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[药物名称]治疗功能性消化不良的安全性和有效性:一项随机、双盲、安慰剂对照研究。 (这里原文“of”后面缺少具体药物名称,所以补充了[药物名称]使句子完整通顺)

Safety and Efficacy of in Functional Dyspepsia: A Randomized, Double-Blinded, Placebo-Controlled Study.

作者信息

Mala K N, Thomas Jestin, Syam Das S, Maliakel Balu, Krishnakumar I M

机构信息

Sri Rama Hospital, Fort road, Doddaballapur, Bangalore, India.

Leads Clinical Research & Bio Services Pvt. Ltd., Bangalore, India.

出版信息

Evid Based Complement Alternat Med. 2018 Aug 26;2018:4813601. doi: 10.1155/2018/4813601. eCollection 2018.

DOI:10.1155/2018/4813601
PMID:30224930
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC6129344/
Abstract

Despite the availability of various synthetic drugs for the treatment of functional dyspepsia (FD), the side effects and their cost have always created a great interest in the search for novel natural alternatives for the management of gut disorders. The present contribution reports the safety and efficacy of the kitchen spice asafoetida () in FD for the first time. In the double-blinded, placebo-controlled study, 43 subjects diagnosed to have moderate to severe discomforts of nonulcer FD were randomized to receive hard-shell capsules (250 mg × 2/day) of either placebo (n=22) or a food-grade formulation of asafoetida (Asafin) (n=21) for 30 days. When evaluated by a set of validated indexing tools (GSRS, GDSS, and NDI), almost 81% in the Asafin group showed significant () improvement in the overall score and quality of life as compared to the placebo. At the end of the study, 66% of subjects in the Asafin group remained symptoms-free. Although the symptoms score improved significantly in both the groups (from -5.67 to -25.29 in Asafin group versus -1.55 to -6.0 in the placebo; ), the relative percentage of subjects in the Asafin group with more than 80% reduction in various symptoms were: bloating (58%), appetite (69%), postprandial fullness (74%) motion sickness (75%), and digestion (77%) as compared to less than 10% nonspecific improvement in the placebo group. All the subjects remained safe with no adverse events or variations in haematological and biochemical parameters. The study was registered at http://ctri.nic.in/ (CTRI/2018/ 01/011149).

摘要

尽管有各种合成药物可用于治疗功能性消化不良(FD),但其副作用和成本一直引发人们对寻找治疗肠道疾病的新型天然替代药物的浓厚兴趣。本研究首次报告了厨房香料阿魏()在功能性消化不良中的安全性和有效性。在这项双盲、安慰剂对照研究中,43名被诊断为患有中度至重度非溃疡性功能性消化不良不适的受试者被随机分为两组,分别接受安慰剂(n = 22)或食品级阿魏制剂(Asafin)(n = 21)的硬壳胶囊(250 mg×2/天),为期30天。当通过一组经过验证的索引工具(GSRS、GDSS和NDI)进行评估时,与安慰剂组相比,Asafin组中近81%的受试者在总体评分和生活质量方面有显著()改善。在研究结束时,Asafin组66%的受试者症状消失。虽然两组的症状评分均有显著改善(Asafin组从 -5.67降至 -25.29,而安慰剂组从 -1.55降至 -6.0;),但Asafin组中各种症状减轻超过80%的受试者相对百分比分别为:腹胀(58%)、食欲(69%)、餐后饱胀感(74%)、晕动病(75%)和消化(77%),而安慰剂组的非特异性改善不到10%。所有受试者均安全,未出现不良事件,血液学和生化参数也无变化。该研究已在http://ctri.nic.in/(CTRI/2018/01/011149)注册。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a0a5/6129344/d34fa6cb1ab2/ECAM2018-4813601.003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a0a5/6129344/025667760e6a/ECAM2018-4813601.001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a0a5/6129344/a9c545781afc/ECAM2018-4813601.002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a0a5/6129344/d34fa6cb1ab2/ECAM2018-4813601.003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a0a5/6129344/025667760e6a/ECAM2018-4813601.001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a0a5/6129344/a9c545781afc/ECAM2018-4813601.002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a0a5/6129344/d34fa6cb1ab2/ECAM2018-4813601.003.jpg

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