NIS - libdoc.who.int - World Health Organization

WHO monographs on medicinal plants commonly used in the Newly Independent States (NIS)
Uterine stimulant and abortifacient effects
The methanol extract of the aerial parts of the plant at a dose of approximately
2.5 g/kg/day, offered in food or in drinking suspension to female
rats for 30 days, significantly prolonged diestrus by 1 day. At doses of 2,
2.5 and 3.5 g/kg/day, the extract appeared to cause a significant dosedependent
decrease in litter size. No change in the physical and nutritional
status of the animals and no other adverse toxicological effects were
observed (65).
Effects on male fertility
Intragastric administration of the dried seeds of Herba Pegani harmalae
(100 mg/kg bw) to male rats caused a significant (p < 0.05) increase in
sperm motility and testosterone level, and augmentation of weight of epididymis,
prostate, seminal vesicles and testes (66).
Toxicology
The therapeutic and toxic effects in relation to an oral dose of the aqueous
extract of Herba Pegani harmalae were studied in Wistar rats. In acute
studies, a median lethal dose of 2.70 ± 0.05 g/kg was reported. In chronic
studies, oral administration of the extract six times per week at doses of 1,
1.35 and 2 g/kg bw for a 3-month period increased transaminase activity.
Histological examination showed liver degeneration and spongiform
changes in the central nervous system in rats treated with the 2 g/kg dose,
but not in those that received the therapeutic dose of 1 g/kg (67). Subcutaneous
administration of the 95% ethanol extract (120 mg/kg) of fresh
Herba Pegani harmalae to rats, and intraperitoneal administration of the
extract to mice (250 mg/kg bw) resulted in toxic effects including stiffness,
trembling, frequent urination, hypothermia, weakness, stimulation
of the central nervous system, convulsions and death. A median lethal
dose of 500 mg/kg was determined from studies of oral administration of
the ethanol extract to mice (68, 69). An analysis of 56 medical records of
patients admitted to a toxicological intensive care unit from 1983 to 1998
following the ingestion of medicinal plants in Tunisia was performed. The
sex ratio of patients (men/women) was 1:2; the mean age of patients was
26 years. A number of plant species were involved; in 7% of the cases
Peganum harmala was associated with toxicity. Poisoning involved the
neurological (91%), gastrointestinal (73%) and cardiovascular systems
(18%) (70).
Clinical pharmacology
No information was found.
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