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José Illnait,Iván Rodríguez,Sarahí Mendoza,Yolanda Fernández,Rosa Mas,Mirtha Miranda,Jesús Piñera,Julio César Fernández,Meilis Mesa,Lilia Fernández,Daisy Carbajal,Rafael Gámez 대한내과학회 2013 The Korean Journal of Internal Medicine Vol.28 No.4
Background/Aims: 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.
Evaluation of the effect of D-002, a mixture of beeswax alcohols, on osteoarthritis symptoms
Roberto Puente,José Illnait,Rosa Mas,Daisy Carbajal,Sarahí Mendoza,Julio César Fernández,Meilis Mesa,Rafael Gámez,Pablo Reyes 대한내과학회 2014 The Korean Journal of Internal Medicine Vol.29 No.2
Background/Aims: Nonsteroidal anti-inflammatory drugs relieve osteoarthritis(OA) symptoms but cause adverse effects. D-002, a mixture of beeswax alcohols,is effective against experimental OA. A pilot study found that D-002 (50 mg/day)for 8 weeks improves OA symptoms. The aim of this study was to investigate theeffects of D-002 (50 to 100 mg/day) administered for 6 weeks on OA symptoms. Methods: Patients with OA symptoms were double-blindly randomized to D-002(50 mg) or placebo for 6 weeks. Symptoms were assessed by the Western Ontarioand McMaster Individual Osteoarthritis Index (WOMAC) and the visual analogscale (VAS) scores. Patients without symptom improvement at week 3 were titratedto two daily tablets. The primary outcome was the total WOMAC score. WOMACpain, joint stiffness and physical function scores, VAS score, and use of rescuemedications were secondary outcomes. Results: All randomized patients (n = 60) completed the study, and 23 experienceddose titration (two in the D-002 and 21 in the placebo groups). At study completion,D-002 reduced total WOMAC (65.4%), pain (54.9%), joint stiffness (76.8%), andphysical function (66.9%) WOMAC scores, and the VAS score (46.8%) versusplacebo. These reductions were significant beginning in the second week, andbecame enhanced during the trial. The use of rescue medication by the D-002(6/30) group was lower than that in the placebo (17/30) group. The treatment waswell tolerated. Seven patients (two in the D-002 and five in the placebo group)reported adverse events. Conclusions: These results indicate that D-002 (50 to 100 mg/day) for 6 weeksameliorated arthritic symptoms and was well tolerated.