Safety profile of suppository Hamamelis virginiana leaf extract

Abstract

The increased use of herbal remedies combined with their increasing availability in pharmacies, beauty and nutrition shops and supermarkets necessitates the evaluation of their efficacies and safety. The objective of the present study is to evaluate the safety of the rectal administration of the dry leaf extract of witch hazel (Hamamelis virginiana L. Family: Hamamelidaceae), one of the traditionally used herbs for treating hemorrhoids. H. virginianadry leaf extract was formulated in suppositories. An acute single dose study on rabbits and a 28 day repeated dose rectal administration of hamamelis extract on rats were preformed. No deaths occurred in either the placebo or the hamamelis treated rabbits. The general condition of all the rabbits was normal without any significant changes in their body weights. The changes in clinical and hematological parameters were non significant (p > 0.05). In the 28 day repeated dose study, no deaths occurred and normal body weight gains were recorded in all groups. Before sacrifice, the rats behaved normally with no detected signs of sickness or discomfort. After sacrifice, the inspected organs were normal in morphology and histopathology without any detected weight differences. All treated rats showed normal biochemical and hematological profiles compared to placebo treated animals (p > 0.05). The results obtained from the present study indicate that the rectal administration of H. virginianadry leaf extract (up to 300 mg/kg) formulated as suppositories was devoid of systemic toxicity. Key words: Witch hazel, rectal, safety, hemorrhoids, astringent, suppositories.