| Objective and Significance:Functional dyspepsia (FD) is a common clinical condition of functional gastrointestinal disorders, characterized by clinical symptoms such as postprandial abdominal discomfort, early satiety, upper abdominal pain or fullness, or heartburn, without evidence of organic disease. FD is prevalent and impacts upon quality of life, interfering with daily activities. Its pathological mechanism is very complicated and the pathophysiology of FD remains unclear but several theories have been proposed including motility disorder of stomach and the small intestine, visceral hypersensitivity, helicobacter pylori infection and psychosocial factors. In TCM, it attributes to "Fullness and Oppression" or "Stomach Pain", failure to transport due to spleen deficiency as the root and failure to descend the stomach as the manifestation. FD involves the stomach and pertains to liver and spleen. Until now there has no great breakthrough in the therapeutic methods. Commonly used medications includes promotility agents, antisecretory agents, anti-H pylori eradication treatment, antidepressants, and psychological therapy, et al. And promotility agents are the main factor. But the above-mentioned methods cannot provide satisfactory therapeutic efficacy and have side effect resulting in low compliance of the patients. At the other hand, with the characterization of differentiation, TCM shows a specific advantage in the treatment of FD.This study totally aims to summarize FD study document from systems of TCM and western medicine. To explore the therapeutic effects and life quality improvement, we measured the effect of Invigorating Spleen and Regulating Qi Decoction (hereinafter referred to as DISRQ) on treating FD patients suffered from Spleen Deficiency and Qi Stagnation by means of randomized controlled prospective clinical study. To investigate the mechanism of the DISRQ, the model rats suffered from FD were used. We observe the therapeutic effect of DISRQ on motility disorder of the stomach and the small intestine, gastrointestinal hormone in blood serum, and visceral hypersensitivity This study can set on researching foundation for further application of TCM on this kind of FD, and provide particular plan and material for further exploitation and research.Methods:The study includes three parts:literature summary, clinical research and experimentation.Literature summary of FD in Chinese and Western documents were consolidated and reviewed.Clinical Research Methods:According to the prospective, randomized, control study,96 patients who met the inclusion criteria were randomly divided into 64 patients as treatment group with DISRQ and 32 as placebo control group. It lasted for 4 weeks to observe Syndrome before and after treatment, the overall effective rate, quality of life and psychological factors in the change situation.Animal experiment:choosing 144 Wistar rats of SPF degree. First,12 rats were randomly selected as normal group without any manipulation. the remaining 60 are modeled and randomly divided into 5 groups:model group (control group), low dose of DISRQ group, middle dose of DISRQ group, high dose of DISRQ group and MCT group,12 cases in each group, male and female in half, and of manufacturing FD model appropriate folder. Begin the study 7 days after modeling, the model and the normal group are treated by physiological saline intragastrically every day; other four groups were fed with different doses of DISRQ and mosapride, a total of medication was used for 14 days. After the treatment, the situations such as general situations, body weight, food intake, water intake as well as moving gastric emptying and small intestinal conditions, plasma motilin and gastrin content situation, NOS2, CGRP, SP expression in gastric mucosa of rats were observed in each group respectively. Research Results:The document summarizes TCM pathogenesis, syndrome differentiation and treatment, the history of diagnostic standard and the research progress of the treating methods and mechanism of modern medicine of FD which applied a thinking way and basis for the further research.1 Clinical results1.1 The results of DISRQ:the medium-term treatment (2 weeks) effects, comparing with that of pre-treatment, patients felt better by statistical analysis (P<0.05) on symptoms such as epigastric or abdominal distention, epigastric pain, early satiety, belching acid reflux, nausea and vomiting, fatigue, bowel movement, insomnia and other syndromes. Comparing with that of before treatment, the symptoms of patients in control group such as epigastric fullness, epigastric pain, insomnia and other syndromes have improved by statistical analysis (P<0.05); there is no significant different in the trend of improvement in other syptoms(P>0.05).1.2 After the treatment for 4 weeks, the treatment group compared with patients with the syndrome before treatment improved in varying degrees, there is significant difference in above-mentioned symptoms (P<0.05-0.01). In control group, syndromes of patients were better compared with that of before treatment, there is significant difference in other symptoms (P<0.05) except nausea and vomiting, belching back to acid, increasing abdominal distention after eating, bowel weakness and tongue. The results showed longer treatment courses with better effects within observation period, indicating that the effect of DISRQ treating patients suffered from fullness due to spleen qi deficiency and qi stagnation is related to treatment courses.1.3 Among 61 cases in observation group, after 2 weeks of treatment,2 cases was cured clinically,8 cases were markedly effective,28 cases were effective,23 cases were ineffective, the total effective rate was 62.30%; among 30 cases in control group, no case was cured clinically, no case was markedly effective,7 cases were effective,23 cases were ineffective, the total effective rate was 23.33%. Statistically, the effect in group of DISRQ is better than the placebo group, there is significant difference (P<0.01).1.4 After 4 weeks of treatment, among 61 cases of observation group,9 cases were cured clinically,23 cases were markedly effective,22 cases were effective,7 cases were ineffective, the total effective rate was 88.52%; among 30 cases of control group,1 case was cured clinically,1 cases was markedly effective,12 cases were effective,16cases were ineffective, the total effective rate was 46.66%. Statistically, the effect in group of DISRQ is better than that of the placebo group, there is remarkably significant difference (P<0.01).1.5 After 4 weeks of treatment, among 61 cases in observation group,26 cases were PDS (postprandial distress syndrome) with total effective rate 96.15%, 12 cases were EPS(epigastric pain syndrome)with total effective rate75.00%, and 23 cases were PDS+ EPS with with total effective rate 86.95%. The total effective rate between PDS and EPS showed no significant difference(P>0.05). Among 30 cases in control group,13 cases were PDS (postprandial distress syndrome) with total effective rate 53.85%,12 cases were EPS (epigastric pain syndrome)with total effective rate 33.33%, and 11 cases were PDS+ EPS with with total effective rate 45.45%. The total effective rate between PDS and EPS showed no significant difference(P>0.05)The effective rates of PDS or PDS+EPS between the control group and the treatment group showed significant difference (P<0.01) which indicated that the effective rate of DISRQ is better than that of placebo. But there is no significant difference between the EPS in the two groups(P>0.05).1.6 The effect of DISRQ on quality of life of FD patients suffered form spleen deficiency and qi stagnation:after four-week treatments with DISRQ, the score of following 5 fields including bodily pain(BP), role-physical(RP), general health(GH), vitality(VT) and mental health(MH) increased significantly (P<0.05) comparing to those before treatment course. While in control group, the score of the 3 fields including bodily pain(BP), vitality(VT) and mental health(MH) increased markedly (P<0.05) comparing to those before the treatment course. But, there was significant difference on score increase of Body Function (PE), Role-Physical (RP), General Health (GH), Social Function (SF) and Emotional Function(EF) (P>0.05). It shows that TCM treatment has dual advantages on physical and psychological regulation to improve clinical symptom and quality of life of FD patients suffered from spleen deficiency and qi stagnation.1.7 The effect of DISRQ on psychosocial factors of FD patients:After treatment, the scale of HAMA and HAMD was lowered significantly than before in observation group (P<0.05). While in the placebo control group, after four-week treatment, the scale of HAMA and HAMD showed a trend of decreasing, but with no significant difference (P>0.05).2 Experimental results:2.1 FD rat model was successful according to the situations such as manifestation of all rats, body weight, water intake, and changes in food intake and gastric mucosa HE staining.2.2 Effect of on the gastric emptying and gastrointestinal movement of FD rats: different doses of DISRQ can improve the function of gastric emptying and promote intestinal propulsion of FD rats in different extent. And the effect of the high dosage showed no significant difference with those in the positive control group (cispride) (P>0.05). and pharmacological effects of DISRQ were related to dosage2.3 Effect of DISRQ on blood motilin(MTL) and gastrin(GAS) in FD rats:compared with those in normal group, the plasma MLT and GAS in the model group were remarkably decreased (P<0.05). different doses of DISRQ can increase the content of MLT and GAS in different extent (P< 0.05). There was no significant difference between of high dose group of DISRQ with those in positive control group (cisapride) (P>0.05).2.4 Effect of DISRQ on the expression of NOS2 in FD rat's sinus ventriculi mucosa:the expression of NOS2 in the model group increased significantly than that in the normal group (P< 0.05 or P< 0.01). DISRQ of different dosages can decrease the expression of NOS2 and the effect of the high dose showed no significant difference with those in the positive control group (cisapride) (P>0.05).2.5 Effect of DISRQ on the expression of visceral hypersensitivity related factors in FD rats:2.5.1 the expression of CGRP in the sinus ventriculi mucosa of the FD rats in model group increased significantly than that of normal group(P< 0.05 or P<0.01). DISRQ of different doses can decrease the expression of CGRP and there is no significant difference between high dose group and positive control group (cisapride) (P>0.05).2.5.2 The expression of SP in the sinus ventriculi mucosa of the FD rats in the model group increased significantly than that in the normal group(P< 0.05 or P< 0.01). DISRQ of different doses can decrease the expression of SP and there is no significant difference between high dose group and positive control group (cisapride) (P>0.05).Conclusions:The clinical research results shows that DISRQ has unique curative effects for treating FD patients suffered from spleen deficiency and qi stagnation on improving the clinical symptoms, quality of life and psychosocial factors. And the placebo can have certain effect as well.The experiment results show that ISRQ exerts its effect for treating FD probably by enhancing the gastrointestinal motility and gastrointestinal movement, decreasing the visceral hypersensitivity and so on.
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