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Randomized Controlled Trial
. 2018 Oct;8(5):994-999.
doi: 10.1007/s13346-018-0531-7.

A hyaluronic acid- and chondroitin sulfate-based medical device improves gastritis pain, discomfort, and endoscopic features

Affiliations
Randomized Controlled Trial

A hyaluronic acid- and chondroitin sulfate-based medical device improves gastritis pain, discomfort, and endoscopic features

Tommaso Iannitti et al. Drug Deliv Transl Res. 2018 Oct.

Abstract

Gastritis is an inflammation of the gastric mucosa. In this study, we investigated the efficacy of a medical device, Esoxx®, based on hyaluronic acid and chondroitin sulfate on gastritis-related upper abdominal pain/discomfort and endoscopic features. Fifty patients, affected by gastritis, were randomised to receive the medical device or placebo. The primary endpoint was the medical device efficacy on upper abdominal pain/discomfort associated with gastritis and measured by Visual Analogue Scale (VAS). The secondary endpoints were the efficacy of the medical device on gastritis-related mucosal erosions, blood oozing, and hyperemia (redness)/edema, as assessed by endoscopy, and the patients' rating of their compliance with the treatments. A significant reduction in VAS pain was observed in the treatment group after a 5-week treatment, if compared with placebo (p < 0.001). In summary, administration of a medical device, based on hyaluronic acid and chondroitin sulfate, improves gastritis-related upper abdominal pain/discomfort and decreases mucosal erosions, blood oozing, and hyperemia (redness)/edema at 5-week follow-up in patients affected by gastritis.

Keywords: Chondroitin sulfate; Discomfort; Endoscopy; Gastritis; Hyaluronic acid; Pain.

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Conflict of interest statement

Conflict of interest

The authors declare that they have no conflict of interest.

Informed consent

Written informed consent was obtained from the patients for publication of the data included in this manuscript.

Figures

Fig. 1
Fig. 1
Comparison of gastritis-related upper abdominal pain/discomfort between patients treated with the medical device (n = 25) and patients receiving placebo (n = 25), as assessed by VAS at 5-week follow-up. Data are reported as the means ± SEM. ***p ˂ 0.001 VAS Visual Analogue Scale, SEM, standard error of the mean
Fig. 2
Fig. 2
Gastritis at baseline (a and b) and 5 weeks following medical device administration (c and d). Gastric erosions with fibrin streaks are visible in (a). Gastric erosions with hematin pigments are visible in (b). Definite improvement is observed after treatment with the medical device (c and d)
Fig. 3
Fig. 3
Gastritis at baseline (a) and 5 weeks following placebo administration (c). Gastritis with reddening and swelling at baseline (b) and 5 weeks following placebo administration (d). No improvement in gastritis can be observed at the 5-week follow-up (c and d)

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