Improvement of Disease-Specific Quality of Life and Dyspeptic Symptoms with Dlbs2411, A Bioactive Fraction of Cinnamomum Burmannii, in Patients with Functional Dyspepsia
Main Article Content
Functional dyspepsia is a common disorder of gut–brain interaction that substantially impairs quality of life, while available pharmacological treatments provide modest benefits and may cause adverse effects during prolonged use. This study aimed to evaluate the effects, durability, and safety of DLBS2411, a standardized bioactive fraction of Cinnamomum burmannii, in adults with functional dyspepsia. This prospective multicenter study enrolled 53 adults with Rome IV-defined, Helicobacter pylori-negative functional dyspepsia from seven hospitals in Indonesia. Participants received DLBS2411 at a dose of 250 mg twice daily for 28 days and were followed for an additional eight weeks. Disease-specific quality of life was assessed using the Short-Form Nepean Dyspepsia Index (SF-NDI), while eight dyspeptic symptoms were evaluated using visual analog scales (VAS). Safety was assessed through adverse event monitoring, vital signs, electrocardiography, and laboratory examinations. The mean SF-NDI score improved by 53% at Week 4 and 67% at Week 12. All eight dyspeptic symptoms showed significant improvement, and the proportion of participants reporting adequate relief increased from 55% at Week 2 to 76% at Week 12. DLBS2411 was generally well tolerated, with no treatment-related serious adverse events reported. In conclusion, DLBS2411 was associated with early and sustained improvements in disease-specific quality of life and dyspeptic symptoms; however, placebo-controlled trials are required to confirm its efficacy and clinical therapeutic value.
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