Introduction From 2009 to 2011 in our randomised prospective, blinded clinical trial we studied the effect of polyunsaturated phosphatidylcholine—PUPC (Essentiale® forte N, A. Nattermann & Cie.GmbH) and Sibutramin in patients with obesity (BMI 30–35 kg/m2). We studied 80 patients with obesity mean age of 38±7 years and 40 were males. High resolution B mode ultrasonography was carried out twice for screening NAFL patients and after 6 months treatment.
Methods Liver function markers ALT, AST and GGT were measured twice, before and after 6 months treatment. All patients followed the basic treatment scheme included dietary and physical regimen. 50 patients of investigational group (IG) additionally were treated by Sibutramin, daily dosage contained 15 mg and PUPC (daily dosage contained 1368 mg Phosphatidylcholine). 30 patients of control group (CG) were treated by Sibutramin, daily dosage contained 15 mg.
Results All 50 patients of IG and 30 patients of CG were available for follow-up reliable decrease (12.8%) of BMI and leptin level. In IG patients BMI and leptin level (24.7±2.1%—16.2±1.2%) was registered compared to CG patients (BMI decrease—9.3%, leptin level 24.5±1.5% to 19.9±1.1%). Moreover after 6 months of treatment the mean value of disease activity evaluated by Metavir scale was A1 in IG and A3 in CG. The results of liver biopsy (histological examination) and Fibromax test showed, that in patients with ALD additionally treated by PUPC, the progress of hepatic fibrosis was significantly slowly, then in CG (Fibromax test result: F1 vs F3) (p<0.05). In addition after 6 months of treatment we found significant increase of steatosis in CG, and its reduction in IG (p<0.05). Ultrasound studies were performed on the basis of liver attenuation value assessment and revealed the hepatic echo-texture had become significantly improved after Sibutramin treatment in 46/50 (92%) of patients, while there was no change in 7/30 (23.3%) individuals. Also in patients additionally treated by polyunsaturated phosphatidylcholine and Sibutramin we found significant reduction of glucose, insulin levels and of insulin resistance index HOMA. The usage of Sibutramin itself did not reveal significant changes.
Conclusion Study results suggest that Sibutramin combined with PUPC improves liver function and insulin-sensitivity, reduces steatosis and fibrosis in patients with obesity and effect of combined therapy is higher than of Sibutramin itself.
Competing interests None declared.
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