The Efficacy and Safety of GCWB104 (Flos Lonicera Extract) in Functional Dyspepsia: A Single-Center, Randomized, Double-Blind, Placebo-Controlled Study
Abstract
Background/Aims: The Flos Lonicera extract GCWB104 has been shown to have significant protective effects against gastritis and gastric ulcers in vivo.The aim of this study was to investigate the efficacy and safety of GCWB104 in subjects with functional dyspepsia (FD).Methods: In this singlecenter, double-blind, randomized clinical trial, 92 subjects diagnosed with FD using the Rome III criteria were allocated to either the test group (300 mg of GCWB104, containing 125 mg of Flos Lonicera extract, twice daily) or the placebo group (300 mg placebo, twice daily).The total score improvement on the Gastrointestinal Symptom Rating Scale (GSRS) for individual symptoms, changes in antioxidant levels, changes in dyspepsia-related quality of life according to the Nepean Dyspepsia Index (NDI), and adverse effects were compared before and after 8 weeks of treatment.Results: The differences in total GSRS scores and score improvements after 8 weeks of treatment were significant between the GCWB104 and control groups (p=0.0452 and p=0.0486, respectively).Thirteen of 15 individual symptoms on the GSRS improved in the GCWB104 group, while six symptoms improved in the control group.In addition, statistically significant changes in rumbling, loose stool, and stool urgency were observed in the GCWB104 group.Blood 8-hydroxy-2'-deoxyguanosine (8-OHdG) levels, known as antioxidants, showed significant reductions after 8 weeks of administration of GCWB104.There were no adverse events related to…
How strong is the evidence?
Evidence Hub reads this as a randomized trial. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 92 participants or records.
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