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低和极低碳水化合物饮食对 2 型糖尿病缓解的疗效和安全性:已发表和未发表随机试验数据的系统评价和荟萃分析。

Efficacy and safety of low and very low carbohydrate diets for type 2 diabetes remission: systematic review and meta-analysis of published and unpublished randomized trial data.

机构信息

Department of Nutrition, Texas A&M University, College Station, TX, USA.

Helfgott Research Institute, National University of Natural Medicine, Portland, OR, USA.

出版信息

BMJ. 2021 Jan 13;372:m4743. doi: 10.1136/bmj.m4743.


DOI:10.1136/bmj.m4743
PMID:33441384
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC7804828/
Abstract

OBJECTIVE: To determine the efficacy and safety of low carbohydrate diets (LCDs) and very low carbohydrate diets (VLCDs) for people with type 2 diabetes. DESIGN: Systematic review and meta-analysis. DATA SOURCES: Searches of CENTRAL, Medline, Embase, CINAHL, CAB, and grey literature sources from inception to 25 August 2020. STUDY SELECTION: Randomized clinical trials evaluating LCDs (<130 g/day or <26% of a 2000 kcal/day diet) and VLCDs (<10% calories from carbohydrates) for at least 12 weeks in adults with type 2 diabetes were eligible. DATA EXTRACTION: Primary outcomes were remission of diabetes (HbA <6.5% or fasting glucose <7.0 mmol/L, with or without the use of diabetes medication), weight loss, HbA, fasting glucose, and adverse events. Secondary outcomes included health related quality of life and biochemical laboratory data. All articles and outcomes were independently screened, extracted, and assessed for risk of bias and GRADE certainty of evidence at six and 12 month follow-up. Risk estimates and 95% confidence intervals were calculated using random effects meta-analysis. Outcomes were assessed according to a priori determined minimal important differences to determine clinical importance, and heterogeneity was investigated on the basis of risk of bias and seven a priori subgroups. Any subgroup effects with a statistically significant test of interaction were subjected to a five point credibility checklist. RESULTS: Searches identified 14 759 citations yielding 23 trials (1357 participants), and 40.6% of outcomes were judged to be at low risk of bias. At six months, compared with control diets, LCDs achieved higher rates of diabetes remission (defined as HbA <6.5%) (76/133 (57%) 41/131 (31%); risk difference 0.32, 95% confidence interval 0.17 to 0.47; 8 studies, n=264, I=58%). Conversely, smaller, non-significant effect sizes occurred when a remission definition of HbA <6.5% without medication was used. Subgroup assessments determined as meeting credibility criteria indicated that remission with LCDs markedly decreased in studies that included patients using insulin. At 12 months, data on remission were sparse, ranging from a small effect to a trivial increased risk of diabetes. Large clinically important improvements were seen in weight loss, triglycerides, and insulin sensitivity at six months, which diminished at 12 months. On the basis of subgroup assessments deemed credible, VLCDs were less effective than less restrictive LCDs for weight loss at six months. However, this effect was explained by diet adherence. That is, among highly adherent patients on VLCDs, a clinically important reduction in weight was seen compared with studies with less adherent patients on VLCDs. Participants experienced no significant difference in quality of life at six months but did experience clinically important, but not statistically significant, worsening of quality of life and low density lipoprotein cholesterol at 12 months. Otherwise, no significant or clinically important between group differences were found in terms of adverse events or blood lipids at six and 12 months. CONCLUSIONS: On the basis of moderate to low certainty evidence, patients adhering to an LCD for six months may experience remission of diabetes without adverse consequences. Limitations include continued debate around what constitutes remission of diabetes, as well as the efficacy, safety, and dietary satisfaction of longer term LCDs. SYSTEMATIC REVIEW REGISTRATION: PROSPERO CRD42020161795.

摘要

目的:评估低碳水化合物饮食(LCDs)和极低碳水化合物饮食(VLCDs)对 2 型糖尿病患者的疗效和安全性。 设计:系统评价和荟萃分析。 资料来源:从建库至 2020 年 8 月 25 日,对 CENTRAL、Medline、Embase、CINAHL、CAB 和灰色文献来源进行检索。 研究选择:符合条件的研究为随机临床试验,评估了 LCDs(碳水化合物摄入量<130 g/天或<2000 千卡/天饮食的 26%)和 VLCDs(碳水化合物供能<10%),在 2 型糖尿病成人中至少持续 12 周。 资料提取:主要结局为糖尿病缓解(HbA <6.5%或空腹血糖<7.0 mmol/L,无论是否使用糖尿病药物)、体重减轻、HbA、空腹血糖和不良事件。次要结局包括健康相关生活质量和生化实验室数据。所有文章和结局均由独立的人员进行筛选、提取和评估偏倚风险以及 6 个月和 12 个月随访时的证据等级确定性。使用随机效应荟萃分析计算风险估计值和 95%置信区间。根据预先确定的最小重要差异评估结局,以确定临床重要性,并根据偏倚风险和七个预先确定的亚组进行异质性调查。对具有统计学意义的交互检验的任何亚组效应进行五点可信度检查表评估。 结果:检索到 14759 条参考文献,产生 23 项试验(1357 名参与者),其中 40.6%的结局被认为偏倚风险较低。在 6 个月时,与对照饮食相比,LCD 治疗组糖尿病缓解率更高(定义为 HbA <6.5%)(76/133(57%)比 41/131(31%);风险差异 0.32,95%置信区间 0.17 至 0.47;8 项研究,n=264,I=58%)。相反,当使用不使用药物的 HbA <6.5%作为缓解定义时,出现了较小的、无统计学意义的效应大小。亚组评估确定符合可信度标准的结果表明,在纳入使用胰岛素的患者的研究中,LCD 治疗组的缓解明显减少。在 12 个月时,关于缓解的数据很少,范围从较小的效应到糖尿病风险轻微增加。在 6 个月时,体重减轻、甘油三酯和胰岛素敏感性方面出现了较大的临床重要改善,但在 12 个月时这些改善会减弱。根据被认为可信的亚组评估,VLCD 治疗组的体重减轻效果不如限制较少的 LCD 治疗组。然而,这一效果是由于饮食依从性的原因。也就是说,在对 VLCD 治疗高度依从的患者中,与对 VLCD 治疗依从性较低的患者相比,体重明显减轻。参与者在 6 个月时的生活质量没有显著差异,但在 12 个月时生活质量和低密度脂蛋白胆固醇出现了临床重要但无统计学意义的恶化。否则,在 6 个月和 12 个月时,在不良事件或血脂方面未发现组间有显著或临床重要的差异。 结论:基于中等到低确定性证据,坚持 LCD 治疗 6 个月的患者可能会经历糖尿病缓解,而不会产生不良后果。局限性包括围绕糖尿病缓解的定义、长期 LCD 的疗效、安全性和饮食满意度的持续争议。 系统评价注册:PROSPERO CRD42020161795。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/76f7/7804828/b58bdc5f2dae/golj060117.f4.jpg
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https://cdn.ncbi.nlm.nih.gov/pmc/blobs/76f7/7804828/29a852cfce87/golj060117.f1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/76f7/7804828/12542d429fa6/golj060117.f2.jpg
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