Efficacy, Quality, Safety and Toxicity of Herbal Medicine
Dilip Ghosh, Pulok K. Mukherjee in Natural Medicines, 2019
In the European Union (EU), HMPs are officially recognised as medicines based on directives set out in 2001 and 2004. On the other hand, in the United States (US), HMPs are still classified as botanical products and are controlled by food legislation due to their chemical complexity. In 2008, the FDA approved its first botanical drug Veregen® (sinecatechins) derived from green tea for application on genital and perianal warts. In 2012, Crofelemer was approved for the symptomatic relief of diarrhoea in HIV/AIDs patients under antiretroviral therapy. Despite the reluctance to register HMPs as official medicine, it is widely recognised today that they can be important alternative sources of medicines for chronic diseases such as cancer and heart conditions. For example Chinese medicine–based PHY906 has passed phase I and II trials for cancer and Dantonic® underwent phase III trial for angina in the United States (Chen et al. 2008; Yen et al. 2008; Fan et al. 2012).
Ethnobotany Post-Genomic Horizons and Multidisciplinary Approaches for Herbal Medicine Exploration: An Overview
T. Pullaiah, K. V. Krishnamurthy, Bir Bahadur in Ethnobotany of India, 2017
Consistency in high quality, effectiveness of treatment, safety and patient affordability are the major player in the drug development. The principles underlying in translational research is the standard bottom up bench to bed side. Clinical studies should be conducted in parallel. A well-defined methodology for standardized assessment of the quality, efficacy, and safety is must before starting of any basic project (Yang et al., 2014). For topical treatment of external genital and perianal warts Veregen (sinecatechins) is the first FDA approved herbal drug in the year of 2006 and the second is Fulyzaq (crofelemer) for symptomatic relief of noninfectious diarrhea in patients with HIV/AIDS on antiretroviral therapy in 2012. It shows that herbal drugs can be developed to comply the FDA standards of quality, safety, and efficacy (Lee, 2015).
How can we improve the safe use of herbal medicine and other natural products? A clinical pharmacologist mission
Published in Expert Review of Clinical Pharmacology, 2020
Elena Y. Enioutina, Kathleen M. Job, Lubov V. Krepkova, Michael D. Reed, Catherine M. Sherwin
Botanical drugs are often extracts prepared medicinal plants, algae, and/or macroscopic fungi (Figure 1) [4]. Highly purified or chemically modified NP constituents are not considered to be botanical drugs and are classified as conventional drugs. The pharmacological properties of a botanical drug cannot always be ascribed to a specific constituent. Furthermore, the pharmacological effects of botanical multi-constituent drugs are most likely the result of the combined activity of all constituents present in the extract. Specific recommendations for botanical drug production, safety, and efficacy testing were clarified in a ‘Guidance for Industry: Botanical Drug Products’ initially published by the Center for Drug Evaluation and Research Botanical Review team in 2004 and revised in 2016 [1,5]. The U.S. FDA has received > 800 IND and PINDs in the last 34 years [5]. The marketing of botanical drugs is labor-intensive and expensive [5,20]; therefore, only two botanical drugs have currently fulfilled the directives given in the Guidance for Botanical Drugs (i.e. Veregen® (sinecatechins) ointment and Mytesi® (crofelemer)) [2,5]. Veregen® (sinecatechins) is a water extract of green tea leaves from Camellia sinensis (L.) intended for the cutaneous treatment of external genital and perianal warts in immunocompetent patients aged ≥18 years [21]. The extract consists of eight known catechins (i.e. Epigallocatechin gallate, Epicatechin, Epigallocatechin, Epicatechin gallate, Gallocatechin gallate, Gallocatechin, Catechin gallate, and Catechin) and other constituents such as gallic acid, caffeine, and theobromine. Crofelemer is a botanical drug isolated from the red sap of the Croton lechleri tree intended for symptomatic relief of noninfectious diarrhea in adult patients with HIV/AIDS on antiretroviral therapy [22].
Drug development and acute gastrointestinal infections
Published in Expert Opinion on Investigational Drugs, 2018
Hania Szajewska, Maciej Kołodziej, Jan Łukasik
One of the novel antisecretory drugs is crofelemer. It prevents chloride (Cl-) and fluid secretion into the lumen by inhibiting the cystic fibrosis transmembrane conductance regulator (CFTR) Cl- channel and the calcium-activated Cl- channel (CaCC). Currently, crofelemer is only approved for the management of noninfectious diarrhea in HIV/AIDS patients receiving antiretroviral therapy [8].
Related Knowledge Centers
- Gastroenteritis
- Irritable Bowel Syndrome
- Oligomer
- Proanthocyanidin
- Dragon'S Blood
- Croton Lechleri
- Clinical Trial
- Cystic Fibrosis Transmembrane Conductance Regulator
- Calcium-Dependent Chloride Channel
- Chloride