Trial reportAlimentary pharmacology & therapeutics2017
Randomised clinical trial: mucosal protection combined with acid suppression in the treatment of non-erosive reflux disease - efficacy of Esoxx, a hyaluronic acid-chondroitin sulphate based bioadhesive formulation.
Trial report in Alimentary pharmacology & therapeutics, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 31 papers, 1 of them a synthesis that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
31 citing papers in PubMed, 1 synthesis or guideline pooled it, 102 citations in OpenAlex.
- Guidelines on diagnosis and management of gastroesophageal reflux disease in infants, children and adolescents: a joint consensus from Italian pediatric societies (SIP and SIGENP) -Part II: management.Italian journal of pediatrics · 2026Guideline
- Prospective uncontrolled clinical study shows rapid and long lasting relief of heartburn and acid related gastric discomfort with Refluthin.Scientific reports · 2025Trial
- Gatherings in Esophagology: Innovations and Future Directions in the Diagnosis and Management of Reflux Disease.Annals of the New York Academy of Sciences · 2026Article
- Self-Management of Reflux-Like Symptoms: A Patient-Centered Decision-Making Approach.Digestive diseases (Basel, Switzerland) · 2026Review
- E-GastryalJournal of clinical medicine · 2025Article
- The progress of hyaluronic acid's application in therapeutic delivery.Therapeutic delivery · 2025Review
- Review Article: Individualised Management of Reflux-Like Symptoms-Strategies Beyond Acid Suppression.Alimentary pharmacology & therapeutics · 2025Review
- Review
- A Non-Pharmacological Paradigm Captures the Complexity in the Mechanism of Action of Poliprotect Against Gastroesophageal Reflux Disease and Dyspepsia.International journal of molecular sciences · 2025Article
- Hyaluronic acid and chondroitin sulfate-based medical devices: formulations, esophageal mucosal protection, and their place in the management of GERD.Therapeutic advances in gastroenterology · 2025Review
- Refractory Gastroesophageal Reflux Disease: Diagnosis and Management.Journal of neurogastroenterology and motility · 2024Review
- Patient journey in gastroesophageal reflux disease: real-world perspectives from Italian gastroenterologists, primary care physicians, and ENT specialists.Therapeutic advances in gastroenterology · 2024Article
- Current status and advances in esophageal drug delivery technology: influence of physiological, pathophysiological and pharmaceutical factors.Drug delivery · 2023Review
- Gastroprotective Effects of Oral Glycosaminoglycans with Sodium Alginate in an Indomethacin-Induced Gastric Injury Model in Rats.Veterinary sciences · 2023Article
- Article
- Gastroesophageal reflux disease in children: What's new right now?World journal of gastrointestinal endoscopy · 2023Review
- Gastrointestinal functional disorders can benefit from the use of medical devices made of substances.Frontiers in drug safety and regulation · 2023Review
- Esoxx added to standard therapy accelerates the healing of esophagitis.Przeglad gastroenterologiczny · 2023Article
- Review article: rethinking the "ladder" approach to reflux-like symptom management in the era of PPI "resistance" - a multidisciplinary perspective.Alimentary pharmacology & therapeutics · 2022Review
- The Effect of Hyaluronic Acid and Chondroitin Sulphate-Based Medical Device Combined with Acid Suppression in the Treatment of Atypical Symptoms in Gastroesophageal Reflux Disease.Journal of clinical medicine · 2022Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
4 authors at 3 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundSeveral studies have shown that patients with non-erosive reflux disease (NERD) are less responsive to proton pump inhibitors (PPIs) than those with erosive disease as they belong to different subgroups, in whom factors other than acid can trigger symptoms.
aimTo evaluate whether combined therapy (mucosal protection plus acid suppression) would improve symptom relief compared to PPI treatment alone.
methodsIn a multicenter, randomised, double-blind trial, 154 patients with NERD were randomised to receive Esoxx (Alfa Wassermann, Bologna, Italy), a hyaluronic acid-chondroitin sulphate based bioadhesive formulation, or placebo, in addition to acid suppression with standard dose PPIs for 2 weeks. Symptoms (heartburn, acid regurgitation, retrosternal pain and acid taste in the mouth) and health-related quality of life (HRQL) were evaluated before and after treatment. The primary endpoint was the proportion of patients with at least a 3-point reduction in the total symptom score.
resultsAt the end of treatment, the primary endpoint was reached by 52.6% of patients taking Esoxx compared to 32.1% of those given placebo (P < 0.01). The same was true also for HRQL, evaluated by means of the Short Form-36 questionnaire, which improved with both treatments, but some items were significantly better after Esoxx plus PPI therapy.
conclusionThe synergistic effect of Essox with PPI treatment suggests that mucosal protection added to acid suppression could improve symptoms and HRQL in NERD patients.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.