Current Review of Chinese Medicine

The following sections are included:

• Editorial Board

• Contents

• Contributors

• Preface to Series

Authentication and consistent quality are the basic requirements for TCHM and its commercial products, regardless of the kind of research conducted to modernise the TCM. The complexities of TCHM challenge the current official quality control mode, for which only a few markers were selected for identification and quantitative assay. Referring to too many unknown factors existed in TCHM, it is impossible and unnecessary to pinpoint qualitatively and quantitatively every single component contained in the herbal drug. Chromatographic fingerprinting is a rational option to meet the need for more effective and powerful quality assessment to TCHM. The optimised chromatographic fingerprint is not only an alternative analytical tool for identification, but also an approach to express the various pattern of chemical ingredients distribution in the herbal drugs and preserve such “database” for further multi-faceted sustainable studies. Some examples demonstrated the role of fingerprinting in quality control and assessment.

The efficacy and safety assessments of medicines, whether modern or herbal, invariably encounter challenges or problems during the course of pre-clinical and clinical research. Some of the challenges in evidence based herbal medicinal research are unique, and the researcher must be cognizant of them in order to safeguard the quality of the data obtained. Key challenges are: the quality of raw materials; appropriateness of biological/pharmacological activity assessment methodology, and data interpretation; standardisation methodology; pharmacokinetics and bioavailability of active constituents and metabolites; clinical dosage formulation/ production; and clinical study designs and outcome measures. These challenges were encountered, and resolved, at the UIC/NIH Center for Botanical Dietary Supplements Research in Chicago, IL, USA. Although the University of Illinois at Chicago studies were directed at botanicals for women's health, the challenges and solutions encountered are also applicable to research on the efficacy and safety of herbal medicinal materials in general.

While users of herbal formulae have been disappointed with the lack of uniformity in the quality of herbs provided by the herb suppliers of different standings, they do not have better guarantee apart from relying on the more reputable ones. The tradition of identifying special geographic sites as being specific for the supply of certain herbal items is no longer reliable since the high demand for large quantities of quality supply would have drained any traditional supply dry. Since the European Union started to advocate a quality supply of the first manufacturing material for herbal products by introducing a comprehensive recommendation of practices: from seedling, planting, fertilising, harvesting, storage and distribution, the idea of good agricultural practice becomes an attractive reality. There is good prospect of an excellent supply of quality herbal products with uniformity, if Good Agricultural Practice (GAP) could be enforced. The substantiation of GAP will be a great blessing for both the manufacturers and consumers of herbal products.

Although the need for GAP is urgent, and Japan, China and the World Health Organization have, one after the other, written up their recommendation, to put GAP into real practice would take time. GAP in China is particularly difficult, not only because the herbal items involved are in great numbers but also because the current practice of growing medicinal herbs, their marketing and distribution, have been counterproductive to the introduction of the new system of GAP.

Unless the demand for herbal supply was limited, otherwise, GAP will not be able to satisfy the extensive need for uniformity. Short of the knowledge of the exact, accurate nature of the active component within a herb, there will be no perfect guarantee on the quality supply. Henceforth, even when GAP becomes a mature practice, what is required for quality control, viz, different levels of authentication, from chemical fingerprinting to molecular, DNA identification, will remain necessary as cross-checking mechanisms to make sure that uniformity in scientific experiments and drug development is not violated.

The supply of Chinese herbal medicine has evolved from wild to mainly cultivation-oriented. In order to ensure sufficient supply and reliable quality, it is very important to carry out Good Agricultural Practice (GAP) of medicinal plants. This article summarises the market status of Kampo medicines in Japan, the general status of cultivation of medicinal plants in Japan, the main content of technical guidelines on cultivation of medicinal plants in Japan, and Japan Good Agricultural Practices (J-GAP). The content offers some references for other countries to bring GAP into practice.

Good Agricultural Practice (GAP) guidelines have been developed internationally to ensure consistency of practice and Australian National Standard for Organic and Bio-dynamic Produce has broader implications. Both of them have been applied to the production of herbal medicines including Chinese herbal medicines. This paper compares the similarities and differences of these two set of standards and illustrated the application of these standards in a Chinese herbal medicine farming project funded by the Australian Government and RMIT University, Australia through an effective collaboration of academic institution with local government, farmers' association as well as the industry. This collaboration will contribute to the development of herbal medicine as a responsible industry and provide means to ensure quality of herbal medicines for safe use.

As a result of the growing popularity of herbal medicines, the need for the assessment of quality, safety and efficacy of these products is increasingly important. Compared to conventional preparations, herbal products present a number of unique problems when quality aspects are considered. These arise due to the complex mixtures of constituents which can vary considerably with a large number of factors. Research in this area is increasing and with modern analytical techniques becoming widely available, there are numerous methods for the quality control of herbal medicines. This paper reviews the various methods that have been used for the quality control of herbal medicines, using Panax species and P. notoginseng products as an example.

While gaining popularity worldwide, botanical products are facing the challenge of product quality and safety. Authentication and quality control of medical herbs have become critical issues. Since DNA composition for a living organism remains consistent throughout development and is not affected by various environmental conditions, DNA profiling can specifically identify a herb species or cultivar, to ensure its quality if there is linkage of its genetic identity with either chemical constituents or bioactivities and to ensure the genetic uniformity of herb materials. Among the many techniques, Amplified Fragment Length Polymorphism (AFLP) and Simple Sequence Repeat (SSR or microsatellite) are gaining popularity due to their high level of polymorphism, reliability and robustness. DNA sequencing of rDNAs, internal transcribed spacers (ITS) and chloroplast genes have also been used. While DNA profiling has been used successfully in differentiating authenticated herbs from other related species and adulterants, in finding intra-specific variation and even genetic diversity in a single farm, there has been comparatively less work done on correlating genetic identity with chemical constituents or bioactivities. In view of the fact that no single authentication procedure can be applied to every medical herb, we suggest a holistic approach by combining use of DNA profiling together with chemical profiling and/or biological activity testing for authentication of medical herbs. For the wider adoption and acceptance of DNA profiling, there is a need for international collaboration in gaining access to authenticated specimens, working out standard operating procedures (SOPs) for DNA profiling, sharing DNA profile information and building mechanisms to deposit and gain access to DNAs.

A protocol based on Fourier transform infra-red spectroscopy, twodimensional correlation IR spectroscopy and computer-aided analysis technology has been established for the quality control of traditional Chinese medicine (TCM) commodities. This method does not need the extraction and separation that follow the integrated principle of TCM, and has obtained many amazing achievements during the years.

Good Laboratory Practice (GLP) is becoming more and more important in the research and development of Traditional Chinese Medicine (TCM) and its globalisation. If a TCM product is to be registered as Over-the-Counter (OTC) drug and enter international markets, the safety and efficacy studies conducted according to GLP requirements is necessary. The article introduces the content of GLP requirements and the recent development of GLP in China. The safety and efficacy assessment for TCM or herbal medicines under GLP are also covered. This paper also briefly describes the areas that should be covered by GLP regulation and the areas that do not need to follow GLP requirements.

Traditional Chinese medicine (TCM) has an ancient history and a unique system that includes theory, methodology, prescription formulation and drugs. It has been widely used clinically for thousands of years in China. Therefore, TCM plays an important role in health care in China. This paper will briefly introduce about the present state of pharmacokinetics and drug metabolism research in TCM. This article includes five parts: (1) advances on pharmacokinetic studies of major active compounds from TCM; (2) characteristics on pharmacokinetic studies by combination of diagnosis (Zheng); and recipe (Fangji) and pharmacokinetics of TCM; (3) effects of traditional Chinese herbal medicine on cytochrome P450 enzymes; (4) key issues in the modernisation of TCM, which are the lack of standardisation of TCM products and the lack of scientifically accepted clinical efficacy and safety data. Thus, valid data from well-designed studies pertaining to these two areas are needed to modernise of TCM. The pharmacokinetics of TCM, including quantitatively describing the kinetic changes of absorption, distribution, metabolism and elimination/ excretion of TCM, involving many theories and technologies, is a marginalised subject that focuses on pharmacology, chemistry of TCM, analytical chemistry, mathematics in one entity; and (5) challenges and opportunities in pharmacokinetic research of TCM. In fact, Fanji is different from chemical drug as it is a mixture of many clear and unclear single chemical entities. It integrates the theory, therapeutics and pharmacy of TCM. It has often used as tool to study the physiology, pathophysiology and action mechanism of TCM. So, it has important significance in exploring the mechanism of TCM and the scientific connotation, accelerating the improvement of new medicine and quality control and the globalisation of TCM. It needs mutual collaboration and the efforts of different experts in multiple subjects. Pharmacokinetic studies can be very helpful towards the modernisation of TCM.

The intestine has a great ability to metabolise active constituents of traditional Chinese medicine (TCM). Since the majority of TCM are orally administered, the biological importance of such an ability of the gut must not be underrated. In the gut, TCM undergoes extensive metabolism by intestinal flora (IF) and enterocytes before and during absorption.

The metabolic reactions affected by IF tend to be reductive or deconjugative rather than oxidative or conjugative, and therefore appear to be antagonistic and complementary to those of liver, and as a result, lead to decreased molecular size, enhanced lipophilicity and increased biological activity. By now, a large amount of active constituents of TCM, especially glucosides such as glycyrrhizin, baicalin, sennoside, gerberinside, gensenosides, barbaloin, paeoniflorin, geniposide, etc., have been widely recognised as natural prodrugs, which are activated by IF and therefore produce their pharmacological effects. The toxicity of some active constituents has been attributed to IF-mediated hydrolysis or other forms of conversion. The metabolic reactions carried out by enterocytes are both degradative and synthetic, but mostly synthetic, frequently with detoxicative character, similar to that of the liver. Epithelium cells of intestinal mucosa have many important drug metabolising enzymes, leading to a significant first-pass metabolism and low bioavailability.

Great progress in the study on intestinal metabolism of TCM have been witnessed in recent years. A large amount of active constituents isolated from TCM have been studied extensively. New theories and ideas have been increasingly proposed. Today, a growing number of advanced micro-analytic techniques, methodologies and experiment models are used, which greatly promote the study on intestinal metabolism of TCM. However, much more work still needs to be urgently done to clarify the rules, mechanisms as well as biological significance of intestinal metabolism of TCM, particularly of compound prescriptions.

Purpose: To investigate the effect of anti-metastasis of a herbal formula in operated colorectal cancer.

Methods: One hundred and one post-operation patients are randomly divided into two groups: patients in group 1 take a herbal formula capsule after operation and patients in group 2 performed operation without the herbal formula. Survival, metastasis and death rate were observed.

Results: Three-year survival rate of Dukes C period of group 1 is 70.83%, and that of group 2 is 41.66% (p < 0.05). Three-year metastasis and death rate of group 1 is 29.16%, and that of group 2 is 66.66%, p < 0.01. The results indicated that the herbal formula could improve the survival rate of colorectal cancer patients, particularly in Dukes C period.

Conclusion: Development of the herbal formula as an adjuvant medicine for post-operation colorectal cancer is feasible.

The research on the protection and treatment of diabetes and its complications has received significant achievement with the principle of mainly using Chinese medicine (CM) combined with Western medicine (WM). Research of combined CM and WM on diabetes has already become the main part in medical research areas in China. The theory of combined CM and WM is advanced with inheritance and new ideas. The basis of combined CM and WM is established by the permeation of theory of aetiology and pathogenesis. The prevention and treatment of diabetes with combined CM and WM are improved by the new ideas, which depend on the basis of inheritance. The method of differential types, which are standardised scientifically, is the new model for studying diabetes with combined CM and WM. Researchers should pay attention not only to diabetes treatment, but also to the prevention and treatment of its complications. The advantage of combined CM and WM should be developed; we should look for the combined point between CM and WM and absorb the modern pharmacological results from past research. Much achievement is obtained through the research on clinical trials and experimental studies of diabetes and its complications, and through the rational selection of Chinese herbs and WM. Some new, effective and easily ingested herb products are developed and widely used in the clinics.

In this article, we describe the theory of acupuncture manipulation of dangerous acupoints in ancient classic works; introduce the methods of stratified anatomy and layer anatomy; and sum up the safe needling depths, dangerous needling depths and needling angles for dangerous acupoints on the cervical part, chest, abdomen and back. This paper serves as a reference for clinical acupuncturists seeking to improve therapeutic effects and prevent accidents.

Background: Acupuncture has been evaluated in clinical studies for its effect in reducing some of the common symptoms experienced by cancer patients.

Methods: Clinical studies of acupuncture in cancer-related symptoms, published in the English language, are reviewed. The data are summarised. Implications in cancer care are discussed.

Results: There is good evidence supporting acupuncture's effects in the reduction of cancer-related pain and chemotherapy-induced acute nausea and vomiting. There are preliminary data suggesting that acupuncture may help reduce post-chemotherapy fatigue, hot flashes resulting from hormonal treatment and xerostomia caused by radiation. Acupuncture has a good safety record when performed by qualified practitioners.

Conclusion: Acupuncture is a useful complementary therapy in cancer care. Integration of acupuncture into regular oncology practice can improve supportive care of cancer patients.

The following sections are included:

• Index