TY - JOUR
T1 - The clinical effect of benesco™ on reflux symptoms
T2 - A double-blind randomized placebo-controlled trial
AU - Kuipers, Thijs
AU - Oude Nijhuis, Renske A. B.
AU - Schuitenmaker, Jeroen M.
AU - Bredenoord, Albert J.
N1 - Funding Information: This investigator‐initiated study was financially supported by Thelial BV. Publisher Copyright: © 2023 The Authors. Neurogastroenterology & Motility published by John Wiley & Sons Ltd.
PY - 2023/10
Y1 - 2023/10
N2 - Background: Gastroesophageal reflux disease (GERD) is one of the most prevalent gastrointestinal diseases in the western world. Lifestyle modifications and proton pump inhibitors (PPIs) form the basis of the management of GERD. A subset of patients seeks for (natural) alternative therapies besides PPIs. benesco™ is an over-the-counter nutrition based on quercetin which has a presumed positive effect on esophageal barrier function. Therefore we aim to assess the effect of benesco™ on reflux symptoms. Methods: We performed a double-blind randomized placebo-controlled trial in participants with reflux symptoms. Participants were assigned randomly (1:1) to receive 6 weeks of benesco™ (three times daily one lozenge containing 200 mg of quercetin) or placebo. The primary outcome was treatment success (≥50% reduction in Reflux Disease Questionnaire Score). Secondary outcomes included GERD-related quality of life, reflux-free days and nights, and participant-reported treatment success. Key Results: One hundred participants were randomized. Treatment success was seen in 18 (39%) of 46 participants in the intervention group versus 21 (47%) of 45 in the placebo group (p = 0.468). In the intervention group 10 (1–21) reflux-free days were reported compared to 10 (2–25) in the placebo group (p = 0.673). In addition, 38 (34–41) versus 39 (35–42) reflux-free nights were reported (p = 0.409). Conclusions & Inferences: In our trial benesco™ showed no significant benefit over placebo at group level.
AB - Background: Gastroesophageal reflux disease (GERD) is one of the most prevalent gastrointestinal diseases in the western world. Lifestyle modifications and proton pump inhibitors (PPIs) form the basis of the management of GERD. A subset of patients seeks for (natural) alternative therapies besides PPIs. benesco™ is an over-the-counter nutrition based on quercetin which has a presumed positive effect on esophageal barrier function. Therefore we aim to assess the effect of benesco™ on reflux symptoms. Methods: We performed a double-blind randomized placebo-controlled trial in participants with reflux symptoms. Participants were assigned randomly (1:1) to receive 6 weeks of benesco™ (three times daily one lozenge containing 200 mg of quercetin) or placebo. The primary outcome was treatment success (≥50% reduction in Reflux Disease Questionnaire Score). Secondary outcomes included GERD-related quality of life, reflux-free days and nights, and participant-reported treatment success. Key Results: One hundred participants were randomized. Treatment success was seen in 18 (39%) of 46 participants in the intervention group versus 21 (47%) of 45 in the placebo group (p = 0.468). In the intervention group 10 (1–21) reflux-free days were reported compared to 10 (2–25) in the placebo group (p = 0.673). In addition, 38 (34–41) versus 39 (35–42) reflux-free nights were reported (p = 0.409). Conclusions & Inferences: In our trial benesco™ showed no significant benefit over placebo at group level.
KW - gastroesophageal reflux disease
KW - natural supplement
KW - proton pump inhibitors
KW - quercetin
UR - http://www.scopus.com/inward/record.url?scp=85164595682&partnerID=8YFLogxK
U2 - https://doi.org/10.1111/nmo.14648
DO - https://doi.org/10.1111/nmo.14648
M3 - Article
C2 - 37427678
SN - 1350-1925
VL - 35
JO - Neurogastroenterology and Motility
JF - Neurogastroenterology and Motility
IS - 10
M1 - e14648
ER -