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OBJECTIVE:To observe the clinical effect of pricking and penetrating moxibustion therapy on refractory insomnia.METHODS:Totally 60 subjects were randomly divided into treatment group and control group,30 in each group.The treatment group was treated with pricking and penetrating moxibustion therapy,the control group with penetrating moxibustion therapy,the treatment was given once every day,two groups of patients were treated 20 times,compared the efficacy,pinsburgh sleep quality index (PSQI) and Traditional Chinese Medicine symptom,safety evaluation between the two groups.RESULTS:Compared with 10,20 times after the treatment,the effective rate of the treatment group (93.3％) higher than that of the control group (80.0％) (P ＜ 0.05);Compared with before treatment,20 times after treatment,the PSQI and TCM symptom patt scores of the two groups were significantly decreased (P ＜ 0.01);Compared with 10,20 times after the treatment,the treatment group are better than the control group in improving the total score and the integral of PSQI (P ＜0.05 or P ＜ 0.01);The treatment group are better than the control group in improving the TCM symptom patt score,difficulty in going to sleep,palpitation,amnesia,fidget,sweating,impaired concentration (P ＜ 0.01 or P ＜ 0.05).CONCLUSION:The pricking and penetrating moxibustion therapy is safe and effective in the treatment of refractory insomnia and the treatment can improve the curative effect of the therapy that uses penetrating moxibustion only.