Volume 7, Number 3 | Fall 2012

EditorialClinical Trials and Kampo
Clinical trials have become extremely difficult to perform in recent years, even in Western medicine.
Strong emphasis is placed on protecting privacy, ensuring proper storage of clinical data and maintaining
authenticity without risk of manipulation. Furthermore, it goes without saying that heavy weight isplaced on managing sensitive personal information such as genetic information, depending on the datathat is handled. In evidence-based medicine (EBM), randomized control trials (RCT) with a high level ofevidence are valued, because researchers’ bias is not reflected, and subjective evidence can be acquired.
In Europe and USA, RCT is thus actively performed. However, in these clinical trials it is necessary tonote in particular that the criteria of choosing subject patients will necessarily form a group of subjects
who are readily able to participate, and that the trial would be performed under a limited patient. In otherwords, the problem lies in the fact that cases included in such trials represent only a portion of all patients.
Nonetheless, our Kampo specialists wish to answer to doubts by Western doctors of whether Kampo
really works (we, personally, do not need such data, because we have no doubt that Kampo is effective).
The problem, however, is that Kampo diagnosis is characteristically based on proof and evidence (sho),and emphasizes individualization. RCT and similar trials are intrinsically unsuited for evaluating Kampo
drugs. To preserve sho used for Kampo medicine is difficult to perform clinical trials of Western medicineby Kampo medicine method. One of a clinical study design is to classify the diseases in Western medicine.
When performing an RCT under this method, the effects of Kampo drugs are likely to be underestimated,
but if RCT could prove effects of them, it would be considered valid to administer Kampo drugs by
disease name (that means these diseases exhibit homogenous conditions (sho)). On the other hand, studies
have also been performed by combining the selection of a disease name and the sho concept in Kampo
medicine. For example, there are ways to choose patients by physical data, health conditions and thepatient’s complaints. There are some previous reports proved the efficacy of Kampo drugs by thesemethod.
Now, the question is why Japanese Kampo is able to perform clinical trials at a high level of quality.
The greatest reason lies in the consistent and stable extract products made by Japanese pharmaceuticalcompanies. This means that Kampo clinical studies particularly for short-term trials of a few cases could
be performed by using Kampo extracts preparations decocted with the same rod and contained same
ingredients Additionally, unlike decoctions, extract preparations could be considered drugs that canmaintain their quality for a long period (years) if they are stored appropriately. When examining
decoctions in a study, it is necessary to unify the quality and amount of herbs, and using the addition andsubtraction method would render the study unsuitable for RCT. Severe paying attention also is needed at
the method of decoction. In a certain study, it was found that the same decoction prepared at home by apatient had largely varying ingredients on different occasions. While there are apt to be differences in thequality of herbs, even taking this into consideration, it can be said that each patient takes a different
decoction every day. Decoction studies thus require extremely careful attention.

The Journal of Kampo, Acupuncture and Integrative Medicine (KAIM)

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Volume 7, Number 3 | Fall 2012

To perform clinical studies of Kampo drugs at a high level of quality, we adopt principles that lean
toward Western medicine. However, while this has proven that Kampo drugs as a whole havepharmaceutical effects, the largest issue lies in how to apply the interpretation of EBM results to thetreatment of individual patients at hand. I offer that concurrently adopting the Kampo concept of sho is apossible solution to such individualization, and intend to study examination methods and administrationof medicine toward making sho reproducible.

Takao Namiki
Department of Japanese-Oriental Kampo Medicine
Graduate School of Medicine and School of Medicine
Chiba University

2The Journal of Kampo, Acupuncture and Integrative Medicine (KAIM)