No clinical evidence base to support the hygiene hypothesis.

The hygiene hypothesis is a popular explanation for recent increases in allergy in the western world. This hypothesis suggests that development of allergy (or asthma) could be prevented by exposure to immune stimulants such as viruses, bacteria and endotoxins, in particular in the prenatal period or early childhood. How evidence-based are the observations which support the hygiene hypothesis? All clinical epidemiological indications in favour of the hypothesis are based on observational (cross-sectional and cohort) studies and not on observations in randomised controlled intervention studies. In cross-sectional studies no causal relationships can be assessed with sufficient validity. Also in cohort studies there are validity problems, as the exposure is not determined by chance (by means of randomisation) and could be influenced by behaviour. And behaviour might well be a confounder, since it can be associated with both exposure and outcome. A problem is that, without being appropriately tested in well designed prospective research, the hygiene hypothesis has currently already become so popular in the news media that an increased occurrence of asthma might even be induced as a result of an increased exposure. Although the currently available evidence to support the hygiene hypothesis is poor, it appears that the hypothesis has to some become a matter of faith or ideology. Scientists should take care that messages imparted to the general public do not go beyond or conflict with existing evidence.