In health food stores, pharmacies, and supermarkets herbal products are usually available as extracts (e.g. tablets, capsules, teas, tinctures, lotions, ointments, lozenges, syrups). Many of these are sold without prescription as over-the-counter products. The legal situation regarding these products varies according to the country.
In the USA most herbal extracts are sold as dietary supplements, which are a food category. Labelling may only refer to the effects on the structure or function of the body therapeutic claims are not allowed. Herbal medicines in the UK fall into two categories:
a. licensed products that are required to meet safety, quality, and efficacy criteria, in a similar manner to any other licensed medicine...
b.the majority of herbal products, which are not licensed and are therefore sold as dietary supplements with no therapeutic claims on the label.
However, somewhat devious methods of advertising have been employed. In Germany and some other European Union countries, herbal medicinal products are treated in the same way as any other medicinal products and must satisfy, as a pre-condition for marketing, the same criteria of safety, quality, and efficacy as any other medicine. Efforts are being made to harmonize the situation within the European Union but this will probably take a long time.
The development of a new medical drug by a pharma ceutical company is a long and expensive process, taking between 10 and 12 years and costing about £350 million
(US$600 million). It involves a survey of a large number of potentially useful chemicals, and animal and human (clinical) trials, before a licence can be granted by bodies such as the US Food and Drug Administration, or the UK Medicines Control Agency. Similar bodies exist in other countries. The development of a herbal product does not usually seem to appeal to major pharmaceutical companies, because of the cost involved, the complexity of the chemical make-up of the product, and the difficulty of patenting. Nevertheless, the marketing of herbal medicines is now attracting the attention of some large pharmaceutical companies.
In those countries where herbal medicines may be licensed, proof of efficacy (ability to achieve claimed actions) can be obtained from experiments and clinical studies (animal and human), and if these are not fully available then consideration is given to traditional experience of the product.
Germany has a long history of using herbal medicines.In the late 1970s an expert committee of physicians, pharmacists, and others was established to report on the safety and efficacy of a number of herbal medicines. The results were published as the Commission E monographs, later translated into English in the USA. These monographs were comprehensive, covering uses, contraindications (interference with existing conditions), side-effects, interactions with other drugs, chemical constituents, and dosage. The information was taken from clinical studies and other sources.
Monographs were produced on about 400 herbal medicines, about a third of which were not approved. Another similar project is the European Scientific Cooperative on Phytotherapy (ESCOP) which, in addition to other activities, has produced a number of herbal monographs. Even if herbal products are sold as dietary supplements,i.e, without therapeutic claims, there is usually information on dosage, often with a statement of standardization to the presumed active principles. Clearly, dosage is important for all medicines, and for herbals it is one area that could warrant further research. A number of the German Commission E monographs refer to different ginkgo extracts, but only one is supported. Some herbal products are mixtures of species, and it is difficult in these cases to be clear about the active principles involved. When presumed active principles have been isolated from herbal material, they do not necessarily have the same therapeutic effect as the complete material which suggests that either the presumption is wrong or that the therapeutic effect is the result of an interaction between the chemical substances in a herb. In Western countries, physicians vary in their interest in herbal medicine.
Some 70% of physicians in Germany prescribe herbal products; in the UK there is an increasing but still limited interest. Whatever the situation, a patient should tell his or her doctor if herbal medicines are being used, because they may interact with the synthetic medicine being prescribed. This, of course, assumes that the physician has a knowledge of herbal medicines. It must be realized that a patient may feel that a herbal medicine is producing good results. This could well be a psychological (a placebo) rather than a physiological effect; nevertheless, in some situations this might be a satisfactory state of affairs.
The published literature reveals a vast number of scientific and clinical investigations into herbal products, although these may be restricted with certain species. There seems to be a place for herbal medicine in our culture, but more research is required into certain aspects, such as active principles, purification, dosage, and control.
It should be pointed out that self-diagnosis and self-medication can be dangerous a number of fatalities have occurred through the ingestion of herbal products, and
many herbal medicines should not be taken during pregnancy and lact(breastfeeding). Expert advice should always be sought. In some countries, e.g. Germany, a physician may have had training in herbal medicine; in others this may not be the case, and in those situations an approach should be made to an experienced and professional herbalist. For example, in the UK there is the
National Institute of Medical Herbalists, whose members observe a strict code of ethics.
The development of a new medical drug by a pharma ceutical company is a long and expensive process, taking between 10 and 12 years and costing about £350 million
(US$600 million). It involves a survey of a large number of potentially useful chemicals, and animal and human (clinical) trials, before a licence can be granted by bodies such as the US Food and Drug Administration, or the UK Medicines Control Agency. Similar bodies exist in other countries. The development of a herbal product does not usually seem to appeal to major pharmaceutical companies, because of the cost involved, the complexity of the chemical make-up of the product, and the difficulty of patenting. Nevertheless, the marketing of herbal medicines is now attracting the attention of some large pharmaceutical companies.
In those countries where herbal medicines may be licensed, proof of efficacy (ability to achieve claimed actions) can be obtained from experiments and clinical studies (animal and human), and if these are not fully available then consideration is given to traditional experience of the product.
Germany has a long history of using herbal medicines.In the late 1970s an expert committee of physicians, pharmacists, and others was established to report on the safety and efficacy of a number of herbal medicines. The results were published as the Commission E monographs, later translated into English in the USA. These monographs were comprehensive, covering uses, contraindications (interference with existing conditions), side-effects, interactions with other drugs, chemical constituents, and dosage. The information was taken from clinical studies and other sources.
Monographs were produced on about 400 herbal medicines, about a third of which were not approved. Another similar project is the European Scientific Cooperative on Phytotherapy (ESCOP) which, in addition to other activities, has produced a number of herbal monographs. Even if herbal products are sold as dietary supplements,i.e, without therapeutic claims, there is usually information on dosage, often with a statement of standardization to the presumed active principles. Clearly, dosage is important for all medicines, and for herbals it is one area that could warrant further research. A number of the German Commission E monographs refer to different ginkgo extracts, but only one is supported. Some herbal products are mixtures of species, and it is difficult in these cases to be clear about the active principles involved. When presumed active principles have been isolated from herbal material, they do not necessarily have the same therapeutic effect as the complete material which suggests that either the presumption is wrong or that the therapeutic effect is the result of an interaction between the chemical substances in a herb. In Western countries, physicians vary in their interest in herbal medicine.
Some 70% of physicians in Germany prescribe herbal products; in the UK there is an increasing but still limited interest. Whatever the situation, a patient should tell his or her doctor if herbal medicines are being used, because they may interact with the synthetic medicine being prescribed. This, of course, assumes that the physician has a knowledge of herbal medicines. It must be realized that a patient may feel that a herbal medicine is producing good results. This could well be a psychological (a placebo) rather than a physiological effect; nevertheless, in some situations this might be a satisfactory state of affairs.
The published literature reveals a vast number of scientific and clinical investigations into herbal products, although these may be restricted with certain species. There seems to be a place for herbal medicine in our culture, but more research is required into certain aspects, such as active principles, purification, dosage, and control.
It should be pointed out that self-diagnosis and self-medication can be dangerous a number of fatalities have occurred through the ingestion of herbal products, and
many herbal medicines should not be taken during pregnancy and lact(breastfeeding). Expert advice should always be sought. In some countries, e.g. Germany, a physician may have had training in herbal medicine; in others this may not be the case, and in those situations an approach should be made to an experienced and professional herbalist. For example, in the UK there is the
National Institute of Medical Herbalists, whose members observe a strict code of ethics.
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