| Objective: To explore the advantages of Chaizhu Paste in treating liver stagnation and spleen deficiency syndrome of ulcerative colitis through a comparison of clinical therapeutic effect between Chaizhu Paste combined with mesalazine sustained-release granules and mesalazine sustained-release granules alone in treating the liver stagnation and spleen deficiency syndrome of ulcerative colitis,so that traditional Chinese medicine(TCM)may play a more important role in clincial treatment of ulcerative colitis.Methods: The study included a total of 60 patients with ulcerative colitis who met the inclusion criteria and typed as liver stagnation and spleen deficiency based on TCM syndrome differentiation.All of them were treated at the Outpatient Service for Spleen and Gastric Diseases,Yantai Hospital of Traditional Chinese Medicine for diarrhea accompanied by mucous bloody purulent stool,abdominal pain,and tenesmus between November 2018 and October 2020.A randomized controlled design was adopted for the test.The60 cases were randomized into test group and control group,30 cases each group.Both groups received conventional treatment: mesalazine sustained-release granules 1.0g,orally,4 times a day.The control group received the conventional treatment alone,while the test group,based on conventional treatment,was given oral Chaizhu Paste,20 m L each time,twice a day,taken with an appropriate amount of warm water 1 hour after meal in the morning and evening.For both groups,a course of treatment lasted for 30 days,and there were 2 courses for a treatment cycle.The clinical manifestations and colonoscopy findings before and after treatment were recorded respectively,and a face-to-face follow-up was conducted for effective cases at the end of each treatment course and at the end of the whole treatment cycle respectively.The clinical efficacy evaluation,disease activity score(modified Mayo activity index),TCM syndrome based scores for primary symptoms,TCM syndrome based scores for secondary symptoms,TCM syndrome based efficacy,endoscopic histological findings for mucosa(Baron score),quality of life and adverse reactions before and after treatment were compared between the two groups.Results:1.Before treatment,there were no significant statistical differences in gender,age,course of disease,severity,and range of lesion among the included patients(P > 0.05),and so,they were comparable.2.Clinical efficacy evaluation: the total effective rates of the test group and the control group were 92.86% and 75.86% respectively.The test group was superior to the control group in terms of excellent or effective grade for relevant evaluation and the total effective rate.The number of ineffective cases in the test group was less than in the control group,i.e.,the test group was also superior to the control group in this aspect.Relevant differences were statistically significant(P < 0.05).3.Disease activity(modified Mayo activity index)score: Before treatment,the two groups were comparable for the score(P > 0.05),and after treatment,the score decreased to different degrees in the two groups.The test group was superior to the control group in the improvement of disease activity(P < 0.05).4.TCM syndrome based scores for primary symptoms: There was no significant difference in the scores between the two groups before treatment(P > 0.05),i.e.,the two groups were comparable in this aspect,while after treatment,the scores in the test group decreased to different degrees as compared with those before treatment(P < 0.05),and in the control group,the scores for diarrhea,mucous bloody purulent stool,emotional stress or depression/anger,which induced diarrhea or tenesmus decreased to different degrees as compared with those before treatment(P < 0.05).The test group was superior to the control group in improvement of the primary symptoms(P< 0.05).5.TCM syndrome based scores for secondary symptoms: There was no significant difference in the scores between the two groups before treatment(P > 0.05),i.e.,the two groups were comparable in this aspect,while after treatment,the scores in the test group decreased to different degrees as compared with those before treatment(P < 0.05),and in the control group,the score for abdominal distension decreased as compared with that before treatment(P < 0.05).The test group was superior to the control group in improvement of the secondary symptoms(P < 0.05).6.TCM syndrome based efficacy: the TCM syndrome based total effective rates in the test group and the control group were 89.29% and 69.00%respectively.The cured cases,cases with excellent effect and effective cases in the test group were more than in the control group,while the ineffective cases in the test group were less than in the control group.Therefore,the test group was superior to the control group in this aspect,and the difference was statistically significant(P < 0.05).7.Endoscopic Baron score for mucosa: Before treatment,there was no significant difference in the Baron score between the two groups(P > 0.05),i.e.,the two groups were comparable.After treatment,the score decreased in both groups as compared with that before treatment(P < 0.05),but the test group was superior to the control group in this aspect of improvement(P <0.05).8.Quality of life: After treatment,the quality of life was improved in both groups as compared with that before treatment(P < 0.05),but the test group was superior to the control group in total score for social functions and quality of life(P < 0.05).9.No obvious adverse reactions were found in both groups during the treatment process,i.e.,relevant treatment methods were safe.Conclusion:1.Both Chaizhu Paste combined with mesalazine sustained-release granules and mesalazine sustained-release granules alone were effective in treating the liver stagnation and spleen deficiency syndrome of ulcerative colitis.2.Chaizhu Paste combined with mesalazine sustained-release granules was superior to mesalazine sustained-release granules alone for treating the liver stagnation and spleen deficiency syndrome of ulcerative colitis(UC)in the following aspects: clinical efficacy evaluation,disease activity score(modified Mayo activity index),TCM syndrome based scores for primary symptoms,TCM syndrome based scores for secondary symptoms,TCM syndrome based efficacy,endoscopic histological findings for mucosa(Baron score).3.The clinical effect of Chaizhu Paste combined with mesalazine sustained-release granules for treating liver stagnation and spleen deficiency syndrome of ulcerative colitis(UC)was definite.The life quality of relevant patients was improved significantly,and no adverse reactions were observed in the treatment process.Therefore,the treatment method may be further explored and popularized. |
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