An Investigation of the toxic effects of a herbal formulation with anti-carcinogenic properties

A decoction prepared from a mixture of Nigella sativa seeds, Hemidesmus indicus root, and Smilax glabra rhizome used by some traditional medical practitioners in Sri Lanka is considered to be useful for the treatment of cancer patients. However, there is a lack of information about any adverse effects of this decoction. Experiments were carried out using Wistar rats and ICR mice as the experimental model, to evaluate any adverse effects mediated by the above decoction. Results of the investigations showed that administration of the decoction (at doses of 4g/kg body weight/day and 6g/kg body weight/day) to rats for three months had no adverse effects on the liver functions (as assessed by its effects on serum levels of alanine and aspartate aminotransferase and alkaline phosphatase) or haematological parameters (red blood cell count, white blood cell count, haemoglobin concentration, packed cell volume, mean corpuscular haemoglobin, mean corpuscular volume and mean corpuscular haemoglobin concentration). No significant pathological changes were observed in sections of the major body organs (liver, heart, lungs, stomach, duodenum and kidney) of animals treated with the decoction for three months. The investigations also demonstrated that the decoction did not have anti-ovulatory, anti-implantation, spermicidal activity. An attempt to determine the LDM concentration was unsuccessful. Even at a dose equivalent to 40 times (240g/kg/day) the normal therapeutic dose (6g/kg/day), no mortality or other toxic symptoms (loss of consciousness, salivation, muscle tremor, incoordination, hyperaesthesia, polyuria, anuria, polydipsea, defecation, piloerection, changes in locomotor activity, changes in posture, ataxia and loss of reflexes) were observed. Three month treatment with the decoction also did not produce any changes in average feed consumption, average body weight: liver weight ratios, or the general behaviour of the animals.