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Jollab治疗功能性消化不良的疗效与安全性:一项随机安慰剂对照临床试验

Efficacy and safety of jollab to treat functional dyspepsia: a randomized placebo-controlled clinical trial.

作者信息

Pasalar Mehdi, Choopani Rasool, Mosaddegh Mahmoud, Kamalinejad Mohammad, Mohagheghzadeh Abdolali, Fattahi Mohammad Reza, Ghanizadeh Ahmad, Bagheri Lankarani Kamran

机构信息

School of Traditional Medicine, Shahid Beheshti University of Medical Sciences, Vali Asr Ave., Tehran, Iran.

School of Traditional Medicine, Shahid Beheshti University of Medical Sciences, Vali Asr Ave., Tehran, Iran.

出版信息

Explore (NY). 2015 May-Jun;11(3):199-207. doi: 10.1016/j.explore.2015.02.007. Epub 2015 Feb 17.


DOI:10.1016/j.explore.2015.02.007
PMID:25777290
Abstract

BACKGROUND: Functional dyspepsia (FD) is a common gastrointestinal disease that is highly prevalent worldwide. Because of its heterogeneous pathophysiology, treatment options for FD can be difficult to choose; in this context, complementary and alternative medicine modalities have been suggested as promising options. AIM: To evaluate the efficacy of a traditional Persian medicine, jollab, in reducing patients' FD symptoms. METHODS: In a double-blind randomized clinical trial, 160 patients with a diagnosis of FD were enrolled and treated with either jollab or placebo (15ml, t.i.d., four weeks, orally). The outcomes reported were changes in symptom frequency and severity as recorded in patients' diaries and evaluated with the Short Form of the Leeds Dyspepsia Questionnaire (SF-LDQ), and physical examination. RESULTS: The response rate was higher in the treatment group (78%) than in the placebo group (31%) according to per-protocol sample analysis (P < .001). Symptoms of FD disappeared significantly more frequently, and the rate of concomitant synthetic drug consumption was significantly lower, in the jollab group compared to the placebo group at the end of the trial. Mean total symptom frequency and severity according to the SF-LDQ score was 1.55 ± 2.78 in the treatment group versus 5.61 ± 3.80 in the placebo group at the last follow-up time point (P < .001). A promising safety profile for jollab was observed throughout the trial. CONCLUSIONS: In patients with FD, jollab appeared to be more effective than the placebo. Complementary and alternative therapies such as the use of this traditional medicinal substance may be beneficial in relieving symptoms of dyspepsia [ACTRN12613000584730].

摘要

背景:功能性消化不良(FD)是一种常见的胃肠道疾病,在全球范围内高度流行。由于其病理生理学的异质性,FD的治疗方案可能难以选择;在此背景下,补充和替代医学模式被认为是有前景的选择。 目的:评估传统波斯药物jollab减轻FD患者症状的疗效。 方法:在一项双盲随机临床试验中,纳入160例诊断为FD的患者,分别用jollab或安慰剂(15ml,每日三次,共四周,口服)进行治疗。报告的结果包括患者日记中记录的症状频率和严重程度的变化,采用利兹消化不良问卷简表(SF-LDQ)进行评估,以及体格检查。 结果:根据符合方案样本分析,治疗组的缓解率(78%)高于安慰剂组(31%)(P <.001)。在试验结束时,与安慰剂组相比,jollab组FD症状消失的频率明显更高,同时服用合成药物的比例明显更低。在最后随访时间点,根据SF-LDQ评分,治疗组的平均总症状频率和严重程度为1.55±2.78,而安慰剂组为5.61±3.80(P <.001)。在整个试验过程中观察到jollab具有良好的安全性。 结论:对于FD患者,jollab似乎比安慰剂更有效。使用这种传统药物等补充和替代疗法可能有助于缓解消化不良症状[澳大利亚新西兰临床试验注册中心编号:ACTRN12613000584730]。

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[7]
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[8]
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