Controlled Clinical Trial Of Treating Primary Dysmenorrheal With Abdominal Acupuncture And Placebo Acupuncture

ObjectiveTo objectively evaluate the clinical effectiveness and safety of treating primary dysmenorrheal with abdominal acupuncture through controlled clinical trial of treating primary dysmenorrheal with abdominal acupuncture and placebo acupuncture.Methods59cases consistent with the standard were recruited and randomly divided into treatment group (29cases) and control group (29cases).The points’selections of both groups were Yinqiguiyuan, which included Zhongwan, Xiawan, Qihai and Guanyuan, Zigong and Xiaf engshidian. For treatment group, the operator located the acupuncture points under the standardization of abdominal acupuncture with the acupuncture needles of0.25mm×25mm or0.25mmX40mm. The needles were punctured into the subcutaneous tissue quickly and were touched into the earth part slowly for the points of Yinqiguiyuan while into the heaven part for the points of Zigong and Xiafengshidian. The patients could feel no needling sensation or feel a bit of bloating sensation. It was unnecessary to do the acupuncture manipulation such as lifting, inserting, twirling and rotating. For control group, telescopic blunt placebo needles were adopted. The bases of the placebo needles were fixed on the points as well as treatment group, and the left hand was used to fix needle pipes while the right hand was used to rap the blunt needles quickly, so that the patient could feel the acmesthesia on the,skin. Keep the acupuncture needles for30minutes for both groups.For both groups, take treatment every other day during10days before menstruation. One course of treatment was one menstrual cycle for5treatments, and there were3courses totally for15treatments.Visual Analogue Scale (VAS) and TCM Syndrome Score (SDSVD) would be exploited as the measuring scale before treatment, after1,2,3course of treatment and follow-up after1month between and within two groups. For statistical analysis, SPSS19.0would be employed to establish the database. Chi square test helped to analyze enumeration data, x±s as well as T test for the description of measurement data, and Ridit text for ranked data. The level of significance test was a=0.05.Results1.58cases were brought into this study, which included4shedding cases and2exclusion cases in the control group. The shedding rate was6.90%and the exclusion rate was3.45%.2. Comparison of baseline levels:Statistical analysis showed that there were no significant differences among age, stage, VAS and SDSVD before treatment (P>0.05), indicating two groups were comparable.3. Visual Analogue Scale (VAS):①For treatment group:In the four assessment time spots of after1,2,3course of treatment and follow-up after1month, the VAS scores were3.955±1.30,3.190±1.23,2.735±1.31and2.000±0.88. In comparison with before treatment, the scores of t were5.922,10.313,8.552and11.330, and the scores of P were all0.000. The differences had significant statistically significance.②For control group:In the four assessment time spots of after1,2,3course of treatment and follow-up after1month, the VAS scores were4.624±1.02,4.330±1.16,4.424±1.24and4.518±1.47. In comparison with before treatment, the scores of t were3.367,2.956,2.768and2.212, and the scores of P were0.004,0.009,0.140and0.420. The differences had statistically significances after1,2course of treatment, while had no significant differences after3course of treatment and follow-up after1month.③In comparison between two groups:In the four assessment time spots of after1,2,3course of treatment and follow-up after1month, the scores of t were3.468,2.639,1.321and2.547, and the scores of Pwere0.027,0.042,0.031and0.001. The differences had statistically significance after1,2,3course of treatment and significant statistically significance for follow-up after1month. It showed that the treatment group is better in lowering the VAS score.④There were7cases of cure,13cases of obvious improvement,4cases of good results in the treatment group, while1cases of cure,4cases of obvious improvement,8cases of good results in the control group. The efficacious rate in treatment group was82.76%, and the one in control group was56.52%. In comparison of the cure efficiency rate between two groups, the Chi-square value was11.460and the score of P was0.001, which indicated the differences had significant statistically significance. In comparison of the total effective rate between two groups, the Chi-square value was4.302and the score of P was0.038, which indicated the differences had statistically significance.4. TCM Syndrome Score (SDSVD):①For treatment group:In the four assessment time spots of after1,2,3course of treatment and follow-up after1month, the SDSVD scores were19.375±8.31,16.500±7.24,15.225±7.56and16.925±7.22. In comparison with before treatment, the scores of t were5.738,7.945,9.609and6.712, and the scores of P were all0.000. The differences had significant statistically significance.②For control group:In the four assessment time spots of after1,2,3course of treatment and follow-up after1month, the SDSVD scores were26.059±8.60,25.618±8.00,25.059±7.80and26.265±8.17. In comparison with before treatment, the scores of t were1.189,1.176,1.912and0.822, and the scores of Pwere0.252,0.257,0.074and0.423. It had no significant differences.③In comparison between two groups:In the four assessment time spots of after1,2,3course of treatment and follow-up after1month, the scores of t were-1.753,-2.279,-2.440and-2.125, and the scores of P were0.048,0.029,0.020and0.041. The differences had statistically significance. It showed that the treatment group was better in lowering the SDSVD score.④There were6cases of clinical control,9cases of obvious improvement,12cases of good results in the treatment group, while0cases of clinical control,5cases of obvious improvement,8cases of good results in the control group. The efficacious rate in treatment group was93.10%, and the one in control group was56.52%. In comparison of the cure efficiency rate between two groups, the Chi-square value was4.873and the score of P was0.027, which indicated the differences had statistically significance. In comparison of the total effective rate between two groups, the Chi-square value was9.670ind the score of Pwas0.002, which indicated the differences had significant statistically significance.5. There were no adverse reactions before, during and after treatment.Conclusion Both abdominal acupuncture and placebo acupuncture could decrease the scores of Visual Analogue Scale (VAS) and TCM Syndrome Score (SDSVD), but abdominal acupuncture is better than placebo acupuncture. There were no adverse reactions during treatment.