在一项随机、安慰剂对照、双盲人体初步研究中，紫苏提取物可改善胃肠道不适。

Perilla extract improves gastrointestinal discomfort in a randomized placebo controlled double blind human pilot study.

作者信息

Buchwald-Werner Sybille, Fujii Hajime, Reule Claudia, Schoen Christiane

机构信息

Vital Solutions GmbH, Hausingerstrasse 6, Langenfeld 40764, Germany.

出版信息

BMC Complement Altern Med. 2014 May 27;14:173. doi: 10.1186/1472-6882-14-173.

DOI:10.1186/1472-6882-14-173

PMID:24885816

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC4038823/

Abstract

BACKGROUND

Gastrointestinal (GI) discomfort, e.g. bloating or rumbling, is a common symptom in otherwise healthy adults. Approximately 20% of the population, particularly women suffer from gastrointestinal discomfort and this affects quality of life. Recent studies discovered a link between the body and mind, called the gut-brain axis. Psychosocial factors, such as e.g. daily stress may cause altered gut physiology leading to ileum contractions and consequently gastrointestinal symptoms. In vitro and ex vivo studies clearly showed that a Perilla frutescens extract combines prokinetic, antispasmodic and anti-inflammatory effects. The aim of the intervention was to investigate the effects of the proprietary Perilla extract on GI discomfort in healthy subjects with gastrointestinal discomfort and reduced bowel movements in comparison to a placebo product.

METHODS

The pilot study was performed according to a double-blind, randomized, placebo-controlled parallel design. Fifty healthy subjects with gastrointestinal discomfort and reduced bowel movements, 30-70 years, documented their GI symptoms, stool frequency and consistency daily during a 2-week run-in phase and a 4-week intervention phase with Perilla frutescens extract or placebo. GI symptoms were assessed on a 5-point scale daily and average scores over 14 days intervals were calculated.

RESULTS

All GI symptoms were significantly improved over time by Perilla frutescens extract during the intervention phase (bloating: -0.44±0.56, p=0.0003; passage of gas: -0.30±0.66, p=0.0264; GI rumbling: -0.55±0.87, p=0.0014; feeling of fullness: -0.36±0.72, p=0.0152; abdominal discomfort: -0.54±0.75, p=0.004), whereas in the placebo group only abdominal discomfort was significantly improved (-0.31±0.55, p=0.0345). In the subgroup of women results were strengthened and a subscore out of bloating and abdominal discomfort was significantly improved against placebo (95%CI 0.003 to 0.77; p=0.048).

CONCLUSION

The demonstrated effects of Perilla frutescens extract to improve GI complaints offer very promising results, taking into consideration the challenging set up of a nutritional human study with healthy subjects and in the area of digestive health, which is known for high placebo effects.

TRIAL REGISTRATION NUMBER

NCT01931930 at ClinicalTrials.gov, Registration date 23rd August 2013.

摘要

背景

胃肠道不适，如腹胀或肠鸣，是健康成年人常见的症状。约20%的人群，尤其是女性，患有胃肠道不适，这会影响生活质量。最近的研究发现了身体与心理之间的联系，即肠-脑轴。心理社会因素，如日常压力，可能导致肠道生理改变，引发回肠收缩，进而导致胃肠道症状。体外和离体研究清楚地表明，紫苏提取物具有促动力、解痉和抗炎作用。本干预研究的目的是，与安慰剂产品相比，调查专利紫苏提取物对有胃肠道不适和排便减少的健康受试者胃肠道不适的影响。

方法

该初步研究按照双盲、随机、安慰剂对照的平行设计进行。50名年龄在30至70岁、有胃肠道不适和排便减少的健康受试者，在为期2周的导入期和为期4周的用紫苏提取物或安慰剂干预期内，每天记录他们的胃肠道症状、大便频率和稠度。每天用5分制评估胃肠道症状，并计算14天间隔期的平均得分。

结果

在干预期，紫苏提取物使所有胃肠道症状随时间推移均有显著改善（腹胀：-0.44±0.56，p = 0.0003；排气：-0.30±0.66，p = 0.0264；肠鸣：-0.55±0.87，p = 0.0014；饱腹感：-0.36±0.72，p = 0.0152；腹部不适：-0.54±0.75，p = 0.004），而在安慰剂组，只有腹部不适有显著改善（-0.31±0.55，p = 0.0345）。在女性亚组中，结果得到强化，与安慰剂相比，腹胀和腹部不适的分项评分有显著改善（95%CI 0.003至0.77；p = 0.048）。