| Objective:On the basis of the pre-treatment experiences of Idiopathic Chronic Fatigue formed diagnosis and treatment of TCM programs of Idiopathic Chronic Fatigue trough the liver and spleen ZangFu. and.By clinical trials and Randomized double-blind placebo-controlled clinical study to conduct a preliminary evaluation on the effectiveness and safety of the program.Method:1. The program of clinical trials:Treatment programs conducted during the trial period 2012-2014, During the trial of 52 patients with ICF patients eligible for inclusion to analyze and Summarize, from Syndromes and syndrome elements analyzed clinical features, analyzing efficacy of fatigue Relief level (50% decrease as valid),, analyzing herb laws by Chinese Herbal Medicine intensity of DDDs as the index of 52 patients,2.optimization in the early use on the basis of clinical trials, Selecting liver stagnation and heart and spleen deficiency, liver stagnation and the liver fire,and heart and spleen deficiency as two main syndromes, to evaluate the efficacy and safety of the program by randomized, double-blind, placebo-controlled clinical study. To meet the relevant definition of idiopathic fatigue and diagnosis of the 1994 CDC standard, and the liver stagnation and heart and spleen deficiency, liver stagnation and the liver fire and heart and spleen deficiency as two main syndromes for study, by 2:1 stratified random,3 weeks for a course of treatment, to preliminary assessment in two weeks, while the main symptoms of fatigue remission <20%, end of the experiment in advance,and to Differential Treatment in outpatient, Clinical data related to the missing part of the carry-over manner for statistical analysis.Results:Results of clinical trials of the program:(1) syndromes Diagnosis and syndrome elements:Syndrome elements of the first three of 52 patients is Liver depression of 49 cases, Spleen deficiency of 41 cases,Heart qi deficiency of 32 cases; Syndrome Diagnosis of Heart deficiency with Liver stagnation (11/52 cases)And liver depression and Spleen deficiency (8/52 cases) is Majority, Suggesting that liver qi stagnation with both heart and spleen deficiency as the main pathogenesis machine of ICF. (2) Fatigue main deficiency syndrome:The main symptom remission group of patients with fatigue than 50% accounted for 79% (41/52 patients), the onset time of 5 to 35 days,The onset time of five days in 1 case,7 days in 28 cases,More than two weeks of onset in 11 cases,Longest onset time of 35 days in 1 case, shows that effective treatment to alleviate fatigue of the program,Clinical treatment may be appropriate to the defender. (3) The Chinese medicine:From point of traditional Chinese medicine 119prescriptions intensity of use of DDDs, DDDs value greater than reasonable gas class 3 including Recuperating qi class,removing heat class, quiet down the mind class, Where Recuperating qi class ranks first, followed by the removing heat class and quiet down the mind class, DDDs value greater than 2 is less than 3 Nourishing qi class, DDDs value greater than 1 is less than 2, there is huatan class, Warming kidney yang class,It reflects t based therapies of he Recuperating Recuperating liver and qi removing heat, Nourishing heat and spleen qi quiet down the mind.it also showed a high frequency of herbs prescription, the medication with big strength, the tendency of big herbs of choice. (4) commonly used in traditional Chinese medicine:Viewed from the frequency of use of prescription herbs, Chaihu (89/119) in most, It followed Astragalus (81/119),chaihu is herb of Recuperating liver and qi removing heat, Astragalus is herb of Nourishing qi, suggsting commonly used herbs are the main treatment,Fit its syndrome elements, syndrome and treatment method. In addition, Poria, Albizia, gardenia is accompanied spleen, stagnation, nourishing the heart, soothe the nerves heat.90 cases of idiopathic fatigue randomized, double-blind, placebo-controlled clinical study results:1. clinical efficacy:(1) FS-14 Rating Scale effect:The total test score the Test group decreased 5.27±3.00, The control group decreased 3.80 ± 3.23,the Test group decreased more than the control group (P= 0.036);the Test group physical fatigue scores decreased 3.95 ±2.12,The control group decreased 2.47±2.34,Test group decreased more than the control group (P= 0.003);Mental fatigue score similar in both groups. (2) the efficacy of TCM symptom score:The total score of the test group decreased 16.23±7.12, the control group decreased 10.83±9.78, P= 0.004;Main symptoms integral test group decreased 4.60±2.39, the control group decreased 3.13 ±2.50, P= 0.010;Secondary symptoms integral test group decreased 11.65± 6.20, the control group decreased 8.23 ±6.00, P= 0.013, the test group decreased more than the control group both in The total score, Main symptoms,Secondary symptoms. (3) TCM Therapeutic Grade aspect (nimodipine method):Test group the total efficiency of 93%(56/60), in which clinical remission 8%(5/60), effective in 35%(21/60), effective 50%(30/60); the control group, the total efficiency of 70%(21/30), in which clinical remission 7%(1/30), effective in 20%(6/30), effective 43%(13/30), the experimental group than the control group (P= 0.03).2. Anxiety and Depression Scale score:the patients have been ruled out, depression and anxiety disorders before go into trial, but SAS scores in the test group was 36.57 ±7.32, control group 35.27±6.95, SDS scores in the test group scored 39.12±7.30, control group was 36.10±8.93, patients with higher anxiety and depression scores, there may be some anxiety and depression, suggesting that the disease with emotional factors. After treatment the test group SAS score decreased 7.10±7.73, the control group decreased 4.53 ±6.95, the test group decreased more than the control group (P= 0.12), SDS score the test group decreased 8.47±6.20, 5.03±control group decreased 7.09, the test group decreased more than the control group (P= 0.02). Suggesting treatment of idiopathic fatigue need Psychosomatic.3. The early exit test case:according to clinical research programs, the test group of 3 patients treated for 2 weeks.the main symptoms of fatigue decrease of less than 20% and to end the experiment advancely, the control group of 9 patients.4. Security index changes:After treatment, test of liver function, kidney function, blood, urine, blood glucose and lipid abnormalities were no significant changes in the indicators in the normal range or with no significant change comparing with before treatment.there are 17 cases of adverse events during the test, which in the test group of 13 patients,in the control group of 4cases(P= 0.34). And four cases related to trials may in test group 2 cases,the control group 2 cases, showed syndromes of sore throat and/or mouth sores, ear swelling.It has nothing to do with the trial in 13 cases,10 cases of test group and 3 cases of control group, including 6 cases of colds, the test group of 4patients, in the control group 2 cases; fever in 3 cases, the test group 3 patients, in the control group 0 cases; 4 cases of sore throat, in test group 3 patients, in the control group 1 cases.Conclusion:By the data analysis of 52 cases of clinical trial, show that the "Liver stagnation and spleen deficiency syndrome, mind dystrophy syndrome, Liver-fire syndrome" as the three main Zhenghou of TCM diagnosis and treatment program used in the clinical treatment of fatigue have a certain effect, while Conditioning qi and removing heat, Strengthen Spleen and qi, Nourishing heart and quiet down the mind are the main treatment and differentiation characteristics. By randomized double-blind placebo-controlled trial of 90 cases, suggesting that the program can significantly improve the fatigue syndrome of the patient, which eliminate physical fatigue effect is more prominent; Chinese medicine can relieve symptoms of fatigue in patients; patients with anxiety and depression can improve the situation. The safety test before and after treatment showed no significant changes in indicators, the indicators were normal, no serious adverse reactions, indicating that treatment of Idiopathic Chronic Fatigue TCM diagnosis treatment program through Liver and spleen ZangFu clinically effective and application security. |
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