[ADA2015]中國薈萃分析：2型糖尿病降糖藥物的安慰劑效應®醫學論壇網-網聚醫學的力量

[ADA2015]中國薈萃分析：2型糖尿病降糖藥物的安慰劑效應

作者：醫脈通來源：醫脈通日期：2015-06-12

導讀

總體上，綜合所有研究，安慰劑治療能使HbA1c相比基線降低0.03%，但無顯著統計學意義（(95% CI, -0.17% to 0.11%, p>0.05）。結論：該薈萃分析為2型糖尿病降糖治療中的安慰劑效應提供了全麵臨床證據。

關鍵字： Placebo | 降糖藥物 | 安慰劑效應 | 噻唑烷二酮類 | 磺脲類藥物

　　2015年第75屆美國糖尿病協會（ADA）科學年會在美國波士頓召開。北京大學人民醫院內分泌代謝科紀立農教授團隊的的一項薈萃分析結果在ADA2015年會普通壁報專場（General Poster Session）上發布。該研究通過對248項研究的薈萃分析，評估2型糖尿病降糖治療中的安慰劑效應。以下是研究摘要譯文。

　　目的：安慰劑是指對於疾病沒有確切的藥物治療作用、但可能產生非特異性心理或生理積極作用的治療手段。本研究旨在評估2型糖尿病降糖治療中安慰劑的影響。

　　方法：入選MEDLINE、EMBASE及CENTRAL數據庫2013年12月之前的研究。所有研究都是雙盲、有安慰對照、在2型糖尿病患者中開展的研究，研究持續時間≥12周、且采用與基線相比HbA1c的變化來評估降糖療效。最終有248項研究入選。

　　結果：在對比磺脲類藥物與安慰劑的研究中，安慰劑治療使HbA1c降低0.03%（95% CI, 0.37% to 0.44%, p>0.05）；在對比二甲雙胍與安慰劑的研究中，安慰劑治療使HbA1c降低0.19%（95% CI, 0.18% to 0.57%, p>0.05）；在對比糖苷酶抑製劑與安慰劑的研究中，安慰劑治療使HbA1c降低0.06%（95% CI, 0.12% to 0.23%, p>0.05）；在對比噻唑烷二酮類藥物與安慰劑的研究中，安慰劑治療使HbA1c降低0.09%（95% CI, -0.06% to 0.23%, p>0.05）；在對比DPP-4抑製劑與安慰劑的研究中，安慰劑治療使HbA1c降低0.09%（95% CI, -0.20% to 0.03%, p>0.05）；在對比SGLT-2抑製劑與安慰劑的研究中，安慰劑治療使HbA1c降低0.26%（95% CI, -0.54% to 0.02%, p>0.05）；在對比GLP-1類似物與安慰劑的研究中，安慰劑治療使HbA1c降低0.11%（95% CI, -0.30% to 0.08%, p>0.05）。總體上，綜合所有研究，安慰劑治療能使HbA1c相比基線降低0.03%，但無顯著統計學意義（(95% CI, -0.17% to 0.11%, p>0.05）。薈萃回歸分析顯示，患者年齡及女性所占比例與安慰劑組HbA1c相對於基線時的變化幅度呈負相關。

　　結論：該薈萃分析為2型糖尿病降糖治療中的安慰劑效應提供了全麵臨床證據。安慰劑治療可使HbA1c降低0.03%，但無顯著統計學意義。

　　【研究摘要】　　

Abstract Number:	1137-P
Title:	Placebo Effect of Hypoglycemic Drugs in Type 2 Diabetes—A Meta-analysis
Authors:	XIAOLING CAI, WENJIA YANG, LINGLI ZHOU, XUEYAO HAN, LINONG JI, Beijing, China
Abstract:	Placebo has been 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. The aim of this study is to evaluate placebo effect of hypoglycemic treatment in type 2 diabetes. The MEDLINE , EMBASE , CENTRAL were searched until Dec 2013 and qualified studies were included. All the studies were double blind, placebo-controlled randomized trials in type 2 diabetes patients; study length of ≥12 weeks with the efficacy evaluated by changes in HbA1c from baseline in groups. 248 studies were included. In studies compared SU with placebo, treatment with placebo led to a HbA1c change of 0.03% (95% CI, 0.37% to 0.44%, p>0.05); in studies compared MET with placebo, treatment with placebo led to a HbA1c change of 0.19% (95% CI, 0.18% to 0.57%, p>0.05); in studies compared AGI with placebo, treatment with placebo led to a HbA1c change of 0.06% (95% CI, 0.12% to 0.23%, p>0.05); in studies compared TZD with placebo, treatment with placebo led to a HbA1c change of 0.09% (95% CI, -0.06% to 0.23%, p>0.05); in studies compared DPP-IV inhibitors with placebo, treatment with placebo led to a HbA1c change of -0.09% (95% CI, -0.20% to 0.03%, p>0.05); in studies compared SGLT2 with placebo, treatment with placebo led to a HbA1c change of -0.26% (95% CI, -0.54% to 0.02%, p>0.05); in studies compared GLP-1 analogue with placebo, treatment with placebo led to a HbA1c change of -0.11% (95% CI, -0.30% to 0.08%, p>0.05). Totally, in all studies, treatments with placebo led an HbA1c change from baseline of -0.03% without significance (95% CI, -0.17% to 0.11%, p>0.05). Meta-regression analyses revealed that the age of patients and percentage of female were negatively associated with HbA1c changes from baseline in placebo group. This meta-analysis provided comprehensive clinical evidence on placebo effect of hypoglycemic treatment in type 2 diabetes. Treatment with placebo led an HbA1c change from baseline of -0.03% without significance.