Efficacy and Safety of a Natural Remedy for the Treatment of Gastroesophageal Reflux: A Double-Blinded Randomized-Controlled Study

Umberto Alecci, Francesco Bonina, Andrea Bonina, Luisa Rizza, Santi Inferrera, Carmen Mannucci, Gioacchino Calapai, Umberto Alecci, Francesco Bonina, Andrea Bonina, Luisa Rizza, Santi Inferrera, Carmen Mannucci, Gioacchino Calapai

Abstract

Gastroesophageal reflux (GER) is a common, chronic, relapsing symptom. Often people self-diagnose and self-treat it even though health-related quality of life is significantly impaired. In the lack of a valid alternative approach, current treatments focus on suppression of gastric acid secretion by the use of proton pump inhibitors (PPIs), but people with GER have a significantly lower response rate to therapy. We designed a randomized double-blinded controlled clinical study to evaluate the efficacy and the safety of a formulation based on sodium alginate/bicarbonate in combination with extracts obtained from Opuntia ficus-indica and Olea europaea associated with polyphenols (Mucosave®; verum), on GER-related symptoms. Male/female 118 (intention to treat) subjects with moderate GER and having at least 2 to 6 days of GER episodes/week were treated with verum (6 g/day) or placebo for two months. The questionnaires Gastroesophageal Reflux Disease-Health-Related Quality of Life (GERD-HRQoL) and Gastroesophageal Reflux Disease Symptom Assessment Scale (GSAS) were self-administered by participants before the treatment and at the end of the treatment. Verum produced statistically significant reduction of GERD-HRQoL and GSAS scores, -56.5% and -59.1%, respectively, in comparison to placebo. Heartburn and acid regurgitation episodes for week were significantly reduced by verum (p < 0.01). Results indicate that Mucosave formulation provides an effective and well-tolerated treatment for reducing the frequency and intensity of symptoms associated with gastroesophageal reflux.

Figures

Figure 1
Figure 1
Flow diagram for the study (FAS: full analysis set; PP: per protocol).
Figure 2
Figure 2
GERD-HRQoL score in subjects with GER before (blue) and after (red) 60 days' treatment with verum (N = 55) or placebo (N = 53). ∗p < 0.05 versus red placebo.
Figure 3
Figure 3
GSAS score in subjects with GER before (blue) and after (red) 60 days' treatment with verum (N = 55) or placebo (N = 53). ∗p < 0.05 versus red placebo.
Figure 4
Figure 4
Heartburn and acid regurgitation episodes per week in subjects with GER before (blue) and after (red) 60 days' treatment with verum (N = 55) or placebo (N = 53). ∗p < 0.05 versus red placebo.

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