alginate--aluminium-hydroxide--magnesium-trisilicate--sodium-bicarbonate-drug-combination and Laryngopharyngeal-Reflux

There is a paucity of large-scale studies evaluating the clinical benefit of the Gaviscon Double Action (DA) alginate-antacid formulation for treating gastroesophageal reflux disease (GERD) symptoms.. Randomised double-blind placebo-controlled parallel-group study to evaluate efficacy and safety of Gaviscon DA in reducing heartburn, regurgitation and dyspepsia symptoms in individuals with mild-to-moderate GERD in China.. Participants with symptomatic GERD (n = 1107) were randomised to receive Gaviscon DA or placebo (two tablets four times daily) for seven consecutive days. The primary endpoint compared the change in Reflux Disease Questionnaire (RDQ) score for the GERD (heartburn + regurgitation) dimension between Gaviscon DA and placebo. Secondary endpoints compared the change in RDQ scores for individual heartburn, regurgitation and dyspepsia dimensions, overall treatment evaluation (OTE) scores and incidence of adverse events (AEs).. Mean RDQ GERD scores: 2.51 for Gaviscon DA and 2.50 for placebo at baseline; 1.25 for Gaviscon DA and 1.46 for placebo post treatment. Gaviscon DA was statistically superior to placebo in reducing GERD and dyspepsia RDQ scores [least-squares mean (LSM) difference: GERD -0.21, P < 0.0001; dyspepsia -0.18, P = 0.0004], despite a substantial placebo response. The Gaviscon DA group reported more favourable overall treatment responses than the placebo group across all OTE categories (P < 0.0001). Superior relief of GERD symptoms was observed both in those with non-erosive and those with erosive reflux disease (LSM difference -0.14 [P = 0.038] and -0.29 [P < 0.0001] respectively). Incidence of AEs was similar in both groups.. Gaviscon DA tablets provide effective and safe reduction in acid reflux and dyspepsia symptoms in Chinese individuals with mild-to-moderate GERD. ClinicalTrials.gov: NCT01869491.

Topics: Adolescent; Adult; Aged; Alginates; Aluminum Hydroxide; Antacids; Anti-Ulcer Agents; China; Double-Blind Method; Drug Combinations; Dyspepsia; Female; Gastroesophageal Reflux; Heartburn; Humans; Laryngopharyngeal Reflux; Male; Middle Aged; Placebos; Silicic Acid; Sodium Bicarbonate; Surveys and Questionnaires; Treatment Outcome; Upper Gastrointestinal Tract; Young Adult

Management of laryngopharyngeal reflux (LPR) typically comprises alginates and proton pump inhibitors (PPIs) alone or in combination, yet evidence to support any particular treatment regimen is lacking. We sought to evaluate the efficacy of Gaviscon® Advance alone versus co-prescription with a PPI in treating LPR.. One hundred consecutive LPR patients with a reflux symptom index (RSI) score > 10 attending our joint voice clinic (JVC) were studied prospectively. All were treated with Gaviscon® Advance four times daily. If patients had been started on a PPI prior to their JVC attendance, this was optimised to a twice-daily dosing regimen and continued. RSI scores were recorded at first attendance and 3 months post-treatment via postal questionnaire. Scores were analysed using t tests and Levene's test for equality of variances.. Follow-up RSI scores were returned by 72 patients, 39 of whom were treated with Gaviscon® Advance only (group A) and 33 with Gaviscon® Advance + PPI (group B). Mean pre-treatment RSI scores were similar between groups [group A: 19.2, 95% confidence interval (CI) ± 2.4; group B: 21.3, 95% CI ± 3.2 (p = 0.65)]. No significant differences were observed with respect to 3-month post-treatment RSI scores [group A: 9.9, 95% CI ± 2.8; group B: 12.6, 95% CI ± 4.2 (p = 0.82)] and change in RSI scores [group A: 9.3, 95% CI ± 3.0; group B: 8.7, 95% CI ± 2.9 [p = 0.75]).. Gaviscon® Advance alone is effective in treating symptoms of LPR, while co-prescription with a high-dose PPI offers no additional benefit.

Topics: Adult; Aged; Aged, 80 and over; Alginates; Aluminum Hydroxide; Antacids; Dose-Response Relationship, Drug; Drug Combinations; Female; Humans; Laryngopharyngeal Reflux; Male; Middle Aged; Silicic Acid; Sodium Bicarbonate; Surveys and Questionnaires; Treatment Outcome; Voice

Topics: Adult; Aged; Aged, 80 and over; Alginates; Aluminum Hydroxide; Antacids; Cough; Drug Combinations; Drug Therapy, Combination; Female; Follow-Up Studies; Humans; Laryngopharyngeal Reflux; Laryngoscopy; Male; Middle Aged; Proton Pump Inhibitors; Retrospective Studies; Silicic Acid; Sodium Bicarbonate; Treatment Outcome