[Diisopropylamine dichloroacetate in the treatment of nonalcoholic fatty liver disease: a multicenter random double-blind controlled trial].
OBJECTIVE
To investigate the efficacy and safety of diisopropylamine dichloroacetate in the treatment of nonalcoholic fatty liver diseases (NAFLD).


METHODS
A randomized, double-blind, dose-paralleled control trial was carried out with NAFLD patients. The patients were randomly assigned to 2 groups treated with either a high dosage (120 mg/d) or a low dosage (60 mg/d) of diisopropylamine dichloroacetate for 8 weeks and the efficacy and safety of the drug were examined.


RESULTS
127 cases were recruited for the trial, 63 in the high dosage group, and 64 in the low dosage group. No case dropped out in the trial but four cases were eliminated (4/127, 3.1%). The final number in this trial was 123, with 61 in the high dosage group and 62 in the low dosage group. After 8 weeks of treatment, the overall improvement of clinical symptoms in the high dosage and in the low dosage group was 87.8% and 79.6%, respectively. ALT normalization was found in 55.7% and 69.4% of the cases in the two groups, serum lipids were lowered in 67.2% and 67.7% and ultrasound grading of the liver alteration severity was lowered in 51.7% and 43.5% in the two groups. The differences found between the two groups were of no statistical significance. One case from each group was found having an adverse drug reaction of dryness of the mouth (1.6%). No severe adverse drug reactions were found.


CONCLUSIONS
Diisopropylamine dichloroacetate could be used as a safe and effective drug in the treatment of nonalcoholic fatty liver diseases.
Lu
Lun Geng
LG
Departmnt of Gastroenterology, Renji Hospital, Shanghai Institute of Digestive Diseases, Shanghai Second Medical University, Shanghai 200001, China.
Zeng
Min De
MD
Mao
Yi Min
YM
Chen
Cheng Wen
CW
Fu
Qing Chun
QC
Wang
Ji Yao
JY
Xie
Wei Fen
WF
Fan
Jian Gao
JG
D000328:Adult; D004311:Double-Blind Method; D005234:Fatty Liver / Q000188:drug therapy*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D000644:Quaternary Ammonium Compounds / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*
D000644:Quaternary Ammonium Compounds; C001002:diisopropylamine dichloroacetate