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提取物治疗功能性消化不良的疗效与安全性:一项随机双盲安慰剂对照多中心研究。

Efficacy and Safety of the Extract on Functional Dyspepsia: A Randomized Double-Blind Placebo-Controlled Multicenter Study.

作者信息

Shin Jinyoung, Oh Tae-Hoon, Kim Joo-Yun, Shim Jae-Jung, Lee Jung-Lyoul

机构信息

Department of Family Medicine, Research Institute on Healthy Aging, Konkuk University School of Medicine, Seoul 05030, Korea.

Division of Gastroenterology, Vievis Namuh Hospital, Seoul 06117, Korea.

出版信息

J Clin Med. 2021 Nov 16;10(22):5323. doi: 10.3390/jcm10225323.

Abstract

is a folk remedy used to treat inflammation in patients with tumors or liver damage. This study investigated the efficacy of extract (CTE) for relieving the symptoms of functional dyspepsia. In an 8-week, randomized, double-blind, placebo-controlled study, 100 adults with any condition featured in the Rome IV criteria and a Gastrointestinal Symptoms Scale (GIS) score ≥4 were randomly allocated to take either a placebo (maltodextrin) or a 50 mg CTE tablet, which equally included celluloses, magnesium stearate, and silicon dioxide, twice daily, 20 January 2020, and 3 August 2020. Among the 83 participants finally analyzed, the CTE group was associated with a significant reduction in the gastrointestinal symptom rating scale (day 0: 8.0 ± 5.2, day 28: 4.7 ± 3.9, and day 56: 2.3 ± 2.4, < 0.001, respectively) in comparison with the control group (day 0: 8.1 ± 4.7, day 28: 7.8 ± 5.7, and day 56: 7.5 ± 6.6, > 0.05) after adjusting for smoking, drinking, eating habits, stress levels, and caffeine intake. The CTE group resulted in significant improvements of GIS, Nepean Dyspepsia Index (Korean version), and functional dyspepsia-related quality of life over time. There were no different adverse events ( = 0.523). These findings suggest that CTE is safe and efficacious for alleviating gastrointestinal symptoms in patients with functional dyspepsia.

摘要

是一种用于治疗肿瘤或肝损伤患者炎症的民间疗法。本研究调查了提取物(CTE)缓解功能性消化不良症状的疗效。在一项为期8周的随机、双盲、安慰剂对照研究中,100名符合罗马IV标准且胃肠道症状量表(GIS)评分≥4的成年人被随机分配服用安慰剂(麦芽糊精)或50毫克CTE片剂,该片剂同样包含纤维素、硬脂酸镁和二氧化硅,每日两次,时间为2020年1月20日至2020年8月3日。在最终分析的83名参与者中,与对照组(第0天:8.1±4.7,第28天:7.8±5.7,第56天:7.5±6.6,P>0.05)相比,调整吸烟、饮酒、饮食习惯、压力水平和咖啡因摄入量后,CTE组胃肠道症状评定量表显著降低(第0天:8.0±5.2,第28天:4.7±3.9,第56天:2.3±2.4,P<0.001)。随着时间的推移,CTE组在GIS、内皮恩消化不良指数(韩文版)和功能性消化不良相关生活质量方面有显著改善。不良事件无差异(P=0.523)。这些发现表明,CTE对缓解功能性消化不良患者的胃肠道症状是安全有效的。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9fa0/8621513/4383ba5c5c0e/jcm-10-05323-g001.jpg

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