Volume 2, Number 4 | Winter 2007

Kampo Medicine - Current Research
Can Kampo Formulations become First-Line Drugs forRheumatoid Arthritis?

contains a description of RA. Practitioners today useprescriptions from this classical textbook to someeffect. After the concept of the disease was clarified

Hiromichi Yasui

in recent years, RA has been treated with Kampo

Japan Institute of TCM Research

medicine under stricter diagnostic guidelines. Mostof the treatments, however, are performed on theIntroduction

basis of short-term follow-ups and there are very

There are 600,000 to 700,000 patients withfew long-term records of the treatments available.

rheumatoid arthritis (RA) in Japan (0.4–0.5% of theThis is because a follow-up system for the long-term

population, 1% of people aged over 30) with threeprognosis of the disease was not established, such as

times as many women as men afflicted by RA. Onset

whether joint destruction can be prevented or not.

is most frequent between the ages of 30 and 50. The

Koji EBE focused attention on the time within

initial symptoms of the disease are symmetrical

three to four years after onset when it becomes clear

manifestation of pain in finger and toe joints andwhether the disease goes into remission, rapidly

swelling of the joints (in some patients theseworsens, or gradually degenerates. He hypothesised

symptoms start from the knee joints or other joints).

that intervention with Kampo formulations at a

Subsequently,achieve

very early stage would increase cases of earlyremission within one to two years. On the otherremission and observed the course of treatment inhand, about 5 to 10% of patients exhibit rapid joint

10 cases of primary RA onset. He then provided

degeneration as well as a strong inflammatory

further insights into the results.

about20%ofpatients

condition in a short period of time. The other 70% ofpatients experience alternate improvement andexacerbation in symptoms, progressing to gradualjoint degeneration.
Pharmacological therapy by Western medicine
aims to inhibit inflammation or joint destruction
and non-steroid anti-inflammatory drugs (NSAIDs)
or steroid drugs are used to manage joint swellingand pain caused by inflammation. In recent years,
disease-modifying anti-rheumatic drugs (DMARDS)
have come to be used early in the course of thedisease, and if these are ineffective, TNF blockers

Subjects and prescriptions
The subjects are ten individuals that satisfied the“Rheumatoid Arthritis Criteria” (Table 1) of theAmerican College of Rheumatology (ACR) with aduration of one year or less from the start ofsymptoms. For all subjects, formulae were designed
according to “sho” and decoctions were administered(Table 2).
Table 1: Rheumatoid Arthritis Criteria (AmericanCollege of Rheumatology: ACR)
1

Morning stiffness lasts for an hour or more

2

Swelling of three or more joint areas

3

Swelling of the hand joints (wrist joints,metacarpophalangeal [MCP] joints, proximal
interphalangeal [PIP] joints)

will introduce research that indicates Kampo

4

Symmetrical joint swelling

formulations used in the early stages could inhibit

5

Abnormal hand radiographs

disease progression.

6

Subcutaneous nodules

7

Blood test shows positive for rheumatism
RA is diagnosed if 4 items out of the 7 above aresatisfied (however, items 1 to 4 must last for 6
weeks or more).

are combined with DMARDS.
Is Kampo medicine able to open a new chapter inthe treatment of RA? Although treatment of RA
with Kampo formulations is common in Japan, I

Ebe’s trial
Kampo medicine has long been engaged in RA
treatment. “Jinkui Yaolue,” written in ancient times,

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

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Volume 2, Number 4 | Winter 2007

Table 2
Date ofDisease

First

Duration

Consultati

Sex・Age23

Feb. 9,1991

Jul. 9,1985

Apr. 30,
1999

Stage

Male 81

Male 70

Female 51

1.5 months

5 months

6 months

Chinese Medicine)

Treatment

Prescriptions

DiagnosisConsultation

on1

before FirstTCM (Traditional1

11

Dampness-heat
impediment

Dampness-heat
impedimentWind-damp impediment

Clear heat to transform
into dampness

CombinedDrugsenpito with adjustment

Analgesic

senpito with adjustment

Analgesic

Clear heat to transform
into dampness. Then,reinforce kidney
Dissipate cold to

Kedishikajutsubuto with additiontransform intoof Ephedrae Herba, Asiasari

dampness

Radix and Coicis Semen

Analgesic

Stephaniae Tetrandrae Radix
Coicis Semen, Atractylodis
4May 22,
1955

Male 50

3 months

1Damp impedimentTransformed dampnessLanceae Rhizoma, Atractylodes

to modify statis

Rhizoma, Phaseoli Semen,

Analgesic

Paeoniae Radix Rubra,
Clematidis Radix and others

56Mar. 27,
1995

Mar. 11,1987

Dissipate cold toFemale 58

11 months2Wind-damp impedimenttransform into
dampness
Dissipate cold toFemale 43

3 months1

Damp-wind impediemnt

transform into
dampnesskeishikajutsubuto withadjustmentkeishikaryoujutsubuto withadjustment

None

None

Dissipate cold to7Jan. 12,
1990

Male 70

3 months

1

Wind-damp impedimenttransform intokeishikajutsubuto with

dampness. Convertadjustment. Later senpito with

damp heat-impedimentadjustment

Analgesic

in mid-course
Stephania tetrandra Radix,

8

Apr. 17,
1992

Female 58

12 months

2Damp-wind impedimentTransformed dampness
to dissipate cold

Armeniacae Semen, Coicis
Semen、Clematidis Radix、None

Aconiti Radix Processa,
Cinnamomi Cortex, and others

910

12

Apr. 18,
1997

Jul. 10,1994

Dissipate cold toFemale 45

7 months

1

Wind-damp impedimenttransform intodampness

Female 41

3 months

1

Dampness-heat
impediment

Clear heat to transform
into dampness

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

Keishikajutsubuto withadjustment

Nonesenpito with adjustment laterkeishikajutsubuto withadjustment

Analgesic

Volume 2, Number 4 | Winter 2007

Assessment (Evaluation Criteria)
Remission criteria developed by Pinals et al. wasused for the assessment (Arthritis Rheum 1981).
It is essential that 5 or more of the following besatisfied for at least two months.
1.

Morning stiffness does not last for 15
minutes or more

failure occurred concurrently and dialysis
started in June. The patient died in October.
As described above, Ebe reports that remission
was attained in 9 cases out of 10 primary RA caseswith incomplete remission in one case. Excellent
treatment effects are shown.

2.

No fatigue

3.

No joint pain4.

No joint tenderness or no pain on motion

5.

No soft tissue swelling in joints and tendon

However, due to the low number of cases availablesheaths
6.

arthritis nodosa was diagnosed. Chronic renal

Erythrocyte sedimentation rate is less than
30 mm/h for males and less than 20 mm/hfor females

for the research, it is too early to conclude whether
theseresultswereproduced

underbiasedevaluations or were fortuitous, and that Kampo
medicines are extremely effective for cases ofprimary RA onset. If a number of future primary RA
cases yield good results, Kampo medicines could
become first-line drugs in the treatment of RA.

Results
1． Complete remission was attained in 9 cases outof 10.
2． Case 10 ended in complete remission with 2.5
years of treatment. However, 2 years later inJanuary 1999, the disease recurred. Fourmonths of Kampo treatment starting in April
led to another remission.
3． Case 9 ended in incomplete remission after one
year of Kampo treatment. The case sometimes
satisfied 5 of the 6 remission criteria andsometimes satisfied 3 to 4 criteria. However, 7months after the start of Kampo treatment, thepatient was able to run. About a year later(March 1998), the patient commenced hard
work that required steady walking of 10,000 to20,000 paces a day. As of March 2000, thepatient was continuing work of a similar
nature.
4． Case 7 ended in complete RA remission after
three years of Kampo treatment. Six years later
in March 1998, however, connective tissue
disease accompanied by vascular inflammation
developed. The disease was controlled byConclusion
This research by Ebe contributes to extending thepossibility of Kampo therapy, resulting in increased
treatment options available for patients with RA. In
assessing the effectiveness of Kampo therapy,
DB-RCTs (double blind-randomized controlled trial)
are difficult to conduct. Thus, to satisfy a similarlevel of EBM requirements, Ebe has suggested thatinvestigations use a definite number of subjects who
have received Kampo treatment from an initialperiod (six months to one year from onset). He alsosuggests that if 10-year follow-up reveals a lower
rate of shifting to polyarticular destruction type andmutilans type compared to Western medicine
research groups, it could be said that Kampo
treatment is efficacious. Later in 2008, he presented
an additional report on the research at the 23rd
Kyoto

Kampo

AcademicSymposium,

contained more cases that referred to the ACR’s“Rheumatoid

Arthritis

Criteria”

and“EarlyDiagnosis of Rheumatoid Arthritis” prepared by thethen Ministry of Health and Welfare of Japan. I willreport on this at a later date.

Kampo medicines and Predonin (6–20 mg). InReference

March, the disease worsened and the patient

1) Ebe K.: Φυτο Vol.1 No.4, 4-12,1999

was admitted to a university hospital where

which

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

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