title: Effects of D-002, a mixture of high molecular weight beeswax alcohols, on patients with nonalcoholic fatty liver disease.
abstract: OBJECTIVE
  Nonalcoholic fatty liver disease (NAFLD) is intimately related to insulin resistance and ranges from a benign course to liver fibrosis and cirrhosis. NAFLD management mainly involves dietary modification and weight loss. Although no fully successful pharmacological intervention is available, alternative therapies to treat NAFLD have shown promising results. Experimental studies have shown that D-002, a mixture of beeswax alcohols with antioxidant effects, is hepatoprotective. The aim of this study was to investigate the efficacy and safety of D-002 in patients with NALFD.
  
  
  METHODS
  Fifty patients with NAFLD were randomized to receive a placebo or D-002 (100 mg/day) for 24 weeks. The primary endpoint was a significant ultrasonography-detected reduction of liver fat infiltration versus a placebo. Secondary endpoints were decreases in the homeostatic model assessment (HOMA) index, insulin levels, serum liver enzymes, increases in plasma total antioxidant status (TAS) and improved clinical symptoms versus the placebo recipients.
  
  
  RESULTS
  At randomization, all indicators were comparable in both groups. At study completion, seven (28.0%) D-002-patients, but none of the placebo recipients, exhibited a normal liver echo pattern on ultrasonography (p < 0.01). Also, D-002 significantly reduced (p < 0.01 vs. baseline and placebo) the HOMA index and insulin levels and increased the TAS, but did not affect other parameters. The proportion of D-002-patients (12/25, 48.0%) showing symptom improvement was higher (p < 0.001) than that of the placebo group (1/25, 4.0%). The treatment was safe and well tolerated. Three patients in each group withdrew from the study.
  
  
  CONCLUSIONS
  D-002 (100 mg/day) improved ultrasonographic findings, indicators of insulin resistance, plasma TAS and clinical evolution on NAFLD patients. Further studies, however, are needed to confirm these results.
authors.affiliation: Centre of Natural Products, National Centre for Scientific Research, Havana, Cuba.
authors.forename: José
authors.initials: J
authors.lastname: Illnait
authors.forename: Iván
authors.initials: I
authors.lastname: Rodríguez
authors.forename: Sarahí
authors.initials: S
authors.lastname: Mendoza
authors.forename: Yolanda
authors.initials: Y
authors.lastname: Fernández
authors.forename: Rosa
authors.initials: R
authors.lastname: Mas
authors.forename: Mirtha
authors.initials: M
authors.lastname: Miranda
authors.forename: Jesús
authors.initials: J
authors.lastname: Piñera
authors.forename: Julio César
authors.initials: JC
authors.lastname: Fernández
authors.forename: Meilis
authors.initials: M
authors.lastname: Mesa
authors.forename: Lilia
authors.initials: L
authors.lastname: Fernández
authors.forename: Daisy
authors.initials: D
authors.lastname: Carbajal
authors.forename: Rafael
authors.initials: R
authors.lastname: Gámez
mesh_terms: D000328:Adult; D000368:Aged; D000975:Antioxidants / Q000009:adverse effects / Q000302:isolation & purification / Q000627:therapeutic use*; D015415:Biomarkers / Q000097:blood; D001786:Blood Glucose / Q000378:metabolism; D003462:Cuba; D004311:Double-Blind Method; D004798:Enzymes / Q000097:blood; D005233:Fatty Alcohols / Q000009:adverse effects / Q000302:isolation & purification / Q000627:therapeutic use*; D005234:Fatty Liver / Q000097:blood / Q000000981:diagnostic imaging / Q000188:drug therapy*; D005260:Female; D006801:Humans; D007328:Insulin / Q000097:blood; D008055:Lipids / Q000097:blood; D008099:Liver / Q000000981:diagnostic imaging / Q000187:drug effects* / Q000201:enzymology; D008297:Male; D008875:Middle Aged; D065626:Non-alcoholic Fatty Liver Disease; D011446:Prospective Studies; D013997:Time Factors; D016896:Treatment Outcome; D014463:Ultrasonography; D014885:Waxes / Q000737:chemistry*
chemical_list: D000975:Antioxidants; D015415:Biomarkers; D001786:Blood Glucose; C104511:D 002; D004798:Enzymes; D005233:Fatty Alcohols; D007328:Insulin; D008055:Lipids; D014885:Waxes; C038228:beeswax
keywords: Beeswax; D-002; Fatty liver; Insulin resistance; Non-alcoholic fatty liver disease