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口香糖对糖尿病胃轻瘫症状的影响:一项随机、三盲、安慰剂对照临床试验。

Effect of gum on diabetic gastroparesis symptoms: a randomized, triple-blind placebo-controlled clinical trial.

作者信息

Mahjoub Fatemeh, Salari Roshanak, Yousefi Mahdi, Mohebbi Masoud, Saki Azadeh, Rezayat Kambiz Akhavan

机构信息

M.D., Ph.D. Candidate of Persian Medicine, Department of Persian Medicine, School of Persian and Complementary Medicine, Mashhad University of Medical Sciences, Mashhad, Iran.

Ph.D. of Drug Control, Assistant Professor, Department of Pharmaceutical Sciences in Persian Medicine, School of Persian and Complementary Medicine, Mashhad University of Medical Sciences, Mashhad, Iran.

出版信息

Electron Physician. 2018 Jul 25;10(7):6997-7007. doi: 10.19082/6997. eCollection 2018 Jul.

DOI:10.19082/6997
PMID:30128090
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC6092141/
Abstract

BACKGROUND

Gastroparesis is a recognized problem of type 1 and 2 diabetes mellitus that is defined by delayed gastric emptying. Due to insufficient satisfaction of current treatments, the use of complementary and alternative medicine in this field seems essential. According to Persian medicine, gum has proper effect on gastrointestinal disorder specially stomach diseases.

OBJECTIVE

The aim of this study was to assess the effect of gum on diabetic gastroparesis symptoms.

METHODS

A triple-blind randomized placebo-controlled trial on subjects with diabetic gastroparesis was conducted at the clinic of Imam Reza Hospital in Mashhad city in Iran, from November 2016 to May 2017. Fifty-four patients (16.7% males and 83.3% females) enrolled in the 8-week study and were randomly divided into two groups of intervention and placebo groups. Both of the groups had received current dietary advice. Severity of gastroparesis symptoms was assessed with a Gastroparesis cardinal symptom index (GCSI) questionnaire. SPSS software version 16 was used to analyze the data and Generalized Estimating Equation (GEE) model, Independent-samples t-test, Paired-samples t-test, Mann-Whitney U test, and Wilcoxon signed-rank test were used to assess variables.

RESULTS

All gastroparesis symptoms of patients (14.6% diabetes type 1 and 85.4% diabetes type 2) including nausea/vomiting, postprandial fullness/early satiety, and bloating were significantly declined in each group during study (p<0.0001). gum significantly reduced severity of gastroparesis symptoms including Postprandial fullness/early satiety (p=0.04), Bloating (p<0.0001), and GCSI scores (p=0.001) versus placebo. Systolic blood pressure (p=0.006), BMI (p=0.018), and HbA1c (p=0.038) significantly decreased in the group after the intervention.

CONCLUSION

This study showed that daily consumption of gum for one month improves diabetic gastroparesis symptoms.

TRIAL REGISTRATION

The trial was registered at the Iranian Registry of Clinical Trials (http://www.irct.ir) with the code of IRCT2016110630739N1.

FUNDING

This study was supported by funding (grant no.: 950153) from the Mashhad University of Medical Sciences Research Council, Mashhad, Iran.

摘要

背景

胃轻瘫是1型和2型糖尿病公认的一个问题,其定义为胃排空延迟。由于目前的治疗效果欠佳,在这一领域使用补充和替代医学似乎很有必要。根据波斯医学,[某种]胶对胃肠道疾病尤其是胃部疾病有良好疗效。

目的

本研究旨在评估[某种]胶对糖尿病性胃轻瘫症状的影响。

方法

2016年11月至2017年5月,在伊朗马什哈德市伊玛目礼萨医院诊所对患有糖尿病性胃轻瘫的受试者进行了一项三盲随机安慰剂对照试验。54名患者(男性占16.7%,女性占83.3%)参与了这项为期8周的研究,并被随机分为干预组和安慰剂组。两组均接受了当前的饮食建议。采用胃轻瘫主要症状指数(GCSI)问卷评估胃轻瘫症状的严重程度。使用SPSS 16版软件分析数据,并采用广义估计方程(GEE)模型、独立样本t检验、配对样本t检验、曼-惠特尼U检验和威尔科克森符号秩检验来评估变量。

结果

在研究期间,患者(14.6%为1型糖尿病,85.4%为2型糖尿病)的所有胃轻瘫症状,包括恶心/呕吐、餐后饱胀/早饱以及腹胀,在每组中均显著减轻(p<0.0001)。与安慰剂相比,[某种]胶显著降低了胃轻瘫症状的严重程度,包括餐后饱胀/早饱(p=0.04)、腹胀(p<0.0001)和GCSI评分(p=0.001)。干预后,[某种]胶组的收缩压(p=0.006)、BMI(p=0.018)和糖化血红蛋白(p=0.038)显著降低。

结论

本研究表明,每天食用[某种]胶一个月可改善糖尿病性胃轻瘫症状。

试验注册

该试验在伊朗临床试验注册中心(http://www.irct.ir)注册,注册号为IRCT2016110630739N1。

资助

本研究得到了伊朗马什哈德医科大学研究委员会的资助(资助编号:950153)。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e261/6092141/5e431814f5d2/EPJ-10-6997-g004.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e261/6092141/7c2e0336e1d2/EPJ-10-6997-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e261/6092141/cedb55d6fa6d/EPJ-10-6997-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e261/6092141/2c4187c38386/EPJ-10-6997-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e261/6092141/5e431814f5d2/EPJ-10-6997-g004.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e261/6092141/7c2e0336e1d2/EPJ-10-6997-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e261/6092141/cedb55d6fa6d/EPJ-10-6997-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e261/6092141/2c4187c38386/EPJ-10-6997-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e261/6092141/5e431814f5d2/EPJ-10-6997-g004.jpg

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