[Immunomodulation by herbal agents. A double-blind study in a medical university hospital involving a hepatitis B vaccine adjuvant model].
OBJECTIVE
Using the hepatitis B vaccination as a model, to investigate the extent to which the herbal immunomodulator, Esberitox N, supports seroconversion.


METHODS
346 medical students participated in the placebo-controlled, randomized double-blind study. They took 3 x 2 tablets of the test substances daily, beginning 3 days prior to the injection and ending two weeks after it. The target outcomes were seroconversion and the level of the anti-HBs titer.


RESULTS
The data of 157 volunteers treated with the test substance, and 161 treated with placebo were analysed. After the first injection, the seroconversion rate was 22% in both test substance and placebo groups, and showed no advantage for the volunteers receiving the test substance. After the second injection, 89% of all members of each group revealed seroconversion. After the first injection, anti-HBs titers were appreciably higher in the test substance group (n = 34) than in the placebo group (n = 36; PWilcoxon = 0.003). The respective median values were 37.0 IU/L (95% CI: 18-68) and 15.5 IU/L (95% CI: 8-30).


CONCLUSIONS
The immunomodulator tested has negligible influence on seroconversion, but does enhance the immune response of subjects experiencing seroconversion.
Bostelmann
H C
HC
BOSCON MEDICAL GmbH, Bad Malente-Gremsmühlen. hc@boscon.de
Bödeker
R H
RH
Dames
W
W
Henneicke-von Zepelin
H H
HH
Siegers
C P
CP
Stammwitz
U
U
D000276:Adjuvants, Immunologic / Q000008:administration & dosage / Q000494:pharmacology; D000293:Adolescent; D000328:Adult; D016001:Confidence Intervals; D004311:Double-Blind Method; D006509:Hepatitis B / Q000517:prevention & control*; D006510:Hepatitis B Antibodies / Q000032:analysis*; D017325:Hepatitis B Vaccines; D006801:Humans; D010919:Placebos; D010936:Plant Extracts / Q000008:administration & dosage / Q000494:pharmacology
D000276:Adjuvants, Immunologic; D006510:Hepatitis B Antibodies; D017325:Hepatitis B Vaccines; D010919:Placebos; D010936:Plant Extracts; C026057:Esberitox