Indian Journal of Pharmacology Medknow Publications on behalf of Indian Pharmacological Society ISSN: 0253-7613 EISSN: 1998-3751 Vol. 38, Num. 5, 2006, pp. 355-356

Indian Journal of Pharmacology, Vol. 38, No. 5, September-October, 2006, pp. 355-356

Research Letter

Evaluation of the female reproductive toxicity of the aqueous extract of Labisia pumila var. alata in rats

Ezumi MFW, Amrah SS, Suhaimi AWM, Mohsin SSJ

Department of Pharmacology, School of Medical Sciences, Universiti Sains Malaysia Health Campus, 16150 Kubang Kerian,Kelantan
Correspondence Address:Department of Pharmacology, School of Medical Sciences, Universiti Sains Malaysia Health Campus, 16150 Kubang Kerian,Kelantan, sbsamrah@kb.usm.my

Code Number: ph06098

Labisia pumila var. alata (LPA ) or Kacip Fatimah (KF), as it is popularly known in Malaysia, is a very popular herb among the local women. Traditionally, the water decoction of the root or the whole plant of KF is consumed by Malay women for induction and facilitation of labour.[1] Currently, many commercial products, containing this herb, have emerged in the Malaysian market, claiming to enhance vitality and libido. However, there is no scientific data on their quality, safety and efficacy to substantiate such claims. Studies supported by the Government of Malaysia, conducted at various universities and institutes, are in various stages of progress, such as the extract preparation-standardisation (undergoing patenting), authentication and evaluation of safety and efficacy. Reports have shown that LPA displayed a non-significant response to in vitro estrogen activity[2]and had appreciable amount of iron.[3] In addition, LPA root and leaves were found to contain two novel benzoquinoid compounds 1, 2 as major components.[3] More information regarding this herb is expected to be available in the near future.

The objectives of the present study are to evaluate the female reproductive toxicity and potential effect of KF in inducing labour in rats. A standardised aqueous extract of LPA, at doses of 2-800 mg/kg/day, was administered, to determine the safety and efficacy of this herb. The general acute and sub-acute (28 days) toxicity studies of the same extract in rats had already been performed by a team at the Herbal Medicine Research Centre of the Institute for Medical Research, Kuala Lumpur, Malaysia. The results of the study revealed that the estimated LD ₅₀ of the extract is more than 5 g/kg, body weight and the extract produced no significant adverse effects (personal communication). A chronic toxicity study is ongoing and at present, no deleterious effects have been observed in rats. A Phase II clinical trial, conducted in postmenopausal women, by a research team at the School of Medical Sciences, Universiti Sains, Malaysia, concluded that the therapeutic dose of the extract is 2.5 mg/kg/day (personal communication).

Forty eight female Sprague Dawley rats were used in the Segment I (female reproductive toxicity) study. Rats with a regular estrous cycle (4-6 days) were given vehicle (distilled water) as control or LPA at 2, 20, 200, 400 or 800 mg/kg daily, by gavage, 10 days prior to mating, during mating (a maximum period of 10 days), throughout gestation and lactation periods of 7 days. Dams were permitted to deliver their litters, naturally. At birth (Day 1), the pups were individually counted, weighed, examined for external malformation and sexed. Dams and foetuses were sacrificed on Day 7, postpartum.[4] The parameters measured are presented in [Table - 1]. Data were analysed using SPSS version 11.0. Data on maternal body weight, throughout the study, were analysed using General Linear Model Repeated Measures. Mean days of estrous cycle, length of pregnancy (days), pregnancy index, number of pups, both at birth and on Day 7 lactation (litter size), pups' body weight during lactation and number of implantation sites per litter were analysed, using the one-way ANOVA, followed by the Scheffe test, if differences were found. Additionally, the Kruskal-Wallis test (non-parametric), followed by the Mann Whitney test (when appropriate), were used to assess the live birth index, viability index and percentage of post-implantation death. The level of significance was set at 5%. The parametric data were expressed as mean±SEM or ratio, while the non-parametric data were expressed as median (Interquartile range).

Table 2

Results indicated that the LPA extracts did not alter the general health or estrous cycle of rats. All studied animals proceeded towards successful mating and pregnancies. The mean duration of pregnancy (in days) was shortened to 21 days in animals which received the herbal extract at a dose of 20 mg/kg/day and above. However, it was not statistically significant. All pregnant rats delivered normally with no evidence of prematurity or abortion, suggesting that the extract is not an abortifacient or causes prostaglandin-like activity when consumed orally. None of the rats exhibited a significant amount of foetal resorption, indicating that the herb was non-toxic to the foetuses. Statistically, no test agent-related changes in the maternal body weight, number of implantations, litter size and pup body weights were observed. No significant difference in pup sex ratio, live birth index, pup viability index and percentage of post-implantation death, was noted in this study.

The present findings indicated that the water based extracts of LPA do not pose any significant reproductive toxicity or complication in pregnancy, delivery and early pup growth in rats. The no observable adverse effect level (NOAEL) of the extract in this study is 800 mg/kg/day. A closer observation of the duration of the pregnancy (in hours) and parturition time were not evaluated in this study to support the traditional claim of this herb.

References

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