Modified Banxia Xiexintang for Treatment of Simple Obesity in Children with Syndrome of Stomach Hyperactivity and Spleen Stagnation： A Randomized Controlled Study / 中国实验方剂学杂志

ABSTRACT

ObjectiveTo observe the clinical efficacy and safety of modified Banxia Xiexintang in treating simple obesity in children with the syndrome of stomach hyperactivity and spleen stagnation. MethodA randomized， double-blind， placebo-controlled study was conducted， in which 78 children with simple obesity due to stomach hyperactivity and spleen stagnation were randomized into an observation group （39 cases） and a control group （39 cases）. On the basis of diet and exercise intervention， the observation group received modified Banxia Xiexintang and the control group received placebo. The two groups were compared in terms of the therapeutic effect regarding TCM symptoms， body mass index （BMI）， waist circumference， hip circumference， obesity， and visual analogue scale of appetite after 2 months of treatment， and the treatment safety was observed. ResultAfter treatment， the response rate in the observation group was 88.89% （32/36）， which was higher than that （77.14%， 27/35） in the control group （Z=-2.301， P<0.05）. After 2 months of treatment， the body weight， BMI， waist circumference， hip circumference， and obesity decreased in both groups （P<0.05，P<0.01）. The TCM symptom scores and visual analogue scale scores of appetite in the observation group declined （P<0.05）. The control group showed decreased scores of TCM symptoms except gluttony and overeating （P<0.05）， declined scores of desire to eat， hunger， and willingness to eat declined （P<0.05）， and no significant change in the score of fullness before and after treatment. Compared with the control group， the observation group showed decreased total score of TCM symptoms， scores of primary and secondary TCM symptoms， body weight， BMI， waist circumference， hip circumference， obesity， and scores of desire to eat， hunger， and willingness to eat （P<0.05） and no significant difference in the score of fullness after treatment. No adverse reaction related to the drug application was observed during the treatment period. ConclusionModified Banxia Xiexintang can reduce the body weight， BMI， waist circumference， hip circumference， and obesity， improve the body shape， alleviate the symptoms， and enhance the therapeutic effect and compliance of children with simple obesity， being safe in clinical application.