Guidance on assessing efficacy and harms in traditional Chinese medicine dietotherapy: Introducing the Dietotherapy Intention, Evaluation, and Harm Tracking (DIET) pathway

Abstract

IntroductionTraditional Chinese medicine (TCM) dietotherapy, based on the principle of “medicine and food homology”, is widely used across diverse healthcare domains. However, the dual attributes of “medicine” and “food” possessed by medicinal and edible herbs make it challenging to assess the efficacy and harms of TCM dietotherapy using currently available methodological systems. This limits the advancement of health services and regulations in this field. This study introduces the Dietotherapy Intention, Evaluation, and Harm Tracking (DIET) pathway, a staged approach for assessing the efficacy and harms of TCM dietotherapy. ResultsThe DIET pathway was developed through comprehensive analysis and two rounds of Delphi expert consensus. Based on the distinct characteristics and management requirements of TCM dietotherapy, the DIET pathway divides the assessment process into three stages: Stage 1 (Intention) aims to establish intended efficacy goals, Stage 2 (Evaluation) aims to validate efficacy and harms, and Stage 3 (Harm Tracking) aims to assess harms in special scenarios. Elaborate methodological guidelines are provided for each stage. ConclusionThe DIET pathway has created a methodological environment that enables systematic and efficient assessment of the efficacy and harms of TCM dietotherapy regimens, which will facilitate the application and management of TCM dietotherapy.