Research Article
A Randomized Controlled Pilot Trial of Chinese Medicine (Di-Tan Decoction) in the Treatment of Alzheimer's Disease
Ka-Kit Chua1,2, Adrian Wong3,4, Pauline Wing-Lam Kwan3,4, Ju-Xian Song1, Lei-Lei Chen1, Andrew Lung-Tat Chan5, Zhao-Xiang Bian1,2, Vincent Mok3,4* and Min Li 1,2*1Chi-Ming Centre for Parkinson’s Disease Research, School of Chinese Medicine, Hong Kong Baptist University, Hong Kong
2Hong Kong Chinese Medicine Clinical Study Centre, Hong Kong Baptist University, Hong Kong
3Institute of Integrative Medicine, Department of Medicine and Therapeutics, the Chinese University of Hong Kong, Hong Kong
4Therese Pei Fong Chow Research Centre for Prevention of Dementia, the Chinese University of Hong Kong, Hong Kong
5Divisions of Neurology and Geriatrics, Department of Medicine, Queen Elizabeth Hospital, Hong Kong
- *Corresponding Author:
- Min Li, Director
Teaching and Research Division
Director of Mr. & Mrs. Ko Chi-Ming Centre for Parkinson’s Disease Research
Associate Director of Clinical Division, School of Chinese Medicine
Hong Kong Baptist University, Kowloon Tong, Kowloon, Hong Kong
Tel: +852-3411 2919
E-mail: limin@hkbu.edu.hk - Vincent Mok
Director, Therese Pei Fong Chow Research Centre for Prevention of Dementia
Director of Master Programme in Stroke and Clinical Neurosciences
Department of Medicine and Therapeutics, Prince of Wales Hospital
The Chinese University of Hong Kong, Shatin, New Territories, Hong Kong
Tel: + 852-2632 2195
E-mail: vctmok@cuhk.edu.hk
Received date: August 08, 2016; Accepted date: August 11, 2016; Published date: August 18, 2016
Citation: Chua K, Wong A, Kwan PW, Song J, Chen L, et al. (2016) A Randomized Controlled Pilot Trial of Chinese Medicine (Di-Tan Decoction) in the Treatment of Alzheimer’s Disease. J Alzheimers Dis Parkinsonism 6:256. doi:10.4172/2161-0460.1000256
Copyright: © 2016 Chua K, et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
Abstract
Objective: This double-blind, randomized, placebo-controlled, add-on pilot study aimed at providing information for conducting a full-scale trial assessing “Di-tan decoction” (DTD), which is a traditional Chinese medicine (TCM) formula frequently used in TCM to treat symptoms that are now defined as Alzheimer’s disease (AD), in treating AD in the future. Methods: We randomly assigned 38 patients with AD to receive either DTD or placebo for 24 weeks. Primary outcome was changes in the total score of AD Assessment Scale-cognitive subscale (ADAS-cog) and secondary outcome was changes in the total score of Chinese version of the Disability Assessment for Dementia (C-DAD). Results: Although we observed some improvement in the total scores of ADAS-cog in the DTD group comparing to the placebo group, the changes were not statistically significant. The ADAS-cog sub-scores of the DTD group also showed non-significant trends of improvement in ideational praxis (p=0.100) and in comprehension (p=0.106) comparing to placebo group. Adverse events were mild and comparable between two groups. Conclusion: This is the first rigorous randomized control trial of DTD focusing on AD. At least five factors could explain the failure of the trends to be significant, namely length of trial, size of trial, stage of AD, palatability of the drug, and sensitivity of the scoring system. Given the limitation but with the safety and century’s use of DTD, a modified pilot study is needed to support the clinical effects of DTD. In conclusion, there is no evidence supporting the efficacy of DTD to act as a single treatment for AD.