Dataset Information

Safety and efficacy assessment of standardized herbal formula PM012.

ABSTRACT:

Background

This study was conducted to evaluate the efficacy of the herbal formula PM012 on an Alzheimer's disease model, human presenilin 2 mutant transgenic mice (hPS2m), and also to evaluate the toxicity of PM012 in Sprague-Dawely rats after 4 or 26 weeks treatment with repeated oral administration.

Methods

Spatial learning and memory capacities of hPS2m transgenic mice were evaluated using the Morris Water Maze. Simultaneously, PM012 was repeatedly administered orally to male and female SD rats (15/sex/group) at doses of 0 (vehicle control), 500, 1,000 and 2,000 mg/kg/day for 4 or 26 weeks. To evaluate the recovery potential, 5 animals of each sex were assigned to vehicle control and 2,000 mg/kg/day groups during the 4-week recovery period.

Results

The results showed that PM012-treated hPS2m transgenic mice showed significantly reduced escape latency when compared with the hPS2m transgenic mice. The repeated oral administration of PM012 over 26 weeks in male and female rats induced an increase and increasing trend in thymus weight in the female treatment groups (main and recovery groups), but the change was judged to be toxicologically insignificant. In addition, the oral administration of the herbal medicine PM012 did not cause adverse effects as assessed by clinical signs, mortality, body weight, food and water consumption, ophthalmology, urinalysis, hematology, serum biochemistry, blood clotting time, organ weights and histopathology. The No Observed Adverse Effects Levels of PM012 was determined to be 2,000 mg/kg/day for both sexes, and the target organ was not identified.

Conclusion

These results suggest that PM012 has potential for use in the treatment of the Alzheimer's disease without serious adverse effects.

SUBMITTER: Sohn SH

PROVIDER: S-EPMC3342231 | biostudies-literature | 2012 Mar

REPOSITORIES: biostudies-literature

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Publications

Safety and efficacy assessment of standardized herbal formula PM012.

Sohn Sung-Hwa SH Kim Soo-Jeong SJ Kim Yong Y Shim Insop I Bae Hyunsu H

BMC complementary and alternative medicine 20120329

<h4>Background</h4>This study was conducted to evaluate the efficacy of the herbal formula PM012 on an Alzheimer's disease model, human presenilin 2 mutant transgenic mice (hPS2m), and also to evaluate the toxicity of PM012 in Sprague-Dawely rats after 4 or 26 weeks treatment with repeated oral administration.<h4>Methods</h4>Spatial learning and memory capacities of hPS2m transgenic mice were evaluated using the Morris Water Maze. Simultaneously, PM012 was repeatedly administered orally to male ...[more]

PMID: 22458507

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Project description:When confronted with non-psychotic mental disorders, pregnant women often refrain from using synthetic drugs. Instead, they resort to well-known herbal medicines (phytopharmaceuticals) such as St. John's wort, California poppy, valerian, lavender, and hops, which have proven sedative, anxiolytic, or antidepressant properties. Nevertheless, these herbal medicines are not officially approved in pregnancy due to lack of safety data. Using a variety of in vitro methods (determination of cytotoxicity, apoptosis induction, genotoxicity, effects on metabolic properties, inhibition/induction of differentiation) in a commonly used placental cell line (BeWo b30), we could previously show that extracts from these plants are likely to be safe at usual clinical doses. In the present work, we wanted to deepen our safety assessment of these herbal medicines by (i) looking for possible effects on gene expression and (ii) using the same in vitro methods to characterize effects of selected phytochemicals that might conceivably cause safety issues. Proteomics results were promising as none of the five extracts significantly affected the protein expression by up- or down-regulation. Protopine (contained in California poppy), valerenic acid (in valerian), and linalool (in lavender) were inconspicuous in all experiments and showed no adverse effects. Hyperforin and hypericin (two constituents from St. John's wort) and valtrate (typical for valerian) were the most discernible phytochemicals with respect to the selected safety parameters (cytotoxic and apoptotic effects). A decrease in BeWo b30 viability was evident with hypericin (≥ 1 µM) and valtrate (≥ 10 µM), whereas hyperforin (≥ 3 µM), hypericin (30 µM) and valtrate (≥ 10 µM) induced cell apoptosis. None of the tested phytochemicals resulted in genotoxic effects at concentrations of 0.1 and 1 µM and thus are not DNA damaging. No decrease in glucose consumption or lactate production was observed under the influence of the phytochemicals, except for valtrate (at all concentrations). No compound induced or inhibited BeWo b30 cell differentiation, except for hyperforin (≥ 1 µM) that had an inhibitory effect. This study confirms previous observations suggesting that the extracts from St. John's wort, California poppy, valerian, lavender, and hops are likely to be safe during pregnancy. Attainment of high plasma concentrations of a few relevant compounds – hyperforin and hypericin from St. John's wort and valtrate from valerian – deserves though special attention. Clinical studies during pregnancy are needed to substantiate these in vitro data.

Dataset Information

Safety and efficacy assessment of standardized herbal formula PM012.

Background

Methods

Results

Conclusion

Publications

Safety and efficacy assessment of standardized herbal formula PM012.

Similar Datasets

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