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亚洲和高加索 2 型糖尿病患者安慰剂效应的比较:一项荟萃分析。

Comparison of Placebo Effect between Asian and Caucasian Type 2 Diabetic Patients: A Meta-Analysis.

机构信息

Department of Emergency, Peking University People's Hospital, Beijing 100044, China.

Department of Endocrinology and Metabolism, Beijing Airport Hospital, Beijing 101318, China.

出版信息

Chin Med J (Engl). 2018 Jul 5;131(13):1605-1612. doi: 10.4103/0366-6999.235107.

Abstract

BACKGROUND

Placebo was defined as any therapy that is used for its nonspecific psychological and physiologic effect but has no specific pharmacologic impact on the condition being treated. Besides medication therapies, studies have found that the optimal dietary approach as well as physical activity and education are useful to control hyperglycemia in patients with type 2 diabetes (T2DM). The aim of this study was to evaluate the placebo effects of antidiabetic therapies in Asian and Caucasian T2DM patients and make a comparison between the two ethnicities.

METHODS

A search using the MEDLINE database, EMBASE, and Cochrane Database was performed, from when recording began until December 2016. The main concepts searched in English were sulfonylurea (SU); alpha glucosidase inhibitors (AGI); metformin (MET); thiazolidinediones (TZD); dipeptidyl peptidase-4 inhibitors (DPP-4i); sodium-glucose cotransporter 2 inhibitors (SGLT2i); glucagon-like peptide-1 receptor agonist (GLP-1RA); type 2 diabetes (T2DM); placebo controlled; and randomized controlled trials. Using the Cochrane instrument, we evaluated the adequacy of randomization, allocation concealment procedures, and blinding.

RESULTS

This study included 63 studies with a total of 7096 Asian patients involved and 262 studies with a total of 27,477 Caucasian patients involved. In Caucasian population, the use of placebo led to significant reductions of glycosylated hemoglobin (HbA1c), -0.683% (P = 0.008) in SU monotherapy treatment, -0.193% (P = 0.001) in DPP-4i treatment, and -0.230% (P < 0.001) in SGLT2i treatment, respectively. In Asian population, the use of placebo resulted in significant decreases of HbA1c, -0.162% (P = 0.012) in DPP-4i treatment and -0.269% (P = 0.028) in GLP-1RA add-on therapy, respectively. The placebo also significantly reduced body weight. In Caucasian population, placebo use resulted in 0.833 kg (P = 0.006) weight loss by SU treatment and 0.953 kg (P = 0.006) weight loss by GLP-1RA treatment. In Asian population, the placebo led to a weight change of 0.612 kg (P < 0.001) by GLP-1RA analog treatment. The changes of HbA1c and weight due to the placebo effect in other treatments were not significant in both Asian and Caucasian population. Comparisons of the placebo effect on HbA1c change and weight change in each treatment group indicated that no significant difference was found between Asian and Caucasian population.

CONCLUSIONS

The overall differences of the placebo effect on HbA1c changes as well as on body weight changes were not significant between Asian and Caucasian T2DM patients. The placebo effect on HbA1c changes and weight changes was not associated with baseline age, gender, baseline body mass index, baseline HbA1c, duration of diabetes, or study duration.

摘要

背景

安慰剂被定义为任何具有非特异性心理和生理效应的治疗方法,但对所治疗的疾病没有特定的药理作用。除了药物治疗外,研究还发现,最佳的饮食方法以及体育活动和教育对于控制 2 型糖尿病(T2DM)患者的高血糖是有用的。本研究旨在评估亚洲和高加索 2 型糖尿病患者的抗糖尿病治疗的安慰剂效应,并对两种族裔进行比较。

方法

使用 MEDLINE 数据库、EMBASE 和 Cochrane 数据库进行搜索,从开始记录到 2016 年 12 月。用英文搜索的主要概念是磺酰脲类(SU);α葡萄糖苷酶抑制剂(AGI);二甲双胍(MET);噻唑烷二酮(TZD);二肽基肽酶-4 抑制剂(DPP-4i);钠-葡萄糖共转运蛋白 2 抑制剂(SGLT2i);胰高血糖素样肽-1 受体激动剂(GLP-1RA);2 型糖尿病(T2DM);安慰剂对照;和随机对照试验。我们使用 Cochrane 工具评估了随机分组、分配隐匿程序和盲法的充分性。

结果

本研究共纳入 63 项研究,共计 7096 例亚洲患者,纳入 262 项研究,共计 27477 例高加索患者。在高加索人群中,安慰剂的使用导致糖化血红蛋白(HbA1c)显著降低,SU 单药治疗降低 0.683%(P=0.008),DPP-4i 治疗降低 0.193%(P=0.001),SGLT2i 治疗降低 0.230%(P<0.001)。在亚洲人群中,安慰剂的使用导致 HbA1c 显著降低,DPP-4i 治疗降低 0.162%(P=0.012),GLP-1RA 附加治疗降低 0.269%(P=0.028)。安慰剂也显著降低了体重。在高加索人群中,安慰剂导致 SU 治疗体重减轻 0.833kg(P=0.006),GLP-1RA 治疗体重减轻 0.953kg(P=0.006)。在亚洲人群中,安慰剂导致 GLP-1RA 类似物治疗体重减轻 0.612kg(P<0.001)。安慰剂对其他治疗组的 HbA1c 和体重变化的影响在亚洲和高加索人群中均不显著。比较安慰剂对各组 HbA1c 变化和体重变化的影响,发现亚洲人和高加索人之间没有显著差异。

结论

亚洲和高加索 2 型糖尿病患者的安慰剂对 HbA1c 变化和体重变化的总体影响无显著差异。安慰剂对 HbA1c 变化和体重变化的影响与基线年龄、性别、基线体重指数、基线 HbA1c、糖尿病病程或研究时间无关。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c3cb/6032690/5eeb124b50d9/CMJ-131-1605-g001.jpg

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