Efficacy and Safety of the <i>Cudrania tricuspidata</i> Extract on Functional Dyspepsia: A Randomized Double-Blind Placebo-Controlled Multicenter Study

<i>Cudrania tricuspidata</i> is a folk remedy used to treat inflammation in patients with tumors or liver damage. This study investigated the efficacy of <i>Cudrania tricuspidata</i> extract (CTE) for relieving the symptoms of functional dyspepsia. In an 8-week, randomized, d...

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Autores principales: Jinyoung Shin, Tae-Hoon Oh, Joo-Yun Kim, Jae-Jung Shim, Jung-Lyoul Lee
Formato: article
Lenguaje:EN
Publicado: MDPI AG 2021
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Acceso en línea:https://doaj.org/article/2bc043a0b5584640bcb1f7fdced734d7
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Sumario:<i>Cudrania tricuspidata</i> is a folk remedy used to treat inflammation in patients with tumors or liver damage. This study investigated the efficacy of <i>Cudrania tricuspidata</i> extract (CTE) for relieving the symptoms of functional dyspepsia. In an 8-week, randomized, double-blind, placebo-controlled study, 100 adults with any condition featured in the Rome IV criteria and a Gastrointestinal Symptoms Scale (GIS) score ≥4 were randomly allocated to take either a placebo (maltodextrin) or a 50 mg CTE tablet, which equally included celluloses, magnesium stearate, and silicon dioxide, twice daily, 20 January 2020, and 3 August 2020. Among the 83 participants finally analyzed, the CTE group was associated with a significant reduction in the gastrointestinal symptom rating scale (day 0: 8.0 ± 5.2, day 28: 4.7 ± 3.9, and day 56: 2.3 ± 2.4, <i>p</i> < 0.001, respectively) in comparison with the control group (day 0: 8.1 ± 4.7, day 28: 7.8 ± 5.7, and day 56: 7.5 ± 6.6, <i>p</i> > 0.05) after adjusting for smoking, drinking, eating habits, stress levels, and caffeine intake. The CTE group resulted in significant improvements of GIS, Nepean Dyspepsia Index (Korean version), and functional dyspepsia-related quality of life over time. There were no different adverse events (<i>p</i> = 0.523). These findings suggest that CTE is safe and efficacious for alleviating gastrointestinal symptoms in patients with functional dyspepsia.