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洋蓍草胶囊对肠易激综合征患者症状严重程度及生活质量的疗效和安全性:一项随机、安慰剂对照临床试验

Efficacy and safety of Achillea wilhelmsii C. Koch capsules on symptom severity and quality of life in patients with irritable bowel syndrome: a randomized, placebo-controlled clinical trial.

作者信息

Derakhshande Padide, Navabi Seyed Jafar, Shokoohinia Yalda, Rouhi-Broujeni Hojjat, Deris Fateme, Behbood Leila, Shahbazi Foroud, Amiri Mahtab, Farzaei Mohammad Hosein

机构信息

Students research Committee, Faculty of Pharmacy, Kermanshah University of Medical Sciences, Kermanshah, Iran.

Department of Internal Medicine, Faculty of Medicine, Kermanshah University of Medical Sciences, Kermanshah, Iran (Islamic Republic of).

出版信息

J Complement Integr Med. 2019 Aug 23;16(4):/j/jcim.2019.16.issue-4/jcim-2018-0123/jcim-2018-0123.xml. doi: 10.1515/jcim-2018-0123.

Abstract

Background Irritable bowel syndrome (IBS) is one of the most common digestive diseases. The aim of this clinical trial was to determine the effectiveness of Achillea wilhelmsii C. Koch on the symptom severity and quality of life (QOL) in patients with IBS. Methods The patients were randomized into two groups of 45 each. The QOL and symptom severity of the patients were evaluated at baseline and at completion of the treatments by means of IBS-QOL and IBS severity index. Results The mean severity of clinical symptoms in the Achillea wilhelmsii C. Koch receiving groups before and after the treatment was 282.56 ± 103.57 and 178.06 ± 88.40, and in the placebo group was 265.93 ± 93.56 and 197.74 ± 106.26, respectively. The mean QOL in the Achillea wilhelmsii C. Koch receiving group before and after treatment was 51.49 ± 11.98 and 50.44 ± 13.39 and in the placebo group was 60.71 ± 11.97 and 58.39 ± 11.67, respectively. In both groups, there was a significant difference in the recovery rate in each group (p<0.05). However, the mean difference between the two groups before and after intervention was not significantly different (p>0.05). Also, no patient reported any adverse events during the trial. Although the symptom severity and QOL in both groups were improved compared to those before intervention, there was no significant difference between the two groups. Conclusion It is recommended to conduct future studies with larger sample size and longer treatment periods, and also investigate the efficacy on the IBS subtypes, separately.

摘要

背景 肠易激综合征(IBS)是最常见的消化系统疾病之一。本临床试验的目的是确定洋蓍草对IBS患者症状严重程度和生活质量(QOL)的有效性。方法 将患者随机分为两组,每组45人。通过IBS-QOL和IBS严重程度指数在基线和治疗结束时评估患者的QOL和症状严重程度。结果 接受洋蓍草治疗组治疗前后临床症状的平均严重程度分别为282.56±103.57和178.06±88.40,安慰剂组分别为265.93±93.56和197.74±106.26。接受洋蓍草治疗组治疗前后的平均QOL分别为51.49±11.98和50.44±13.39,安慰剂组分别为60.71±11.97和58.39±11.67。两组中每组的恢复率均有显著差异(p<0.05)。然而,两组干预前后的平均差异无显著差异(p>0.05)。此外,试验期间没有患者报告任何不良事件。虽然两组的症状严重程度和QOL与干预前相比均有所改善,但两组之间无显著差异。结论 建议未来进行更大样本量和更长治疗期的研究,并分别研究对IBS亚型的疗效。

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