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.
BackgroundTo develop an effective, patient-centred and sustainable service, we set up a virtual clinic (VC) for patients with Parkinson’s disease, combining phone consultations and reports from wearable technology. The Parkinson’s Kinetigraph (PKG) is a wrist-worn device providing objective motor assessment, generating a report used by clinicians to optimise medication regimens.InterventionsA pilot study of VC was designed using quality improvement methodology. For a VC appointment, patients were phoned by a clinician. After discussing symptoms and reviewing the PKG report, the clinician could decide on any medication changes or other interventions and relay this to the patient’s general practitioner in a clinic letter. Patient feedback was gathered via questionnaires and data collected on the outcomes and timings of the consultations.ResultsOver 12 clinics, 61 patients had VC appointments. Of questionnaire respondents, 89% were satisfied with VC (n=41). At VC, the clinician was able to make a treatment decision comparable to a face-to-face clinic in 79% of cases (n=48). Reasons appointments were deemed unsuccessful included issues with the PKG, speech or hearing problems and complex phase of disease. VC appointments, including administration time, last on average 22 min. This compares to 20 min face-to-face appointments but these do not include administration time.ConclusionsWe have demonstrated a safe and effective VC template. Most VC appointments are equivalent to face-to-face clinic in terms of treatment outcome. Success could be further improved by appropriate patient selection. Using VC is time saving and can result in releasing face-to-face appointment slots for those in urgent need or newly referred patients. Further cost analysis is required; the cost of the PKG alone is more expensive than a face-to-face appointment, but this does not take into account other value added, such as patient convenience and satisfaction, and reduced need for ambulance transport.
Gastro-oesophageal reflux (GER) and the symptoms of heartburn and regurgitation are common in pregnancy. These symptoms are transient and mostly resolve postpartum but have a negative impact on quality of life. Here, we present a prospective clinical evaluation of the safety and efficacy of an alginate raft-forming oral suspension that is licensed for use in pregnancy. The study was a multicentre, prospective, open-label, and baseline-controlled study of Liquid Gaviscon (LG) in the treatment of heartburn in pregnant women with current symptoms of heartburn and/or reflux requiring treatment (recruited 144). The efficacy of the study medication was rated by the investigator (primary endpoint) and patient. Treatment was deemed to be a success in 91% of patients as judged by the investigator (95% CI 85.0–95.3) and 90% (95% CI 84.1–94.8) when assessed by the patient themselves. Very few adverse events or serious adverse events were reported that were considered to be related to the study medication, and these were consistent with the normal population incidences. Serum sodium levels remained unchanged. This prospective open-label study in a large number of pregnant women has shown that LG is both safe and highly efficacious in the treatment of heartburn and GER symptoms in pregnancy.
This was a randomized, controlled, four-way crossover study in 45 subjects with a tendency to suffer from moderate heartburn following some meals. The study was designed to assess the time to onset of the perceived soothing and cooling effects of the alginate raft-forming products, Gaviscon Liquid (peppermint), Gaviscon Double Action Liquid (peppermint) and Gaviscon Powder Formulation (fresh tropical), compared with a non-active sublingual control. All three Gaviscon products provided significantly faster soothing and cooling effects compared with the control. Based on the upper 95% confidence limits for the median, time to onset of soothing was perceived within 3.15 min, 3.08 min and 4.05 min for Gaviscon Liquid, Double Action Liquid and Powder Formulation, respectively. Similarly, time to onset of cooling was perceived within 1.95 min, 1.23 min and 11.22 min for Gaviscon Liquid, Double Action Liquid and Powder Formulation, respectively. The results show that Gaviscon Liquid and Gaviscon Double Action soothe within 3.15 min and cool within 1.95 min.
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