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一项针对海湾战争疾病的植物药制剂的安慰剂对照、伪随机、交叉试验:姜黄素( Boswellia () 和法国滨海松皮提取物()。

A Placebo-Controlled, Pseudo-Randomized, Crossover Trial of Botanical Agents for Gulf War Illness: Curcumin ( Boswellia (), and French Maritime Pine Bark ().

机构信息

Department of Psychology, Virginia Commonwealth University, White House, 806 West Franklin Street, Richmond, VA 23284, USA.

Department of Psychology, Vanderbilt University, PMB 407817, 2301 Vanderbilt Place, Nashville, TN 37240, USA.

出版信息

Int J Environ Res Public Health. 2021 Mar 3;18(5):2468. doi: 10.3390/ijerph18052468.

Abstract

This report is part of a larger study designed to rapidly and efficiently screen potential treatments for Gulf War Illness (GWI) by testing nine different botanicals. In this placebo-controlled, pseudo-randomized, crossover clinical trial of 20 men with GWI, we tested three botanical agents with putative peripheral and central anti-inflammatory actions: curcumin (), boswellia (), and French maritime pine bark extract (). Participants completed 30 +/- 3 days of baseline symptom reports, followed by 30 +/- 3 days of placebo, 30 +/- 3 days of lower-dose botanical, and 30 +/- 3 days of higher-dose botanical. Participants then repeated the process with a new botanical until completing up to three botanical cycles. Data were analyzed using linear mixed models. Curcumin reduced GWI symptom severity significantly more than placebo at both the lower ( < 0.0001) and higher ( = 0.0003) dosages. Boswellia was not more effective than placebo at reducing GWI symptoms at either the lower ( = 0.726) or higher ( = 0.869) dosages. Maritime pine was not more effective than placebo at the lower dosage ( = 0.954) but was more effective than placebo at the higher dosage ( = 0.006). This study provides preliminary evidence that curcumin and maritime pine may help alleviate symptoms of GWI. As a screening study, a final determination of the efficacy of these compounds for all individuals with GWI cannot be made, and further studies will need to be conducted to determine strength and durability of effects, as well as optimal dosage. These results suggest that GWI may, at least in part, involve systemic inflammatory processes. This trial was registered on ClinicalTrials.gov (NCT02909686) on 13 September 2016.

摘要

本报告是一项更大规模研究的一部分,该研究旨在通过测试九种不同的植物药,快速有效地筛选治疗海湾战争综合征(Gulf War Illness,GWI)的潜在疗法。在这项针对 20 名 GWI 男性患者的安慰剂对照、伪随机、交叉临床试验中,我们测试了三种具有潜在外周和中枢抗炎作用的植物药制剂:姜黄素(Curcumin)、乳香(Boswellia)和法国马尾松皮提取物(French maritime pine bark extract)。参与者完成了 30±3 天的基线症状报告,随后进行 30±3 天的安慰剂、30±3 天的低剂量植物药和 30±3 天的高剂量植物药治疗。然后,参与者使用新的植物药重复该过程,直到完成最多三个植物药周期。数据采用线性混合模型进行分析。与安慰剂相比,姜黄素在低剂量(<0.0001)和高剂量(=0.0003)下均能显著降低 GWI 症状严重程度。在低剂量(=0.726)和高剂量(=0.869)下,乳香均不如安慰剂有效。在低剂量下(=0.954),马尾松不如安慰剂有效,但在高剂量下(=0.006)比安慰剂更有效。这项研究初步表明,姜黄素和马尾松可能有助于缓解 GWI 症状。由于这是一项筛选性研究,因此不能确定这些化合物对所有 GWI 患者的疗效,还需要进一步研究以确定其疗效的强度和持久性,以及最佳剂量。这些结果表明,GWI 可能至少部分涉及全身性炎症过程。本试验于 2016 年 9 月 13 日在 ClinicalTrials.gov(NCT02909686)上注册。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/62a0/7967595/87bc40a13162/ijerph-18-02468-g001.jpg

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