| Objective : To investigate the clinical efficacy of Sangma Runchang Decoction in treating of constipation-predominant irritable bowel syndrome(IBS-C)with yin deficiency and intestinal dryness syndrome,to evaluate and discuss its effectiveness and security,to investigate the benefits of traditional Chinese medicine in treating this disease,and to offer a rationale for the treatment of IBS-C with yin deficiency and intestinal dryness syndrome by “nourishing yin liquid and moistening intestines”.Methods : 60 patients,who met the diagnostic criteria of IBS-C with yin deficiency and intestinal dryness syndrome,and who were seen in the outpatient clinic and ward of the First division of Gastroenterology,Affiliated Hospital of Shandong University of Traditional Chinese Medicine were selecte.Dividing the patients into two groups,30 individuals each in the test and control groups,using the random number table method.For4 weeks,the test group took Sangma Runchang Decoction,while the control group took Shouhui Tongbian Capsule.Recording the changes in the total TCM scores and individual TCM scores,the severity of IBS,the quality of life of IBS and stool traits before and after treatment in both groups.SPSS 20.0 was used to analyze and scientifically evaluate the efficacy and security of Sangma Runchang Decoction in clinical application.Results :(1)General information : This project plan included 60 cases,and finally completed 58 cases,including 29 individuals each in the treatment and control groups.Statistically insignificant differences were observed between the two groups in terms of sex,age,and duration of illness distribution.(P>0.05).(2)Comprehensive efficacy : After 4 weeks of treatment,2 patients in the treatment group were clinically cured,14 patients had remarkable results and 11 patients were effective,with a total effective rate of93.10%;1 patient in the control group achieved clinically cured,8 patients had remarkable results,and 12 patients were effective,with a total effective rate of 72.41%.By the effective rate of the treatment group was substantially greater than that of the control group(P<0.05),it was proved that the clinical efficacy of Sangma Runchang Decoction is greater than that of Shouhui Tongbian Capsule.(3)Comparison of symptom efficacy : Before treatment,statistically insignificant difference were observed between the two groups in the field of total and individual TCM symptom scores(P>0.05).After 4 weeks of treatment,symptom scores were lower in both groups than the pre-treatment period(P<0.05),suggesting that both drugs were effective in relieving patients’ clinical symptoms.Sangma Runchang Decoction is better than Shouhui Tongbian Capsule in increasing the frequency of bowel movements,improving stool properties,relieving difficult bowel movements and relieving bloating and dry mouth(P<0.05).Both are similarly effective in relieving abdominal pain and less fluid in patients(P>0.05).(4)Comparison of IBS severity : Before treatment,there was a statistically insignificant difference in the severity of IBS between the two groups(P>0.05).Scores decreased in both groups compared to the pretreatment period(P<0.05).Demonstrated that both groups of drugs can alleviate the patients’ condition.Patients in the test group had a significantly higher reduction in IBS severity score than the control group(P<0.05).It shows that Sangma Runchang Decoction is superior to Shouhui Tongbian Capsule in improving the severity of IBS,such as relieving abdominal pain,abdominal distension and improving the satisfaction of stool.(5)Comparison of IBS quality of life : Statistically insignificant differences were observed in IBS quality of life scores between the two groups before treatment(P>0.05).Both groups showed a decrease in scores compared to the pre-treatment period(P<0.05),suggesting that the drugs in both groups were truly effective in enhancing the patients’ quality of life.The degree of reduction in points was markedly higher in the test group than in the control group.(P<0.05).It shows that Sangma Runchang Decoction is superior to Shouhui Tongbian Capsule in improving the quality of life of IBS,alleviating anxiety,enhancing interpersonal relationship and improving dietary limitations.(6)Comparison of stool characteristics: Statistically insignificant differences were observed between the two groups in field of stool characteristics(P>0.05).After treatment,there were significantly fewer patients with type 1 and type 2 stool characteristics in both groups(P<0.05).Demonstrated that both groups of drugs can lead to improvement in the stool characteristics of the patients.Patients with type 1 and type2 stool characteristics were significantly more reduced in the test group than in the control group(P<0.05),showing that Sangma Runchang Decoction was superior to Shouhui Tongbian Capsule in improving patients’ stool traits and relieving patients’ dry and hard defecation.(7)Comparison of recurrence and safety : At the follow-up after 8weeks of discontinuation,3 patients in the test group relapsed,with a recurrence rate of 10.34%,while 7 patients in the control group relapsed,with a recurrence rate of 20.69%.Statistically insignificant difference in recurrence rate between the two groups(P>0.05).No adverse effects were observed in either group during treatment and late follow-up.Conclusion : Through clinical observation,the efficacy of Sangma Runchang Decoction in treating IBS-C with yin deficiency with intestinal dryness is remarkable.Sangma Runchang Formula effectivly can improve the frequency and habit of defecation,improve the stool characteristics,relieve the defecation difficulties and symptoms of abdominal pain,bloating,dry mouth,and and less fluid,and enhance the quality of survival of patients.It has good safety and can be further promoted in clinical treatment. |