The starting point in the design of a research protocol is a complete literature review, including the traditional use of the proposed practice and existing scientific research in the field. Where little or no literature exists, the oral tradition and the source of this tradition need to be clearly stated.
A review of the literature should identify the current level of evidence of efficacy and safety for the proposed intervention. Evaluation of the literature should follow well-established and accepted guidelines (see Part 1, section 1.3). However, meta-analysis in traditional medicine may be difficult, mainly due to the lack of large clinical trials of good quality. In addition, the efficacy of a particular treatment may also vary according to the skill and experience of the practitioner. These issues must be considered and kept in mind.