ObjectiveTo observe the clinical efficacy of acupuncture and moxibustion in treatment of functional amenorrhea by establishing artificial cycle. MethodOne hundred and twelve eligible patients with functional amenorrhea were divided into an acupuncture-moxibustion group (64 cases) and a western medication group (48 cases) by adopting random method. According to the pattern differentiation of amenorrhea of traditional Chinese medicine, the patients in the acupuncture-moxibustion group were classified into two types: amenorrhea due to blood depletion and amenorrhea due to stagnation of blood. For patients with amenorrhea due to blood depletion, Guānyuán (▪ CV 4), Zhöngjí (▪ CV 3), Guīlái (▪ ST 29), Géshū (▪ BL 17), Gānshū (▪ BL 18), Píshū (▪ BL 20) and Shènshù (▪ BL 23) were selected. At first, BL 17, BL 18, BL 20 and BL 23 were needled; after deqi, reinforcing method was applied, and the needles were not retained. Then, warming-needle moxibustion was applied at CV 4, CV 3 and ST 29, and the needles were retained for 30 min. For patients with amenorrhea due to stagnation of blood, CV 3, Qìhăi (▪ CV 6), Xuèhăi (▪ SP 10), Sānyīnjiāo (▪ SP 6) and Xíngjiān (▪ LR 2) were selected, reducing method was applied, and the needles were retained for 30 min. The treatment was performed once a day, and treatment for 15 consecutive days were the 1st cycle. The 2nd and 3rd cycles started from the 5th day of menstruation (for the patients still not menstruating, the 2nd and 3rd cycles started from the 29th and 57th days since the 1st day of treatment), and the treatment lasted for 15 days. Three cycles were needed. In the western medicine group, estrogen-progestogen was taken orally for 21 days (one cycle) to establish a artificial cycle. The levels of FSH and LH were tested and compared on the 3rd day of menstruation before treatment and after the 3rd cycle of treatment, and the adverse effects were analyzed statistically. Follow-up visit was conducted for the patients after treatment for three cycles, and the recurrence rate was calculated. ResultThe levels of FSH and LH of patients with functional amenorrhea were enhanced significantly through establishing artificial cycle by acupuncture and moxibustion. There was no significant difference between the acupuncture-moxibustion group and the western medication group in effective rate (P>0.05); but the adverse effect rate (1.49%) and recurrence rate (25.0%) of the acupuncture-moxibustion group were lower than that of the western medication group (with the adverse effect rate of 4.14%, and recurrence rate of 69.8%) (both P<0.05). ConclusionThe levels of FSH and LH of patients with functional amenorrhea can be enhanced significantly through establishing artificial cycle by acupuncture and moxibustion. The efficacy of acupuncture and moxibustion in treatment of functional amenorrhea by establishing artificial cycle is equivalent to that of oral administration of estrogen-progestogen in treatment of functional amenorrhea by establishing artificial cycle, but the adverse effect rate and recurrence rate of acupuncture and moxibustion group are lower.