| ObjectiveThe project aims to study the functional dyspepsia disease, the use of advanced parallel subgroups stratified randomized, controlled clinical trial study design, selection, and Western mutually acceptable clinical outcome evaluation, in order to objectively accurate evaluation system based on two different theories, but to serve the clinical efficacy of traditional Chinese medicine and Western medicine the same purpose for specific diseases, and thus explore the establishment of such diseases clinical evaluation system. Patients before and after combined treatment of neuropsychiatric symptoms score changes and nerve-related serum markers associated endocrine network to explore the pathogenesis of functional dyspepsia pathogenesis may exist and can be expected to further provide drug development in the pharmaceutical necessary clinical evidence.MethodsUsing parallel subgroups stratified randomized, controlled clinical trial study design, patients met the inclusion criteria for indigestion, does not meet the exclusion criteria of functionality, according to a random sequence of numbers by the researcher were to be two different interventions week, and before the intervention, after two observation point were recorded to fill the main symptoms of functional dyspepsia efficacy evaluation form, clinical symptoms classification table, the Department of Chinese patients with stomach illness reported outcome Scale, health status questionnaire SF-36, Hamilton self-Rating Anxiety scale (HAMA), Hamilton depression rating Scale(HAMD), such as this, and at the same peripheral venous blood drawn about10ml to detect motilin (MTL),5respectively-serotonin (5-HT), gastrin (GAS), nitrous oxide nitrogen (NO), vasoactive intestinal peptide (VIP), P substance (SP) and other related neuro-endocrine indicators. Finally, through the intervention of former participants, after the change of the indicators for statistical analysis, objective and accurate evaluation, the clinical efficacy of Western medicine treatment of the disease.Results1Which, after a large group and the Western subgroup analysis comparing the efficacy of the treatment itself can be seen, the major individual symptom scores in each group after treatment, total symptom score, SF-36score, SSD-PRO scores and Before changing HAMA, HAMD scores and most other symptoms, entry or aspects of treatment compared statistically significant (P<0.05). However, a large group of Chinese and Western medicine treatment before and after their efficacy point of view, the group for the SF-36score in the PF, RE, MH and other three dimensions, and SSD-PRO scores of F5, F6, F7, F8, D2, improve D3, D4and other aspects and fields are not statistically significant (P>0.05). Also part of the subgroup of patients before and after their treatment efficacy, such as medicine subgroup Spleen group before and after treatment in the SF-36score in the GH, VT, MH, etc., and SSD-PRO scores in Fl, F7, D3etc., have not changed in the field of statistical significance(P>0.05); SSDH their treatment after four dimensions PF, VT, RE, MH, etc. in SF-36scores and SSD-PRO scale of F5, change F7, D2and other aspects and fields are not statistically significant (P>0.05); cold and heat mixed group of patients before and after treatment in their SF-36scores changed VT, RE, MH, such as three dimensions are not statistically significance(P>0.05); the Western subgroup own pain syndrome patients before and after treatment, the SF-36score in four dimensions VT, SF, RE, MH, etc., and SSD-PRO scale of F5, F6, F7changes F8, D2, D3, D4and other aspects and fields are not statistically significant (P>0.05); postprandial distress syndrome patients before and after treatment itself, burning sensation in the upper abdomen, SF-36score in PF,5dimensions of VT, SF, RE, MH, etc., and the SSD-PRO scale F5, F6, F7, F8, D2, D3, D4, etc. areas and not statistically significant score.2From this, a comparative analysis between the two groups and each subgroup Western group therapy patients, the middle between the two Western groups, using qualitative analysis can be found that patients with main single symptom improvement and disappear rate compared to traditional Chinese medicine treatment efficacy compared with western medicine big group were showed statistical difference (P<0.05), shows that curative effect is superior to western medicine treatment of traditional Chinese medicine treatment group curative effect;And using the quantitative analysis can be confirmed between them in addition to relieve the symptoms of upper abdominal burning sensation in the two groups were not statistically significant (P>0.05), but in other key areas such as individual symptoms, total symptom score, SF-36score, SSD-PRO score, HAMA and HAMD score, etc., TCM therapy showed a statistically significant difference compared in both Chinese and Western Medicine(P<0.05); while for comparison between subgroups in terms of group therapy, there is also a comparison between similar problems and in a large group of Chinese and Western medicine group.3Which, after serum Neuroscience Medicine therapeutic intervention endocrine indicators point of view, a large group of Chinese medicine treatment of their patients after their5-HT, GAS, MTL, NO, SP, VIP and other indicators were statistically significant change in circumstances (P<0.05), while a large group of Chinese and Western medicine treatment compared before and after itself, except there is no statistical significance in GAS, SP change the situation in the two indicators (P>0.05), changes in other relevant indicators were statistically significant (P<0.05); while passing between in Western patients can be seen the two groups after treatment efficacy, there were statistically significant between the two in NO, SP, VIP and other three indicators of changes in terms of(P<0.05)ConelusionThrough this research, we can draw the following conclusions:①from Western medicine large group and the subgroup of patients before and after treatment efficacy of comparative analysis itself can be seen in Western medicine treatment FD has the exact opposite effect of the intervention, for ease patient discomfort symptoms and improve quality of life of patients and improving patient had a positive effect of anxiety, depression and so on, but each treatment methods have their own shortcomings;②from between the two groups and various Western subgroup of patients comparing the efficacy of the treatment group analysis, compared to Western medicine therapy, in addition to burning sensation in the upper abdomen to ease the symptoms rather than the terms of efficacy in patients relieve other symptoms, improve quality of life of patients and improving patient anxiety, depression, etc. are much better than Western medicine treatment group;③from Western medicine treatment interventions serum Neuroscience-endocrine indicators point of view, in Western medicine treatment can produce a clear effect on the brain-gut peptide related FD patients, but the Chinese group therapy in improving the NO, SP, VIP cases significantly better than Western medicine treatment group, which can be inferred mechanism of Chinese medicine treatment of FD may be related to enhanced gastrointestinal motility and gastrointestinal motility, regulate and improve the function of the stomach suffer visceral hypersensitivity and other factors. However, because this study is still a small study, and the relatively short study period, it may be difficult to assess the results of the current study long-term efficacy of Chinese medicine, is not sufficient to more in-depth treatment of all evidence of the features and advantages of Chinese medicine and so on. This study needs to be further expanded follow-up studies related to such a large sample, multi-center, a relatively long period of follow-up studies, in order to be able to further the objective and accurate assessment of the effect of Chinese medicine clinics, diagnosis and treatment of more prominent features and advantages of Chinese medicine lies. |
PDF Full Text Request