AIM: To verify the clinical effect of acupuncture and moxibustion in the treatment of bell's palsy by the multi-center demixing randomized controlled trial, and compare with the effects of western medicine. METHODS: A total of 480 patients from out-patient clinic and hospitalization of four centers. Affiliated Hospital of Chengdu University of Traditional Chinese Medicine, First Affiliated Hospital, West China Medical Center, Sichuan University, Jinyang Hospital of Traditional Chinese Medicine, Sichuan People's Hospital were involved in this trial were selected from September 2001 to July 2003. They were divided randomly into 3 groups: 1 Basic group (n = 161). They were treated with basic treatment by delta prenovis, Vit B1, VitB12 and bendazol etc for 2 to 4 weeks. 2 Acupuncture and moxibustion group (n = 160). The filiform needle was used for acupuncture and moxibustion at Dicang (ST4), Jiache (ST6), Hegu (LI4), Yangbai (GB14), Xiaguan (ST7) and Yifeng (SJ17). The double sides of Hegu were gained, and injured side of the others was gained. The acupuncture was performed by filiform needle for 30 minutes retaining needle. The moxibustion was performed at the upper points, suspending moxibustion for 5 minutes, totally 30 minutes, once a day, having a rest for 2 days at weekends, totally treating 4 weeks for 20 times. 3 Base adding acupuncture and moxibustion group. Basic treatment plus acupuncture and moxibustion. The course (acute, non-acute) and patient's condition (mild, severe) was specially taken as two factors of delamination when compared to perform demixing randomized trial. The House-Brackmann scale evaluated the facial nerve function. The facial disability index scale was used to assess the related changes of residual physical disability and social psychology. Meanwhile the effect analysis was conducted between the group and subgroup. RESULTS: According to the intention-to-treat analysis, 439 cases were involved in the result analysis. (1) Comparison of the effect in subgroup of each group. The effect of acute mild facial paralysis in the basic group was better than that of the acute severe, non-acute mild and non-acute severe (p < 0.05, 0.01). The effect of acute mild facial paralysis in the base adding acupuncture and moxibustion group was better than that of acute (p < 0.05). The effect of acute mild facial paralysis in the acupuncture and moxibustion group was better than that of non-acute severe (p < 0.01). (2) According to course and patient's condition performing delamination analysis. The effect of mild neural paralysis no matter acute or subacute 3 groups had no difference (p > 0.05), and the effects of severe neural paralysis no matter acute or subacute basic adding acupuncture and moxibustion group and acupuncture and moxibustion group were better than that in the basic group, and that in the acupuncture and moxibustion group was the best (p < 0.05, 0.01). CONCLUSION: In terms of mild Bell paralysis, no matter acute or non-acute, the three treatment methods can be applied, while for the severe Bell paralysis, no matter acute or non-acute, the effect of acupuncture and moxibustion treatment is better than that of the medical treatment.

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