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Abstract
A combined polyherbal formulation containing tongkat ali (Eurycoma longifolia) and kacip fatimah (Labisia pumila) aqueous extracts was evaluated for its safety aspect. A repeated dose 28-day toxicity study using Wistar rats was conducted where the polyherbal formulation was administered at doses 125, 500 and 2000 mg/kg body weight to male and female treatment groups daily via oral gavage, with rats receiving only water as the control group. In-life parameters measured include monitoring of food and water consumption and clinical and functional observations. On day 29, blood was collected for haematological and biochemical analysis. The rats were necropsied and the organs were collected for histopathological examination. This study showed that the combined formulation did not induce any significant toxicity effect at any dose level in terms of morbidity, mortality, behaviour, functional observation, body weight, food and water consumption, whole blood haematology and serum biochemistry. However, there were some microscopic changes in the histopathological examinations of some organs given 2000 mg/kg body weight, which may suggest an early response to the polyherbal formulation. From this study, the no observed adverse effect level is estimated to be more than 500 mg/kg body weight but not exceeding 2000 mg/kg body weight. The observed effects at the highest dose indicate the need for further study of longer dosing duration.
Highlights
Medicinal plants have been used in disease prevention and treatment for many generations and their potential pharmaceutical values have drawn worldwide attention
The World Health Organization (WHO) has launched the WHO Traditional Medicine Strategy 2014–2023 to reinforce the use of medicinal plants in healthcare services and management [1]
Chromatographic identification analysis is commonly used for the quality assessment and species authentication of medicinal plants, including herbal products such as health supplements
Summary
Medicinal plants have been used in disease prevention and treatment for many generations and their potential pharmaceutical values have drawn worldwide attention. The World Health Organization (WHO) has launched the WHO Traditional Medicine Strategy 2014–2023 to reinforce the use of medicinal plants in healthcare services and management [1]. The trend towards maintaining health and wellbeing using medicinal plants as an alternative treatment is expanding. Some medicinal plants have been reported to trigger allergic reactions [4,5], modify bioavailability of conventional drugs [6,7,8]. The consumption of medicinal plants merely based on traditional practices that lack valid scientific evidence may overrule their benefits due to these possible undesirable health effects. Evidence-based safety studies investigating medicinal plants and the products thereof are beneficial to both the scientific community for pharmaceutical development, as well as to the consumers in seeking alternative plant-based therapies
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