OBJECTIVE: To evaluate the analgesic and therapeutic effects of electro-superficial-acupuncture (ESA) of Sanyinjiao (SP6) for treating primary dysmenorrhea (PD). METHODS: A total of 171 patients were randomly divided into ESA (n=57), superficial acupuncture (SA) (n=57) and medication (n=57) groups. For patients in SA group, bilateral SP6 were punctured superficially with special single-use needles, and for those in ESA group, after puncturing, electric stimulation (60 Hz, 2-3 V) was applied to SP6 for 30 min. Patients of medication group were ordered to take Brufen sustained-release capsules (0.3 mg, b. i. d., for 3 days), then, take it again from the 3rd day on before the onset of menstruation to the 2nd day after the onset. The cumulative score of clinical symptoms were evaluated before and after the treatment. RESULTS: Comparison among 3 groups showed that the difference values of score (pre-treatment--post-treatment) of both ESA and SA groups were significantly bigger than that of medication group (P<0.001). After the treatment from 1 min to 30 min, patients with complete relief of dysmenorrhea of ESA group were significantly more than those of SA group during the 1st menstrual cycle (P<0.05). Results of intention-to-treat (ITT) analysis showed that of the three 57 cases in ESA, SA and medication groups, the cured cases were 40, 38 and 10, the markedly effective were 9, 10 and 27, the effective were 5, 4 and 7, and the failed were 3, 5 and 13, with the total effective rates being 94.74%, 91.23% and 77.19% respectively. The effective rates of ESA and SA groups were significantly higher than that of medication group (P<0.01), and the results of per-protocol analysis (PP) were similar to those of ITT analysis. CONCLUSION: The analgesic effect of both ESA and SA at SP6 for PD patients is significantly better than that of oral administration of Brufen.
RCT Entities:
OBJECTIVE: To evaluate the analgesic and therapeutic effects of electro-superficial-acupuncture (ESA) of Sanyinjiao (SP6) for treating primary dysmenorrhea (PD). METHODS: A total of 171 patients were randomly divided into ESA (n=57), superficial acupuncture (SA) (n=57) and medication (n=57) groups. For patients in SA group, bilateral SP6 were punctured superficially with special single-use needles, and for those in ESA group, after puncturing, electric stimulation (60 Hz, 2-3 V) was applied to SP6 for 30 min. Patients of medication group were ordered to take Brufen sustained-release capsules (0.3 mg, b. i. d., for 3 days), then, take it again from the 3rd day on before the onset of menstruation to the 2nd day after the onset. The cumulative score of clinical symptoms were evaluated before and after the treatment. RESULTS: Comparison among 3 groups showed that the difference values of score (pre-treatment--post-treatment) of both ESA and SA groups were significantly bigger than that of medication group (P<0.001). After the treatment from 1 min to 30 min, patients with complete relief of dysmenorrhea of ESA group were significantly more than those of SA group during the 1st menstrual cycle (P<0.05). Results of intention-to-treat (ITT) analysis showed that of the three 57 cases in ESA, SA and medication groups, the cured cases were 40, 38 and 10, the markedly effective were 9, 10 and 27, the effective were 5, 4 and 7, and the failed were 3, 5 and 13, with the total effective rates being 94.74%, 91.23% and 77.19% respectively. The effective rates of ESA and SA groups were significantly higher than that of medication group (P<0.01), and the results of per-protocol analysis (PP) were similar to those of ITT analysis. CONCLUSION: The analgesic effect of both ESA and SA at SP6 for PDpatients is significantly better than that of oral administration of Brufen.