Safety and efficacy assessment of standardized herbal formula PM012.
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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
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]
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Project description:PM014 (HL301) is a standardized herbal mixture derived from a traditional Korean medicine, Chung-Sang-Bo-Ha-Tang. Previously, we reported that PM014 treatment significantly suppressed pulmonary fibrosis, one of the frequent adverse effects of anticancer therapy in lung cancer. Before the clinical application of PM014 in anticancer therapy, the safety and efficacy of PM014 in combination with conventional anticancer drugs should be addressed to determine whether PM014 can be used in lung cancer. Lewis lung cancer-bearing mice were injected with 10 mg/kg of cisplatin or paclitaxel on day 5. Starting on day 7, the mice were administered 200 mg/kg PM014 every 2 days. On day 15, all mice were assessed by biochemical and histological analyses. PM014 did not block the antitumor activity of cisplatin and paclitaxel. Coadministration of PM014 and antitumor agents did not elevate the aspartate transaminase/alanine transaminase ratio or the blood urea nitrogen/creatinine ratio. Histopathological analysis also showed that PM014 did not induce hepatic or renal injury. Moreover, PM014 had no apparent inhibitory effects on drug metabolizing enzymes, indicating that PM014 did not alter the pharmacokinetics of chemotherapeutic drugs. Overall, these data show the safety and compatibility of combination therapy of PM014 and chemotherapies for the treatment of lung cancer.
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Project description:BackgroundHeart failure with preserved ejection fraction (HFpEF) is a large subtype of heart failure (HF) characterized by exercise intolerance and reduced quality of life. Studies have shown that traditional Chinese medicine (TCM) combined with conventional Western medicine has a good effect on improving exercise tolerance and quality of life in patients with HFpEF, but the overall quality of evidence is low. This study aimed to determine the safety and efficacy of Yangyin Shuxin (YYSX) decoction in the treatment of HFpEF.MethodsA prospective, single-blind, single-center, randomized controlled clinical study was conducted. 64 patients with HFpEF were randomly assigned to receive oral YYSX decoction (150 ml, twice a day) combined with conventional Western treatment or conventional Western treatment alone at a ratio of 1 : 1. The course of treatment was 2 weeks, and the follow-up was 3 months. The primary outcome was peak oxygen uptake (peak VO2) measured by the cardiopulmonary exercise test (CPET). Furthermore, the safety of YYSX decoction was assessed.Results63 patients (31 in the YYSX group and 32 in the control group) were included in the full analysis set. The peak VO2 of the YYSX group was significantly higher than that of the control group (12.04 ± 3.41 vs. 11.02 ± 3.33, P = 0.013) after 2 weeks. The maximum voluntary ventilation (MVV) was significantly higher in the YYSX group compared with the control group (P < 0.05). The YYSX group had a higher EQ-visual analogue scale (EQ-VAS) score (71.13 ± 13.95 vs. 70.94 ± 13.70, P < 0.05) and a lower TCM Four-Dimensional Diagnostic Information Scale (TCMFDIS) score (49.74 ± 24.73 vs. 64.16 ± 27.15, P < 0.05) than the control group. There was no statistical difference between two groups (P = 0.160), although 51.61% of patients in the YYSX group showed a decrease in brain natriuretic peptide (BNP) levels of at least 30%, compared with 37.50% of patients in the control group. No serious adverse events were reported in either group, but systolic and diastolic blood pressure decreased and serum sodium levels increased slightly in the control group.ConclusionThe YYSX decoction combined with conventional Western treatment was superior to the conventional Western treatment alone in improving exercise tolerance, quality of life, and cardiopulmonary function of patients with HFpEF. YYSX decoction is safe and may prevent a drop in blood pressure and sodium retention. Trial Registration. Chinese Clinical Trial Registry (www.chictr.org/cn/, No. ChiCTR-IOR-17014206).
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