Therapy of primary biliary cirrhosis with p-tolylmethylcarbinol nicotinic acid ester in combination with alpha-naphthylacetic acid.
OBJECTIVE
To assess the effect of choleretic treatment with p tolylmethylcarbinol nicotinic acid ester and alpha-naphthylacetic acid (Galle-Donau) on laboratory parameters of cholestasis, lipids, immunologic activity and on clinical signs in primary biliary cirrhosis patients.


METHODS
Prospective, non-randomized case control study; retrospective evaluation of pre-treatment period, evaluation of six months of treatment, open study after six month of treatment with evaluation of patients further treated and patients who discontinued treatment.


METHODS
Twelve consecutive patients with proven primary biliary cirrhosis, all female. Patients were to take six to nine capsules of Galle-Donau, containing 37.5 mg p-tolymethylcarbinol nicotinic acid ester and 75 mg alpha-naphthylacetic acid (5 mg per kg of body weight and 10 mg), daily in three doses, together with meals. Six patients discontinued treatment with Galle-Donau after six months and were followed up further.


RESULTS
After six months of Galle-Donau treatment the average alkaline phosphatase level dropped from 670.8 IU/ml to 577.1 IU/ml; the levels of total bilirubin (1.46 vs. 1.15 mg/100 ml) and unconjugated bilirubin (0.82 vs. 0.63 mg/100 ml) also decreased under therapy. This drop was not significant, while the decrease in triglycerides (149.2 vs. 103.1 mg/100 ml) reached statistical significance. During further treatment for up to two years patients showed no significant change in triglycerides, cholesterol or alkaline phosphatase. y-Glutamyl transpeptidase was not changed by treatment. Discontinuance of treatment resulted in significant increases in alkaline phosphatase and y-glutamyl transpeptidase, as well as in bilirubin levels. Triglyceride values also rose significantly when treatment was stopped, while the increase in cholesterol did not reach statistical significance. No influence of Galle-Donau treatment was found on IgM level. Pruritus (five patients) and Sicca symptoms (six patients) resolved within the treatment period in all but one patient (Sicca symptoms) who did not take the medication regularly. In the group of patients who discontinued therapy pruritus returned in both patients who had complained of it before therapy. Sicca symptoms returned in one out of three patients.


CONCLUSIONS
Treatment with p-tolylmethylcarbinol nicotinic acid ester and alpha-naphthylacetic acid leads to relief of symptoms and ameliorates biochemical parameters of cholestasis may, therefore, be of value for PBC therapy.
Kaserbacher
R
R
Universitätsklinik für Innere Medizin, Innsbruck.
Propst
A
A
Vogel
W
W
D000328:Adult; D000368:Aged; D016022:Case-Control Studies; D002756:Cholagogues and Choleretics / Q000008:administration & dosage* / Q000009:adverse effects; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D008105:Liver Cirrhosis, Biliary / Q000175:diagnosis / Q000188:drug therapy*; D008111:Liver Function Tests; D008875:Middle Aged; D009280:Naphthaleneacetic Acids / Q000009:adverse effects / Q000032:analysis*; D011446:Prospective Studies; D012189:Retrospective Studies; D016896:Treatment Outcome
D002756:Cholagogues and Choleretics; D009280:Naphthaleneacetic Acids; C034182:1-naphthaleneacetic acid