Herbalism definition

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Medicines Act for relevant medicinal products, including section 7 (and consequently all exemptions relating to section 7). Relevant medicinal products are defined in the 1994 Regulations as those medicinal products for human use to the provisions of Directive 2001/83/EC apply. This broad definition includes most medicinal products. The exceptions are medicinal products for clinical trial use, products prepared in a pharmacy in accordance with a pharmacopoeial formula for direct supply to a patient, intermediate products, registered homoeopathic products, non-industrially produced herbal remedies and some products which are not medicinal products within the meaning of the Directive, but which by order have been made subject to control under the Medicines Act 1968. For products designated under such an order, the old provisions on particular patient supply are still applicable. In practice, there are very few such products. 

In the United States, the use of products, including botanicals, thought to fall within the realm of complementary and alternative medicine is very common. It is difficult to obtain reliable estimates of use or to compare many of the current publications in this area because of diverse definitions for categorizing these products (e.g., dietary supplement, food supplement, herbal medicine, natural remedy, traditional medicine, etc.) in both the United States and elsewhere. A recent report on the use of complementary and alternative medicine by U.S. adults in 2002 indicated that approximately 19% of the population used nonvitamin, nonmineral, and natural products, 19% used folk medicine, and 3% used megavitamin therapy in the past 12 months (1). 

No single definition adequately captures the range of practices that fall under the CAM rubric. Those that define CAM as practices that are not part of mainstream medicine, or as practices used by patients to manage their own health care, or as therapies not widely taught in Western medical schools or available in most hospitals, fail to capture the complexity of this field. CAM includes health-care practices that range from the use of vitamins, herbal remedies, and massage therapies to the ancient traditions of Ayurveda and Chinese medicine, along with chiropractic techniques, naturopathy homeopathic medicine, meditation, hypnosis, acupuncture, and a host of other less well-known approaches to health and health care. 

Although plants are by definition natural, they contain many chemical substances, some of which can be used as drugs but others may be very toxic. Unfortunately many of the general public think that, as they are natural, herbal remedies and herbal medicines must be safe. But just as with man-made synthetic drugs, herbal remedies can and do cause harm to patients taking them. 

The DSHEA classified herbal products as dietary supplements intended to supplement the diet. Also included in the definition of dietary supplement were vitamins, minerals, botanicals, amino acids, and other substances intended to supplement the diet. Dietary supplements were not considered foods or drugs and therefore were exempt for FDA oversight and the premarket approval process. For all products introduced before October 1994, the burden of proof to demonstrate safety was now in the hands of the FDA and not in the hands of the manufacturer. Products introduced after October 1994 must be proven safe by the manufacturer. Manufacturers are currently not required to submit safety and efficacy data, and there are no good manufacturing standards (GMP) in place. However, the FDA does have the authority to establish GMP standards, and they are currently under development. Preliminary proposals indicate these GMP standards will more likely reflect GMP for food rather than for drugs. 

Tyler VE. Product definition deficiencies in clinical studies of herbal medicines. Sci Rev Altern Med 2000 4 17-21. 

Products used for a therapeutic purpose are categorised as medicines, related products, herbal remedies or mediccil devices. Definitions of other categories (e.g., cosmetics, dietary supplements, herbal remedies, etc.) are also provided in the legislation and official standards and are further described in various guidelines. 

In definition, herbal remedies used as medicines may be traditionally or serendipitously derived, varying in formulation, preparation, and standardization, sometimes unreliable as to plant identification or to chemical composition, and depending on their cultural source, infrequently validated, in conventional ways, as to efficacy or safety. They may be prescribed by a healer of experience and training or of questionable skill, or they may be used in self-medication. As exemplified in American and African indigenous populations, prayers, mantras, or other forms of healing ceremonies may be used as an adjunct to phytotherapy. The applications of energy medicine to potentiate the curative process are still poorly understood (Elvin-Lewis, 2003, 2004). 

Munday, S. Herbal History and Definitions A Report to NIH . Medical Horizons (web report). 

The unique or peculiar aspect of herbal materials that is different from conventional pharmaceuticals is in the definition. The crude drug material or... 

Definition-, a qualitative statement of the botanical source, plant part used, and its state (e.g., whole, reduced, powdered, fresh, dry). It is also important to know the geographical source(s) and the conditions tmder which the herbal substance is obtained. 

Definition a statement of the botanical source, and the type of preparation (e.g., dry or liquid extract). The ratio of the herbal substance to the herbal preparation must be stated. 

About 75% of the 400 million people with chronic HBV live in Asia. Herbal medication use is a common therapeutic modality in many parts of the world and has been studied extensively in China. A meta-analysis of over 500 papers, including randomized controlled trials, concluded that existing studies were of poor quality, limiting the definitive interpretation of results. However, the meta-analysis did identify that bufotoxin and kurorinone were associated with increased seroconversion of HBeAg and clearance of HBV DNA. Further evaluation of these active components as a possible therapeutic alternative is warranted, but they are not currently being recommended for routine use. 

Owing to growing demand of herbals, the need of the hour is to intensify research in the field of medicinal herbs and to get authentical information on the subject. Herbal products are often questioned for quality control and assurance. Majority of the herbal products fails in the laboratory test for active constituents mentioned on the label. Extracts standardised to active constituents and marker compounds have definite advantage over the crude dmgs. 

It is obvious that consistent quality for products of herbal origin can only be assured if there is a rigorous and detailed definition of the starting materials. Failure to ensure exact botanical identification of the plant material puts the patient at risk not only of ineffective therapy but also of exposure to potentially toxic plants. 

Within the United States, the most recent attempt to balance the interests of all involved is the Dietary Supplement Health and Education Act (DSHEA) which includes herbal products within the definition of a dietary supplement. DSHEA assures availability of supplements as long as they are not unsafe and allows producers to make certain structure and function claims on the label, but in words which do not apparently provide the exact information a consumer needs. In addition the DSHEA requires a disclaimer to appear on the label which indicates to the patient/consumer that the product has not been evaluated by the Food and Drug Administration and that it is not intended to diagnose, treat, cure or prevent disease. 

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