Efficacy and Safety of a Natural Remedy for the Treatment of Gastroesophageal Reflux: A Double-Blinded Randomized-Controlled Study
Autor: | Andrea Bonina, Santi Inferrera, Umberto Alecci, Carmen Mannucci, Francesco Bonina, Luisa Rizza, Gioacchino Calapai |
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Jazyk: | angličtina |
Rok vydání: | 2016 |
Předmět: |
QUALITY-OF-LIFE
OLEA-EUROPAEA L ANTIINFLAMMATORY ACTIVITY CONTROLLED TRIAL SODIUM ALGINATE CLINICAL-TRIALS DISEASE OMEPRAZOLE RABEPRAZOLE SYMPTOMS medicine.medical_specialty Article Subject Placebo Gastroenterology law.invention 03 medical and health sciences 0302 clinical medicine Quality of life Randomized controlled trial law Internal medicine medicine Intention-to-treat analysis business.industry Reflux Heartburn lcsh:Other systems of medicine lcsh:RZ201-999 Surgery Complementary and alternative medicine 030220 oncology & carcinogenesis Regurgitation (digestion) Gastric acid 030211 gastroenterology & hepatology medicine.symptom business Research Article |
Zdroj: | Evidence-Based Complementary and Alternative Medicine, Vol 2016 (2016) Evidence-based Complementary and Alternative Medicine : eCAM |
Popis: | 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 fromOpuntia ficus-indicaandOlea europaeaassociated 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 withverum(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.Verumproduced 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 byverum(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. |
Databáze: | OpenAIRE |
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