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Non-Clinical Studies of Botanical Medicines as New Drugs-U.S. Regulatory Perspectives

Kampo Medicine.2005;56(2):221-230. doi:10.3937/kampomed.56.221

To encourage development of new drugs from botanical sources, the U. S Food and Drug Administration (FDA) has published a draft Guidance for Industry: Botanical Drug Products (www.fda.gov/cder/guidance/1221.dft.pdf) in August of 2000.
The Guidance stipulates that for herbal preparations with substantial marketing history, past human experiences may be taken into consideration for safety assessment. In contrast with development of pure chemical drugs, clinical studies on herbal medicines can thus be initialed with less extensive lesting of non-clinical toxicity. However, most of the historical human experlences are not well documentad and often of poor quality data. In such cases, animal toxicity and toxicology studies may still be required for many botanical preparations, especially to support large scale or long term clinical trials. In this presentation, conventional non-clinical requirements for approval of pure chemical drugs will be reviewed briefly and how such requirements may be modified in scale/timing and applied to the development of botanical new drugs will be discussed.

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Clinical Studies of Botanical Medicines as New Drugs-U.S. Regulatory Perspectives

Shaw T. CHEN

Kampo Medicine.2005;56(2):231-241. doi:10.3937/kampomed.56.231

While numerous herbal preparations have been used to treat human illnesses for extensive period of time in many different cultures, very few have been subject to rigorous clinical testing of modern scientific standards. To facilitate more clinical development of new drugs from botanical sources, the US FDA has published a draft Guidance for Industry: Botanical Drug Products in August 2000.
www.fda.gov/cder/guidance/1221dft.pdf. For herbal preparations with substantial marketing history, past human experiences may be taken into consideration for safety assessment and clinical studies may be initiated with less extensive product characterization and non-clinical testing. However, efficacy of almost all herbal products remains to be established with clinical trials that should be no different from those required for non-botanical new drugs. The objective of the regulatory approach is to confer the same degree of confidence in the clinical effectiveness of herbal medicines as that of modem non-botanical drugs. In this presentation, basic principles of clinical trial in all new drug development will be described, and unique issues related to studies of herbal medicines discussed.

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Importance of "Question and Answer" about Psychological Background in Cases of Chronic Urticaria Successfully Treated with Kampo Therapy

Nobuyasu SEKIYA ; Katsumi HAYASHI ; Yukitaka HIYAMA ; Takao NAMIKI ; Yuji KASAHARA ; Atsushi CHINO ; Kenji OHNO ; Toshiaki KITA ; Yoshiro HIRASAKI ; Katsutoshi TERASAWA

Kampo Medicine.2007;58(4):723-728. doi:10.3937/kampomed.58.723

We experienced four cases of urticaria (two patients with cholinergic urticaria, one patient with chronic idiopathic urticaria and one patient with cold urticaria) successfully treated with Kampo therapy. The factors for outbreak or aggravation of urticaria were stress of looking after the father in law and hysterectomy in the first case, psychological stress due to familial trouble in the second case, panic disorder like episode in the third case, and solicitude and anxiety for family in the fourth case. The effective Kampo formulae that improved the dermatological symptom were keishibukuryogan, hangekobokuto, yokukansankachimpihange and kamishoyosan, respectively. It was helpful that to clarify the psychological background affecting the dermatological symptom in the determination of Kampo formulae. It would be useful that careful and repetitious question and answer about psychological background in the treatment of intractable urticaria.

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Acupuncture and Moxibustion in Hospitals-Current roles of acupuncture and moxibustion in Japan-

Ikuro WAKAYAMA ; Shuichi KATAI ; Hiroshi KITAKOJI ; Daichi KASUYA ; Satoru YAMAGUCHI ; Seigo AKAO

Kampo Medicine.2008;59(4):651-666. doi:10.3937/kampomed.59.651

Acupuncture and moxibustion were introduced to Japan from China in the 6 th Century. Since then our ancestors adapted these unique techniques and knowledge to our climate and ethnicity, and eventually developed the Japanese system of acupuncture and moxibustion.
Whether acupuncture and moxibustion therapy is successful or not depends on the knowledge and skill of the individual acupuncturist. However, in recent years, the role of medical doctors, nurses, physical therapist and other medical professionals working as a team has become particularly important, with some acupuncturist starting to work in university hospitals as part of these teams, and contributing to patient well-being.
In this paper, to elucidate the roles of acupuncture and moxibustion in modern medicine, we show how acupuncture and moxibustion are applied in university hospitals, and how acupuncturists evaluate the effectiveness of their acupuncture and moxibustion.

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The Meaning of "Fukuchukan" in the Abdominal Symptom of Daikenchuto-syo

Hisashi INUTSUKA ; Mosaburo KAINUMA ; Toru YAMADA ; Nobukazu HORIE ; Yoshiko NAKAMURA ; Humiji MIYASAKA ; Hideo KIMURA ; Tadamichi MITSUMA

Kampo Medicine.2008;59(5):715-719. doi:10.3937/kampomed.59.715

Daikenchuto is recorded in Kampo textbooks as a prescription for abdominal disorders. We considered fukuchukan (coldness in the abdomen) as equaling a sensation of coldness centering on the navel, and we examined the usefulness of using Daikenchuto as a medication for this symptom. We administered Daikenchuto to 90 patients who presented with coldness of the navel. The patients were divided into 2 groups:the first group had accompanying digestive symptoms, the second had no accompanying digestive symptoms. We then examined their response rates, and improvement rates for coldness centering on the navel. We also examined the abdominal strength and pulse strength for responders and non-responders, respectively.
The Digestive Symptoms group consisted of 64 patients. In this group, the response rate was 81.3%.The improvement rate of coldness centering on the navel was 92.3% in responders and 41.7% in non-responders, and the difference was highly statistically significant (p<0.001). The Non-digestive Symptoms group consisted of 26 patients. In this group, the response rate was 38.5%. The improvement rate of coldness centering on the navel was 100% in responders and 43.8% in non-responders, and the difference was statistically significant (p=0.022).
In a comparison of all 90 responder and non-responder cases, weak abdominal strength was 62.9% in responders and 42.9% in non-responders, intermediate abdominal strength or above was 37.1% in responders and 57.1% in non-responders, and the difference between abdominal strength and response rate (p=0.076) was non-significant. Weak pulse was 54.8% in responders and 40.7% in non-responders, intermediate pulse strength or above was 45.2% in responders and 59.3% in non-responders, and the difference between pulse strength and response rate(p=0.221) was non-significant. 13 of these cases were above intermediate, for both abdominal strength and pulse strength.
We conclude that for patients presenting with a sensation of coldness centering on the navel, there is a strong possibility that the efficacy of Daikenchuto-syo is suggested, regardless of whether or not there are other digestive symptoms. Moreover, Daikenchuto proved effective in 13 cases where both abdominal strength and pulse strength were above an intermediate level, suggesting that a sensation of coldness centering on the navel can be the key to finding the sensho of Daikenchuto-sho.

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The Complaints of Weak Patients-Using Medical Questionnaires-

Yoriko MORIOKA ; Hiroshi SATO

Kampo Medicine.2009;60(3):371-378. doi:10.3937/kampomed.60.371

We examined the complaints of adult patients with ‘weak’ sho symptoms using their first-visit medical questionnaires. Our subjects were 39 patients (3 males and 36 females) who fatigued easily, and who had a weak constitution with stress and the changing of seasons.
Over 60% of these ‘weak’ patients complained of excessive sensitivity to cold. The majority had stiff shoulders, a stiff neck, low back pain, sleeplessness, headache, fatigue of the eyes and vertigo. Their gastrointestinal constitutions were poor because of over eating.
Although we understood many of the complains these ‘weak’ patients had through their medical questionnaires, their chief complaints were various. We hope these results are useful in understanding treatments for patients with ‘weak’ sho.

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Six Cases with 'Honton' Disease Successfully Treated with Combination of Goshuyuto Extract and Ryokeijutsukanto Extract

Yuji KASAHARA ; Yutaka KOBAYASHI ; Atsushi CHINO ; Nobuyasu SEKIYA ; Takao NAMIKI ; Kenji OHNO ; Masaki RAIMURA ; Sumire HASHIMOTO ; Keiko OGAWA ; Hirokuni OKUMI ; Yumiko KIMATA ; Yoshiro HIRASAKI ; Toshiaki KITA ; Katsutoshi TERASAWA

Kampo Medicine.2009;60(5):519-525. doi:10.3937/kampomed.60.519

We report six cases with honton disease successfully treated with a combination of goshuyuto extract and ryokeijutsukanto extract. Five of the cases were diagnosed as panic disorder, and the remaining case as generalized anxiety disorder. All six cases complained of palpitation, nausea, dizziness, headache and anxiety attacks. We diagnosed them as a hontonto (Zhouhou fang) indication. Their various complaints disappeared after combination therapy with those extracts. Furthermore, efficacy of the combination therapy was proven to be equal to hontonto. These cases suggest that the combination therapy with goshuyuto extract and ryokeijutsukanto extract is useful in place of hontonto.

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All About Abdominal Palpation-The Traditional Diagnosis Method

Terutane YAMADA

Kampo Medicine.2009;60(6):573-582. doi:10.3937/kampomed.60.573

In Japanese Kampo, we use abdominal palpation as a clinical examination method. Abdominal palpation, a kind of tactile inspection method, which in turn is one of the four mainstays inspection methods (palpation, visual, auditory, and verbal), is the most effective technique giving one information to determine a patient's sho diagnosis. Moreover, abdominal palpation is the only clinical examination method of those traditional techniques passed down to the countries and regions of East Asia, which was developed solely in Japan. Abdominal palpation as it is practiced today stems mainly from the Koho-ha Old School of thought, which traces back to ancient Shokanron (Treatise of Cold Damage Disorders) text medicine, although it also influences the Secchu-ha Compromise School of thought. And although an awareness of abdominal palpation is perfunctory, it does require a certain amount of training and proficiency, as it is a skill. In this paper, we discuss abdominal palpation findings amassed over many long years since ancient times.

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Paradigms in Academics-The Scientific Nature of Kampo Medicine-

Tomoaki ISHIKAWA

Kampo Medicine.2010;61(3):267-281. doi:10.3937/kampomed.61.267

The fight against pestilence has been the major theme of both western and eastern medicine since ancient times, and bacteriology has been founded on the modern scientific idea of ensuring reproducibility, the socalled Koch's four postulates, by identifying and isolating pathogenic bacteria, then proving their infectious cause.
However, although the major factors surrounding infectious disease are host/parasite relationships and drugrelated causes, more importance has been placed on developing new drugs. With the emergence of compromised hosts as treatment methods become widespread, such thinking is no longer valid.
There is now no clear logic to the question of reproducibility in clinical medicine, against a background of the enormous contributions the human system makes. Kampo medicine, the study of therapeutics in humans, has long been used to treat people through an understanding of the pathological conditions humans express as a system, with their Six Stages of Disease (rikkei) theory, yin-yang, hypo- and hyper-function sho (symptoms), and through those sho that people present with, it can provide highly reproducible therapies. Moreover, the oral traditions (koketsu, gugyeol) of Japanese Kampo which bring increased therapeutic efficacy and reproducibility through the achievements of predecessors, provide indispensable therapeutic bias. In future, the systematic medical concepts of Kampo will also become essential in Western medicine.

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Aim of Editing of Kokon Hoi

Tatsuhiko SUZUKI

Kampo Medicine.2010;61(3):289-298. doi:10.3937/kampomed.61.289

The Kokon Hoi was the most widely used formulary in the Edo era.Here the author examines tendencies in the ways various Kokon Hoi editions were quoted, how Koga Tsugen approached his re-compilations, and how this influenced later, traditional Japanese medicine.
1. Editions of the Kokon Hoi compiled before Koga Tsugen are mainly quotations from newer works such as the Wanbinghuichun, the other of Gong Tingxian's works and the Yixuerumen.
2. Koga Tsugen re-compiled the Kokon Hoi twice as the (essential) Sanpo Kokon Hoi, and the (revised) Jutei Kokon Hoi.In the Jutei Kokon Hoi, the most popular edition of Kokon Hoi today, there are numerous quotes from the Wanbinghuichun, the Yixuerumen and Xue Ji's medical treatises.
3. In the re-compiling the Kokon Hoi, Koga Tsugen not only added the new prescriptions, he revised the list of references, and corrected prescription names, as well as the component drugs and doses of prescriptions.
4. The original Kokon Hoi was compiled to collect newly introduced prescriptions. Afterward Koga Tsugen aimed to adopt experiential prescriptions by editing the Kokon Hoi.The Kokon Hoi is one of the first formularies in traditional Japanese Kampo to enumerate prescriptions in which experiential effectiveness is regarded as important.
5. The Shuhokiku on the other hand, is based on a medical system of ”basic and modified prescriptions”.But the Shuhokiku gradually had become nearer a system of numerous enumerated experiential prescriptions like the Kokon Hoi.

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