Randomised clinical trial: relief of upper gastrointestinal symptoms by an acid pocket‐targeting alginate–antacid (Gaviscon Double Action) – a double‐blind, placebo‐controlled, pilot study in gastro‐oesophageal reflux disease

Abstract

SUMMARY BackgroundThe alginate-antacid, Gaviscon Double Action (Gaviscon DA; Reckitt Benckiser, Slough, UK) suppresses reflux after meals by creating a gel-like barrier that caps and displaces the acid pocket distal to the oesophago-gastric junction. The effect of Gaviscon DA on reflux and dyspepsia symptoms has not yet been demonstrated with a modern trial design. AimA pilot study to assess the efficacy and safety of Gaviscon DA compared with matched placebo for decreasing upper gastrointestinal symptoms in symptomatic gastro-oesophageal reflux disease (GERD) patients. MethodsA randomised, double-blind, parallel group study was performed in 110 patients with symptoms of GERD. Patients received Gaviscon DA or placebo tablets for 7 consecutive days. The primary endpoint compared the change in overall Reflux Disease Questionnaire (RDQ) symptom score (combined heartburn/regurgitation/ dyspepsia). Secondary endpoints assessed individual dimensions, GERD dimension (heartburn and regurgitation) and overall treatment evaluation (OTE). ResultsThere was a greater decrease in overall RDQ symptom score in the Gaviscon DA group compared with the placebo group (Least Squares Mean difference À0.55; P = 0.0033), and for each of the dimensions independently. Patients in the Gaviscon DA group evaluated their overall treatment response higher than patients in the placebo group [mean (standard deviation) OTE 4.1 (2.44) vs. 1.9 (3.34); P = 0.0005]. No differences in the incidence of adverse events were observed between treatment groups. ConclusionsGaviscon DA decreases reflux and dyspeptic symptoms in GERD patients compared with matched placebo and has a favourable benefit-risk balance. Larger scale clinical investigations of medications targeting the acid pocket are warranted.

Cardiovascular risk associated with high sodium-containing drugs: A systematic review

“…Among these, 35 were excluded for the following reasons: the study was not comparative, sodium was the active ingredient (one study), lack of quantitative data, or the study was not original or out of topic. Four studies finally met the inclusion criteria [11,17–19]. We found four additional records through other sources, including grey literature, by manual research [20–23].…”

“…Most of the studies were single-centre (6/8). The study design also varied, half were randomized controlled trials [19,21–23], three were uncontrolled before-after studies [17,18,20], and one was a nested case-control study [11]. Baseline cardiovascular and renal functions, and exclusion criteria are given in Table 2.…”

“…These studies all evaluated blood pressure fluctuations as a surrogate marker for cardiovascular outcomes. Three studies did not find a significant effect of oral HSCD exposure on blood pressure [19–21]. The drug-associated sodium intake varied widely (ranging from 464 to 4623 mg/day).…”

“…For ethical reasons (it was not possible to expose high risk patients to HSCD), Thomas et al . [19] excluded patients with hypertension and/or chronic kidney disease, which are important demographic factors associated with SSBP [9]. This may have limited the power of the trial to detect a possible iatrogenic consequence of exposure to HSCD.…”

Between GERD and NERD: the relevance of weakly acidic reflux

“…Controlling heartburn in patients with NERD can also be achieved with antacid or alginate compounds. Many clinical trials have demonstrated the benefit of these drugs, which continue to have a role in quickly relieving typical reflux symptoms in both NERD and ERD . However, these over‐the‐counter drugs require multiple doses during the day because of their short duration of action.…”