Clinical Observation On The Treatment Of Spleen Deficiency Cold Dampness Diarrheal Irritable Bowel Syndrome With Wenpi Huashi Formula

Objective: To design a randomized controlled trial to observe the effectiveness and advantages of warming the spleen and transforming dampness formula in the treatment of irritable bowel syndrome with spleen deficiency and cold dampness diarrhea,to evaluate its safety,and to provide a clinical basis for the treatment of IBS-D patients with Chinese medicine in order to improve their quality of life.Methods: Sixty-six patients with irritable bowel syndrome of spleen deficiency cold dampness diarrhea type who met the inclusion criteria were collected from November 30,2021 to December 1,2022 from the outpatient clinic of the Department of Liver,Gallbladder,Spleen and Stomach,Ningxia Hospital of Traditional Chinese Medicine and Ningxia Institute of Traditional Chinese Medicine according to the method of randomized controlled trial.These 66 patients were randomly divided into a control group and a treatment group,with 33 patients in each group,and the control group was treated with Bacillus subtilis dibacterium enteric solution capsules orally,while the treatment group was treated with the formula for warming the spleen and resolving dampness for 1 month,and the TCM symptom score,overall symptom efficacy,stool properties score and IBS-SSS score scale were observed and recorded before and after treatment,and statistical analysis was performed to evaluate and compare them.Results:1.Case completion: a total of 66 patients were included in the trial,and 64 cases were actually completed in the trial,with a total shedding of 2 cases.There were 32 cases each in the treatment and control groups.The total shedding rate was 3.03%.2.Comparison of baseline data: The test showed that before treatment,there were no statistical differences between the two groups in age,gender,course of disease,single TCM symptom score,TCM syndrome score,IBS-SSS scale score and Bristol stool character typing score(P < 0.05),which could be compared.3.Comparison of single symptom scores of traditional Chinese medicine: After treatment,the score of single symptom was statistically different between the two groups before and after treatment(P < 0.05).Compared between the two groups,the efficacy in cold and loose stool,sticky stool,fatigue or cold aggravation,loss of appetite symptoms were similar(P >0.05);It was better than the control group in abdominal pain,distension,fatigue and fatigue symptoms,and the difference was statistically significant(P < 0.05).4.Comparison of the curative effect of TCM syndromes: After treatment,the total score of comparative syndromes in the two groups were statistically different(P < 0.05);The total score of syndrome in treatment group was significantly different from that in control group(P< 0.05).The total clinical effective rate was 84.38% in the treatment group and 75.00% in the control group.The overall efficacy of the treatment group was better than that of the control group(P < 0.05).5.IBS-SSS scale assessment: After treatment,there were statistically significant differences in total scores and individual scores between the two groups(P < 0.05).Between the two groups,the treatment group was better than the control group in abdominal pain discomfort,abdominal distension discomfort degree score,intestinal symptoms on life disturbance score(P < 0.05);However,the number of days of abdominal pain every 10 days and the satisfaction of stool situation were similar between the two groups(P > 0.05).6.According to the comparison of Bristol stool character classification score and intra-group comparison after treatment,there was statistical significance(P < 0.05).There was no statistical significance between the two groups(P > 0.05),and the two groups had similar curative effects.Conclusion:(1)Warming Spleen and dampness prescription has the effect of warming middle and dispersing cold,invigorating spleen and dampness,and can effectively relieve abdominal pain,abdominal distension,cold and loose stool,sticky stool,dull abdominal distension,loss of appetite,fatigue,aggravation after cold or fatigue,and other clinical symptoms of spleen deficiency cold and dampness IBS-D,with significant overall efficacy.(2)In improving fatigue and fatigue,Wenpi Huashi formula was better than enteric-coated capsules combined with Bacillus subtilis.It is better than subtilis enteric-coated capsules in abdominal pain and abdominal distension.There was no significant difference in the efficacy of loose stool,sticky stool,fatigue or cold aggravation,loss of appetite,and Bacillus subtilis enteric-coated capsules.(3)During the treatment of spleen deficiency cold and dampness type IBS-D,there was no significant difference in the improvement of fecal properties between Wenphuashifang and Bacillus subtilis combined with enteric-soluble capsules.