Evidence map›Paper›PMID 25925312›Full record

Trial reportTrials2015

The efficacy and safety of the Chinese herbal medicine Di-Tan decoction for treating Alzheimer's disease: protocol for a randomized controlled trial.

Ka-Kit Chua, Adrian Wong, Pauline Wing-Lam Kwan, Ju-Xian Song, Lei-Lei Chen, Andrew Lung-Tat Chan, Jia-Hong Lu, Vincent Mok, Min Li

Open access · goldAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Trials, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed
0.4field-weighted citation impact, top 35% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

7 citing papers in PubMed, 16 citations in OpenAlex.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors at 4 institutions in 4 countries.

Ka-Kit ChuaSchool of Chinese Medicine, Hong Kong Baptist University, Kowloon Tong, Kowloon, Hong Kong. 11467142@life.hkbu.edu.hk.
Adrian WongStroke and Clinical Neurosciences, Institute of Integrative Medicine, Department of Medicine and Therapeutics, Prince of Wales Hospital, The Chinese University of Hong Kong, Shatin, New Territories, Hong Kong. adrianwong@cuhk.edu.hk.
Pauline Wing-Lam KwanStroke and Clinical Neurosciences, Institute of Integrative Medicine, Department of Medicine and Therapeutics, Prince of Wales Hospital, The Chinese University of Hong Kong, Shatin, New Territories, Hong Kong. paulinekwan@cuhk.edu.hk.
Ju-Xian SongSchool of Chinese Medicine, Hong Kong Baptist University, Kowloon Tong, Kowloon, Hong Kong. juxian.song@gmail.com.
Lei-Lei ChenSchool of Chinese Medicine, Hong Kong Baptist University, Kowloon Tong, Kowloon, Hong Kong. leilei.chen2011@gmail.com.
Andrew Lung-Tat ChanDivisions of Neurology & Geriatrics, Department of Medicine, Queen Elizabeth Hospital, Kowloon, Hong Kong. betterdementiacare@gmail.com.
Jia-Hong LuState Key Laboratory of Quality Research in Chinese Medicine, Institute of Chinese Medical Sciences, University of Macau, Taipa, Macau. JiahongLu@umac.mo.
Vincent MokStroke and Clinical Neurosciences, Institute of Integrative Medicine, Department of Medicine and Therapeutics, Prince of Wales Hospital, The Chinese University of Hong Kong, Shatin, New Territories, Hong Kong. vctmok@cuhk.edu.hk.
Min LiSchool of Chinese Medicine, Hong Kong Baptist University, Kowloon Tong, Kowloon, Hong Kong. limin@hkbu.edu.hk.
Hong Kong Baptist University · HKChinese University of Hong Kong · CNQueen Elizabeth Hospital · CNUniversity of Macau · MO

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundAlzheimer's disease (AD) is the most common type of dementia in the elderly. It is estimated that the global prevalence of dementia will rise from 24.3 million in 2005 to 81.1 million in 2040. AD has a devastating impact on sufferers, caregivers, their communities and the healthcare system in general. "Di-tan decoction" (DTD) is a traditional Chinese medicine (TCM) formula frequently used to treat symptoms that are now defined as AD in clinical treatment. However, the existing evidence for recommending DTD in clinical practice derives from studies that were methodologically flawed. In this study, we aim to determine the efficacy and safety of DTD in AD patients based on a rigidly randomized controlled trial. It will provide critical information on sample size and treatment regimen for conducting a full-scale clinical trial of DTD later. METHODS/

designThis study will be a double-blind, randomized, placebo-controlled, add-on trial. After a 2-week run-in period, eligible patients with mild to moderate AD will be recruited and given either DTD or placebo twice daily for 24 weeks with follow-up 6 weeks after the last treatment. An increase of four points or greater on the scores of Alzheimer's Disease Assessment Scale-cognitive subscale (ADAD-cog) will be considered as a positive primary outcome. Total scores of the ADAD-cog, the Chinese version of Mini-Mental State Examination (C-MMSE), and the Chinese version of the Disability Assessment for Dementia (C-DAD) score will be used as secondary outcomes. Adverse events will also be reported. DISCUSSION: This randomized trial will be the first rigorous empirical study on the efficacy of DTD for treating cognitive symptoms in AD patients. Its success will justify and warrant a large-scale clinical trial to further consolidate the evidence for DTD's efficacy in treating AD.

trial registrationChinese Clinical Trial Registry ( ChiCTR-TRC-12004548 , Date of registration: 22 November 2012).

Indexed as

Alzheimer DiseaseClinical ProtocolsCognitionDisability EvaluationDouble-Blind MethodDrugs, Chinese HerbalHong KongHumansPsychiatric Status Rating ScalesResearch DesignSeverity of Illness IndexTime FactorsTreatment Outcomedi-tan decoctionDrugs, Chinese Herbal

Identifiers

PMID25925312
PMCPMC4426181
OpenAlexW2058090474

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.