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姜黄素提取物(Curcugen™)对有自述消化问题的成年人胃肠道症状和肠道微生物群的功效:一项随机、双盲、安慰剂对照研究。

Efficacy of a curcumin extract (Curcugen™) on gastrointestinal symptoms and intestinal microbiota in adults with self-reported digestive complaints: a randomised, double-blind, placebo-controlled study.

机构信息

Clinical Research Australia, Perth, Western Australia, 6023, Australia.

College of Science, Health, Engineering and Education, Murdoch University, Perth, Western Australia, 6150, Australia.

出版信息

BMC Complement Med Ther. 2021 Jan 21;21(1):40. doi: 10.1186/s12906-021-03220-6.

Abstract

BACKGROUND

There is preliminary evidence to suggest curcumin can alleviate digestive symptoms in adults with self-reported digestive complaints and irritable bowel syndrome. However, in all these trials, curcumin was used as a component of a multi-herbal combination and there were consistent concerns associated with risk of bias in most studies. The goal of this study was to investigate the effects of a curcumin extract (Curcugen™) on gastrointestinal symptoms, mood, and overall quality of life in adults presenting with self-reported digestive complaints. Moreover, to determine the potential therapeutic mechanisms of action associated with curcumin, its effects on intestinal microbiota and small intestinal bowel overgrowth (SIBO) were examined.

METHODS

In this 8-week, parallel-group, double-blind, randomised controlled trial, 79 adults with self-reported digestive complaints were recruited and randomised to receive either a placebo or 500 mg of the curcumin extract, Curcugen™. Outcome measures included the Gastrointestinal Symptom Rating Scale (GSRS), intestinal microbial profile (16S rRNA), Depression, Anxiety, and Stress Scale - 21 (DASS-21), Short Form-36 (SF-36), and SIBO breath test.

RESULTS

Based on self-report data collected from 77 participants, curcumin was associated with a significantly greater reduction in the GSRS total score compared to the placebo. There was also a greater reduction in the DASS-21 anxiety score. No other significant between-group changes in self-report data were identified. An examination of changes in the intestinal microbial profile and SIBO test revealed curcumin had no significant effect on these parameters. Curcumin was well-tolerated with no significant adverse events.

CONCLUSIONS

The curcumin extract, Curcugen™, administered for 8 weeks at a dose of 500 mg once daily was associated with greater improvements in digestive complaints and anxiety levels in adults with self-reported digestive complaints. Compared to the placebo, there were no significant changes in intestinal microbiota or SIBO; however, further research using larger samples and testing methods that allow more detailed microbial analyses will be important. An investigation into other potential mechanisms associated with curcumin's gastrointestinal-relieving effects will also be important such as examining its influence on the intestinal barrier function, inflammation, neurotransmitter activity, and visceral sensitivity.

TRIAL REGISTRATION

Australian New Zealand Clinical Trials Registry, Trial ID. ACTRN12619001236189 . Registered 6 September 2019.

摘要

背景

有初步证据表明姜黄素可缓解有消化系统症状自述和肠易激综合征的成年人的消化系统症状。然而,在所有这些试验中,姜黄素被用作多种草药组合的一种成分,并且大多数研究都存在与偏倚风险相关的一致问题。本研究的目的是研究姜黄素提取物(Curcugen™)对有消化系统症状自述的成年人的胃肠道症状、情绪和整体生活质量的影响。此外,为了确定与姜黄素相关的潜在治疗作用机制,还检查了其对肠道微生物群和小肠细菌过度生长(SIBO)的影响。

方法

在这项为期 8 周、平行分组、双盲、随机对照试验中,招募了 79 名有消化系统症状自述的成年人,并将他们随机分配接受安慰剂或 500mg 的姜黄素提取物 Curcugen™。结果测量包括胃肠道症状评分量表(GSRS)、肠道微生物谱(16S rRNA)、抑郁、焦虑和压力量表-21(DASS-21)、短格式 36(SF-36)和 SIBO 呼吸试验。

结果

基于从 77 名参与者收集的自述数据,与安慰剂相比,姜黄素与 GSRS 总分的显著降低相关。DASS-21 焦虑评分也有更大的降低。没有发现其他有意义的自述数据的组间变化。对肠道微生物谱和 SIBO 试验的变化的检查表明,姜黄素对这些参数没有显著影响。姜黄素耐受性良好,无明显不良反应。

结论

在剂量为 500mg 每日一次的情况下,姜黄素提取物 Curcugen™ 给药 8 周与有消化系统症状自述的成年人的消化系统症状和焦虑水平的改善相关。与安慰剂相比,肠道微生物群或 SIBO 没有显著变化;然而,使用更大的样本和允许更详细的微生物分析的测试方法进行进一步的研究将很重要。研究与姜黄素的胃肠道缓解作用相关的其他潜在机制也很重要,例如检查其对肠道屏障功能、炎症、神经递质活性和内脏敏感性的影响。

试验注册

澳大利亚新西兰临床试验注册中心,试验 ID。ACTRN12619001236189。2019 年 9 月 6 日注册。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/49f5/7818735/3f093a26db85/12906_2021_3220_Fig1_HTML.jpg

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