Effect of (+)-cyanidanol-3 (Catergen) in chronic active hepatitis. (Catergen plus prednisolone versus prednisolone in a controlled study).

Thirty-six patients with biopsy-proved chronic active hepatitis (CAH) were randomized. Of these 18 patients, 15 of them HBsAg and/or anti-HBc positive, received (+)-cyanidanol-3 (Catergen, Zyma) in doses of 1.5 g daily for 6 months in addition to the previously started low dose (10-15 mg/day) prednisolone. The other 18 patients, 16 of them HBsAg and/or anti-HBc positive, continued on the former corticosteroid treatment exclusively. After 6 months an overall clinical-biochemical improvement was noted in 10 cyanidanol-treated and in 6 control patients, while the condition deteriorated in 4 drug-treated and 8 control subjects. Serum GPT activity decreased to less than twice the normal in 12/16 drug-treated and in 7/13 control subjects, gamma-GT fell to normal in 7/16 cyanidanol-treated and in 1/10 control patients, IgG fell to normal in 4/8 drug-treated and in 1/9 control patients who all had initially elevated values. The percentage of "active" E-rosette forming cells fell in both groups but the decrease was significant only in the control cases, i.e. cyanidanol inhibited the progressive fall in circulating T cells during the course of the disease. Lymphocyte proliferative response to phytohaemagglutinin stimulation, as measured by 3H-thymidine incorporation, significantly increased in the cyanidanol group. Anti-HBs titres were markedly raised in 7/15 drug-treated and in 2/16 control patients. Thus, cyanidanol had some slight beneficial effect on biochemical liver function tests and the immunological activity in CAH patients. Its use may be recommended as an adjuvant constituent of the complex therapy of the disease.

RCT Entities:   Population Interventions Outcomes