In the study on mice, TAHT with LD50
could be considered safe [11
]. Although safety studies in animal models could often be extrapolated to humans, it does not necessarily follow that such products would be completely safe in humans. Therefore, actual controlled clinical trials on human subjects would be more definitive evidence on safety. TAHT did not cause the contraction of guinea pig ileum preparation and did not produce any significant effect on acetylcholine, histamine and nicotine-evoked contractions of the tissue. This result suggests that the pro-kinetic effect of TAHT on GIT may not be mediated by a direct effect on muscarinic, histaminergic or nicotinic receptors stimulation. Although the laxative effect of TAHT recorded in the whole animal experiments could support the benefits claimed in the use of TAHT for indigestion, constipation and bloating of stomach, the exact mechanism by which TAHT induces increase in the intestinal motility is not clear from the study.
The lower mean birth weights recorded in the group treated with TAHT could be ascribed to the higher number of litter size (a total of 30 for test group and 21 for control group), since higher multiple pregnancy could lead to lower mean birth weights. Subsequent monitoring of the litters in both groups showed that there was no significant difference in the percentage increase in weight over 21-day observation period, indicating lack of developmental effect on lactating animals. Although the study demonstrates some fertility promotion effect of TAHT, more studies will be required to definitively confirm any possible effect on sexuality, fertility and fertility hormones. The study also showed that TAHT lacks abortifacient and teratogenic effects.
TM and CAM are now attracting increasing attention and many governments are now according relevance to CAM in the provision of health care all over the world [12
]. Some important issues must be addressed if the potentials of TM/CAM are to be developed successfully. It is known that herbs in their natural state vary in potency and may contain multiple pharmacological substances which can cause undesirable effects. In most instances, herbal medicines are not made with isolated and purified active substance that will permit standardization of dosages, and testing for safety and efficacy before approval [13
]. Some toxic reactions to the use of herbal remedies are related to improper preparation, excessive quantities of some herbs, substitution of a herb with related herbs believed to possess similar effects and the effect of using herbal medications concomitantly with other pharmacologic products [14
In this study, a scientific assessment of a highly patronized herbal preparation marketed and used in Nigeria was undertaken. The results of this study show some level of efficacy and safety, which are related to some of the claimed indications of the phytomedicine. The results also showed some favorable pharmacological effects in animal models, which authenticates some of the label claims. However, further exhaustive studies, especially in human volunteers, would be necessary to succinctly validate the safety and efficacy of this herbal tonic.