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- Traditional Medicine > Traditional, Complementary and Herbal Medicine
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2.2 Evaluation of Safety and Efficacy
Theories and concepts
The theories and concepts of the various systems of traditional medicine are very important for the research and evaluation of traditional procedure-based therapies. These are discussed in Part 1 (section 1.3).
In general, traditional procedure-based therapies are relatively safe, if they are performed properly by well-trained practitioners. But accidents do occasionally occur, most probably when practitioners are not fully trained. Therapies should be performed within accepted parameters, and the indications for a therapy should be evidence based when possible. Serious adverse effects of therapies are rare, but supportive data on adverse effects are not readily available. Accordingly, the evaluation of adverse effects should be considered a priority area for systematic evaluation of safety of these therapies.
One problem in ensuring safety of a therapy is variable quality control in the manufacture of therapy equipment. The most effective safety measures, therefore, are to ensure that the equipment used is of good quality, as well as ensuring that the practitioners who use it have had sound and well supervised theoretical and practical training. These are the appropriate ways to minimize incompetent examination of patients, incorrect diagnoses and errors of technique, and to ensure that patients are properly selected for traditional procedure-based therapy. It should also ensure that the practitioner knows how to deal with accidents when they do occur, and knows how to refer the patient to an appropriate physician if the patient does not respond to therapy or if there is a medical emergency. The WHO Guidelines on basic training and safety in acupuncture5 promote the safe use of acupuncture to prevent adverse effects occurring in patients who have been incorrectly selected for treatment. Similar guidelines could be prepared by WHO Member States. WHO can provide technical assistance to facilitate such efforts.
Many kinds of traditional procedure-based therapies, such as acupuncture and manual therapies, have already been widely used in health care systems in a number of countries. However, there is an increasing demand to study and evaluate the efficacy of these therapies.
The efficacy of most forms of traditional procedure-based therapies depends heavily upon the proficiency of the practitioners, including their skills and experience. This may partly explain the disparity or inconsistency of results reported by different authors, even though the methodologies of the studies were equally sound. Non-specific effects of the therapy can also contribute to efficacy, but these are difficult to measure or quantify. Therefore, clinical trials and other research methodologies are extremely important in the evaluation of the efficacy of traditional procedure-based therapies (see Part 3).