The Efficacy and Safety of GCWB104 (<i>Flos</i> 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 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).

Efficacy of herbal treatments for functional dyspepsia: A systematic review and meta‐analysis of randomized clinical trials

“…Quantitative data on the effect of herbal remedies in improving FD symptoms could be extracted from 22 RCTs (total number of 1,531 and 1,423 participants in experimental and placebo groups, respectively). The assessment tools were HKDI (3 studies [Dabos et al, 2010; Khonche et al, 2017; Mohtashami et al, 2015]), GSRS (2 studies [Y. Choi et al, 2020; Suzuki et al, 2014]), SF‐LDQ (2 studies [Chitapanarux et al, 2020; Pasalar et al, 2015a, 2015b]), GIS (2 studies [Braden et al, 2009; Chen et al, 2020]), DDS (1 study [Masuy et al, 2020]), OSS (8 studies [Bortolotti et al, 2002; Holtmann et al, 2003; A Madisch et al, 2004; J.‐W. Park et al, 2013; Su et al, 2018; Tominaga et al, 2018; Von Arnim et al, 2007; Zhao & Gan, 2005]), CDI (1 study [Wen et al, 2020]), TDS (2 studies [Zhang et al, 2013; L. Zhao et al, 2013]), and FD severity scale (1 study [Ghoshegir et al, 2015]).…”

“…Finally, 49 RCTs (Azimi et al, 2017; Bordbar, Miri, Omidi, Shoja, & Akhavan, 2020; Bortolotti, Coccia, Grossi, & Miglioli, 2002; Braden, Caspary, Börner, Vinson, & Schneider, 2009; Chen et al, 2020; Chitapanarux, Lertprasertsuke, & Toworakul, 2020; M.‐G. Choi et al, 2015; Y. Choi, Kim, Noh, Lee, & Lee, 2020; Dabos et al, 2010; Du, Ming, Chen, & Li, 2014; Eftekharafzali, Zahedi, Mehrabani, Ahmadi, & Tajadini, 2018; Fani et al, 2010; Ghoshegir et al, 2015; Giacosa et al, 2015; Holtmann et al, 2003; Jung et al, 2016; Khonche, Huseini, Mohtashami, Nabati, & Kianbakht, 2017; J. B. Kim et al, 2014; Ko et al, 2018; Li, Yang, & Li, 2013; Lin, Cai, & Xu, 1998; Liu, Piao, & Guo, 2013; Lv et al, 2017; Madisch, Heydenreich, Wieland, Hufnagel, & Hotz, 1999; Madisch, Holtmann, Mayr, Vinson, & Hotz, 2004; Mala, Thomas, Syam, Maliakel, & Krishnakumar, 2018; Masuy et al, 2020; May, Köhler, & Schneider, 2000; Mohtashami et al, 2015; C. H. Park, Kim, & Lee, 2014; J.‐W.…”

“…Of these, 359 articles remained for the full-text review, in which 171 studies met inclusion criteria. Finally, 49 RCTs (Azimi et al, 2017;Bordbar, Miri, Omidi, Shoja, & Akhavan, 2020;Bortolotti, Coccia, Grossi, & Miglioli, 2002;Braden, Caspary, Börner, Vinson, & Schneider, 2009;Chen et al, 2020;Chitapanarux, Lertprasertsuke, & Toworakul, 2020;M.-G. Choi et al, 2015;Y. Choi, Kim, Noh, Lee, & Lee, 2020;Dabos et al, 2010;Du, Ming, Chen, & Li, 2014;Eftekharafzali, Zahedi, Mehrabani, Ahmadi, & Tajadini, 2018;Fani et al, 2010;Ghoshegir et al, 2015;Giacosa et al, 2015;Holtmann et al, 2003;Jung et al, 2016;Khonche, Huseini, Mohtashami, Nabati, & Kianbakht, 2017;J.…”

“…(2 studies [Y. Choi et al, 2020;Suzuki et al, 2014]), SF-LDQ (2 studies [Chitapanarux et al, 2020;Pasalar et al, 2015aPasalar et al, , 2015b), GIS (2 studies [Braden et al, 2009;Chen et al, 2020]), DDS (1 study [Masuy et al, 2020]), OSS (8 studies [Bortolotti et al, 2002;Holtmann et al, 2003;A Madisch et al, 2004;J.-W. Park et al, 2013;Su et al, 2018;Tominaga et al, 2018;Von Arnim et al, 2007 Gan, 2005]), CDI (1 study [Wen et al, 2020]), TDS (2 studies [Zhang et al, 2013;), and FD severity scale (1 study [Ghoshegir et al, 2015]). The pooled SMD of FD symptoms improvement after treatment with an herbal remedy versus the placebo was À0.58, 95% CI [À0.66-À0.51] (Z = 15.04, p < .00001) with significant heterogeneity detected among studies (χ 2 = 292.94, p < .00001, I 2 = 93%).…”

“…Quantitative data on the effect of herbal remedies on QoL could be obtained from 17 RCTs (total number of 1,061 and 1,023 participants in experimental and placebo groups, respectively). The assessment tools were NDI (10 studies [Azimi et al, 2017;Y. Choi et al, 2020;Eftekharafzali et al, 2018;Holtmann et al, 2003;J.…”