May Brian H, Feng Mei, Hyde Anna J, Hügel Helmut, Chang Su-Yueh, Dong Lin, Guo Xinfeng, Zhang Anthony L, Lu Chuanjian, Xue Charlie C
The China-Australia International Research Centre for Chinese Medicine, School of Health and Biomedical Sciences, RMIT University, Bundoora, VIC, Australia.
Guangdong Provincial Academy of Chinese Medical Sciences and Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, China.
Int J Geriatr Psychiatry. 2018 Mar;33(3):449-458. doi: 10.1002/gps.4830. Epub 2017 Dec 14.
To evaluate the clinical evidence for traditional medicines (TMs) used in East Asia on measures of cognition in Alzheimer disease, determine the effect sizes at different time points for the TMs and pharmacotherapies, and assess the tolerability of the TMs.
We searched 12 databases in English, Chinese, and Japanese for eligible randomised controlled trials that compared orally administered TMs with pharmacotherapy and reported cognitive outcomes. Meta-analyses were conducted for Alzheimer's Disease Assessment Scale-cognitive subscale and/or Mini-Mental State Examination (MMSE). Mean differences and 95% confidence intervals were calculated to evaluate treatment effects.
Thirty randomised controlled trials met inclusion criteria. Twenty-nine compared TMs with donepezil. Single studies provided comparisons with galantamine, rivastigmine, or memantine. There were no significant differences between the TM and donepezil groups at 12 or 24 weeks for Alzheimer's Disease Assessment Scale-cognitive subscale or MMSE. Improvements over baseline were significant for MMSE at 12 and 24 weeks within the TM and donepezil groups and remained significant at 1 year. Effect sizes were reduced in the 3 double-blind studies. At 24 weeks, donepezil 10 mg/d generally produced greater improvements in MMSE than 5 mg/d. Tolerability reporting was incomplete and inconsistent between studies.
The results suggested that the clinical benefits of the TMs were not less than donepezil at comparable time points, with both groups showing improvements. However, lack of blinding in most studies and other design and measurement issues are likely to have resulted in overestimation of effect sizes in both groups. Further well-designed studies are needed.
评估东亚地区用于阿尔茨海默病认知指标的传统药物(TMs)的临床证据,确定TMs和药物疗法在不同时间点的效应大小,并评估TMs的耐受性。
我们检索了12个英文、中文和日文数据库,以寻找比较口服TMs与药物疗法并报告认知结果的合格随机对照试验。对阿尔茨海默病评估量表认知子量表和/或简易精神状态检查表(MMSE)进行荟萃分析。计算平均差异和95%置信区间以评估治疗效果。
30项随机对照试验符合纳入标准。其中29项将TMs与多奈哌齐进行了比较。单项研究提供了与加兰他敏、卡巴拉汀或美金刚的比较数据。在12周或24周时,TMs组和多奈哌齐组在阿尔茨海默病评估量表认知子量表或MMSE方面无显著差异。TMs组和多奈哌齐组在12周和24周时MMSE较基线均有显著改善,且在1年时仍保持显著。在3项双盲研究中效应大小有所降低。在24周时,多奈哌齐10mg/d通常比5mg/d在MMSE上产生更大的改善。各研究之间耐受性报告不完整且不一致。
结果表明,在可比时间点TMs的临床益处不低于多奈哌齐组,两组均有改善。然而,大多数研究缺乏盲法以及其他设计和测量问题可能导致两组效应大小均被高估。需要进一步进行设计良好的研究。