ABSTRACT
OBJECTIVE: To investigate the short-term and long-term clinical effects of otopoint pellet-pressing combined with medication in the treatment of patients with migraine without aura and its impact on plasma 5-hydroxytryptamine(5-HT) and calcitonin gene-related peptide(CGRP) contents. METHODS: Patients with migraine without aura were randomly divided into medication(control) group(n=48) and otopoint pellet-pressing plus medication (treatment) group(n=49). Patients of the control group were given oral Flunarizine capsules(10 mg/time) twice a day, and those of the treatment group received same dosage of Flunarizine and pellet-pressing of otopoints Nao(Brain), Nie (Temporal), Shenmen(Shenmen), Jiaogan(Sympathy) and Pizhixia(Subcortex), 2 min/point, 3 times a day, simultaneously. The treatment was conducted for 1 month. The short-term and long-term clinical effects were evaluated according to Yang and colleagues' methods, and "Guiding principles for clinical research of new TCM drugs (trial)". The contents of plasma 5-HT and CGRP were detected by ELISA. RESULTS: After one month's treatment, of the 48 and 49 patients in the control and treatment groups, 10(20.83%)and 17(34.69%) were under control, 19(39.59%)and 23(46.94%) experienced marked improvement, 10(20.83%)and 7(14.29%)were effective, 9(18.75%) and 2(4.08%) failed, with the total effective rates being 81.25% and 95.92%, respectively. Six months' follow-up survey showed that of the 48 and 49 patients in the control and treatment groups, 4(8.33%)and 11(22.45%) were under control, 20(41.67%)and 24(48.98%)experienced marked improvement, 11(22.92%)and 9(18.37%)were effective, and 13(27.08%) and 5(10.20%)failed, with the total effective rates being 72.92% and 89.80%, respectively. The number of headache attacks, duration of each attack and the degree of headache were significantly decreased after 1 and 6 months' treatment in both groups in comparison with their own pre-treatment (P<0.05). The contents of plasma 5-HT at the time-points of 1 and 6 months were markedly increased (P<0.05), and those of plasma CGRP at the two time points markedly decreased in both groups in comparison with their own pre-treatment (P<0.05). The therapeutic effects of the treatment group were obviously superior to those of the control group in lowering the number of headache attacks, duration of each attack and the degree of headache and plasma CGRP content, as well as in increasing plasma 5-HT levels after 1 and 6 months' treatment (P<0.05). CONCLUSION: Otopoint pellet-pressing combined with oral administration of Flunarizine can significantly improve the clinical symptoms in patients with migraine without aura, and possess a stable long-term clinical effect, which may be associated with its effect in increasing plasma 5-HT and decreasing CGRP levels.