General Guidelines for Methodologies on Research and Evaluation of Traditional Medicine
(2000; 80 pages) [French] [Spanish] View the PDF document
Table of Contents
View the documentAcknowledgements
View the documentForeword
Open this folder and view contentsIntroduction
Open this folder and view contents1. Methodologies for Research and Evaluation of Herbal Medicines
Open this folder and view contents2. Methodologies for Research and Evaluation of Traditional Procedure-Based Therapies
Open this folder and view contents3. Clinical Research
Open this folder and view contents4. Other Issues and Considerations
View the documentReferences
Open this folder and view contentsAnnexes
Open this folder and view contentsAnnex I. Guidelines for the Assessment of Herbal Medicinesa
Open this folder and view contentsAnnex II. Research Guidelines for Evaluating the Safety and Efficacy of Herbal Medicinesa
Open this folder and view contentsAnnex III. Report of a WHO Consultation on Traditional Medicine and AIDS: Clinical Evaluation of Traditional Medicines and Natural Productsa
Open this folder and view contentsAnnex IV. Definition of Levels of Evidence and Grading of Recommendationa
Close this folderAnnex V. Guidelines for Levels and Kinds of Evidence to Support Claims for Therapeutic Goodsa
View the documentClaims Based on Evidence of Traditional Use
View the documentWhat Kinds of Claims Does the Evidence Support?
View the documentRegistrable Diseases List
View the documentClaims Based on Evidence of Traditional Use
Open this folder and view contentsAnnex VI. Guidelines for Good Clinical Practice (GCP) for Trials on Pharmaceutical Productsa
Open this folder and view contentsAnnex VII. Guidance for Industry: Significant Scientific Agreement in the Review of Health Claims for Conventional Foods and Dietary Supplementsa
Open this folder and view contentsAnnex VIII. Guideline for Good Clinical Practicea
Open this folder and view contentsAnnex IX. WHO QOL (Quality of Life) User Manual: Facet Definitions and Response Scalesa
View the documentAnnex X. Participants in the WHO Consultation on Methodologies for Research and Evaluation of Traditional Medicine
 

Claims Based on Evidence of Traditional Use

In Australia claims which may be made about therapeutic goods using evidence of traditional use are categorised into two levels-medium and general-according to the relative strength of the claim. Medium level claims are stronger claims but their wording is required to be qualified and more evidence is required to support them. This general approach is summarised in Table 4. Specific approaches have been developed for homeopathic and aromatherapy products. These approaches are summarised in Tables 5 and 6 respectively. A summary of the definitions of the types of claims is provided at Attachment 1 to these guidelines.

Table 4. Levels and types of claims and the evidence required to support them - based on evidence of traditional use

Level of claim

Type of claim

Wording of Claim2

Evidence required to support claim

MEDIUM

• Health enhancement1

• Reduction of risk of a disease/disorder.

• Reduction in frequency of a discrete event.

• Aids/assists in the management of a named symptom/disease/disorder.

• Relief of symptoms of a named disease or disorder.5,6

This (tradition) medicine has been used for (indication)5. This claim is based on traditional use3.

Primary evidence:
Two of the following four sources that demonstrate adequate support for the indications claimed:

1. TGA-approved Pharmacopoeia.

2. TGA approved Monograph.

3. Three independent written histories of use in the classical or traditional medical literature4.

4. Availability through any country’s government public dispensaries for the indication claimed.

Notes:

1 Health enhancement claims apply to enhancement of normal health. They do not relate to enhancement of health from a compromised state.

2 Or words to this effect

3 Where scientific evidence is available to support the entire claim, the words, “This claim is based on traditional use” is optional.

4 In cultures where an oral tradition is clearly documented, evidence of use from an oral tradition would be considered acceptable provided the history of use was authenticated. Modern texts that accurately report the classical or traditional literature may be used to support claims.

5 Terms must be in the original language of the traditional medical culture, for example “Shen” not “Kidney” in TCM.

6 All claims relating to symptoms must be accompanied by the advice “If symptoms persist consult your healthcare practitioner”.

Table 4. Levels and types of claims and the evidence required to support them - based on evidence of traditional use (cont’d)

Level of claim

Type of claim

Wording of Claim1

Evidence required to support claim

GENERAL

• Health maintenance, including for example claims relating to nutritional support.

• Relief of symptoms (not referring to a disease or disorder)2.

• Claims for traditional syndromes and actions 3.

This (tradition) medicine has been traditionally used for (indication)3.

Primary evidence:
One of the following four sources that demonstrates adequate support for the indications claimed:

1. TGA-approved Pharmacopoeia.

2. TGA-approved Monograph.

3. Three independent written histories of use in the classical or traditional medical literature4.

4. Availability through any country’s government public dispensaries for the indication claimed.

Notes:

1 Or words to this effect.

2 All claims relating to symptoms must be accompanied by the advice “If symptoms persist consult your healthcare practitioner”.

3 Terms must be in the original language of the traditional medical culture, for example “Shen” not “Kidney” in TCM.

4 In cultures where an oral tradition is clearly documented, evidence of use from an oral tradition would be considered acceptable provided the history of use was authenticated. Modern texts that accurately report the classical or traditional literature may be used to support claims.

Table 4. Levels and types of claims and the evidence required to support them - based on evidence of traditional use (cont’d) - non-primary evidence

Supporting evidence

Commonly referred to in appropriate prescribed teaching textbooks used in tertiary-level training of healthcare professionals.

This evidence does not stand alone and may only be used in conjunction with primary evidence.

 

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