Ref18C14
Randomized open study of the dose-effect relationship of
a short course of IdB 1016 (Silybin Phytosome) in patients with
viral or alcoholic hepatitis
A.
Vailati, L.Aristia, E. Sozze, F. Milani, V. Inglese, PO. Calenda,
P.A. Gossolo, E. Ascari
Department
of Internal Medicine and Medical Therapy, 2nd Meidcal Clinic,
University of Pavia, Italy
M.
Lampertico, S. Comis, C. Marena
Medical
Department, Inverni della Beffa, Via Ripamonti 99, 20041 Milan,
Italy
Not
on Medline
SUMMARY:
A phase-II randomised open trial was performed to clinically
evaluate the dose-response relationship to IdB 1016 (Silybin Phytosome),
in patients with chronic hepatitis of either alcoholic or
viral cause. The results suggest that treatment with (Silybin Phytosome)
is of benefit in patients with viral or alcohol-induced hepatitis
at the dose of 160 mg per day. But significant benefits were
found at the dose of 240 mg per day. Still greater benefits
were found with the dosage at 360 mg per day. All of these
dosages are measured in silybin, which is 33% of the total
in Silybin Phytosome, with phosphatidylcholine making up the balance.
Therefore you must multiply by three to get the actual corresponding
dosage of (Silybin Phytosome).
The
lowest dose had some beneficial effect, but this study collected
sufficient clinical and statistical evidence to indicate as
minimum recommended dose the 240 mg per day (measured as silybin).
Since there are no evidences of greater risks of adverse events
with the 360 mg per day does, whereas there are indications
this may provide greater effects on more parameters than the
240 mg dose, the use of the highest dose may be considered
in patients in need of either a faster onset or of a greater
extent in the pharmacodynamic action of IdB 1060 (Silybin Phytosome).
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