Abstract

Propolis is a natural product collected from several plants by honeybees and mixed with beeswax and salivary enzymes. In animal models, propolis suppressed IgE-mediated allergies. However, there is no clinical evidence that propolis prevents human atopic sensitization, to the best of our knowledge. Therefore, a randomized, double-blind, placebo-controlled trial was conducted to assess whether propolis supplementation for lactating women increases or decreases the level of total IgE and antigen-specific IgE in the serum of their offspring (i.e., atopic sensitization) at the time of their first birthday. In addition, whether propolis supplementation improves or worsens nonspecific symptoms (e.g., eczema) in the lactating women and their offspring was also investigated. This trial is registered with UMIN000020794. Eligible pairs of mothers and their offspring (n=80) were randomized to two groups: propolis (n=40) and placebo (n=40). Participants were evaluated every month, and 31 (78%) of the propolis group and 23 (58%) of the placebo group underwent blood tests at the first birthday of the offspring. Total IgE ≥ 10 UA/ml was seen in 26 (84%) infants whose mothers were given propolis, which was not significantly different from the 19 (86%) given placebo (P=0.80). Total IgE as a continuous variable was not significantly different between the propolis and placebo groups (P=0.70). Antigen-specific IgE levels for mites, egg white, cow's milk, and wheat, as both dichotomous and continuous variables, were not significantly different between the two groups. Both in mothers and their offspring, there were no significant differences in the subjective improvements of nonspecific symptoms between the two groups. Except for one mother who had transient and mild nausea, none of the other mothers or their offspring developed severe adverse events during the follow-up period. In conclusion, compared with placebo, Brazilian propolis supplementation did not influence the risk of atopic sensitization in infants and neither did it improve nor worsen nonspecific symptoms in either mothers or their infants.

Highlights

  • Propolis, so-called bee glue, is a natural resinous product that honeybees collect from various plants and mix with varying amounts of beeswax and salivary enzymes

  • Us, a randomized, double-blind, placebo-controlled trial was conducted to assess whether propolis supplementation for lactating women increases or decreases the level of total IgE and antigen-specific IgE in the serum of their offspring sampled at the time of their first birthday

  • Trial Design. is was a multicenter, double-blind, placebo-controlled trial to assess the safety of propolis supplementation for lactating mothers and their infants and to evaluate its efficacy for atopic sensitization by measuring IgE at the first birthday of the infants. e trial protocol was approved by the Ethics Committee of the Jikei University School of Medicine, and the institutional review board of Fuji City General Hospital, as well as of Atsugi City General Hospital

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Summary

Introduction

-called bee glue, is a natural resinous product that honeybees collect from various plants and mix with varying amounts of beeswax and salivary enzymes. Bees use propolis on their hives as protection against predators and microorganisms, to repair damage, as a thermal isolator, and to build aseptic locales to prevent microbial infection of larvae [1, 2]. Animal model studies suggested that propolis could suppress IgE-mediated allergies, e.g., asthma [5], food allergy [6, 7], and allergic rhinitis [8], by inhibiting degranulation of basophils [9] through NFκB [10, 11]. To the best of our knowledge, there is no clinical evidence supporting these results in the animal models

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