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Efficacy and Safety of GutGard® in Managing Gastroesophageal Reflux-Related Symptoms: A Phase III, Single-Centre, Double-Blind, Randomized Placebo-Controlled Trial
Raj JP, Saxena U, Belhekar MN, et al. (2025)
Complement Med Res · PMID 39929150
Abstract
INTRODUCTION: Liquorice (Glycyrrhiza glabra) is a traditional herbal remedy with various pharmacological activities mainly used for digestive and respiratory ailments. GutGard® is a flavonoid-rich, deglycyrrhizinated liquorice root extract and is standardized to glabridin (≥3.5% w/w), and others viz., glabrol, eicosanyl caffeate, docosyl caffeate, and total flavonoids (≥10% w/w) with glycyrrhizin (≤3.0% w/w)  as glycyrrhizin causes electrolyte imbalance, hypertension, and water retention. Hence, the objective of the current study was to assess the efficacy, safety, and tolerability of GutGard® in managing gastroesophageal reflux (GER)-related symptoms when compared to placebo. METHODS: It was a double-blind, parallel group, randomized, placebo-controlled trial with participants randomized in a 1:1 ratio to either the placebo group or GutGard® group. The duration of the interventions/treatment was for 28 days and the follow-up visits were done at day 7, day 14, day 28, and day 35. A telephonic follow-up was also done on day 21. The primary outcome measures studied was the change in the Gastroesophageal Reflux Disease-Health-Related Quality of Life and the Gastroesophageal Reflux Disease Symptom Assessment Scale. RESULTS: We screened a total of n = 296 participants and enrolled n = 200 participants and obtained written, informed consent from them. Participants in the GutGard® group reported a significantly better quality of life at the end of the intervention period (p = 0.014). They also reported earlier resolution of symptoms of GER as against the placebo group, especially the symptoms of heartburn (p = 0.017 on day 14 and p = 0.005 on day 28) and regurgitation (p = 0.025 on day 7, p = 0.029 on day 14, and p = 0.022 on day 28). CONCLUSIONS: The GutGard® group showed better and earlier resolution (within 2 weeks) of symptoms of GER as against the placebo group, especially heartburn and regurgitation. INTRODUCTION: Liquorice (Glycyrrhiza glabra) is a traditional herbal remedy with various pharmacological activities mainly used for digestive and respiratory ailments. GutGard® is a flavonoid-rich, deglycyrrhizinated liquorice root extract and is standardized to glabridin (≥3.5% w/w), and others viz., glabrol, eicosanyl caffeate, docosyl caffeate, and total flavonoids (≥10% w/w) with glycyrrhizin (≤3.0% w/w)  as glycyrrhizin causes electrolyte imbalance, hypertension, and water retention. Hence, the objective of the current study was to assess the efficacy, safety, and tolerability of GutGard® in managing gastroesophageal reflux (GER)-related symptoms when compared to placebo. METHODS: It was a double-blind, parallel group, randomized, placebo-controlled trial with participants randomized in a 1:1 ratio to either the placebo group or GutGard® group. The duration of the interventions/treatment was for 28 days and the follow-up visits were done at day 7, day 14, day 28, and day 35. A telephonic follow-up was also done on day 21. The primary outcome measures studied was the change in the Gastroesophageal Reflux Disease-Health-Related Quality of Life and the Gastroesophageal Reflux Disease Symptom Assessment Scale. RESULTS: We screened a total of n = 296 participants and enrolled n = 200 participants and obtained written, informed consent from them. Participants in the GutGard® group reported a significantly better quality of life at the end of the intervention period (p = 0.014). They also reported earlier resolution of symptoms of GER as against the placebo group, especially the symptoms of heartburn (p = 0.017 on day 14 and p = 0.005 on day 28) and regurgitation (p = 0.025 on day 7, p = 0.029 on day 14, and p = 0.022 on day 28). CONCLUSIONS: The GutGard® group showed better and earlier resolution (within 2 weeks) of symptoms of GER as against the placebo group, especially heartburn and regurgitation. <title>Einleitung</title> Süßholz (<italic>Glycyrrhiza glabra</italic>) ist ein traditionelles pflanzliches Heilmittel mit vielfältiger pharmakologischer Aktivität, das hauptsächlich bei Leiden des Verdauungstrakts und der Atemwege eingesetzt wird. GutGard® ist ein flavonoidreicher, deglycyrrhizinierter Süßholzwurzelextrakt und ist standardisiert auf Glabridin (≥ 3,5 % Gew./Gew.) und andere, nämlich Glabrol, Eicosanylkaffeat, Docosylkaffeat und Gesamtflavonoide (≥ 10 % Gew./Gew.). mit Glycyrrhizin (≤ 3,0 % Gew./Gew.) da Glycyrrhizin Elektrolytungleichgewicht, Bluthochdruck und Wassereinlagerung verursacht. Das Ziel dieser Studie war die Beurteilung der Wirksamkeit, Sicherheit und Verträglichkeit von GutGard® zur Behandlung der Symptome von gastroösophagealem Reflux (GER) im Vergleich zu Placebo.<title>Methoden</title> Es handelte sich um eine doppelblinde, randomisierte, placebokontrollierte Parallelgruppenstudie, in der die Teilnehmenden per Randomisierung im Verhältnis 1:1 der Placebo- oder der GutGard®-Gruppe zugeteilt wurden. Die Dauer der Interventionen/Behandlung betrug 28 Tage; Beobachtungstermine erfolgten an Tag 7, Tag 14, Tag 28 und Tag 35. Eine telefonische Beobachtung erfolgte außerdem an Tag 21. Die primären Endpunkte der Studie waren die Veränderungen der Ergebnisse des GERD-HRQL-Fragebogens (Gastroesophageal Reflux Disease – Health Related Quality of Life) und der GSAS (Gastroesophageal Reflux Disease Symptom Assessment Scale).<title>Ergebnisse</title> Insgesamt <italic>n</italic> = 296 Personen nahmen am Screening teil, davon nahmen wir <italic>n</italic> = 200 in die Studie auf und holten ihre schriftliche Einwilligungserklärung nach Aufklärung ein. Die Teilnehmenden in der GutGard®-Gruppe berichteten am Ende des Interventionszeitraums über eine signifikant höhere Lebensqualität (<italic>p</italic> = 0.014). Sie berichteten auch über ein schnelleres Abklingen der GER-Symptome im Vergleich zur Placebogruppe, insbesondere im Hinblick auf die Symptome Sodbrennen (<italic>p</italic> = 0.017 an Tag 14 und <italic>p</italic> = 0.005 an Tag 28) und Regurgitation (<italic>p</italic> = 0.025 an Tag 7, <italic>p</italic> = 0.029 an Tag 14 und <italic>p</italic> = 0.022 an Tag 28).<title>Schlussfolgerungen</title> Die GutGard®-Gruppe zeigte schnelleren und stärkeren Rückgang (innerhalb von zwei Wochen) der GER-Symptome als die Placebogruppe, insbesondere im Hinblick auf Sodbrennen und Regurgitation.
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