Choi Yonghoon, Kim Nayoung, Lee Dong Ho
Department of Internal Medicine, Seoul National University Bundang Hospital, Seongnam, Gyeonggi-do, Korea.
Department of Internal Medicine and Liver Research Institute, Seoul National University College of Medicine, Seoul, Korea.
J Neurogastroenterol Motil. 2024 Oct 30;30(4):468-479. doi: 10.5056/jnm23180.
BACKGROUND/AIMS: NOVAponin, a functional health food derived from Linne extract improves gastric mucosal injury and increases regeneration and proliferation. This study aims to investigate the efficacy and safety of NOVAponin in individuals with mild functional dyspepsia (FD).
In this single-center, double-blind, randomized clinical trial, 131 patients with FD meeting the Rome IV criteria were enrolled. Changes in the gastrointestinal symptom rating scale (GSRS), FD-related quality of life (FD-QoL), gastrointestinal symptom (GIS) scores, inflammatory and anti-inflammatory markers, and adverse effects before and after administration were compared.
After 12 weeks of administration, GSRS upper abdominal symptom scores were significantly improved in the test group compared to the control group (-5.30 ± 0.60 vs -2.35 ± 0.56, < 0.001). GSRS upper abdominal symptom scores (-5.13 ± 0.55 vs -1.92 ± 0.44, < 0.001), GSRS total scores (-7.02 ± 0.91 vs -3.33 ± 0.73, < 0.001), GIS total scores (-11.21 ± 0.53 vs -6.65 ± 0.70, < 0.001) after 6 weeks of administration, GSRS total scores (-7.54 ± 0.94 v. -3.31 ± 0.85, < 0.001), GIS total scores (-11.90 ± 0.52 vs -7.61 ± 0.73, < 0.001), and FD-QoL total scores (-11.41 ± 1.75 vs -5.55 ± 1.20, = 0.007) after 12 weeks of administration also showed significant differences between groups. The differences were slightly more pronounced in epigastric pain syndrome subtypes and in females than the others, although more females were assigned to the test group. There were no significant changes in inflammatory and anti-inflammatory markers or adverse reactions.
NOVAponin significantly improved mild FD symptoms especially in epigastric pain syndrome subtype and in females, and was found to be safe.
背景/目的：诺瓦波宁是一种源自林奈提取物的功能性健康食品，可改善胃黏膜损伤并促进再生和增殖。本研究旨在探讨诺瓦波宁对轻度功能性消化不良（FD）患者的疗效和安全性。
在这项单中心、双盲、随机临床试验中，纳入了131例符合罗马IV标准的FD患者。比较给药前后胃肠道症状评分量表（GSRS）、FD相关生活质量（FD-QoL）、胃肠道症状（GIS）评分、炎症和抗炎标志物以及不良反应的变化。
给药12周后，试验组的GSRS上腹部症状评分与对照组相比有显著改善（-5.30±0.60对-2.35±0.56，P<0.001）。给药6周后，GSRS上腹部症状评分（-5.13±0.55对-1.92±0.44，P<0.001）、GSRS总分（-7.02±0.91对-3.33±0.73，P<0.001）、GIS总分（-11.21±0.53对-6.65±0.70，P<0.001），给药12周后，GSRS总分（-7.54±0.94对-3.31±0.85，P<0.001）、GIS总分（-11.90±0.52对-7.61±0.73，P<0.001）以及FD-QoL总分（-11.41±1.75对-5.55±1.20，P=0.007）在组间也显示出显著差异。尽管试验组女性患者较多，但上腹部疼痛综合征亚型和女性患者的差异比其他患者略为明显。炎症和抗炎标志物或不良反应无显著变化。
诺瓦波宁显著改善了轻度FD症状，尤其是在上腹部疼痛综合征亚型和女性患者中，且被发现是安全的。
