Establishment and popularization of a Kampo mibyo control system using ICT

The broad aim of this research is to achieve a society in which mibyo, a concept derived from Kampo medicine, can be controlled by a Kampo medicinal approach. The establishment and broad implementation of a mibyo control system in which mibyo is detected via Kampo docks (comprehensive health examinations) and Kampo health application will require the standardization of Kampo clinical practice as a Kampo platform.

Issues to Resolve

The development of a Kampo mibyo control system will require the explicit articulation of the Kampo diagnostic process, which has been dependent on implicit knowledge. This requires organizing the knowledge of highly experienced Kampo practitioners and gathering clinical data to formalize the logic of Kampo diagnosis on the basis of scientific evidence.

Research Overview

In the Kampo Practice Standardization Project, we have established research collaboration agreements with departments of Kampo Medicine at University of Toyama , Jichi Medical University, Fukushima Medical University, Tokai University, and Chiba University, Japan's key institutions for Kampo practice, research, and teaching. This project is focused on the following two goals.

1.Formalization of Kampo diagnostic logic

By integrating clinical data into the knowledge possessed by highly experienced Kampo practitioners in the form of traditional medical wisdom and applying methods used in machine learning, a branch of artificial intelligence, in addition to conventional statistical techniques, we constructed a Kampo diagnostic logic for determining the appropriate combination of Kampo medical findings and Kampo formulations. The clinical data were gathered in a joint multicenter clinical study of patients visiting a Kampo outpatient clinic for the first time, and comprised Kampo medical findings (monshin, zesshin, myakushin, and fukushin) on initial examination, Kampo formulations prescribed, and their efficacy and safety.

In this process, we made the following agreements for the research process during the planning stage.

(1) Selection of 33 formulations for standardization

Formalizing the diagnostic logic for every Kampo formulation would require a massive volume of data. In practice, this is infeasible; accordingly, we selected a number of Kampo formulations for use in the study.

In a preliminary study carried out at Kitasato University, approximately 80% of first-time patients were treated with around 30 Kampo formulations. We selected the following 33 Kampo formulations for standardization with the objective of constructing a diagnostic logic for Kampo formulations covering 80% of patients from the following aspects.

[Selection Rationale]

(2) Selection of subjective/objective signs and findings

An investigation of the types of subjective signs (monshin findings) and objective findings (zesshin, myakushin, and fukushin findings) and how they are graded at each institution revealed differences among hospitals and clinics. We therefore selected the subjective and objective signs required to distinguish between the 33 Kampo formulations from a Kampo medical perspective, based on those used at Kitasato University.

(3) Finalization of criteria for assessing findings

After selecting the objective findings (zesshin, myakushin, and fukushin) for data collection, we discovered that the assessment criteria for determining these findings varied between institutions. We therefore discussed the assessment criteria for all the zesshin, myakushin, and fukushin findings on the basis of those used in Kitasato University, and documented those to be used when determining findings.

(4) Formulation identification rules

The types of Kampo formulations available include decoctions, pills, and extracts, and different types are prescribed for individual patients and by different hospitals and clinics. Even Kampo formulations with the same name and of the same type may have different crude drug contents, and decoctions in particular may be prescribed with the addition or subtraction of specific crude drugs. For this reason, we prepared a comparison table showing the amounts of each constituent crude drug in the 33 formulations used for standardization prescribed in each of the hospitals or clinics that participated in this project. Based on this comparison table and the ingredients and content ranges given in the New Guide to OTC Kampo Formulations, we specify the crude drug contents and allowable additions and omissions for each formulation in this study to be regarded as the same Kampo formulation.

2.Standardization of Kampo Examination Techniques

Kampo practitioners make full use of their senses of vision, hearing, smell, and touch to determine Kampo medical findings and reach a diagnosis. The objective Kampo medical findings obtained by zesshin, myakushin, and fukushin are factors in the Kampo diagnosis along with monshin signs. Although in this project we documented the assessment criteria for objective findings (see section 1.(3)), the determination of these findings depends in large part on factors involving the five senses (subjectivity) and experience, and the reality is that they vary both between individuals and between hospitals and clinics.

For this reason, in this project we held joint multicenter clinical practice workshops in an attempt to control the procedures and assessments by the Kampo practitioners (mainly Kampo specialists) when they obtain the findings, with the aim of standardizing Kampo examination techniques. These clinical examination workshops are a form of on-site validation in which doctors actually examine the same model patient, determine their findings based on the documented assessment criteria, and verify the results of their examinations. We also raised issues concerning the standardization of Kampo examination techniques and discussions, with a goal of reaching resolutions in conferences and symposia.

As a tool for teaching and training, we also produced a fukushin simulator exhibiting typical fukushin findings that can be palpated by anyone at any time under the same conditions, rather than being limited to the order of examinations for findings.

We are currently engaged in formalizing Kampo diagnostic logic as explicit knowledge and have, to some extent, established a Kampo mibyo control system. We will continue to gather clinical data and are currently engaged in research to improve the accuracy of Kampo diagnostic logic.

Conclusions

Our aim in this study is to achieve a society in which Kampo docks and Kampo health application are widely practiced and everyone understands the importance of preventing disease, rather than going to the doctor after becoming sick. Kampo medicine, which is rooted in coexistence with the natural world, is intimately related to diet, and the outcome of the skillful incorporation of its wisdom into everyday life should include improving people's physical condition.
We will continue to offer regular Kampo dock experiences and hold regular Kampo seminars for both professionals and the general public to raise awareness of the Kampo medical concept of mibyo. We will also continue collaborating with ICT companies, the health industry, and Healthy Cities in further efforts to commercialize a consistent Kampo mibyo control system that extends to the evaluation and treatment of mibyo.