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A multicentre prospective study was conducted to assess the safety and efficacy of using the gel-forming and hyaluronic acid-containing chewable tablet Sobrade as an additional treatment for patients suffering from gastroesophageal reflux disease (GERD) who did not find proton pump inhibitor (PPI) therapy satisfactory.
Adding gel-forming and hyaluronic acid-containing chewable tablets to standard PPI treatment effectively alleviates GERD symptoms, especially heartburn, with good safety and tolerability, offering a promising option for unsatisfied patients.
A multicentre prospective study was conducted to assess the safety and efficacy of using the gel-forming and hyaluronic acid-containing chewable tablet Sobrade as an additional treatment for patients suffering from gastroesophageal reflux disease (GERD) who did not find proton pump inhibitor (PPI) therapy satisfactory.
Overall, 47 volunteers experiencing symptomatic GERD, despite being treated with PPIs, were enrolled. They were instructed to take the gel-forming tablets up to four times every day, following meals and before bedtime. The bioadhesive gel in this tablet creates a protective layer along the esophagus, shielding the mucosa from reflux incidents. The study assessed the severity and frequency of GERD symptoms through two in-person visits: one before and one after a 14-day treatment period.
The GERD score was calculated based on the Reflux Disease Questionnaire. Additionally, patients maintained electronic diaries in which they recorded their symptoms, along with the onset and duration of symptom relief, on a daily basis. To gauge the efficacy of the treatment, non-parametric paired Wilcoxon tests were employed. Furthermore, the study examined anchor-based minimal important differences (MID).
The treatment led to a notable decrease in GERD symptoms. The severity and frequency of eight out of the nine evaluated symptoms showed remarkable improvement during the treatment phase, with the most significant enhancement seen in the case of heartburn. Similarly, all three subcategories of the GERD score demonstrated substantial improvement. According to the MID results, patients considered a mean symptom improvement of more than 30% of the initial severity to be advantageous.
Patients' self-assessments indicated the first noticeable betterments in symptoms, such as regurgitation and heartburn, from day 5 of treatment onwards. Nearly half of the patients (49%) reported symptomatic control within 15 minutes, and this relief typically lasted for an average of 3.5 hours. Throughout the study, there were no reported treatment-emergent adverse events, and in 98% of cases, patients rated the product's tolerability as either good or very good.
The integration of the gel-forming medical device with PPI therapy resulted in significant symptomatic control of GERD while maintaining safety and tolerability.
BMC Gastroenterology
Multicentre prospective study to evaluate effectiveness and safety of gel-forming and hyaluronic-acid containing chewable tablets as add-on treatment in patients with gastroesophageal reflux disease (GERD) symptoms and unsatisfying proton pump inhibitor therapy
Manfred Gross et al.
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