Studies; Severity of Illness Index; Simethicone

Management of functional dyspepsia is still controversial. Different controlled trials reported a superiority of prokinetics, H2-receptor antagonists and proton-pump inhibitors over placebo; nevertheless, symptomatic improvement after therapy is often incomplete and some of these drugs possess serious side effects. The aim of the study was to evaluate the efficacy of a new medical device in respect to domperidone in patients with functional dyspepsia.. In a cross-over, randomized trial, 36 patients with functional dyspepsia ingested two daily doses of a medical device (Digerfast) or domperidone (Peridon) for 21 days. Clinical evaluation was performed at baseline (T0) and after 21 days (T1) for each treatment. A Visual Analogue Scale (VAS) and the generic scale 36-item Short Form (SF-36) were used to assess symptom intensity and changes in health-related quality of life, respectively.. At T0 no statistical difference was found for each symptom between medical device and domperidone. At T1 both treatments significantly improved in respect to baseline values all the evaluated gastrointestinal symptoms (P<0.5 for all comparisons) except for vomiting. No difference in gastrointestinal symptoms between the two treatments was found at T1. Regarding SF-36 evaluation, at T0 no statistical differences were found for each SF-36 parameter between the two regimens. At T1 both treatments significantly improved most of the evaluated SF-36 parameters in respect to baseline values. No difference in SF-36 parameters between the two treatments was found at T1.. Both the medical device and domperidone significantly improved gastrointestinal symptoms and quality of life in subjects with functional dyspepsia, not showing significant difference in efficacy.

Topics: Adult; Cross-Over Studies; Domperidone; Drug Carriers; Drug Combinations; Dyspepsia; Female; Gastrointestinal Agents; Humans; Male; Pain Measurement; Potassium Citrate; Quality of Life; Simethicone; Sorbitol; Statistics, Nonparametric; Treatment Outcome

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.

Topics: Adult; Aluminum Hydroxide; Anesthetics, Local; Antacids; Atropine; Benzocaine; Drug Combinations; Drug Therapy, Combination; Dyspepsia; Female; Humans; Lidocaine; Magnesium Hydroxide; Male; Phenobarbital; Prospective Studies; Scopolamine; Simethicone; Single-Blind Method; Treatment Outcome

To compare the efficacy of simethicone with placebo and the prokinetic cisapride in patients with functional dyspepsia.. One hundred and eighty-five patients with functional dyspepsia were randomized and treated in a double-dummy technique with simethicone (105 mg t.d.s.), cisapride (10 mg t.d.s.) or placebo (t.d.s.). The primary outcome measure was the O'Brien global measure of the patients' rating of 10 upper gastrointestinal symptoms (graded as absent = 0, moderate = 1, severe = 2 or very severe = 3). Outcome measures were assessed at baseline and after 2, 4 and 8 weeks of treatment (intention-to-treat).. At 2, 4 and 8 weeks, treatment with simethicone and cisapride yielded significantly (all P values < 0.0001) better improvement of symptoms compared to placebo. Simethicone was significantly better than cisapride after 2 weeks (P = 0.0007), but the differences were not statistically significant after 4 and 8 weeks. Patients treated with simethicone judged the efficacy of their treatment as very good in 46% of cases, compared to 15% and 16% receiving cisapride and placebo, respectively.. Simethicone and cisapride were significantly better than placebo for symptom control in patients with functional dyspepsia after 2, 4 and 8 weeks of treatment. Simethicone was also superior to the prokinetic cisapride in the first 2 weeks of treatment.

Topics: Adult; Aged; Cisapride; Double-Blind Method; Dyspepsia; Female; Gastrointestinal Agents; Health Status Indicators; Helicobacter Infections; Helicobacter pylori; Humans; Male; Middle Aged; Patient Compliance; Patient Satisfaction; Simethicone; Treatment Outcome

To compare the efficacy of simethicone with cisapride in patients with functional (non-ulcer) dyspepsia.. After standardized diagnostic work-up and at least 6-days wash-out of medication, 177 patients with functional dyspepsia were enrolled; 173 of them (age 19-71 years) were randomized and treated using a double-dummy technique with simethicone (84 mg t.d.s.) or cisapride (10 mg t.d.s.). At baseline and after 2 and 4 weeks, the intensity of the symptoms was scored from 0 (absent) to 3 (severe) using a standardized symptom questionnaire. Efficacy of the treatment was judged by the patients as 'very good', 'good', 'moderate' or 'no effect'.. A total of 166 patients completed the trial. After 2 and 4 weeks, 34% and 46% (respectively), of the patients treated with simethicone judged the improvement in symptoms to be excellent compared to 13% and 22% (respectively) of patients treated with cisapride (P < 0.01). After 2 weeks the difference in the improvement in the global symptom score was significantly better (Delta30.7%, P < 0.001) for simethicone than for cisapride, while this difference failed statistical significance after 4 weeks (Delta10.2%, P=0.11).. In patients with functional dyspepsia, simethicone relieves symptoms during the first 2 weeks of treatment significantly better than cisapride.

Topics: Cisapride; Double-Blind Method; Dyspepsia; Female; Gastrointestinal Agents; Helicobacter pylori; Humans; Male; Middle Aged; Patient Compliance; Simethicone; Time Factors

The results of studies of the effect of simethicone on abdominal gas-related symptoms have been contradictory. In a randomized, double-blind, cross-over study, ten healthy volunteers were given 30 g lactulose and 600 mg simethicone or placebo. End-expiratory breath samples were collected and analyzed for H2, and gastrointestinal symptoms registered. There were no differences in biochemical parameters or symptom score between simethicone and placebo. In contrast to previous studies, we used a sufficiently large dose of lactulose to produce gastrointestinal symptoms, a higher dose of simethicone and placebo tablets containing the same additives as the simethicone tablets. There was no demonstrable effect of simethicone on symptoms or intestinal gas production caused by carbohydrate malabsorption.

Topics: Adolescent; Adult; Double-Blind Method; Dyspepsia; Female; Gases; Humans; Hydrogen; Intestines; Lactulose; Male; Simethicone

The efficacy and tolerability of Cisapride effervescent granules and a metoclopramide-dimethicone combination were compared double-blind in two comparable groups of 15 patients each with dyspepsia. All patients received three sachets daily of either drug for 6 consecutive weeks. As for efficacy, Cisapride effervescent granules was found to reduce 85% (11/13) of symptoms to a statistically significant extent, as against 42% (5/12) in the reference group. Statistical analysis showed Cisapride effervescent granules to be more effective than the reference drug for 6 out of 11 evaluable symptoms. Mean global improvement was 86% for Cisapride effervescent granules vs 41% for the reference combination. Final judgment by the physician was more favorable for Cisapride effervescent granules than for the reference drug (p < 0.0001). Treatment withdrawal was never necessary and no significant changes of laboratory values were observed. No statistically significant difference between the two treatments as to tolerability was observed. In conclusion, Cisapride effervescent granules was found to have a better risk/benefit ratio than the reference combination.

Topics: Adult; Aged; Aged, 80 and over; Capsules; Cisapride; Dose-Response Relationship, Drug; Double-Blind Method; Drug Evaluation; Dyspepsia; Female; Gastric Emptying; Gastrointestinal Transit; Humans; Male; Metoclopramide; Middle Aged; Piperidines; Risk Factors; Simethicone

The treatment of dyspepsia in the emergency department often consists of antacid in combination with viscous lidocaine, even though the specific etiology of the pain is frequently unknown. The efficacy of lidocaine as a component of symptomatic therapy was evaluated in a randomized, patient-blinded protocol. Patients presenting to the ED with dyspeptic symptoms were randomized to receive 30 mL of antacid (Mylanta II), or 30 mL of antacid plus 15 mL of 2% viscous lidocaine (GI cocktail). Patients recorded their pain score on an 11-cm linear analog scale prior to and 30 minutes after treatment. Seventy-six patients were enrolled; three were excluded from analysis due to incomplete data. Thirty-four patients were randomized to receive antacid and 39 to receive GI cocktail. Patients rated their baseline pain at 6.4 +/- 2.8 cm in the antacid group and 6.7 +/- 2.7 cm in the cocktail group (P greater than .50). Improvement in pain score with treatment was 0.9 +/- 2.9 cm in the antacid group compared with 4.0 +/- 3.4 cm in the GI cocktail group (P less than .0001). Assessment of pain relief using a five-point rating scale also indicated greater relief with GI cocktail therapy compared with antacid alone (P = .004). No adverse effects were noted with either treatment. We conclude that a single dose of antacid and viscous lidocaine provides a significantly greater degree of immediate pain relief than antacid alone in patients with dyspepsia.

Topics: Acute Disease; Aluminum Hydroxide; Antacids; Drug Combinations; Drug Therapy, Combination; Dyspepsia; Emergency Service, Hospital; Female; Humans; Lidocaine; Magnesium; Magnesium Hydroxide; Male; Middle Aged; Randomized Controlled Trials as Topic; Silicones; Simethicone

Topics: Aluminum Hydroxide; Antacids; Clinical Trials as Topic; Dimethylpolysiloxanes; Drug Combinations; Dyspepsia; Family Practice; Humans; Magnesium Oxide; Metoclopramide; Simethicone

Topics: Adult; Aged; Cisapride; Constipation; Dyspepsia; Female; Humans; Intestinal Pseudo-Obstruction; Male; Middle Aged; Pilot Projects; Piperidines; Prospective Studies; Simethicone

Topics: Adult; Capsules; Dyspepsia; Humans; Silicones; Simethicone

In an open safety-in-use study, the subjective effectiveness and taste acceptability of a new high-potency antacid product were compared to previous treatment in 109 patients presenting with upper gastro-intestinal disorders of functional origin. Severity of the dominant symptoms prior to treatment was compared with that of symptoms present during treatment. Sixty-seven per cent to 73% of upper gastro-intestinal tract symptoms were completely relieved. Eighty-three per cent versus 48% of patients seen in a private practice setting, as compared with the speciality practice, reported good to excellent results, with 92% versus 56% describing good to excellent taste acceptability. When compared with previous antacid therapy, 70% of the patients preferred the new high-potency formulation to the regular-strength products, for both effectiveness and taste. The incidence of product-related side-effects was low, with only 6.7% experiencing the diarrhoea or loose stools commonly associated with conventional products containing magnesium hydroxide.

Topics: Adolescent; Adult; Aged; Aluminum Hydroxide; Antacids; Colonic Diseases, Functional; Constipation; Diarrhea; Drug Combinations; Drug Evaluation; Dyspepsia; Esophagitis, Peptic; Female; Gastritis; Humans; Magnesium; Magnesium Hydroxide; Male; Middle Aged; Silicones; Simethicone

Topics: Adrenergic beta-Antagonists; Colonic Diseases, Functional; Dietary Fiber; Dyspepsia; Humans; Parasympatholytics; Psychotropic Drugs; Simethicone