Botanical Medicines — The Need for New Regulations

Marcus, Donald M.; Grollman, Arthur P.

doi:10.1056/nejmsb022858

Cited by 206 publications

(148 citation statements)

References 24 publications

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“…54 , 55 These include: (1) requiring manufacturers to register with the FDA, (2) mandating safety tests similar to those required for over-the-counter drugs, (3) requiring all health claims to be supported by data approved by the FDA, and (4) ensuring that product labels provide an accurate list of all ingredients.…”

Section: Future Directionsmentioning

confidence: 99%

Herbal Medicine in the United States: Review of Efficacy, Safety, and Regulation

2008

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Section: Future Directionsmentioning

confidence: 99%

Herbal Medicine in the United States: Review of Efficacy, Safety, and Regulation

2008

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“…In 2001, $17.8 billion was spent on dietary supplements, $4.2 billion of it for herbal remedies. 1 It is estimated that Ͼ12.1% of adults in the United States used herbal medicines in 1997. 2 Interestingly, in the United States, herbal medicines are regulated as dietary supplements and fall under the purview of the 1994 Dietary Supplement and Health Education Act (DSHEA) and thus can be marketed without prior approval by the Food and Drug Administration (FDA).…”

mentioning

confidence: 99%

“…Intriguingly, according to the DSHEA, the manufacturers of dietary supplements are responsible for the truthfulness of any claims and must provide evidence for the claims, yet it neither provides a standard for the evidence needed nor requires the submission of the evidence to the FDA. 1 The perception that herbal remedies, used as folk medicine, are inherently safe and efficacious is based on traditional "knowledge" rather than systematic studies, and recent findings have spurred calls for quality, safety, and efficacy assurance. 3 The present findings about the existence of opposing active principles in one of the most prevalent herbal medicines emphasizes the importance of standardiza- Figure 5.…”

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confidence: 99%

Modulating Angiogenesis

et al. 2004

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Background-Ginseng is a commonly used nutraceutical. Intriguingly, existing literature reports both wound-healing and antitumor effects of ginseng extract through opposing activities on the vascular system. To elucidate this perplexity, we merged a chemical fingerprinting approach with a deconstructional study of the effects of pure molecules from ginseng extract on angiogenesis. Methods and Results-A mass spectrometric compositional analysis of American, Chinese and Korean, and Sanqi ginseng revealed distinct "sterol ginsenoside" fingerprints, especially in the ratio between a triol, Rg1, and a diol, Rb1, the 2 most prevalent constituents. Using a Matrigel implant model and reconstituting the extracts using distinct ratios of the 2 ginsenosides, we demonstrate that the dominance of Rg1 leads to angiogenesis, whereas Rb1 exerts an opposing effect. Rg1 also promoted functional neovascularization into a polymer scaffold in vivo and the proliferation of, chemoinvasion of, and tubulogenesis by endothelial cells in vitro, an effect mediated through the expression of nitric oxide synthase and the phosphatidylinositol-3 kinase3 Akt pathway. In contrast, Rb1 inhibited the earliest step in angiogenesis, the chemoinvasion of endothelial cells. Conclusions-The present study explains, for the first time, the ambiguity about the effects of ginseng in vascular pathophysiology based on the existence of opposing active principles in the extract. We also unraveled a speciogeographic variation impinging on the compositional fingerprint that may modulate the final phenotype. This emphasizes the need for regulations standardizing herbal therapy, currently under the Dietary Supplement and Health Education Act. Furthermore, we propose that Rg1 could be a prototype for a novel group of nonpeptide molecules that can induce therapeutic angiogenesis, such as in wound healing. Key Words: ginsenosides Ⅲ angiogenesis Ⅲ nitric oxide T he use of botanicals as alternative medicine has seen a resurgence of use in the United States and Europe. In 2001, $17.8 billion was spent on dietary supplements, $4.2 billion of it for herbal remedies. 1 It is estimated that Ͼ12.1% of adults in the United States used herbal medicines in 1997. 2 Interestingly, in the United States, herbal medicines are regulated as dietary supplements and fall under the purview of the 1994 Dietary Supplement and Health Education Act (DSHEA) and thus can be marketed without prior approval by the Food and Drug Administration (FDA). 3 Ginseng is a key component in traditional Chinese medicine and is also one of the most extensively used botanical products in the West, which is evident from annual sales of US $0.225 to $0.3 billion. 4 Named by the botanist Carl Meyer, the genus Panax derives its name from the Greek pan (all) and akos (healing). 4 The activity of ginseng extract has been studied extensively. Ambiguously, ginseng extract has been reported to promote wound healing 5 and inhibit tumor growth 6,7 through opposing effects on angiogenesis. To elucidate this perplexity in...

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“…There is a estimation that 12.1% of adult in the united states used herbal medicine in 1997 Ang- Lee et al (2001). In 2001 17.8 billion was spent on dietary supplement, 23.6% of it for herbal remedies Marcus and Grollman (2002). In developing countries, all over the world 80% population continues to use traditional medicine in primary medical problem Grover and Yadav (2004).…”

Section: Introductionmentioning

confidence: 99%

Effect of Hydro-Alcoholic Extract of Cucurbita Maxima, Fruit Juice and Glibenclamide on Blood Glucose in Diabetic Rats

Lal¹,

Gupta²,

Awanish³

et al. 2011

American Journal of Pharmacology and Toxicology

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Problem statement: Cucurbita maxima has been used traditionally in Mexico, China and India as antidiabetic agents. Approach: The present study was to evaluate the hypoglycemic activity of fruit juice and hydro-alcoholic extract of Cucurbita maxima for validation of its folkloric use. Results: Hypoglycemic activity was evaluated on streptozotocin induced diabetic rats at the doses of 100 and 200 mg kg −1 for 28 days. Blood glucose level was evaluated on 0, 7, 14, 21 and 28 days. Oral daily administration of both fruit juice and extract led to significant decrease in hyperglycemia as compared to unfed diabetic control. High dose of both the treatment is more effective than low dose. Extract show more hypoglycemic effect than fruit juice. Conclusion/Recommendations: The result of this study scientifically proved the folkloric use of Cucurbita maxima as hypoglycemic agent. Thus the plant can be key contributor in alternative remedy in the treatment of diabetes.

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Botanical Medicines — The Need for New Regulations

Cited by 206 publications

References 24 publications

Herbal Medicine in the United States: Review of Efficacy, Safety, and Regulation

Herbal Medicine in the United States: Review of Efficacy, Safety, and Regulation

Modulating Angiogenesis

Effect of Hydro-Alcoholic Extract of Cucurbita Maxima, Fruit Juice and Glibenclamide on Blood Glucose in Diabetic Rats

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