Contraindications and Cautions - Standard Process

Contraindications and Cautions

for MediHerb Botanicals

Contraindications and Cautions

Tablets, Capsules & Phytosynergist? Liquid Complexes

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Astragalus Complex Bacopa Complex Bilberry 6000mg Boswellia Complex Broncafect? Broncafect Phytosynergist? Burdock Complex Capsella Complex Phytosynergist? Cat's Claw Complex Chaste Tree ChelaCo Colax Coleus Forte Cramplex Cranberry Complex DermaCo DiaCo Phytosynergist? DiGest DiGest Phytosynergist? Dong Quai Echinacea Premium Eleuthero Euphrasia Complex Evening Primrose Oil Fe-Max Iron Tonic Phytosynergist? Feverfew Ganoderma & Shiitake Garlic 5000mg

Ginkgo 2000mg Golden Seal 500mg Gotu Kola Complex Gut Flora Complex Gymnema 4g Hawthorn Herbal Throat Spray Phytosynergist? HiPep Horsechestnut Complex LivCo? Livton? Complex Nevaton? ProstaCo PulmaCo Rehmannia Complex ResCo? ResCo Phytosynergist? Rhodiola & Ginseng Complex Saligesic Silymarin St John's Wort 1.8g Thyroid Complex Tribulus UriCo Phytosynergist? Valerian Complex Vitanox? Wild Yam Complex Withania Complex Wormwood Complex

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Contraindications and Cautions

Liquid Extracts

Albizia 1:2 Ashwaganda 1:1 Astragalus 1:2 Bacopa 1:2 Bilberry 1:1 Black Cohosh 1:2 Black Walnut Hulls 1:10 Bladderwrack 1:1 Bugleweed 1:2 Bupleurum 1:2 Burdock 1:2 Calendula 1:2 Californian Poppy 1:2 Cat's Claw 1:2 Celery Seed 1:2 Chamomile High Grade 1:2 Chaste Tree 1:2 Chinese Skullcap 1:2 Cinnamon Quills 1:2 Cleavers 1:2 Coleus 1:1 Corn Silk 1:1 Cramp Bark 1:2 Damiana 1:2 Dandelion Leaves 1:1 Dandelion Root 1:2 Dong Quai 1:2 Echinacea Premium Blend 1:2 Echinacea Purpurea 1:2 Echinacea Purpurea 1:3 Glycetract Eleuthero 1:2 Eyebright 1:2 Garlic 1:1 Ginger 1:2 Ginkgo 2:1 Globe Artichoke 1:2 Golden Seal 1:3

Gotu Kola 1:1 Gymnema 1:1 Hawthorn Berries 1:2 Horsechestnut 1:2 Horsetail 1:2 Korean Ginseng 1:2 Licorice 1:1 Licorice High Grade 1:1 Marshmallow Root 1:5 Glycetract Milk Thistle 1:1 Milk Thistle 1:1 Glycetract Mistletoe 1:2 Motherwort 1:2 Nettle Leaf 1:2 Nettle Root 1:2 Oats Seed 1:1 Oregon Grape 1:2 Pau d'Arco 1:2 Poke Root 1:5 Red Clover 1:2 Rehmannia 1:2 Sage 1:2 Sarsaparilla 1:2 Saw Palmetto 1:2 Schisandra 1:2 Skullcap 1:2 St John's Wort 1:2 St John's Wort High Grade 1:2 Tienchi Ginseng 1:2 Turmeric 1:1 Uva Ursi 1:2 Valerian 1:2 White Peony 1:2 Wild Yam 1:2 Wormwood 1:5 Yellow Dock 1:2

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Contraindications and Cautions

Introduction

This volume of contraindication and drug interaction information has been compiled by MediHerb? and Standard Process? as a resource for health care professionals who recommend MediHerb herbal products distributed by Standard Process. In this volume, MediHerb and Standard Process have brought together herb-specific information regarding cautions, potential adverse reactions and interactions with drugs. It is presented in summary form and is drawn from widely used, authoritative herbal references. The reader should recognize, however, that the information presented has not been confirmed or agreed to by MediHerb or Standard Process. For example, some information is based on in vitro data which has not been substantiated by clinical studies. To provide basic information on contraindications and drug interactions, MediHerb and Standard Process referred to fifteen English language reference texts that are used in the United States and worldwide. This compilation of information and references is presented for the convenience of health care professionals who are encouraged to review the source literature directly. This volume should not be understood to be either complete or final. Information on herbs for health, like information on other pharmacologically active compounds, is evolutionary. Health care professionals should be alert to new information and should use reasonably available research materials to keep up-to-date. Readers are also advised that the information presented in this volume covers herbs and essential oils (and not vitamins or minerals).

How to Use this Publication

The information is laid out in order of product name and by category starting with Tablets, Capsules and Phytosynergist? Liquid Complexes and followed by Liquid Extracts. A general caution appears after the product name. Below this, detailed information for each ingredient (herb and essential oil) is presented.

Example: If looking for information on Albizia Complex, go to the Tablets, Capsules and Phytosynergist? Liquid Complexes category. The general caution is indicated with the product name. Below this each of the component herbs in Albizia Complex (Chinese Skullcap, Albizia and Feverfew) are listed with the corresponding information provided from the reference texts. For ease of use the ingredients are listed in descending order with the ingredient of highest amount first. This presentation is consistent with the catalog and product label.

Reference Text Information

Adverse Effects of Herbal Drugs (AEHD),1,2,3 volumes 1, 2 & 3 are P.A.G.M. DeSmet's effort as Managing Editor to draw together information gathered from available herbal pharmacovigilance sources, recognizing as well that the long history of traditional use of herbal medicines provide "a powerful tool, of course, for the identification of adverse effects." These books were relied upon by the American Herbal Products Association in compiling the Botanical Safety Handbook, described below. The British Herbal Compendium (BHC)4 is a handbook of scientific information on widely used plant drugs edited by Peter R. Bradley. Each volume is a companion to the corresponding volume of the British Herbal Pharmacopoeia. The BHC is published by the Scientific Committee of the British Herbal Medicine Association. The basic approach of the BHC is to bring together scientific information from a variety of sources to produce clear and concise summaries on important aspects of individual plant drugs. The Botanical Safety Handbook (BSH)5 was published in 1997 by the American Herbal Products Association, the trade association of the herbal supplement industry in the United States. It's authors include Association President Michael McGuffin and the President and Chief Executive Officer of the American Herbal Pharmacopoeia, Roy Upton. The preface to the BSH succinctly states its goal:

The goal of the present work is to find a rational platform for the evaluation of herb safety, neither assuming that all natural substances are inherently safe, as some popular references suggest, nor blindly accepting reports of toxicity from uncritical sources. In undertaking this task the Editors met with information that presented significant challenges. Many authors utilize unreferenced data, perpetuate historical inaccuracies or display inherent biases against the use of botanicals. Also, contemporary reviews of the toxicity of many herbs are not available. Nonetheless, the Editors are confident that the body of information presented here is largely accurate. It is our sincere hope that readers of this work will find it to be a valuable reference and will address all useful criticisms to our attention. MediHerb's Co-Founder, Kerry Bone, authored Clinical Applications of Ayurvedic and Chinese Herbs (CAACH)6 in October 1996 for the reason set forth in the subtitle, as Monographs for the Western Herbal Practitioner. In his preface, Kerry Bone underscores the importance of looking to traditional sources for guidance: As the pharmacological and clinical information on exotic plants accumulates, largely funded by the governments of India and China, western phytotherapists face an important decision. Do they ignore this useful information, or do they attempt to incorporate these plants into their daily practice? However, there is no need for any soul-searching since a traditional precedent already exists. The western system has continually adopted herbs from exotic locations. As global communication reaches new heights, and the stresses of ever-increasing industrialization create diseases common to all countries, modern phytotherapy must rise to the challenge. One aspect of meeting this challenge is the use of effective herbs, whatever their country of origin.

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Contraindications and Cautions

The European Scientific Cooperation of Phytotherapy (ESCOP) first published monographs on the medicinal uses of plant drugs in March 1996 in loose-leaf form as a series of fascicules. In 2003 the ESCOP monographs were completely revised and expanded and made available as a book.7 ESCOP is the European umbrella organization of national associations of phytotherapy. Members include the trade associations from the major European Union countries. The ESCOP Scientific Committee prepares the monograph as follows:

In preparing drafts, [the] ESCOP Scientific Committee has the advantage that it can incorporate the views, knowledge and experience, not only of different nationalities, but also of individuals from different scientific and professional backgrounds, such as medical doctors, practicing phytotherapists, pharmacognosists, pharmacologists and regulatory affairs specialists. The Committee, operating as two subcommittees, assesses information from published scientific literature on each plant drug with the assistance of leading researchers on specific plants, who are invited to meetings of the Committee for discussion and critical evaluation of the literature.

One of the strengths of Essential Oil Safety: A Guide for Health Care Professionals (EOS)8 is the presentation of concise profiles of essential oils. This includes safety information for the oral use of essential oils ? an area of traditional practice often ignored. The book provides information from a number of scientific sources, including toxicological reports, in a transparent and reliable way. The function of the book, as described by the authors, is to reassure users of essential oils by showing that many supposed dangers do not in fact exist and also to "to hoist some red flags" where appropriate.

The Therapeutic Guide to Herbal Medicine (TGHM),9 the Complete German Commission E Monographs, was published in 1998 by the American Botanical Council, a non-profit organization dedicated to providing scientific information about botanicals. This volume translates the Commission E monographs, the only substantial governmental review of herbal products. These monographs were published in the 1980s and early 1990s. The Commission has since disbanded. Accordingly, some of the work of the Commission is no longer generally accepted as current. Nonetheless, the Commission's work has substantial value to health care professionals. The compiler of the translations, Mark Blumenthal, is founder and Executive Director of the American Botanical Council and is widely respected as an herbal expert. In his foreword to this volume, Varro E. Tyler, Ph.D., Sc.D., Dean and Distinguished Professor of Pharmacognosy Emeritus, Purdue University stated:

. . . in 1978, the Bundesgesundheitsamt (Federal Health Agency), now called the Federal Institute for Drugs and Medical Devices, established an expert committee on herbal remedies, composed principally of members proposed by associations of the health professions, to evaluate the safety and efficacy of phytomedicines. This so-called "Commission E" included physicians, pharmacists, pharmacologists, toxicologists, representatives of the pharmaceutical industry, and lay persons. Its assessment is independent of the Federal Health Agency, which handles only the organizational details.

Unlike the United States Food and Drug Administration which evaluates drugs only in a passive manner based on data supplied by the manufacturer, Commission E actively checks so-called bibliographic data independently. Such data include information obtained from clinical trials, field studies, collections of single cases, scientific literature including facts published in the standard reference works, and expertise of medical associations. If controlled clinical data are lacking, safety and efficacy can still be determined on the basis of information in the literature, the presence of supplemental data supporting clinical results, and significant experimental studies supporting traditional use.

By 1993, about 300 such monographs had been prepared. Approximately two-thirds of them are positive assessments covering herbs that have been found to be safe and effective; the remainder are negative (unapproved), usually because use of the drug presents an unsatisfactory risk-benefit ratio. Although critical scientists and clinicians might quibble with a few of the findings in some of the monographs ? I do so myself ? it is necessary to remember that, taken as a whole, they represent the most accurate information available in the entire world on the safety and efficacy of herbs and phytomedicines. As such, they are worthy of careful study by anyone interested in any type of drug therapy. Ignorance of the Commission E monographs is ignorance of a substantial segment of modern medicine.

Herbal Medicine (HM)10 is another book by Mark Blumenthal and his colleagues. It presents herbal information that expands on the German Commission E monographs. Published in 2000, this volume is one of the few up-to-date publications available in the field. Each herbal monograph is extensively annotated and referenced. Dr. Varro Tyler's foreword to his volume articulated why this expanded text provides value to the field.

Although the pioneering judgments rendered by the Commission E on the safety and efficacy of over 380 herbs remain generally the best available, there is, of course, always room for improvement. The medicinal potential of herbs has become the focus of more and more scientific and clinical studies in the field in recent years. New information has provided additional insights and, in some cases, modified previous judgments. That is only to be expected in such a dynamic field.

Therefore, Mark Blumenthal, Alicia Goldberg, and Josef Brinckmann have performed a substantial service to all those interested in herbal medicine by expanding the content in the Commission E herb monographs of the most widely used herbs in America to include updated, detailed information on their botany, history, composition, safety, efficacy, and therapeutic use. And for those who lamented its initial absence, an extensive list of published references is provided, each of which is appropriately keyed to a specific statement in the monograph. This listing is followed by a compilation of additional literature resources for those who want still more background information on a particular botanical.

In short, these expanded versions of selected original Commission E monographs would seem to fulfill all of the desires of those who felt that the original version did not meet their expectations, or that its large size and price did not allow for its widest distribution and use. I am quite certain that this volume will meet and even exceed those expectations and wishes. It is destined to occupy a prominent position on the shelf of useful herbal literature for the foreseeable future.

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