Clinical Study On Treatment Of Functional Dyspepsia With Cold And Heat By

Functional dyspepsia (FD) is a common gastrointestinal condition seen in clinical practice. Controversies remain regarding the definition and the optimum treatment for this condition. The Rome III criteria defines FD as the presence of one or more symptoms, including postprandial fullness, early satiation, epigastric pain or epigastric burning within the past 3 months with symptom onset at least 6 months earlier. This is in the absence of any organic or structural disease to explain the symptoms. The Rome committee further recommended two subcategories of FD:postprandial distress syndrome (PDS) and epigastric pain syndrome (EPS).FD always has long duration,high recurrence rate, affecting the quality of life seriously, at the same time Causing the waste of medical resources and large social and economic burden. FD is associated with impaired gastric accommodation, as well as gastric hypersensitivity, delayed emptying, and psychosocial comorbidities. At present the etiology and pathogenesis of FD is not clear entirely.Gastrointestinal dynamic drugs, antacids, digestive enzymes and anti-anxiety drugs are main means of FD treatment, but there are still many problems exists, like high recurrence rate during discontinuation, poor long-term drug efficacy and more side effects. Traditional Chinese medicine (TCM) has its unique understanding of the pathogenic factors and pathogenesis of FD,and treatment based on syndrome differentiation. It has many advantages,such as definite curative effects,both psychological and physical therapy, better compliance and fewer side effects, so it deserves further research and extension.Objective:This subject is to carry out a clinical research which by observation and assessment of clinical symptoms and mental status changes of patients with functional dyspepsia mixed cold and heat type, to observe the clinical efficacy and safety of Weikangning.Methods:This clinical trials adopt the method of case itself contrast before and after the treatment. The study collected 100 cases of patients who were in accordance with the inclusive criteria and come from the outpatient and inpatient department of gastroenterology of Wangjing Hospital from September 2013 to December 2015. All the patients treated with Weikangning decoction,which is the self-prescription of Wangjing hospital gastroenterology department. A dose of every day, Water decoction,30min before breakfast and 30min before going to sleep after each taking warm decoction 150ml.Taking seven days for a period of treatment, continuous four courses of treatment, observation period of 28 days.Observe the traditional Chinese medicine syndrome changes and scores before the treatment, treatment 2 weeks and 4 weeks, Western medicine clinical symptoms,the score of SAS,SDS,FDDQL,andsafety evaluation before and after treatment.Compare the differences of curative effect between postprandial distress syndrome (PDS) and epigastric pain syndrome(EPS).Evaluation of efficacy difference between patients comparing with and without anxiety and depression state. Then the data were collected and analyzed with the help of statistical software SPSS 21.0 software.Results:The patients excluded because of lost ten cases shedding caused, completed a total number of cases of clinical observation of 90 cases, including 49 patients with the PDS and 41 with EPS.The clinical observations results are as follows:1.TCM Syndrome Classification quantization table effect:two weeks of treatment,there were 0-case cured,5-case were significantly improved,49-case were in effect and 36-case were non-effective,and the total effective rate is 60%, the efficiency was 5.5%(P<0.05);4 weeks of treatment, there were 5-case cured,30-case were significantly improved,40-case were in effect and 15-case were non-effective,and the total effective rate is 83.3%, the efficiency was 38.9%(P<0.05).Patient’s TCM Syndrome degree of integration and individual scores before and after the differences were statistically significant(P<0.05).2.Western symptomatology grading scale effect:4 weeks of treatment, there were 11-case cured,31-case were significantly improved,39-case were in effect and 9-case were non-effective,and the total effective rate is 90.0%, the efficiency was 46.7% (P<0.05). All the symptoms scores differences of western medicine evaluation index were statistically significant before and after (P<0.05).3.Anxiety and Depression Scale:There’re a total of 34 cases of anxiety state into the group of patients, among them,31 cases of mild anxiety state,3 cases of moderate anxiety state. A total of 24 cases of depression, including 21 cases of mild depression,3 cases of moderate depression status, including 18 cases of anxiety and depression overlap.Treatment of 4 weeks, In the original anxiety depression patients, a total of 8 cases of mild anxiety state, 4 cases of mild depression,1 case of moderate depression status and no overlap. S AS scores of effective rate was 76.4%, SDS score effective rate was 79.1%, the scores differences before and after treatment have obvious statistical significance(P<0.01).4. Quality of life questionnaire:Into the group of patients after treatment, Their quality of life is improved,such as sleep, diet, healthy feeling,anxiety,disease control, and compressive strength are improved(P<0.05).But the daily life state change is not obvious (P>0.05).5.The safety evaluation:During the course of treatment, no significant abnormalities and obvious side effect was found. The safety indexes including blood pressure,pulse rate, respiration,body temperature; routine blood/urine/stool testing and occult-blood,liver function (ALT,AST), kidney function (BUN,CRE),ECG were in the normal range. The whole treatment is effective and safe.6.1n the process of treatment, there were no significant difference of curative effect between postprandial distress syndrome (PDS) and epigastric pain syndrome(EPS). there were no significant difference of curative effect between patients accompanied by psychological barriers (anxiety, depression, anxiety, depression of overlapping) and normal psychological state.Conclusion:the representative decoction of xinkaikujiang method Weikangning Granules has good therapeutic effect on cold and heat mixed type of functional dyspepsia. It can relieve the FD symptoms significantly and rapid onset, And to some extent can relieve patients’anxiety or depression state,improve their quality of life, Also, it has good security and none significant side effects, worthy of clinical promotion and further study on the application.