Grant Suzanne J, Bensoussan Alan, Chang Dennis, Kiat Hosen, Klupp Nerida L, Liu Jian Ping, Li Xun
University of Western Sydney, Locked Bag 1797, Penrith, South DC, Australia, NWS 1797.
Cochrane Database Syst Rev. 2009 Oct 7(4):CD006690. doi: 10.1002/14651858.CD006690.pub2.
Around 308 million people worldwide are estimated to have impaired glucose tolerance (IGT); 25% to 75% of these will develop diabetes within a decade of initial diagnosis. At diagnosis, half will have tissue-related damage and all have an increased risk for coronary heart disease.
The objective of this review was to assess the effects and safety of Chinese herbal medicines for the treatment of people with impaired glucose tolerance or impaired fasting glucose (IFG).
We searched the following databases: The Cochrane Library, PubMed, EMBASE, AMED, a range of Chinese language databases, SIGLE and databases of ongoing trials.
Randomised clinical trials comparing Chinese herbal medicines with placebo, no treatment, pharmacological or non-pharmacological interventions in people with IGT or IFG were considered.
Two authors independently extracted data. Trials were assessed for risk of bias against key criteria: random sequence generation, allocation concealment, blinding of participants, outcome assessors and intervention providers, incomplete outcome data, selective outcome reporting and other sources of bias.
This review examined 16 trials lasting four weeks to two years involving 1391 participants receiving 15 different Chinese herbal medicines in eight different comparisons. No trial reported on mortality, morbidity or costs. No serious adverse events like severe hypoglycaemia were observed. Meta-analysis of eight trials showed that those receiving Chinese herbal medicines combined with lifestyle modification were more than twice as likely to have their fasting plasma glucose levels return to normal levels (i.e. fasting plasma glucose <7.8 mmol/L and 2hr blood glucose <11.1 mmol/L) compared to lifestyle modification alone (RR 2.07; 95% confidence intervall (CI) 1.52 to 2.82). Those receiving Chinese herbs were less likely to progress to diabetes over the duration of the trial (RR 0.33; 95% CI 0.19 to 0.58). However, all trials had a considerable risk of bias and none of the specific herbal medicines comparison data was available from more than one study. Moreover, results could have been confounded by rates of natural reversion to normal glucose levels.
AUTHORS' CONCLUSIONS: The positive evidence in favour of Chinese herbal medicines for the treatment of IGT or IFG is constrained by the following factors: lack of trials that tested the same herbal medicine, lack of details on co-interventions, unclear methods of randomisation, poor reporting and other risks of bias.
据估计,全球约有3.08亿人患有糖耐量受损(IGT);其中25%至75%的人在初次诊断后的十年内会发展为糖尿病。在诊断时,一半患者会出现与组织相关的损害,且所有人患冠心病的风险都会增加。
本综述的目的是评估中药治疗糖耐量受损或空腹血糖受损(IFG)患者的疗效和安全性。
我们检索了以下数据库:Cochrane图书馆、PubMed、EMBASE、AMED、一系列中文数据库、SIGLE以及正在进行的试验数据库。
纳入比较中药与安慰剂、不治疗、药物或非药物干预对IGT或IFG患者疗效的随机临床试验。
两位作者独立提取数据。根据关键标准评估试验的偏倚风险:随机序列生成、分配隐藏、参与者、结局评估者和干预提供者的盲法、不完整的结局数据、选择性结局报告以及其他偏倚来源。
本综述审查了16项持续四周至两年的试验,涉及1391名参与者,他们在八项不同的比较中接受了15种不同的中药。没有试验报告死亡率、发病率或成本。未观察到严重低血糖等严重不良事件。八项试验的荟萃分析表明,与单纯生活方式改变相比,接受中药联合生活方式改变的患者空腹血糖水平恢复正常(即空腹血糖<7.8 mmol/L且餐后2小时血糖<11.1 mmol/L)的可能性高出两倍多(RR 2.07;95%置信区间(CI)1.52至2.82)。在试验期间,接受中药治疗的患者进展为糖尿病的可能性较小(RR 0.33;95%CI 0.19至0.58)。然而,所有试验都存在相当大的偏倚风险,且没有一种特定中药的比较数据可从一项以上研究中获得。此外,结果可能因血糖水平自然恢复正常的比率而混淆。
支持中药治疗IGT或IFG的阳性证据受到以下因素的限制:缺乏对同一种中药进行测试的试验、缺乏联合干预的详细信息、随机化方法不明确、报告不佳以及其他偏倚风险。