Multi-center randomized double-blind controlled study on children's anorexia (spleen-stomach disharmony) treated with Child Compound Endothelium Corneum.
10.19540/j.cnki.cjcmm.20201125.501
- Author:
Yan WANG
1
;
Dan-Dan ZHONG
2
;
Xiao-Hua JI
3
;
Yan-Bo CHENG
1
;
Xiao-Dan GAO
4
;
Yan-Mei ZHENG
5
;
Li ZHAO
6
;
Kai-Wei LI
7
Author Information
1. Paediatrics in Henan Provincial People's Hospital, People's Hospital of Zhengzhou University, People's Hospital of Henan University Zhengzhou 450003, China.
2. Zhengzhou First People's Hospital Zhengzhou 450004, China.
3. Xiyuan Hospital, China Academy of Chinese Medical Sciences Beijing 100091, China.
4. Beihai Hospital of Traditional Chinese Medicine Beihai 536000, China.
5. Taiyuan Maternal and Child Health Care Hospital Taiyuan 030012, China.
6. Shijiazhuang First Hospital Shijiazhuang 050000, China.
7. Huangshi Central Hospital Huangshi 435000, China.
- Publication Type:Randomized Controlled Trial
- Keywords:
Child Compound Endothelium Corneum;
anorexia;
eating less;
inappetence;
spleen-stomach disharmony
- MeSH:
Anorexia/drug therapy*;
Child;
Double-Blind Method;
Endothelium;
Humans;
Reproducibility of Results;
Spleen;
Stomach;
Treatment Outcome
- From:
China Journal of Chinese Materia Medica
2021;46(9):2298-2303
- CountryChina
- Language:Chinese
-
Abstract:
Child Compound Endothelium Corneum(CCEC)has the effects in invigorating the spleen and appetizing the appetite, and dissolving the accumulation of food. The recent studies have proved that it could improve gastrointestinal motility, restore physiological gastrointestinal peristalsis, increase gastrointestinal digestive motility, and enhance appetite. This trial aimed to evaluate its clinical efficacy and safety in the treatment of children's anorexia(spleen-stomach disharmony). A total of 240 children with anorexia in line with the inclusion and exclusion criteria were selected and randomly divided into experimental group and control group, with 120 in each group. Patients in the experimental group took CCEC and Erpixing Granules simulant. Patients in the control group took Erpi-xing Granules and CCEC simulant. After 21 days of treatment, there was no statistical difference in the recovery rate of anorexia, reduced food intake, eating time, weight change, traditional Chinese medicine syndrome effect, single symptom effect, and trace element Zn recovery rate between the two groups. Based on the non-inferiority test, the experimental group was not inferior to the control group in efficacy. How-ever, the effect of CCEC in reducing appetite in children with anorexia was better than that of control drugs(P<0.05). There was no statistical difference in the incidence of adverse events and adverse reactions between the two groups during the trial. This experiment confirmed the efficacy and safety of CCEC in the treatment of children's anorexia(spleen-stomach disharmony), with a safety and re-liability in clinical application. In addition, it was a better choice for children with anorexia who were mainly manifested by reduced appetite. Meanwhile, compared with granule, chewable tablets were more convenient to take in clinic. Therefore, the efficacy and safety of CCEC for the treatment of children's anorexia(spleen-stomach disharmony) were not inferior to those of Erpixing Granules, with a safety and reliability in clnic. However, due to the small sample size of this trial, the efficacy results only show a trend. It is suggested to further carry out a large-sample-size clinical study to define the clinical advantages of CCEC.
