| ObjectiveBy using the Randomized Controlled designed method, the objective of this study was to evaluate objectively the clinical effectiveness and safety of Warm Needle-Moxibustion therapy for primary dysmenorrhea (PD).MethodsThe patients with primary dysmenorrhea are the research object, which come from the doctor Ming's clinic. Sixty eight cases of PD were randomly divided 1:1 into a treatment group (Warm Needle-Moxibustion and Chinese medicine group) and a control group(Chinese medicine group). The study adapted the simple randomize method to divide the patients.Therapeutic Method:For the treatment group:points:qihai (BL24),gua nyuan (BL26),zigong (Ex-CA1),all points are chosen both; method:The patient was in supine posture, using the 34 number needles (1.5Inch in length) of Taiwan YuGuang brand, after disinfecting the needles, then inserting the needles vertically into all points mentioned above. In this process, we used the even reinforcing-reducing method to obtain Qi. After the arival of Qi, a long moxa stick in length of 2.5 cm was put on the needle handle and ignited from botom of moxa stick. To avoid scalding the skin by the moxa ashes, we put a piece of thin paper with 2.5cm*2.5cm on the skin and under the burning moxa stick. After the moxa stick burning out, the needles were still reserved for 30 minutes. The treatment was given once every day, and continuously for 5 days, then arranging 2 days to have a rest. One month was one course and totally,2 courses were given. Chinese Medicine:Herba Leonuri granules. Usage:Before one week of the menstruation every time, patients began to take the Herba Leonuri granules one bag each time and 3 times one day for 2 weeks.2 weeks as one course and totally,2 courses were given. Controlled group:Chinese Medicine:Herba Leonuri granules. Usage:Before one week of the menstruation every time, patients began to take the Herba Leonuri granules one bag each time and 3 times one day for 2 weeks.2 weeks as one course and totally,2 courses were given. During the course of clinical trial, any other drugs which might have therapeutic effect should not be taken.Statistics methods:all segment information was dealt withχ2test, rating information with two samples prepared Wilcoxon Rank sum test (correction), two samples mean prepared with t test or Wilcoxon Rank sum test, yet before and after self-cooperation was handled by t test or Wilcoxon Paired Rank Sum Test. All statistics analysis was dealt with SPSS17.0 statistics soft.ResultsCompared with two groups before treatment, there was no statistical significance in the differences of age,disease course,disease severity,condition of menstruation,clinical symptom,basic temperature,tongue manifestation,pulse manifestation, etc.The total effective rate:The recent cure rate was 55.8% in the treatment group and 47.0% in the control group; the significant efficiency was 26.4% and 29.4% relatively; the efficient was 11.7% and 14.7% relatively; and the total effective rate was 94.2% in the treatment group and 81.2% in the control group. Afterχ2 test, there was no statistical significance in the differences, which suggests that the effectiveness between these two treatments is equal. Compared with two groups after treating 3 months, there was no significance in the differences of improvement of dysmenorrhea,menstrual cycle,menstrual period and menstrual flow; and there was no significance in the differences of recovery rate of menstrual cycle,menstrual period and menstrual flow. Yet there was significance in the differences of disappearance rate of dysmenorrheal after 3 months treatment.For the disappearance rate of clinical symptom and dysmenorrheal accompanying symptoms, there was no difference significantly.Compared with two groups before and after 3 months treatment, there was no significance in the differences of PGF2α,PGE2 level in plasma. Yet compared with pre-treatment, there existed significance in the differences of the level of PGF2αin plasma after 3 months treatment in both groups. There was significance in the differences of PGE2 level in plasma in the treatment group in 3 months. These results suggest considerable effect exist between two therapies in improving the level of PGF2αand PGE2 in plasma and both treatment could significantly improve the PGF2αlevel, however, Warm Needle-Moxibustion therapy was better in improving the PGE2 level.Safety test:Before treatment, the blood routine,urine routine,liver function (GPT),renal function (BUN),cardioelectrogram were tested in both groups and tested again. All the results showed no abnormal. Adverse evens observation:there was no adverse reflect symptoms in the patients after 1 month in both groups. The results suggest the treatment is safe in clinical.ConclusionCompared with using Chinese medicine simply, Warm Needle-Moxibustion therapy could make equal effectiveness and treat safely with Primary Dysmenstrorrhea patients, which should be widely applied.
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