Abstract
Cudrania tricuspidata is a folk remedy used to treat inflammation in patients with tumors or liver damage. This study investigated the efficacy of Cudrania tricuspidata 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, p < 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, p > 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 (p = 0.523). These findings suggest that CTE is safe and efficacious for alleviating gastrointestinal symptoms in patients with functional dyspepsia.
Highlights
Functional dyspepsia (FD) is a complex of symptoms that occur in the gastroduodenal region of the gastrointestinal tract and include epigastric pain, burning, postprandial fullness, or early satiety without structural problems [1]
Weight, blood pressure, and pulse rate, and body mass index (BMI) was calculated as weight divided by height squared
This study confirmed that the intake of Cudrania tricuspidata extract (CTE) in relatively healthy Korean adults was associated with a statistically significant reduction in gastrointestinal symptoms compared to the placebo, after adjusting for confounding factors including smoking, drinking, eating habits, stress levels, and caffeine intake, which were expected to affect gastrointestinal symptoms
Summary
Functional dyspepsia (FD) is a complex of symptoms that occur in the gastroduodenal region of the gastrointestinal tract and include epigastric pain, burning, postprandial fullness, or early satiety without structural problems [1]. The symptom-based criteria in current use for FD are the Rome IV criteria (fourth edition), developed by a group of experts in functional gastrointestinal disorders [2]. A systematic review of 16 studies examining the effect of nutrients, food, and food components found that a diet with reduced wheat and dietary fats may improve FD symptoms [4]. As few randomized controlled trials of dietary manipulation exist, empirical pharmacological therapy is the current treatment strategy [1,5]. As the diagnosis of FD must exclude organic causes of various symptoms, little evidence exists to corroborate the effectiveness of treatments, and none are proven
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