title: [Immunomodulation by herbal agents. A double-blind study in a medical university hospital involving a hepatitis B vaccine adjuvant model].
abstract: 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.
authors.affiliation: BOSCON MEDICAL GmbH, Bad Malente-Gremsmühlen. hc@boscon.de
authors.forename: H C
authors.initials: HC
authors.lastname: Bostelmann
authors.forename: R H
authors.initials: RH
authors.lastname: Bödeker
authors.forename: W
authors.initials: W
authors.lastname: Dames
authors.forename: H H
authors.initials: HH
authors.lastname: Henneicke-von Zepelin
authors.forename: C P
authors.initials: CP
authors.lastname: Siegers
authors.forename: U
authors.initials: U
authors.lastname: Stammwitz
mesh_terms: 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
chemical_list: D000276:Adjuvants, Immunologic; D006510:Hepatitis B Antibodies; D017325:Hepatitis B Vaccines; D010919:Placebos; D010936:Plant Extracts; C026057:Esberitox