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

Abstract

Extraesophageal reflux symptoms are increasingly common in the Western population and their clinical management is still controversial. Although therapy with proton-pump inhibitors (PPIs) represents the gold standard, to date, many patients are refractory to this treatment. The aim of this study was to evaluate, in patients with a recent diagnosis of GERD experiencing extraesophageal symptoms, the efficacy and safety of a 6-week treatment with PPI acid suppression in combination with Gerdoff^® (a hyaluronic acid and chondroitin sulphate-based medical device) compared to PPI monotherapy. The trial verified the reduction in symptom frequency and severity by evaluating the proportion of Responders and Non-Responder patients after 6 weeks of treatment, compared to baseline. The effects of Gerdoff^® + PPI treatment on extraesophageal symptoms were also evaluated after a 12-week follow up only in Responder patients. The analysis of the change in total Reflux Symptoms Index (RSI) score from baseline to the other time points showed that the extent of the decrease from baseline was higher in the Gerdoff^® + PPI group than in the PPI group at any time point. However, the comparison between groups did not show statistically significant differences at any time point. A statistically significant difference, in favor of the Gerdoff^® + PPI group, was observed for individual RSI items. Even if the trial showed some limitations, this is the first published study on the efficacy of a medical device containing hyaluronic acid and chondroitin sulphate with antacid in the treatment of extraesophageal reflux symptoms.

Keywords: chondroitin sulphate; extraesophageal reflux symptoms; gastroesophageal reflux disease; hyaluronic acid.

Figure 1

Study diagram. At baseline visit (visit V1), the enrolled patients were randomized with a 1:1 ratio in one of treatment groups: Group 1 (PPI + Gerdoff^®) or Group 2 (PPI; control group). After the treatment period (6 weeks), the responders of Group 1 were further randomized with a 1:1 ratio in one of following groups defined according to the treatment: Group Gerdoff^® or Group Not-Treated. At week 12 from visit V1 (visit V5), the treatment was interrupted. The assessment of treatment effect maintenance was prolonged for a 6-week follow-up period (visit V6: week 18 from visit V1); PPI, proton pomp inhibitors.

Figure 2

Distribution of responders at week 6 in the two groups. The percentages of responders at Week 6 in the treatment groups (Gerdoff^® + omeprazole or omeprazole) were reported (p = 0.0496 in the Chi-squared test).