I Ramzan

Phytotherapies: Efficacy, Safety, and Regulation I Ramzan

Marc Notes: Includes bibliographical references and index. Biographical Note: Iqbal Ramzan is the Dean of the Faculty of Pharmacy at the University of Sydney, Australia. He is a registered pharmacist and holds a Diploma of the Australian Institute of Company Directors. Dr. Ramzan also served two terms as a Fellow of The University. He is an author/co-author of over 140 publications in pharmacokinetics, pharmacodynamics, drug assays, and drug metabolism. Dr. Ramzan is a member of several professional committees and councils, including the Director of the Council of Pharmacy Schools (Australia and New Zealand). He also serves on the Australian Government's Pharmaceutical SubCommittee of the Advisory Committee on Prescription Medicines. Jacket Description/Back: Variously defined by its practitioners, phytotherapies include herbal therapies, treatments used by indigenous peoples around the world, and alternative medicines to classical western drugs. Despite an increasing trend toward the use of phytotherapies for chemoprevention and management of disease in healthcare, the published work about their efficacy and safety is scattered - and scientists need to understand these key issues along with regulatory aspects of phytotherpeutic agents. A number of herbs are likely to cause adverse effects if not properly standardized in clinical trials. Covering fundamentals and new developments in phytotherapy, this book combines pharmaceutical sciences and chemistry - including herbal medicine clinical trials, specific applications of phytomedicine, successful case studies, and international regulatory perspectives that are essential for research and development of phytotherapeutics. The book discusses a wide range of topics and focuses on the clinical aspect of phytotherapeutic agents. It describes the major groups of phytotherapeutics, scientific and pharmacological basis for efficacy, active components and ingredients, the metabolism and interactions of these drugs, and future perspectives on phytotherapeutics. In addition, chapters deal with international regulatory aspects and crucial topics for proper clinical trials - analytical challenges for quality control, examples of clinical trials, and drug delivery and formulation issues. Specific types of regional phytomedicines feature alongside those used for different applications like cellular drug targets or chemoprevention. Chapters also deal with phytotherapies for major diseases like cancer, liver disorders, inflammation, obesity, and cardiovascular disease. In offering such a thorough collection of information on phytotherapies, this unique book helps practicing scientists and medical and pharmaceutical science researchers understand the fundamentals and most effective application of phytotherapeutic agents. Table of Contents: List of Contributors Preface 1 Phytotherapies--Past, Present, and Future "Iqbal Ramzan and George Q. Li" 1.1 Overview of Phytotherapy 1.1.1 Definition 1.1.2 International Trend in the Usage of Complementary Medicines 1.2 Preclinical Research on Phytotherapies 1.2.1 Pharmacognosy and Quality Standardization of Phytotherapies 1.2.2 Pharmacological Studies and Identification of Bioactive Compounds 1.2.3 Application of Proteomics and Metabolomics in Phytotherapy Research 1.3 Clinical Research on Phytotherapies 1.3.1 Efficacy of Popular Phytotherapies 1.3.2 Chinese Herbal Medicines 1.3.3 Food Nutrition and Translational Research 1.4 Safety of Phytotherapies 1.5 Profile of Research in Complementary Medicine 1.5.1 International Profile 1.5.2 Australian Profile of Research in Complementary Medicines 1.6 Summary and Future Directions References 2 Quality Control and Quality Assurance of Phytomedicines: Key Considerations, Methods, and Analytical Challenges "Wai""?]""Ping Yau, Cheong Hian Goh, and Hwee""?]""Ling Koh" 2.1 Introduction 2.2 Key Considerations in Qc/Qa of Phytomedicines 2.2.1 Identification and Good Agricultural and Collection Practices (GACP) 2.2.2 Contamination 2.2.3 Substitution 2.2.4 Adulteration 2.2.5 Contents and Standardization 2.2.6 Stability 2.2.7 Processing 2.3 Methods for Qc/Qa of Phytomedicines 2.3.1 Macroscopic Evaluation 2.3.2 Microscopic Evaluation 2.3.3 Physicochemical Analysis 2.3.4 Chemical Fingerprinting 2.3.5 DNA Fingerprinting 2.3.6 "Omics" Technology 2.4 Challenges 2.5 Conclusions References 3 Preclinical ("In Vivo") and Laboratory ("In Vitro") Evidence of Phytomedicine Efficacy "Mohi Iqbal Mohammed Abdul and Tom Hsun""?]""Wei Huang" 3.1 Introduction to Development of Drugs from Nature 3.2 Use of "In Vitro and in Vivo "Models in Herb Drug Research: Learning Thus Far 3.2.1 "In Vitro "Assays 3.2.2 "In Vivo "Assays 3.3 Cardiovascular?] and Stroke?]Related Diseases: "In Vitro "and "In Vivo "Focus 3.3.1 Cardiovascular Diseases 3.3.2 Stroke 3.4 Conclusions References 4 Clinical Efficacy Trials with Natural Products and Herbal Medicines "Christina L. Nance" 4.1 Introduction 4.2 Disease States 4.2.1 Profile: RCT of Natural Product in Rheumatoid Arthritis (RA) 4.2.2 Asthma 4.2.3 Cancer 4.2.4 Cardiovascular Disease 4.2.5 Diabetes 4.2.6 Dermatology 4.2.7 Gastroenterology 4.2.8 Viral Infections 4.3 Natural Product: Green Tea 4.3.1 Green Tea Catechin, Epigallocatechin Gallate (EGCG) 4.4 Egcg Clinical Trials 4.4.1 Polyphenon E 4.4.2 Safety, Toxicity, and Pharmacokinetics 4.4.3 Metabolism 4.4.4 Clinical Studies 4.4.5 Cancer Studies 4.5 Human Clinical Study: Egcg and Hiv?]1 Infection 4.5.1 Translational Medicine: EGCG: Bench?]to?]Bedside 4.5.2 Phase I Clinical Trial: Polyphenon E in HIV?]1 Infection 4.6 Conclusion References 5 Novel Formulations and Drug Delivery Systems for Phytotherapies "Shengpeng Wang, Meiwan Chen, Qi (Tony) Zhou, and Hak""?]""Kim Chan" 5.1 Limitations of Conventional Formulations for Herbal Medicines 5.1.1 Barriers in Physicochemical and Biological Properties 5.1.2 Challenges in Quality and Safety Assurance 5.1.3 Conventional Formulations Limit the Therapeutic Efficacy of Herbal Medicines 5.2 Crucial Issues of Developing Novel Delivery Systems for Herbal Medicines 5.2.1 How Novel Delivery Systems Follow the Tradition? 5.2.2 Pharmacokinetic Research on Delivery Systems for Herbal Medicines 5.2.3 Safety Considerations on Delivery Systems for Herbal Medicines 5.3 Novel Delivery Systems of Herbal Medicines 5.3.1 Pulmonary Delivery of Herbal Medicines 5.3.2 Nanocarriers of Herbal Medicines for Drug/Gene Delivery 5.3.3 Surface Modification of Nanocarriers by Herbal Medicines 5.3.4 Herbal Medicines as Photosensitizers for Photodynamic Therapy 5.4 Summary References 6 Phytotherapies Used by Indigenous Populations "Bradley S. Simpson and Susan J. Semple" 6.1 Introduction 6.2 Phytotherapies of Indigenous Australians 6.2.1 Introduction 6.2.2 Philosophy and Knowledge Transmission 6.2.3 Ailments Treated with Medicinal Plants 6.2.4 How Plant Medicines Have Been Used 6.2.5 Methods of Plant Preparation 6.2.6 Prized and Commonly Used Plants in Australian Indigenous Medicine 6.3 Challenges of a Changing Environment 6.3.1 Safety of Australian Phytotherapies 6.3.2 Development and Regulation of Australian Indigenous Medicines 6.3.3 Integration of Traditional and Western Medicine in Indigenous Populations 6.4 Conclusions References 7 Phytotherapies from Traditional Chinese Medicine "Michael Rieder" 7.1 Traditional Chinese Medicine 7.2 Key Concepts in Traditional Chinese Medicine 7.3 Herbal Medicine and Traditional Chinese Medicine 7.4 Issues in the Development of Phytotherapy from Traditional Chinese Medicine 7.5 Phytotherapies Developed from Traditional Chinese Medicine 7.6 Huang Qin Tang and the Development of Phy906 7.7 Ginseng 7.8 Moving Forward References 8 Integrating Traditional Greco?]Arab and Islamic Diet and Herbal Medicines in Research and Clinical Practice "Bashar Saad" 8.1 Introduction 8.2 Food Therapy in Greco?]Arab and Islamic Medicine 8.2.1 Honey 8.2.2 Olive Oil 8.2.3 Dates 8.2.4 Carob ("Ceratonia siliqua") 8.2.5 Fig ("Ficus carica") 8.2.6 Pomegranate ("Punica granatum") 8.2.7 Garlic ("Allium sativum") and Onion ("Allium cepa") 8.2.8 Edible Wild Plants 8.3 Medicinal Plants 8.3.1 Black Seed ("Nigella sativa") 8.3.2 Fenugreek ("Trigonella foenum""?]""graecum") 8.3.3 Sage ("Salvia officinalis") 8.3.4 Khella ("Ammi visnaga") 8.3.5 Milk Thistle ("Silybum marianum") 8.3.6 Marjoram ("Origanum majorana") 8.3.7 Garlic ("Allium sativum") and Onion ("Allium cepa") 8.3.8 Tayun ("Inula viscose") 8.3.9 Rocket ("Eruca sativa") 8.3.10 Nettle ("Urtica dioica") 8.3.11 Peppermint ("Mentha piperita") 8.3.12 Chamomile ("Chamomilla recutita") 8.3.13 Coriander ("Coriandrum sativum") 8.3.14 Anise ("Pimpinella anisum") 8.3.15 Rosemary ("Rosmarinus officinalis") 8.3.16 Devil's Dung ("Ferula asafetida") 8.3.17 Ginger ("Zingiber officinale") References 9 Evolution of Herbal Medicines in Europe and its Relationship with Modern Medicine "Elizabeth M. Williamson and Kelvin Chan" 9.1 Background 9.2 Historical Perspective 9.3 European Herbal Medicine: Relationship with Modern Medicine 9.4 Summary References 10 Chemical Classification and Chemistry of Phytotherapeutics Constituents "Pei H. Cui and Colin C. Duke" 10.1 Introduction 10.2 Phytochemicals 10.2.1 Alkaloids 10.2.2 Flavonoids 10.2.3 Glycosides and Saponins 10.2.4 Phytosterols 10.2.5 Fatty Acids 10.2.6 Essential Oils 10.2.7 Terpenes 10.3 Other Phytochemicals 10.4 Medicinal Effects Relating to Dietary Intake 10.4.1 Anti?]oxidants 10.4.2 Omega?]3 Long Chain Fatty Acids and Derivatives 10.5 Natural Products as Leads for Drug Development 10.5.1 Catechol Moiety of Piceatannol: Implication and Significance 10.5.2 SAR Studies for Drug Development 10.6 Summary References 11 Therapeutic Potential of Ginsenosides in Management of Atherosclerosis "Xiao""?]""Jing Zhang, Huanxing Su, Yi-Tao Wang, " "and Jian-Bo Wan" 11.1 Introduction 11.2 Chemical Diversity of Ginsenosides and Distribution 11.3 Anti?]Atherosclerotic Effects of Ginsenosides 11.4 Underlying Mechanisms of Ginsenosides Against Atherosclerosis 11.4.1 Regulation of Blood Lipid Profile 11.4.2 Anti?]oxidant Activity 11.4.3 Anti?]vascular Inflammation 11.4.4 Effect on Vascular Cells 11.4.5 Anti?]platelet Effects 11.4.6 Anti?]angiogenesis Effects 11.5 Conclusions and Future Perspectives Acknowledgments References 12 Phytotherapy Pharmacophores for Major Cellular Drug Targets "Jennifer A. Ong, Paul W. Groundwater, and David E. Hibbs" 12.1 Introduction 12.2 What is a Pharmacophore? 12.3 Pharmacophore Models of Cardiovascular Drugs 12.4 Pharmacophore Models for Anticancer Drugs 12.5 Pharmacophore Models for Anti?]Inflammatory Drugs 12.6 Pharmacophore Models for Anti?]Infective Drugs 12.7 Pharmacophore Models for Neurological Drugs 12.8 Pharmacophore Models for Miscellaneous Drugs 12.9 Conclusions References 13 Use of Kava as a Phytotherapeutic Agent and Kava?]Related Hepatotoxicity "Dong Fu and Iqbal Ramzan" 13.1 Introduction 13.2 Active Components in Kava 13.3 Therapeutic Applications of Kava 13.4 Pharmacology of Kava 13.4.1 Anti?]psychotic Effects of Kava 13.4.2 Anti?]cancer Effects of Kava 13.5 Side Effects of Kava 13.6 Hepatotoxicity of Kava 13.6.1 Inhibition of Cytochrome P450 Enzymes Activities 13.6.2 Reduction of Liver Glutathione 13.6.3 Induction of Hepatic Inflammatory Responses 13.6.4 Inhibition of Cyclooxygenase Enzyme Activity 13.6.5 Inhibition of Hepatic Transporters 13.6.6 Damage of Hepatic Mitochondria 13.7 Summary and Future Challenges References 14 Phytotherapies as New Drug Sources: Gossypol and Curcumin 330 "Vivian Wan Yu Liao, Rajeshwar Narlawar, David E. Hibbs, " "and Paul W. Groundwater" 14.1 Botanical Sources of Gossypol and Curcumin 14.2 Stereoisomerism, Tautomerism, and Reactivity 14.2.1 Stereoisomerism 14.2.2 Tautomerism 14.2.3 Reactivity 14.3 Biological Activity of Gossypol and its Analogues 14.3.1 Antifertility 14.3.2 Anticancer 14.3.3 Antiviral 14.3.4 Antimalarial 14.3.5 Other Biological Activity 14.4 Biological Activity of Curcumin and its Analogues 14.4.1 Introduction 14.4.2 Anticancer 14.4.3 Anti?]inflammatory and Antioxidant 14.4.4 Curcumin in Neurodegenerative Diseases 14.4.5 Antimalarial 14.4.6 Other Biological Activity References 15 Phytotherapies for the Management of Obesity and Diabetes 370 "Michel Rapinski and Alain Cuerrier" 15.1 Introduction 15.2 Plants from the North American Pharmacopoeia 15.3 Pharmacological Screening: Providing Empirical Evidence for Phytotherapies 15.3.1 Diabetes 15.3.2 Obesity 15.4 Community?]Based Participation: Developing Phytotherapies from Traditional Knowledge 15.5 Conclusions References 16 Phytotherapeutics for Cancer Therapy "Daniel M.""?]""Y. Sze, Hao Liu, Maureen V. Boost, Raimond Wong, " "and Stephen Sagar" 16.1 Introduction 16.2 Anticancer Phytotherapeutics With Nk Enhancement 395 16.2.1 Effects of Clinically Useful Phytocompounds on Cancer Patients' NK Cell Immunity, Quality of Life (QoL), and Overall Survival 16.2.2 Commonly Used Phytotherapeutics in Cancer Management 16.2.3 Phytotherapeutic Formulae for Cancer via NK Modulation 16.3 Conclusions References 17 Phytomedicines for Fatty Liver Disease and Functional Gastrointestinal Conditions "George Q. Li, Moon""?]""Sun Kim, Fangming Jin, " "and Jun""?]""Lae Cho" 17.1 Introduction 17.2 Phytomedicines for Fld 17.2.1 Introduction and Pharmacotherapy 17.2.2 Treatment of Fatty Liver with Herbal Medicines 17.2.3 Common Herbs Used in Fatty Liver Management 17.3 Phytomedicines for Ibs 17.3.1 Introduction and Pharmacotherapy 17.3.2 Treatment of IBS in Traditional Medicine 17.3.3 Common Herbs Used in the Management of IBS 17.4 Phytomedicines for Constipation 17.4.1 Treatment of Constipation with Herbal Medicines 17.4.2 Common Herbs Used in the Management of Constipation 17.5 Summary and Future Perspectives References 18 Phytomedicines for Inflammatory Conditions "Sigrun Chrubasik""?]""Hausmann" 18.1 Traditional Medicines for Inflammatory Conditions in Europe 18.2 Twenty?]First?]Century Update on Paids 18.3 Oral Extracts from "Salix "Species 18.3.1 Efficacy 18.3.2 Safety 18.4 Oral Extracts from "Harpagophytum procumbens" 18.4.1 Efficacy 18.4.2 Safety 18.5 Oral Avocado-Soybean Unsaponifiables 18.5.1 Efficacy 18.5.2 Safety 18.6 Oral Extracts From "Tripterygium wilfordii" 18.6.1 Efficacy 18.6.2 Safety 18.7 Oral Paids Containing Unsaturated Fatty Acids 18.7.1 Efficacy 18.7.2 Safety 18.8 Other Oral Paids 18.9 Topical Paids 18.9.1 Efficacy 18.9.2 Safety References 19 Phytotherapies for Infectious Diseases: Are These Really Useful? "Gail B. Mahady, Gabrielle Escalante, Pooja Mikkilineni, Laura J. Mahady, " "Temitope O. Lawal, and Bolanle A. Adeniyi" The History of Medicine 19.1 Introduction 19.2 Historical Precedent for Natural Products as Antimicrobial Drugs 19.3 Are Phytotherapies Useful for the Treatment of Infectious Diseases? 19.3.1 Cranberry ("Vaccinium macrocarpon "Ait) 19.3.2 Turmeric ("Curcuma longa "L.) as an Antimicrobial Agent 19.3.3 Ginger ("Zingiber officinale "L.) as an Antimicrobial Agent 19.4 Naturally Occurring Compounds that may Reduce Zoonosis 19.5 Synergistic and Additive Effects with Antibiotics 19.6 New Emerging Infectious Diseases and those with no Known Treatments 19.7 Sars 19.8 Reducing Mrsa Carriage 19.9 Conclusions References 20 Phytomedicines for CNS Disorders: Safety Issues for use with Antiepileptic Drugs "Sophia Yui Kau Fong, Rosina Yau Mok, Qiong Gao, Yin Cheong Wong, " "and Zhong Zuo" 20.1 Introduction 20.2 Methodology of Systematic Literature Search 20.3 Pharmacokinetic Interactions 20.3.1 Carbamazepine 20.3.2 Phenytoin 20.3.3 Valproate 20.3.4 Diazepam 20.3.5 Phenobarbitone 20.3.6 Newer Generations of Antiepileptic Drugs 20.4 Pharmacodynamic Interactions 20.4.1 Antiepileptic Effects 20.4.2 Sedative Effects 20.4.3 Anxiolytic Effects 20.4.4 Memory Impairment Effects 20.4.5 Motor Incoordination Effects 20.5 Conclusions References 21 Phytotherapies: Drug Interactions in Cancer "Andrew J. McLachlan and Stephen J. Clarke" 21.1 Introduction 21.2 Use of Herbal and Complementary Medicines by People Living with Cancer 21.3 Mechanisms of Phytotherapy-Drug Interactions 21.4 Selected Examples of Phytotherapy Medicines that have the Potential to Cause Drug Interactions in Cancer 21.4.1 Black Cohosh ("Cimicifuga racemosa") 21.4.2 Echinacea ("Echinacea purpurea") 21.4.3 Fenugreek ("Trigonella foenum graecum") 21.4.4 Ginkgo Biloba 21.4.5 Asian Ginseng ("Panax ginseng") 21.4.6 Green Tea ("Camellia sinensis") 21.4.7 Kava Kava ("Piper methysticum "Forst. f.) 21.4.8 Liquorice ("Glycyrrhiza uralensis") 21.4.9 Milk Thistle ("Silybum marianum") 21.4.10 St. John's Wort ("Hypericum perforatum") 21.4.11 Valerian ("Valeriana officinalis") 21.5 Future Perspectives: Need for Evidence and Advice to Cancer Patients and Physicians 21.6 Conclusions Acknowledgments Conflict of Interest References 22 Quality Use of Medicines: Considerations in Phytotherapy "Lynn Weekes" 22.1 Introduction 22.1.1 Judicious Use 22.1.2 Appropriate Selection 22.1.3 Safe and Effective Use 22.1.4 The QUM Paradigm 22.2 Relevance of Qum for Herbal Medicines 22.2.1 Is the QUM Framework Relevant for Herbal Therapies? 22.3 Use of Phytotherapies by Consumers 22.4 Consumer Attitudes and Beliefs about Herbal Medicines 22.4.1 Holistic View of Health and Well?]Being 22.4.2 It is Natural, So it Must be Safe 22.5 Applying the Qum Framework to Phytotherapies 22.5.1 Judicious Use 22.5.2 Appropriate Selection 22.5.3 Safe and Effective Use 22.5.4 Adverse Reactions 22.5.5 Interactions 22.5.6 Allergy 22.5.7 Safe Formulation 22.5.8 Effectiveness 22.6 Building Blocks for Quality Use of Herbal Medicines 22.6.1 Objective Information and Ethical Promotion 22.6.2 Education and Training 22.6.3 Systems and Interventions 22.6.4 Shared Decision Making 22.7 Conclusion References 23 Intellectual Property and Patent Issues with Phytotherapy Products "Gint Silins, Jennifer Tan, and Kelvin Chan" 23.1 Introduction 23.1.1 Historical and Current Aspects of Intellectual Property 23.1.2 Types of Intellectual Property Rights 23.1.3 Worldwide IP Laws Have Yet to Be Harmonized 23.2 Ip Rights--Phyto?]Industry 23.2.1 IP Protection for Phytotherapy Products and Phytotherapies 23.2.2 Patents 23.2.3 Patents as IP Assets 23.2.4 Patents for Protecting Phyto?]Inventions 23.2.5 Exclusions to Patentability 23.3 Brief Overview of Patents and the Patenting Process 23.3.1 Patent Searching 23.3.2 Patent Ownership 23.3.3 Patent Filing 23.3.4 Examination and Classification 23.3.5 Allowance and Grant 23.3.6 Extension of Patent Term 23.4 Other Types of IP Rights 23.4.1 Trade Secrets 23.4.2 Regulatory Exclusivity and Restricted Third?]Party Access 23.4.3 Plant Variety Protection 23.4.4 Industrial Designs 23.4.5 Trademarks 23.5 Patenting Trends for Phytotherapeutics 23.6 Traditional Knowledge and IP Rights Disclaimer References 24 International Regulatory Status of Phytotherapies "Ernest V. Linek" 24.1 Introduction 24.1.1 Country Law Sources 24.1.2 Common Requirement: Good Manufacturing Practices 24.2 Specific Country Regulations 24.2.1 Current Regulations in Australia 24.2.2 Current Regulations in Canada 24.2.3 Current Regulations in China 24.2.4 Current Regulations in the European Union (EU) 24.2.5 Current Regulations in India 24.2.6 Current Regulations in Japan 24.2.7 Current Regulations: United Kingdom 24.2.8 Current Regulations in the United States 24.3 Future of Phytotherapies: World Health Organization (Who) Further Reading Index