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Background: Auriculotherapy is often applied in the clinical application of traditional Chinese medicine (TCM). Objective: To observe the effect of auriculotherapy on patients with imbalanced constitution in TCM base on the theory of TCM, disease prevention treatment. Methods: Eight hundred and fortyseven patients with imbalanced constitutions of TCM were randomly assigned into two groups, Group 1 (TCM decoction plus auriculotherapy, n = 423) and Group 2 (TCM decoction, n = 424). Both groups were offered TCM decoction for twelve weeks. Patients in Group 1 were also offered auriculotherapy once a week. The scores of the Classification and Determination of Constitutions in TCM Questionnaire (CDCTCMQ) were applied to evaluate the effect at baseline and the end of the study. Results: After 12 weeks of treatment, three hundred and seventy-two participants in Group 1 and three hundred and sixty-seven participants in Group 2 finished this trial. Compared with Group 2, there were significant decrease of the scores of TCM constitutions of qi-deficiency, yang-deficiency, yin-deficiency, blood stagnation and dampness-heat in Group 1 (P < 0.05). The effective rates of qi-deficiency, phlegm-dampness and dampness-heat in Group 1 were significantly higher than those in Group 2 (P < 0.05). And the total effective rates were significantly higher in Group 1 than in Group 2 (P < 0.001). Conclusion: Auriculotherapy has obvious effect on patients with imbalanced constitutions in TCM, and it is easy to operate for practitioners and acceptable for patients. It can be recommended as a new intervention way of health care and the new direction to the theory of TCM, disease prevention treatment. [ABSTRACT FROM AUTHOR]