Volume 4, Number 2 | Summer 2009

Kampo Medicine - Current Research
Kampo Treatment for Psychosomatic Disorders –1. Functional Dyspepsia (FD)Shinji Nishida

Department of Psychosomatic Medicine,Japanese Red Cross Wakayam Medical Center,Wakayama, Japan

Disease concept
Cases in which in spite of complaints ofepigastric pain, epigastric distension and similar
symptoms of the upper gastrointestinal tract
gastroscopy etc. cannot show explicable organic
lesions are called (functional dyspepsia: FD). This
comes close to what has been called chronic
gastritis or neurogenic gastritis in the past. FD isa very common disease and the international
epidemiological study DIGEST showed, that 9%of the adult Japanese population experiences thiscondition at a rate of once a week, presenting
with moderate or stronger symptoms of dyspepsia,
and among those people 34% reportedly visited
medical facilities1).
Currently, the Roma III criteria (Table 1) are
widely used worldwide for the diagnosis of FD.
Moreover, in this connection the condition inpatients presenting with epigastric pain or aburning sensation in the epigastric region isclassified into (1) epigastric pain syndrome (EPS)
and postprandial distress or a feeling of earlysatiety as (2) postprandial distress syndrome(PDS). There are patients, in whom both EPS andPDS coexist at the same time2). Regarding thecause of FD (1) anomalies of gastric motility(derangement of appropriate gastric fundus
relaxation, decreasing the pooling capacity of thestomach etc.), (2) visceral hypersensitivity(patients with FD are hypersensitive to gastric
stretching stimuli as compared to healthy
persons) and (3) central nervous problems(presence of depression or anxiety and similar
psychologicalsymptoms)areconceivable.
Otherwise excessive secretion of gastric acid, H.

pylori infection, affection by food contents and avariety of other causes are involved.
Western medical pharmacological treatment
aims at bacteria elimination in cases of H. pylori
infections, in the group of patients with epigastricpain syndrome drugs inhibiting gastric acidsecretion and in the postprandial distresssyndrome
group
drugs
topromotegastrointestinal motility are used. If thesemeasuresarenoteffective,
tricyclic
antidepressants are administered3).
Table 1 FUNCTIONAL DYSPEPSIA (Rome III)
Diagnostic criteria* Must include:
1. One or more of the following:a. Bothersome postprandial fullness
b. Early satiationc. Epigastric paind. Epigastric burning
2. No evidence of structural disease (including atupper endoscopy) that is likely to explain thesymptoms* Criteria fulfilled for the last 3 months withsymptom onset at least 6 months prior todiagnosis
Postprandial Distress Syndrome
Diagnostic criteria* Must include one or both ofthe following:
1. Bothersome postprandial fullness, occurring
after ordinary-sized meals, at least several times
per week
2. Early satiation that prevents finishing aregular meal, at least several times per week
* Criteria fulfilled for the last 3 months withsymptom onset at least 6 months prior todiagnosis
Supportive criteria
1. Upper abdominal bloating or postprandial
nausea or excessive belching can be present
2. Epigastric pain syndrome may coexist

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Volume 4, Number 2 | Summer 2009

Epigastric Pain Syndrome
Diagnostic criteria* Must include all of thefollowing:
1. Pain or burning localized to the epigastrium ofat least moderate severity, at least once per week
2. The pain is intermittent
3. Not generalized or localized to other abdominalor chest regions
4. Not relieved by defecation or passage of flatus
5. Not fulfilling criteria for gallbladder andsphincter of Oddi disorders* Criteria fulfilled for the last 3 months withsymptom onset at least 6 months prior todiagnosis
Supportive criteria
1. The pain may be of a burning quality, but
without a retrosternal component
2. The pain is commonly induced or relieved byingestion of a meal, but may
occur while fasting
3. Postprandial distress syndrome may coexist

Treatment
In Chinese medicine FD is understoodaccording to concepts of conditions like "epigastricpain" (wei wan tong), "epigastric stuffiness" (xinxia pi), "eructation" (yi qi), "anorexia" (na dai),"frequent vomiting" (fan wei), "gastric upset" (caoza). Possible causes for the pain are stomach heat,stomach yin deficiency, stomach cold, disharmonyof liver and stomach or blood stagnation and inrelation to the stomach upset stomach qi
deficiency and phlegm-dampness.
In Japan shigyakusan and saikokeishito areused in particular for EPS patients with marked
stress factors (disharmony of liver and stomach).
Moreover, for asthenic patients with chilling of
the epigastric region (stomach cold) Anchusan or
Ninjinto are used. In Patients with PDS with thedevelopment of phlegm-dampness due to an
irregular diet including excessive ingestion of

8water, alcohol, dairy products and meat or the likeheiisan, bukuryoin, bukuryoingohangekobokuto areused. Also, when in people with a weak constitution
a qi deficiency induced by a deficiency of spleen andstomach has led to the development ofphlegm-dampness, rikkunshito is used. Moreover,the presence of both epigastric pain and gastricupset is a form of EPS and PDS overlap for whichhangeshashinto is used.
EBM
In Japan almost all research reports are basedon the use of rikkunshito. In some studies
attempts were made to classify the FD according
to the type of morbidity, while others did not
distinguish between pathologies4). FD has in thepast also be called non ulcer dyspepsia (NUD) andthere are many trials based on the relevant
diagnostic criteria.
According to Harasawa et al. DB-RCT showed,that rikkunshito had therapeutic effects for thepostprandial distress syndrome5). Rikkunshito in
the normal dose and a 1/40th dose wasadministered over a period of 2 weeks to 235
NUD patients with postprandial distresssyndrome and the two groups then compared. Theresults showed, that the ratio of symptom
alleviation in the group treated with the normal
dose was significantly higher. Classified
according to symptoms a marked improvement
was observed in particular regarding theinappetence, gastric discomfort and fatiguability
present prior to the treatment and regarding theusefulness too a significant difference wasobserved between the 58.8% in the regular dosegroup and the 39.3% in the low dose group.
Patient background factors influencing theelimination effects were an age in the 60s,
leptosomatic body type, SRQ-D<10 points, weakmuscle tone of the abdominal wall, regular facialcolor, for all of which significant differences wereobserved.

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Regarding RCTs there is a comparative study,
treating NUD patients with rikkunshito andcisapride6) by Miyoshi et al. In this study 246
NUD patients received the drugs at random. As aresult significant differences were observed,
showing a 'better than improvement' regarding
the general condition in 81.3% patients in therikkunshito group (marked improvement 49.5%),
as compared to 75.0% in the cisapride group(similarly 34.0%). Regarding the usefulness too
significant differences were observed for the ratioof 'better than useful', which was 80.7% in therikkunshito group (extremely useful in 45.9%), ascompared to 73.3% in the cisapride group(similarly 31.7%).

References
1) Stanghellini V: Three-month prevelance rates
of gastrointestinal symptoms and the influenceof demographic factors: results from theDomestic/International
Gastroenterology
Surveillance Study (DIGEST). Scand J
Gastroenterol Suppl 231:20-28, 1999
2) Drossman DA. The functional gastrointestinal
disorders and the Rome III process.
Gastroenterology. 130:1377-1390, 2006
3) Geeraerts B, Tack J: Functional dyspepsia:
past, present and future. J Gastroenterol
43:251-255, 2008
4) Okumi H et al.: Evidence for Kampo treatmentofpatients
withpsychosomaticandstress-related disorders1) EBM evaluation ofKampo treatment for functional dyspepsia.
Journal of Japanese Association of Oriental
Psychosomatic Medicine 24: 70-75, 2009
5) Harasawa S: The role of Rikkunshito for thetreatment of NUD (functional maldigestion) ―in particular regarding its usefulness for
Dysmotility-like NUD－．Prog.Med.19:843-848,
19996) Miyoshi S et al.: Clinical evaluation of TJ-43
for the treatment of indefinite complaints
related to the gastrointestinal tract likechronic gastritis ― Multicenter comparative
study using Cisapride as control drug ．
Prog.Med.11:1605-1631, 1991

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