Background: Steatosis of the liver is the most frequent diffuse liver disease and its detection increased markedly due to ultrasonography. The presence of lipid particles in hepatocytes alters the ultrastructure of cellular membranes. The damaged cell is unable to meet adequately the energy requirements of phospholipid synthesis, the latter being the basic component of cellular and subcellular membranes. Substitution of "essential" phospholipids plays an important role in their regeneration.
Objective: The objective of the open trial without controls was to obtain preliminary information on the effectiveness of Essentiale forte cps. in the treatment of steatosis of the liver of varying etiology in a group of 30 women, focused on changes in the ultrasonic pictures and a parallel follow-up of laboratory findings and subjective feelings, to be followed subsequently by a placebo controlled double blind trial.
Methods and results: Ultrasonic examinations were made using a Hewlett-Packard apparatus (77065AR). The sonographic criterium of steatosis was the finding of a diffusely enhanced echogenicity of the liver parenchyma associated as a rule with varying degrees of hepatomegaly with a smooth rounded margin and readily apparent hepatic veins with a normal lumen. The preparation Essentiale forte, cps. Rhône-Poulenc Rorer Co., contains natural "essential" phospholipids, diglyceride esters of cholinephosphoric acid (enriched with unsaturated fatty acids (linolic, linoleic, oleic) 300 mg, vitamin B1 6 mg, vitamin B2 6 mg, vitamin B6 6 mg, vitamin B12 6 micrograms, nicotinamide 30 mg, vitamin E 6 mg. Six tablets per day (2 x 3 tablets) were administered for six months. The clinical, ultrasonic and laboratory examination were made at the onset of the trial and then after the second and sixth month. From the total number of 28 women who completed treatment in 29 % (8 woman) were free from sonographic signs of steatosis and only in 25 % (7 women) the finding remained unaltered. In the remainder the ultrasonic picture improved only partly, in 10 of 11 women (91 %) the non-homogeneity of the parenchyma disappeared, in 3 of 12 women (25 %) the conduction of acoustic signals improved. The authors recorded also regression of hepatomegaly from 12.9 +/- 1.5 cm to 11.4 +/- 1.0 cm (p < 0.0001). There was also a significant decline of laboratory values: ALT from 1.650 +/- 1.612 mu kat/l to 0.812 +/- 0.392 mu kat/l (p < 0.0014), AST from 1.308 +/- 1.341 mu kat/l to 0.613 +/- 0.206 mu kat/l (p < 0.0038), GMT from 2.525 +/- 3.374 mu kat/l to 0.976 +/- 0.727 mu kat/l (p < 0.0078). A statistically significant decline was also found in mean values of total bilirubin (p < 0.0316), cholesterol (p < 0.0129) and triglycerides (p < 0.001). In all patients subjective sensations improved (p < 0.05).
Conclusions: The authors provided evidence than in 53.6 % of patients the effect of six-month treatment with Essentiale forte was very good (improvement of all investigated parameters), partial in 42.9 % (improvement of laboratory findings and subjective complaints) ad not quite satisfactory in 3.6 % (only improvement of subjective feelings).