Evaluation Of The Reproductive And Developmental Toxicities Of The Aqueous Extract Of Labisia Pumila Var. Alata In Female Rats
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Date
2009-10
Authors
Mohd Puad @ Mohd Fuad, Wan Ezumi
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Abstract
Labisia pumi/a var, a/ala (LPA) or Kacip Fatimah has been listed by the
government of Malaysia as one of the priority species for a multi-disciplinary
scientific study towards the development of scientific, evidence-based herbal
medicine. The present study described in this thesis is part of the preclinical
assessment of LPA to evaluate its safety profile. The aims of this study were to
evaluate the potential effects of aqueous extract of LPA on reproductive and
developmental toxicities in Sprague Dawley rats. A preliminary study was
conducted using unstandardised extract of LPA at 2, 20, 200 and 400
mg/kg/day. Commercially prepared standard aqueous extract of LPA, registered
as Biolabisia® at the doses of 2,20, 200,400, 1000 mg/kg/day or distilled water
(control) were administered by gavaging to animals during the main studies.
The Teratogenic study was conducted by treating pregnant animals with
Biolabisia® during the period of organogenesis. Treatments of animals began
from the time prior to mating until lactational periods of seven days in the
Reproductive toxicity study and from before mating up to day 15 of pregnancy in
the Fertility study. Virgin rats were treated with Biolabisia® for duration of three
weeks in the Female toxicity study. A substantial number of reproductive and
developmental parameters were assessed throughout this study. All numerical
data were analysed using SPSS version 12.0.1. Results obtained indicated that
the administration of Biolabisia® at all dose levels did not cause mortality nor
show noticeably any treatment-related signs of toxicity on the physical
appearance and behaviour of all the rats studied. There was a consistent trend
with body weight changes of females in all the experiments performed but they
showed no significant differences except for the significant reduction in the
actual and corrected maternal body weights of Biolabisia® -treated animals in
the Fertility study. Treatment with Biolabisia® did not result in teratogenicity in
rats since no foetus exhibited external congenital malformations. The total
number of corpora lutea, number of implantation sites, percentages of preimplantation
loss and post-implantation death, number of resorptions, number of
live foetuses, foetal body weight and foetal sex ratio were comparable among
all experimental groups. The length of oestrous cycles and reproductive organs
weights of rats were statistically unaffected by Biolabisia®. However, high
number of animals with irregular cycles, presence of ovarian follicular cysts and
a trend of increased serum progesterone and free testosterone levels that were
observed in the Biolabisia® 1000 mg/kg/day dose group do raised some
concern. Taking all the cumulative data together, the current findings suggest
that oral treatment of Biolabisia® of up to 1000 mg/kg/day in female rats is not
associated with significant deleterious effects. However, the body weight and
oestrous cycle of the females may be affected if higher doses of Biolabisia® are
administered for a longer duration. Studies involving non-rodent animal species
need to be performed to complete the safety profile of this herb.
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Keywords
Medical Sciences , The Reproductive