| Objective:This study investigated the feasibility,efficacy,and safety of adding and subtracting weiguanjian Decoction in the treatment of IBS-D by using it to treat the diarrhea type irritable bowel syndrome(IBS-D)in the spleen and kidney yang deficiency type and performing a comparative analysis with the western medicine Bacillus subtilis dual live bacilli enteric coated capsule,in order to provide therapeutic experience for the clinical treatment and long-term management of IBS-D.Methods:In this study,patients who visited the spleen stomach hepatobiliary outpatient clinic and inpatient department of the Affiliated Hospital of Jiangxi University of Chinese medicine(TCM)between 2019-12 and 2020-12 with a definite diagnosis of IBS-D based on traditional Chinese medicine syndrome differentiation consistent with spleen kidney yang deficiency were selected,and a total of 60 cases met the inclusion criteria.They were randomly divided into control and treatment groups in a 1:1 ratio,30 cases in each group.Two cases dropped out during the trial due to treatment group and finally a total of 58 cases in both groups completed the study.Before treatment,the basic conditions of age,gender,disease course,vital signs and auxiliary examinations were counted,and a clinical symptom scoring form was filled.Two groups were given western medicine Bacillus subtilis dual live bacteria enteric coated capsules orally on the basis of reasonable diet,moderate exercise,and regular life,while the treatment group was given plus weiguan Decoction(15g of cooked ground,15 g of stir-fried atractylodes,10 g of dried ginger,5g of ructus,12 g of stir-fried lentil,15 g of yam,6g of stir-fried licorice,5g of myrrh,10 g of poria cocos,10 g of polyporus,10 g of oriental water plantain rhizome)orally for 4 weeks,and after treatment the follow-up of efficacy continued in 2 months.The TCM symptom scores,IBS-SSS scores and IBS-QOL scores before and after treatment were compared,and relevant general data,safety indicators and adverse effects were recorded during the trial,and the efficacy,safety and recurrence were analyzed in both groups.The resulting data were collated and statistical analysis was performed by using spss23.0 software.Results:1.The difference between the treatment and control groups in all aspects of TCM total syndrome scores(cloaca,abdominal cold pain,fatigue and talking laziness,cold limb shape,soreness of waist and knee,and loss of appetite),IBS-SSS score and IBS-QOL score between the pre-treatment and the post-treatment period was p < 0.05,indicating that both groups have some effect in improving diarrhea,alleviating systemic Yang deficiency symptoms,reducing the severity of the condition,and improving the quality of life.However,when post-treatment comparisons were made between the two groups,P < 0.05,indicating that the treatment group performed better.2.Comparison of TCM syndrome scores:The scores of main Symptoms of traditional Chinese medicine(cloaca,abdominal cold pain)and secondary symptoms of traditional Chinese medicine(fatigue and talking laziness,cold limb shape,soreness of waist and knee,and loss of appetite)between the two groups were decreased,and P < 0.05,indicating that the two groups had significant effect in improving the main symptoms and secondary symptoms of traditional Chinese medicine.The P < 0.05 result of the difference in the scores of the treatment main Symptoms of traditional Chinese medicine between the treatment groups indicated that although both groups significantly improved cloaca and abdominal cold pain,which are two main Symptoms of traditional Chinese medicine,the treatment group was superior to the control group in terms of the efficacy in terms of the degree of improvement.Post treatment group comparison of the score difference between the two treatment groups showed a significant difference in the improvement of the three symptoms including loss of appetite this time,and the rest of them all P < 0.05,indicating that the two groups were superior to the control group only in terms of improving the three symptoms,including fatigue and talking laziness,cold limb shape,and soreness of waist and knee,and that the treatment group was equivalent in improving the symptoms of loss of appetite.3.Comparison of curative effect of TCM syndromes:The total effective rate in terms of traditional Chinese medicine syndrome was 43.33% in the control group and 89.28% in the treatment group,and the comparison of the total effective rate between the two groups,P < 0.05,indicated that the two groups are different with each other significantly in terms of TCM efficacy.4.Comparison of efficacy of IBS-QOL: The overall effective rate in IBS-QOL was 92.86% in the treatment group and 66.67% in the control group,P < 0.05 for the comparison between the two groups,indicating that the two groups are different with each other significantly in terms of overall efficacy in IBS-QOL.5.Comparison of recurrence rates:Both groups experienced occasional recurrences during the 2-month follow-up visit at the end of the course,and the recurrence rate was 9.09% in the treatment group and 44.44% in the control group,with P < 0.05 for both comparisons of recurrence rates,indicating that the control group had a poorer long-term outcome than the treatment group.6.During the treatment period,no adverse reactions occurred in both groups,and the safety examination after the end of the course showed no abnormalities,thereby indicating that,whether in the treatment group(plus and minus Weiguan Decoction),or in the control group(subtilis diplococci enteric coated capsules),it was safe in the clinical treatment without adverse reactions.Conclusions:Both treatment regimens,plus and minus Weiguan Decoction and subtilis doublet live bacteria enteric coated capsules,were able to improve the clinical symptoms of patients with spleen and kidney yang deficiency IBS-D,but plus and minus Weiguan decoction had a more obvious advantage in relieving diarrhea,improving the main symptoms of traditional Chinese medicine,some secondary symptoms of traditional Chinese medicine,reducing the severity of the condition,and improving the quality of life,which was safe and reliable without adverse effects,The long-term outcome for IBS-D is also considerable and is worthy of application borrowing. |