A novel approach to evaluate Traditional Chinese Medicine treatment outcomes using pattern identification.

INTRODUCTION: Traditional Chinese Medicine (TCM), a modern interpretation of Chinese medicine, developed in the 1950s. It differentiates biomedical diseases into patterns. Each pattern comprises symptom/signs that have their own unique treatment protocol. Most TCM research has used fixed formula treatments for Western-defined diseases with outcomes often measured using objective biomedical markers. More recently, a number of trials have attempted to accommodate TCM clinical practice within the framework of rigorous evidence-based medical research. The aim of this article is to describe a novel outcome measure based on TCM patterns that was used in a pilot study for people with hepatitis C virus (HCV). METHODS: Sixteen (16) participants with HCV were enrolled in a randomized, controlled pilot study and allocated to a treatment or control group. TCM pattern diagnosis was obtained at baseline and used to guide acupuncture treatment for the treatment group. Each individual's primary, secondary, and tertiary TCM patterns were identified, which involved the systematic evaluation of the participant's information against the TCM patterns and conversion of the pattern to a percentage. Baseline and postintervention percentages for the three TCM patterns for the two groups were compared to assess change. RESULTS: There was a significant mean percentage decrease in pattern expression at week 12 compared to baseline for the secondary and tertiary patterns of the treatment group (56.3% versus 47.5%; p = 0.045 and 48.1% versus 33.6%; p = 0.037, respectively). No significant change was found for the primary, secondary, or tertiary patterns for the control group or for the primary pattern associated with the treatment group. CONCLUSIONS: The quantification of TCM patterns in this study permitted statistical evaluation of TCM pattern change. Previously, TCM pattern identification had only been used as a basis for developing the treatment protocol in clinical trials. This is the first time it has been employed as a novel outcome measure.