The Clinical Study On The Treatment For Cardiac Neurosis With "TCM Rigid-Gentle Syndrome Differentiation"

Aim:①To evaluate the safety and effect of the treatment of Cardiac Neurosis with "TCM Rigid-Gentle Syndrome Differentiation".②To explore brain electrical activity, brain neurotransmitter activity and the mental and psychological characteristics in patients with Cardiac Neurosis.Methods:①Clinical study:The design of the trial is randomized single-blind (patient-masked). According to the inclusive and exclusive criteria of the trial, all selected patients were divided into trial group (TCM group) and control group (placebo group) by means of random number table. The trial group patients were given No.1, No.2, No.3, No.4 formulas respectively according to "TCM Rigid-Gentle Syndrome Differentiation". The control group patients were given TCM placebo. At the same time the patient of two groups received psychological treatments such as cognitive behavioral therapy. The course of treatment of the trail is 8 weeks (56 days). Researchers distributed medicines in every two weeks (the first return visit:after 14 days, the second return visit:after 28 days, the third return visit:after 42 days, the fourth return visit:after 56 days). To compare the change of the TCM syndromes, Hamilton Anxiety Scale (HAMA), Hamilton Depression Rating Scale For Depression (HAMD) electrocardiogram and hepatic and renal function of the all patients before and after treatment. The data was analyzed by SAS6.12.②Brain function study:Based on diagnostic criteria of Cardiac Neurosis in ,50 patients were selected.50 patients were tested by EEG determinations and Super Encephalofluctuograph technology via Quantitative Electroencephalography machine which was produced by Solar Electronic Technologies CO.,Ltd. And the patients were all accessed by Hamilton Anxiety Scale (HAMA)and Hamilton Depression Rating Scale For Depression (HAMD) as well. To analyze brain electrical activity, brain neurotransmitter activity and the mental and psychological characteristics in patients with Cardiac Neurosis. The data was analyzed by SAS6.12. Results:Clinical study:①The evaluation of therapeutic effects based on HAMA Scale: According to the score-reducing rates of HAMA Scale, the therapeutic effects in the trail group are better than the control group(P<0.01). After treatment the scores of HAMA in the trail group are lower than the control group (P<0.01).②The evaluation of therapeutic effects based on HAMD Scale:According to the score-reducing rates of HAMD Scale, the therapeutic effects in the trail group are better than the control group(P<0.01). After treatment the scores of HAMD in the trail group are lower than the control group (P<0.01).③The evaluation of therapeutic effects based on TCM Syndromes Scale:According to the score-reducing rates of TCM Syndromes Scale, the therapeutic effects in the trail group are better than the control group(P<0.01). After treatment the scores of TCM Syndromes Scale in the trail group are lower than the control group (P<0.01).④The therapeutic effects in the trail group are better to improve the syndromes such as palpitation, shortenss of breath, chest distress, (P<0.01) chest pain and insomnia (P<0.05) than in the control group after treatment.⑤From the second return visit, the therapeutic effects in the trail group are better than the control group(P<0.01).⑥There is improvement in ECG of two groups after treatment. There is no difference in abnormal rate of ECG between two group after treatment(P>0.05).⑦In the course of this trial, clear side effect has not been observed.Brain function study:①Inducement exists in 88%of patients. And most patients accompany with different levels of anxiety and depression.②The abnormal rate of EEG is 68%, abnormal appearances include the increase ofθorδwaves in the basic rhythms, no inhibition of basic rhythmical waves by opened the eyes provocation test, asymmetry of bilateral EEG, low and flat amplitude of basic rhythmical.③The scores of HAMD Scale among abnormal EEG patients are higher than normal ones (P <0.05).④There are differences in some brain neurotransmitter activity between 50 Cardiac Neurosis patients and 30 healthy adults:The abnormal neurotransmitters include inhibitory medium(INH)(P<0.05),5-Hydroxytryptamine(5-HT) (P<0.05), dopamine(DA) (P<0.01)and excited medium(EXC)(P<0.01)etc. Refer to INH, there are significant differences in lead parietal 3(P<0.01) and lead occipital 1(P<0.05) between patients and healthy people. Refer to 5-HT, there are significant differences in lead parietal 4(P<0.01), lead frontal 4 (P<0.05)and lead central 4(P<0.05) between patients and healthy people. Refer to DA, there are significant differences in lead frontal 4(P<0.01), parietal 4(P<0.01)and lead central 4(P<0.05) between patients and healthy people. Refer to EXC, there are significant differences in lead frontal 4(P<0.01), lead occipital 1(P<0.01), lead occipital 2(P<0.01), lead central 3(P<0.05), lead parietal 3(P<0.05), lead parietal 4(P<0.05) and lead frontal 8(P< 0.01)between patients and healthy people.⑤Age is the direct influent factor of EEG normality or not in Cardiac Neurosis patients(P<0.05).⑥There are no linear regression relations between the value of all neurotransmitters (such as INH,5-HT, ACH, DA, NE and EXC)and HAMA or HAMD(P>0.05).Conclusions:①Based on the results, it is safe and effective to treatment for Cardiac Neurosis with "TCM Rigid-Gentle Syndrome Differentiation".②It is found that mental factor may take an important role to lead to occurrence of Cardiac Neurosis.③Some brain impairment indeed exists in Cardiac Neurosis patients. The occurrence of Cardiac Neurosis is related to synthesis and release of brain neurotransmitter. The brain neurotransmitter of INH,5-HT, DA and EXC are great relationship to the Cardiac Neurosis.