Evidence map›Paper›PMID 32957414›Full record

ArticleMedicine2020

The efficacy and safety of hachimijiogan for mild Alzheimer disease in an exploratory, open standard treatment controlled, randomized allocation, multicenter trial: A study protocol.

Mosaburo Kainuma, Kouta Funakoshi, Shinji Ouma, Ken-Ichiro Yamashita, Tomoyuki Ohara, Aoi Yoshiiwa, Masayuki Murata, Yoshio Tsuboi

Open access · goldAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in Medicine, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
0.3field-weighted citation impact, top 40% 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

3 citing papers in PubMed, 3 citations in OpenAlex.

  1. Article
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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

8 authors at 4 institutions in 1 country.

Mosaburo KainumaCommunity Medicine Education Unit, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan.ORCID 0000-0001-9929-574
Kouta FunakoshiDepartment of Clinical Research Promotion, Kyushu University Hospital, Fukuoka, Japan.
Shinji OumaDepartment of Neurology, School of Medicine, Fukuoka University, Fukuoka, Japan.
Ken-Ichiro YamashitaDepartment of Clinical Neurophysiology, Faculty of Medicine, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan.
Tomoyuki OharaDepartment of Neuropsychiatry, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan.
Aoi YoshiiwaDepartment of General Medicine, Oita University, Faculty of Medicine, Oita, Japan.
Masayuki MurataDepartment of General Internal Medicine, Kyushu University Hospital, Japan.
Yoshio TsuboiDepartment of Neurology, School of Medicine, Fukuoka University, Fukuoka, Japan.
Kyushu University · JPFukuoka University · JPKyushu University Hospital · JPOita University · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundDementia among the Japanese aged 65 years or over population is estimated to approach about 700 million cases by 2025, and a corresponding rapid increase in Alzheimer disease (AD) can also be expected. The ballooning number of dementia patients, including AD, is creating major medical and social challenges. At present, only 3 drugs are recognized for the treatment of mild AD, and these are only used to alleviate symptoms. Although new therapies are needed to treat mild AD, insufficient development of disease-modifying drugs is being done. METHODS/

designThe aim of this exploratory, open standard, treatment-controlled, randomized allocation, multicenter trial is to determine the efficacy of the traditional Japanese Kampo medicine hachimijiogan (HJG) on the cognitive dysfunction of mild AD.Eighty-six patients with AD diagnosed according to the Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 and as mild AD according to the Mini Mental State Examination (MMSE ≥21) will be included. All will already have been taking the same dose of Donepezil, Galantamine, or Rivastigmine for more than 3 months. The patients will be randomly assigned to receive additional treatment with HJG or to continue mild AD treatment without additional HJG. The primary endpoint is the change from baseline of the Alzheimer's Disease Assessment Scale-cognitive component- Japanese version (ADAS-Jcog). ADAS-Jcog is a useful index for detecting change over time that investigates memory and visuospatial cognition injury from the early stage. The secondary endpoints are the changes from baseline of the Instrumental Activity of Daily Life, Apathy scale, and Nueropsychiatric Inventory scores. In this protocol, we will examine the Geriatric depression scale and do Metabolome analysis as exploratory endpoints. The recruitment period will be from August 2019 to July 2021. DISCUSSION: This is the first trial of Kampo medicine designed to examine the efficacy of HJG for the cognitive dysfunction of patients with mild AD.

trial registrationThis trial was registered on the Japan Registry of Clinical trials on 2 August 2, 2019 (jRCTs 071190018).

Indexed as

AgedAlzheimer DiseaseCognitionDrugs, Chinese HerbalFemaleHumansMaleMedicine, KampoMulticenter Studies as TopicRandomized Controlled Trials as TopicDrugs, Chinese Herbalhachimijiogan

Identifiers

PMID32957414
PMCPMC7505293
OpenAlexW3087514534

What OpenQuestion holds

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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.