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 chronic pelvic inflammatory disease treatment by acupuncture plus Chinese Herbal Medicine with the hope of further standardizing the clinical curative effect and achieving good social benefits.MethodsResearch objects are 60 patients who met the diagnosis criteria of chronic pelvic inflammatory disease and were treated from February 2010 to December 2010 in TCM clinics in Taiwan. They are randomly assigned to the Trial Group (acupuncture+Chinese Herbal Medicine) and the Control Group (pure Chinese Herbal Medicine) with 30 cases in each group. One treatment daily.1 month makes 1 treatment period and there's 1 treatment period in total. Evaluate with TCM Symptom Quantization Scale and Local Sign Evaluation Scale. Test the vaginal sanitation, the pelvic cavity fluidity and inflammatory mass. Observe its efficacy and conduct safety examination.Use EPIDATA 3.1 software to set up a database and analyze with SPSS 15.0. The measurement data is expressed by mean±standard deviation ((?)±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 the x test and the interclass comparison of ranked data by Wilcoxon rank sum test. Statistical graphics were produced by software Graph Pad Prism 4.03. Results60 qualified cases of this research are clinic patients with age between 18 to 55 years old and the course of 1 year-6 years.30 are in the Trial Group with an average age of 33.55±6.75 years old and average disease duration 4.28±1.58 years; 30 cases in the Control Group with an average age of 34.48±5.88 years old and the average disease duration 5.04±2.02 years. The Trial Group adopts acupuncture plus Chinese Herbal Medicine and the Control Group adopts the pure Chinese Herbal Medicine.In comparing the baseline features of patients, there's no statistical significant difference in two groups'age, disease duration, disease condition, comprehensive score before treatment, clinical syndrome score, local sign score, pelvic cavity fluidity and inflammatory mass which indicates that the baseline data of two groups are comparable.After one treatment period, both groups can obviously reduce the chronic pelvic inflammation patients'comprehensive score, syndrome score, local sign score and the major symptom score of inferior abdominal pain, lumbosacral pain, abnormalities of leucorrhea, etc. The interclass comparison shows statistically significant difference (P<0.05). These indicate that acupuncture combined with Chinese Herbal Medicine can effectively improve the clinical symptoms of chronic pelvic inflammation patients, especially the inferior abdominal pain.After one treatment period, the comparison of two groups'curative effect of pelvic cavity fluidity and inflammatory mass shows the difference is statistically significant (P<0.05). The Trial Group has better curative effect than the Control Group. Indication:acupuncture combined with Chinese Herbal Medicine can effectively improve the chronic pelvic inflammation patients'pelvic cavity fluidity and inflammatory mass.Clinical curative effect:The utility number of patients of comprehensive curative effect of the Trial Group and the Control Group are 26 and 18 respectively and the total effective rates are 86.7% and 60.0% respectively; the total effective rates of two groups'clinical syndrome curative effect are 90.0% and 63.3% respectively; the total effective rates of two groups' local signs are respectively 93.3% and 70.0%. The comparison of two groups' curative effect and the total effective rates shows no statistically significant difference (P<0.05). It is confirmed that acupuncture combined with Chinese Herbal Medicine can enhance the comprehensive curative effect, the clinical syndrome efficacy and local sign curative effect.ConclusionWith the above clinical research results, it is preliminarily confirmed that in the treatment of chronic pelvic inflammatory disease, acupuncture plus Chinese Herbal Medicine is convenient, economical, safe and reliable and has significant curative effect, therefore it's worth of further clinical recommendation. |