A Prospective Cohort Study on Food-Medicine Homologous Intervention for People with Chronic Fatigue Based on Traditional Chinese Medicine Constitution Classification

Abstract

This 12-month large-sample prospective cohort study explored the clinical efficacy and mechanism of stepped food-medicine homologous intervention guided by Traditional Chinese Medicine (TCM) constitution classification for Chronic Fatigue Syndrome (CFS). A total of 1,126 CFS patients were enrolled and divided into an observation group and a control group, with 563 cases in each group. The control group received routine health education, while the observation group was given individualized stepped food-medicine homologous intervention according to constitution differentiation. Results showed that the core biased constitutions among CFS participants were Qi‑deficiency (38.72 %), liver‑qi stagnation (26.38 %), and phlegm‑dampness (19.18 %). After 12-month intervention, the total Fatigue Scale (FS) score in the observation group decreased by 18.64 ± 4.21 points, which was significantly superior to 7.12 ± 3.56 points in the control group (P < 0.001). The liver-Qi stagnation and Qi-deficiency constitutions achieved the highest intervention effective rates of 89.2 % and 86.7%, respectively; the phlegm-dampness constitution obtained prominent long-term benefits. The mediating effect of constitution improvement accounted for 62.8 %, serving as the core action pathway. The adverse-event rate was 2.14 %, the adherence rate 94.7 %, and the dropout rate 3.2 %. In conclusion, this individualized dietary intervention is safe and effective. It can durably relieve CFS symptoms by correcting constitution bias and is worthy of precise clinical promotion.