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The Efficacy and Safety of GCWB104 (Flos Lonicera Extract) in Functional Dyspepsia: A Single-Center, Randomized, Double-Blind, Placebo-Controlled Study

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Author(s)
Yonghoon ChoiNayoung KimGi Tark NohJu Yup LeeDong Ho Lee
Keimyung Author(s)
Lee, Ju Yup
Department
Dept. of Internal Medicine (내과학)
Journal Title
Gut and Liver
Issued Date
2020
Volume
14
Issue
1
Keyword
LoniceraDyspepsiaAntioxidant
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 single-center, 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 treatment with GCWB104.

Conclusions:
GCWB104 safely contributed to improvements in mild to moderate FD and irritable bowel syndrome symptoms. Antioxidant effects of GCWB104 were also suggested (Clinicaltrials.gov number NCT04008901).
Keimyung Author(s)(Kor)
이주엽
Publisher
School of Medicine (의과대학)
Citation
Yonghoon Choi et al. (2020). The Efficacy and Safety of GCWB104 (Flos Lonicera Extract) in Functional Dyspepsia: A Single-Center, Randomized, Double-Blind, Placebo-Controlled Study. Gut and Liver, 14(1), 67–78. doi: 10.5009/gnl19283
Type
Article
ISSN
2005-1212
Source
http://www.gutnliver.org/journal/view.html?uid=1658
DOI
10.5009/gnl19283
URI
https://kumel.medlib.dsmc.or.kr/handle/2015.oak/42545
Appears in Collections:
1. School of Medicine (의과대학) > Dept. of Internal Medicine (내과학)
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