Purpose:To evaluate the effectiveness and safety of modified Zexie Wendan deco-ction of overweight and obese children with spleen deficiency and phlegmdampness pattern.Method:76 overweight and obese children with spleen deficiency and phlegmdampness pattern were stratified randomized by gender and severity into treatment group(n=38)and control group(n=38).All children were given health intervention,and additionally those in the treatment group were offer-ed with modified Zexie Wendan decoction orally,1 dose per day for patients aged 7 to 10 years old while 1.5 doses per day for those aged 11 to 14 years old.The course of treatment was 6 weeks.The body mass index(BMI),traditi-onal Chinese medicine(TCM)symptoms score,blood pressure,anxiety score(SCARED score)and quality of life score(PedsQL score)were compared between the two groups before and after treatment.The effectiveness and safety was evaluated after treatment,the variation trend of BMI was compared between the two groups 3 months after treatment,and the adverse reactions were observed.Result:The BMI,TCM symptoms score and blood pressure level were significan-tly decreased after treatment,while SCARED score and PedsQL score were improved(P<0.01).Compared with the control group,the improvement of BMI,TCM symptoms score,blood pressure level,SCARED score and PedsQL score in the treatment group were more significant than those before treatment(P<0.01).The total effective rate of the treatment group was 88.89%,which was better than that of the control group(59.38%)(P<0.05).Follow-up showed that the decreasing trend of BMI in the treatment group was greater than that in the control group(P<0.01).There were no obvious adverse reactions in both groups.Conclusion:1.Modified Zexie Wendan decoction combined with health intervention can safely and effectively reduce the BMI percentile level,blood pressure level and TCM symptoms of overweight and obese children with spleen deficiency and phlegm-dampness pattern,ease their anxiety,improve the quality of life.2.Modified Zexie Wendan decoction combined with health intervention may have a good long-term effect on reducing the level of BMI in overweight and obese children with spleen deficiency and phlegm-dampness pattern,which is worthy of further study. |