title: [Treatment of nonalcoholic steatohepatitis by Jianpi Shugan Recipe: a multi-center, randomized, controlled clinical trial].
abstract: OBJECTIVE
  To evaluate the efficacy and safety of Chinese medicine (CM) intervention in the treatment of nonalcoholic steatohepatitis (NASH) from liver enzyme (ALT), imaging (the liver/spleen CT ratio) and syndrome scores, and to establish standard methods for diagnosis and therapeutic efficacy evaluation with characteristics of CM.
  
  
  METHODS
  A multi-center, stratified randomized, parallel controlled, blindness-method evaluated, superiority trial was performed. Totally 204 patients were randomly allocated into two groups, 102 patients in the experimental group (treated with CM) and 102 patients in the control group [treated with Western medicine (WM)]. The alanine aminotransferase (ALT), liver/spleen CT ratio, and clinical symptoms were observed in both groups.
  
  
  RESULTS
  Of the randomly allocated 204 cases from 4 hospitals, 3 patients were rejected, and 25 were lost. Totally 176 cases con- formed to the plan with complete follow-ups. After 3 months of treatment, syndrome scores and the improvement of partial clinical symptoms (fatigue and sallow complexion) were superior in the experimental group to those in the control group (P < 0.05). After 3 months of follow-up, the syndrome scores and improvement of partial clinical symptoms (fatigue and sallow complexion) were superior in the experimental group to those in the control group (P < 0.05). There was no statistical difference in improving liver enzymes or the liver/spleen CT ratio between the two groups (P > 0.05). There were 4 adverse reactions/adverse events in the two groups in the process of treatment, mainly covering drug-induced liver injury, diarrhea, and epigastric distension. Adverse reactions had nothing to do with CM treatment.
  
  
  CONCLUSIONS
  Jianpi Shugan Recipe had obvious efficacy in treatment of NASH. It could remove the liver fat and play a role in anti-inflammation and liver protection. It also could improve the indices of liver enzymes and the liver/spleen CT ratio effectively, which was superior to Polyene Phosphatidylcholine Capsule (PPC) in improving clinical symptoms, especially for such symptoms as fatigue and sallow complexion.
authors: Department of Digestive Diseases, Dongfang Hospital, Beijing University of Chinese Medicine, Beijing 100078, China. lijunxiang1226@163.com
authors: Jun-Xiang
authors: JX
authors: Li
authors: Department of Digestive Diseases, Dongfang Hospital, Beijing University of Chinese Medicine, Beijing 100078, China.
authors: Yun-Liang
authors: YL
authors: Wang
authors: Department of Digestive Diseases, Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing 100700, China.
authors: Min
authors: M
authors: Liu
authors: Department of Digestive Diseases, Guang'anmen Hospital, Beijing University of Chinese Medicine, Beijing (100053), China.
authors: Shao-Neng
authors: SN
authors: Liu
authors: Department of Liver Diseases, Beijing Hospital of Traditional Chinese Medicine, Capital Medical University, Beijing (100010), China.
authors: Chun-Jun
authors: CJ
authors: Xu
authors: Department of Digestive Diseases, Dongfang Hospital, Beijing University of Chinese Medicine, Beijing 100078, China.
authors: Jing
authors: J
authors: Zhao
authors: Department of Digestive Diseases, Dongfang Hospital, Beijing University of Chinese Medicine, Beijing 100078, China.
authors: Rui
authors: R
authors: Shi
authors: Department of Digestive Diseases, Dongfang Hospital, Beijing University of Chinese Medicine, Beijing 100078, China.
authors: Dong-Mei
authors: DM
authors: Su
authors: Department of Digestive Diseases, Dongfang Hospital, Beijing University of Chinese Medicine, Beijing 100078, China.
authors: Li
authors: L
authors: Zhuge
authors: Department of Digestive Diseases, Dongfang Hospital, Beijing University of Chinese Medicine, Beijing 100078, China.
authors: Xi
authors: X
authors: Chen
authors: Department of Digestive Diseases, Dongfang Hospital, Beijing University of Chinese Medicine, Beijing 100078, China.
authors: Yi-Qun
authors: YQ
authors: Yu
authors: Department of Digestive Diseases, Dongfang Hospital, Beijing University of Chinese Medicine, Beijing 100078, China.
authors: Li
authors: L
authors: Li
authors: Department of Digestive Diseases, Dongfang Hospital, Beijing University of Chinese Medicine, Beijing 100078, China.
authors: Chun-E
authors: CE
authors: Xie
authors: Department of Digestive Diseases, Dongfang Hospital, Beijing University of Chinese Medicine, Beijing 100078, China.
authors: Li-Ming
authors: LM
authors: Hu
authors: Department of Digestive Diseases, Dongfang Hospital, Beijing University of Chinese Medicine, Beijing 100078, China.
authors: Chang
authors: C
authors: Zhang
mesh_terms: D000328:Adult; D004365:Drugs, Chinese Herbal / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D065626:Non-alcoholic Fatty Liver Disease / Q000188:drug therapy*; D008517:Phytotherapy
chemical_list: D004365:Drugs, Chinese Herbal; C534230:shugan jianpi