Traditional System of Medicine: Concept and Overview

 

Search of absolute emancipation from all types of miseries is as old as the beginning of human civilizations. The evolution of different healing systems in different parts of world is the result of this fact. Asian countries were ahead from the west in the philosophical field. Ayurveda: Evolved in the indian sub-continent as most authentic and well documented system before 5000 years ago. Likewise, Chinese system of traditional medicine, Kampo (Japanese), Tibetan (Himalayan region), Naturopathy, Homeopathy, Aromatherapy etc are the other major traditional system of medicine which have their own speciality and practice history.

Complementary/ alternative medicine (CAM)

The terms "complementary medicine" or "alternative medicine" are used inter-changeably with traditional medicine in some countries. They refer to a broad set of health care practices that are not part of that country's own tradition and are not integrated into the dominant health care system.

 

Characteristics features and major concepts associated with Traditional Medicine (TM).

Ø  Guided by different ancient philosophies

Ø  Focuses not only in medicine but in the whole process of life.

Ø  Holistic system rather than analytical.

Ø  Patient oriented rather than disease oriented.

Ø  Remain almost unchanged over a long period of time

Ø  Natural products, mostly herbs are used as the source of medication.

Ø  Different breathing techniques, postures, exercises, spiritual practices (Shamanism) are also the part of TM therapy.

Ø  TM practitioners ethically do not accept any reward of the therapy.

Traditional Medicine: Evidence of efficacy

Ø  Symptomatological improvements such as relief from pain, fever and discomfort.

Ø  Behavioral changes in case of psychological disorders.

Ø  Modern laboratory and analytical tools also prove the efficacy.

Ø  (Bilirubin level in jaundice, absence of stones)

Ø  Improvement in the quality of life.

Ø  Reverse Pharmacology.

 

Safety, Quality Control and Legal Aspects of TM/Herbal drugs

After the famous St. John’s Wort case and the progressive use of herbal remedies, the issues of safety, quality control and the regulation of traditional medicine was immensely felt and different national and international authorities are these days concerned with the aspects and developing different strategies and implementing them.

 

Ø  WHO has announced the strategy to increase the number of nations having national policy and legal framework to deal with CAM and TM.

Ø  WHO Traditional Medicine Strategy 2014-2023.

·         Key needs identified by the WHO are:

·         National regulation and registration of herbal medicines.

·         Post marketing surveillance of herbal products to monitor safety.

·         Support of clinical research in the use of CAM for common health problems.

·         National monographs preparation for medicinal plants.

Ø  In 1991, WHO published guidelines for the assessment of herbal medicines.

Ø  In 1999, WHO published a volume of herbal monographs to establish guidelines for identity, quality, safety and effective use.

Ø  In 2005, WHO published WHO Global Atlas of Traditional, Complementary and Alternative Medicine which explains such practices of 23 countries.

Ø  The WHO launched WHO Herbal Dictionary (published twice a year, March and September) with the aim to regulate the practice by helping in the following matters.

·         Find the trade names of herbal products and code them in the clinical data.

·         Translate the trade name into active ingredients-plants, parts of plants and extraction types.

·         Analyze the coded data by using the new unique Herbal ATC classification.

In Nepalese National Drug Policy, there is provision which states that ‘Define, Promote and Regulate the Ayurvedic, Homeopathic and other Traditional System of Medicines with Scientific Approach’.

 

Assessment of Quality:

Pharmaceutical assessment

This should cover all important aspects of the quality assessment of herbal medicines. It should be sufficient to make reference to a pharmacopoeia monograph if one exists. If no such monograph is available, a monograph must be supplied and should be set out as in an official pharmacopoeia.

Crude plant material

The botanical definition, including genus, species and authority, should be given to ensure correct identification of a plant. The active and characteristic constituents should be specified and, if possible, content limits should be defined. Foreign matter, impurities and microbial content should be defined or limited.

Finished product

The manufacturing procedure and formula, including the amount of excipients, should be described in detail. A finished product specification should be defined. A method of identification and, where possible, quantification of the plant material in the finished product should be defined. If the identification of an active principle is not possible, it should be sufficient to identify a characteristic substance or mixture of substances (e.g. “chromatographic fingerprint”) to ensure consistent quality of the product. The finished product should comply with general requirements for particular dosage forms.

Stability

The physical and chemical stability of the product in the container in which it is to be marketed should be tested under defined storage conditions and the shelf life should be established.

Toxicological studies

Toxicological studies, if available, should be part of the assessment. Literature should be indicated.

 

Documentation of safety based on experience

As a basic rule, documentation of a long period of use should be taken into consideration when assessing safety. This means that, when there are no detailed toxicological studies, documented experience of long-term use without evidence of safety problems should form the basis of the risk assessment. The assessment of risk, whether independent of dose or related to dose, should be documented. In the latter case, the dosage specification must be an important part of the risk assessment. An explanation of the risks should be given, if possible. Potential for misuse, abuse or dependence must be documented. If long-term traditional use cannot be documented or there are doubts on safety, toxicity data should be submitted.

 

Assessment of Efficacy

Activity

The pharmacological and clinical effects of the active ingredients and, if known, their constituents with therapeutic activity should be specified or described.

 

Evidence required to support indications

The indication(s) for the use of the medicine should be specified. In the case of traditional medicines, the requirements for proof of efficacy should depend on the kind of indication.

Combination products

As many herbal remedies consist of a combination of several active ingredients, and as experience of the use of traditional remedies is often based on combination products, assessment should differentiate between old and new combination products.