| ObjectiveThis randomized controlled clinical trial adopts clinical epidemiological, clinical research methodological and mathematical statistical methods and intends to discuss the clinical efficacy and safety of Tourette's Syndrome (TS) treatment by Jin's Three Needle acupuncture therapy with the hope of further standardizing the clinical curative effect and achieving good social benefits.MethodsResearch objects are 60 patients who met the case selection criteria and were treated from January 2010 to December 2010 in Zhu Qiren's TCM Clinic in Taiwan. They are randomly assigned to the Trial Group and the Control Group with 30 cases in each group at the rate of 1:1. One treatment every other day and 15 times of treatment make a treatment period. Quantitize TS patients' clinical symptoms and signs and take them as curative effect evaluation indexes. Conduct the statistical processing, compare the clinical efficacy and conduct safety examination.Use EPIDATA 3.1 software to set up a database and analyze with SPSS 15.0 software. The measurement data is expressed by mean±standard deviation (x±s) and the numeration data by constituent ratio (%). The interclass comparison of the measurement data is expressed by the t-test (t'test or rank sum test for heterogeneity of variance), the self AP comparison by pair t test or Wilcoxon pair rank sum test. The interclass comparison of classified data is expressed by theχ2 test and the interclass comparison of ranked data by Wilcoxon rank sum test. Statistical graphs are produced by software Graph Pad Prism 4.03.Results This randomized double-blind clinical trial has 60 qualified subjects with 30 in the Trial Group and 30 in the Control Group. In comparing the baseline features of patients, there's no statistical significant difference in two groups'age, gender, disease duration, winking and frowning, arm tic disorder, abdominal contracture, palpitation and panic, etc before treatment, which indicates that the baseline data of two groups are consistent and comparable.After treatment, the Trial Group and the Control Group's total curative effect rates of TCM syndromes are respectively 93.3% and 70.0% which indicates the distributional difference has statistical significance (P<0.05). Comparison of two groups'TCM syndrome curative effect shows statistical significance (P<0.05) and the Trial Group is superior to the Control Group.There's no statistically significant difference (P>0.05) in improving symptoms like winking and frowning, abdominal contracture, palpitation and panic which indicates two groups have equivalent curative effect.There's no statistically significant difference (P>0.05) in improving arm tic disorder which indicates two groups have equivalent curative effect.There's no statistically significant difference (P>0.05) in improving vocal tic disorder and movement tic disorder which indicates two groups have equivalent curative effect.There's statistically significant difference (P<0.05) in improving comprehensive trauma conditions which indicates the Trial Groups has better curative effect than the Control Group.Safety examination demonstrates no abnormal changes occur to those with normal blood, urine, stool, liver and kidney function and electrocardiogram examination results which indicate the safe clinical application of this therapy.Conclusion1. Acupuncture plus Chinese Herbal Medicine Therapy has better curative effect than the Simple Acupuncture Therapy in Tourette's Syndrome treatment.2. Acupuncture plus Chinese Herbal Medicine Therapy has better curative effect than the Simple Acupuncture Therapy in relieving patients'arm tic disorder. 3. Acupuncture plus Chinese Herbal Medicine Therapy has better curative effect than the Simple Acupuncture Therapy in the treatment of movement tic disorder and comprehensive trauma. |