Not applicable to the focus of this monograph.
Animal studies: Only minimal classical animal toxicity data are available (Barsanti et al., 2000). These studies did not assess possible effects in utero or in offspring.
Table E summarizes information available from animal experiments related to antiandrogenic activity. In summary, in some model systems, antiandrogenic activity (specifically inhibition of hormonally or chemically induced prostate hyperplasia) can be demonstrated for extracts of saw palmetto fruit. In other model systems, no antiandrogenic activity was demonstrated.
In vitro studies: Table F summarizes relevant information from in vitro experiments with saw palmetto. Inhibition of androgen-dependent proliferation and cellular stimulation have been demonstrated for extracts of saw palmetto fruit.
In vitro inhibition of testosterone metabolism through inhibition of steroid 5-α-reductase and 3-α-hydroxysteroid dehydrogenase was demonstrated. Inhibition of androgen binding was demonstrated in some model systems.
Classical in vitro toxicity data available are minimal (Degenring et al., 2001; Ondrizek et al., 1999a, 1999b) and do not address antiandrogenic concerns in females.
Table G contains information relevant to antiandrogenic safety issues for substances related to saw palmetto. Information about substances that are functionally related because they inhibit steroid 5-α-reductase is included. In summary, several of the substances functionally related to saw palmetto extract are contraindicated for use in women because of potential deleterious effects on the external genitalia and internal reproductive organs of the male fetus.