| ObjectiveThis study carried out a randomized controlled clinical trial to evaluate the clinical effect of Jianpi Yangwei ointment on the treatment of Damp-heat type of spleen deficiency chronic erosive gastritis.By comparing the changes of TCM syndrome integral between and within treatment,gastric mucosal erosion score under gastroscopy and the improvement of patient's health conditionf between the intervention group(Jianpi Yangwei ointment)and the control group(scheme are esomeprazole enteric-coated tablet plus magnesium aluminium carbonate tablet)before and after treatment,which aims to provide theoretical basis and scientific evidence for clinical promotion of ointment in treating chronic erosive gastritis.MethodThis study chose 60 patients with chronic erosive gastritis of spleen deficiency and dampness-heat type for research object,which adopted by randomized controlled clinical trial design.From June 2017 to December 2018,60 patients met the inclusion criteria were divided into treatment group and control group,30 cases in each group.The treatment group was treated with Jianpi Yangwei ointment,while the control group was treated with Esomeprazole enteric-coated tablets plus magnesium aluminium carbonate tablets.To evaluate the clinical effect of Jianpi Yangwei Ointment on Damp-heat type of spleen deficiency chronic erosive gastritis through observing the changes of TCM symptom score,health condition score and gastroscopic mucosal erosion score between the two groups before and after 8 weeks of treatment and six months of follow-up were observed.The data were collected and collated,SPSS17.0 software was used for statistical analysis.Result1.Comparison of baseline data before treatment:There was no significant difference in age,gender,course of disease,TCM syndrome score,health condition between the two groups(P>0.05),which was comparable.2.In the evaluation of the curative effect of TCM symptoms,after 8 weeks of treatment,there was significant differences in the curative effect of TCM symptoms between the two groups(P<0.05).The total effective rate of the treatment group was 83%,and that of the control group was 73%.The curative effect of the treatment group was better than the control group.3.On the research of single symptom score of TCM:by comparing between two groups,there were statistical differences between the treatment group and the control group in epigastric fullness,decreased appetite in eating,dry and bitter mouth after 8 weeks treatment(P<0.05),however,there was no significant differences in epigastric pain,loose stool,belching and acid regurgitation(P>0.05).The curative effect of the treatment group was superior to the control group in epigastric fullness,loss of appetite,dry and bitter mouth after 8 weeks treatment,but the effect of epigastric pain,belching and acid regurgitation in the control group was better than the treatment group.Six months after follow-up,there were statistical differences between the treatment group and the control group in epigastric fullness,decreased appetite in eating,dry and bitter mouth,belching and acid regurgitation,total integral of TCM syndromes(P<0.05),however,there was no significant differences in epigastric pain,loose stool.(P>0.05).The clinical effect of the treatment group was superior to the control group in epigastric fullness,loss of appetite,dry and bitter mouth,but the effect of belching and acid regurgitation was not as good as that of control group.By comparing within the group,the TCM symptoms and the total score of stomach-fullness,epigastric pain,loose stool,belching and regurgitation were all decreased after treatment(P<0.05),which indicating that two schemes are effective in improving TCM symptoms.4.Comparing the scores under gastroscopy:After six month of follow-up,the score of gastric mucosal erosion under gastroscopy were significantly different between the two groups(P<0.05),and the curative effect of the control group was better than treatment control group in promoting gastric mucosal healing.5.On the health related quality of life score:by comparing between two groups,after 8 weeks of treatment,there were significant differences in stool,constitution and emotion between the treatment group and the control group(P<0.05),the improvement of stool in the control group was better than the intervention group,but the effect of constitution and emotion was not as good as the treatment group.After six month follow-up,there were significant differences in total score of quality of life including energy,pain,sleep constitution and emotion between the treatment group and the control group(P<0.05),but there were no significant differences in diet,defecation and urination(P>0.05),and pain,energy,sleep,constitution and emotion in the treatment group was superior to the control group.Comparison within group:After treatment,the total scores of energy,pain,diet,stool and urination,sleep,constitution,mood and quality of life in the treatment group were significantly lower than those before treatment(P<0.05).A majority of the health quality of the control group was improved except for the constitution and emotion after treatment,which showed that the ointment had a significant effect on improving the health condition of patients.6.The difference between the two groups before and after treatment:there were statistical differences in the scores of TCM symptoms and quality of life between the two groups before and after treatment(P<0.05).But therewas no significant difference in the score of mucosal erosion under gastroscopy(P>0.05).7.Safety evaluation:blood routine examination,liver and kidney function and electrocardiogram was not abnormal before and after treatment in both groups.ConclusionJianpi Yangwei Ointment is effective in alleviating epigastric fullness,dry mouth and some gastrointestinal symptoms,improving patient energy,constitution,sleep of TCM health condition was significantly better than the western medicine group.Ointment has the advantages of holistic nourishing,tonifying deficiency and preventing disease,convenient absorbing,high compliance and so on.It is safe and effective in treating spleen deficiency dampness-heat type chronic erosive gastritis.It is worth popularizing and applying in clinical practice. |
PDF Full Text Request