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阿育吠陀草药治疗腹泻型肠易激综合征的疗效与安全性:一项随机对照交叉试验

Efficacy and safety of Ayurvedic herbs in diarrhoea-predominant irritable bowel syndrome: A randomised controlled crossover trial.

作者信息

Lauche Romy, Kumar Syal, Hallmann Julia, Lüdtke Rainer, Rampp Thomas, Dobos Gustav, Langhorst Jost

机构信息

Department of Internal and Integrative Medicine, Kliniken Essen-Mitte, Faculty of Medicine, University of Duisburg-Essen, Essen, Germany; Australian Research Centre in Complementary and Integrative Medicine (ARCCIM), Faculty of Health, University of Technology Sydney, Australia.

Department of Internal and Integrative Medicine, Kliniken Essen-Mitte, Faculty of Medicine, University of Duisburg-Essen, Essen, Germany; Department of Traditional Indian Medicine-Ayurveda, Kliniken Essen-Mitte, Essen, Germany.

出版信息

Complement Ther Med. 2016 Jun;26:171-7. doi: 10.1016/j.ctim.2016.04.002. Epub 2016 Apr 7.

Abstract

OBJECTIVE

Herbal medicines have been used widely for the treatment of irritable bowel syndrome (IBS) patients. The aim of this study is to investigate efficacy and safety of an Ayurvedic herbal compound preparation made from: Murraya koenigii (curry), Punica granatum (pomegranate) and Curcuma longa (turmeric), compared to a placebo in patients with diarrhoea predominant IBS.

MATERIAL AND METHODS

This trial was conducted as a randomised placebo-controlled crossover trial with randomised sequence of verum and placebo for each patient. Verum and placebo were provided as ground powders and delivered in sealed containers. Patients and outcome assessors were blinded. Patients were advised to ingest the decoction twice daily for 4 weeks. The primary outcome measure was IBS symptom intensity; secondary outcomes included: quality of life, anxiety and depression, compliance and safety.

RESULTS

32 IBS patients were included in the trial (19 females, mean age 50.3±11.9years). Eleven people dropped out during the trial resulting in 37 complete verum and 35 complete placebo phases. No group differences were found between verum and placebo for IBS symptom intensity (difference 24.10; 95% CI: -17.12; 65.32, p=0.26). The same was true for secondary outcomes. Compliance was satisfactory to good and the preparation appeared to be safe, but one third of the patients registered at least one minor adverse event that might be related to the study interventions.

CONCLUSION

An Ayurvedic herbal preparation made from Murraya koenigii, Punica granatum and Curcuma longa appeared to be no more effective in improving diarrhoea predominant irritable bowel symptoms than placebo.

摘要

目的

草药已被广泛用于治疗肠易激综合征(IBS)患者。本研究的目的是调查一种由九里香(咖喱)、石榴和姜黄制成的阿育吠陀草药复方制剂与安慰剂相比,对腹泻型IBS患者的疗效和安全性。

材料与方法

本试验为随机安慰剂对照交叉试验,每位患者的真药和安慰剂随机排序。真药和安慰剂均制成细粉并密封包装。患者和结果评估者均不知情。建议患者每天服用两次煎剂,持续4周。主要结局指标为IBS症状严重程度;次要结局指标包括:生活质量、焦虑和抑郁、依从性和安全性。

结果

32例IBS患者纳入试验(19例女性,平均年龄50.3±11.9岁)。11人在试验期间退出,最终有37例完成真药阶段,35例完成安慰剂阶段。真药组和安慰剂组在IBS症状严重程度上无组间差异(差值24.10;95%CI:-17.12;65.32,p=0.2)。次要结局指标情况相同。依从性为满意至良好,制剂似乎安全,但三分之一的患者记录了至少一项可能与研究干预措施有关的轻微不良事件。

结论

由九里香、石榴和姜黄制成的阿育吠陀草药制剂在改善腹泻型肠易激症状方面似乎并不比安慰剂更有效。

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