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WHY PATIENTS USE HERBAL MEDICINE
Over 40 per cent of patients use herbal medicines
Forty one per cent of patients regularly use herbal medicines according to a survey conducted at the Division of Clinical and Administrative Pharmacy, University of Iowa College of Pharmacy, Iowa City, USA.
The researchers assessed patients' usage of herbal remedies as well as their willingness to discuss it with their doctor, and they also looked into the relevant safety factors as well as the efficacy of the remedies.
Out of the 1300 patients who participated in the survey, over 61 per cent ( 794 patients) responded to the questionnaire. The results revealed that 41.6% of the patients had used herbal medicines, however, were disappointed in the availability of information from their doctor or health care provider.
The survey showed that those most likely to be using the herbal remedies werewhite women and those people who are educated beyond high school. Furthermore, those patients who used herbal medicines also tended to use prescription drugs more frequently than those patients who do not use herbal remedies.
The study concluded that a significant minority of patients regularly use herbal medicines and that those patients who use herbal remedies (as well as those who don't)
believe that doctors and other health care providers should be more aware of the benefits and potential side effects of herbal medicines and have readily accessible information for their patients.
Source : Pharmacotherapy 2000 Jan;20(1):83-7
THE TEORY OF HERBALISM
Herbs have been used since the dawn of time as medicines and, in fact, many common drugs are ,in actual fact, made from herbal extracts. The natural chemical properties of certain herbs have been shown to contain of themselves, medicinal value. However, unlike conventional medicine, herbalists use the 'whole' herb or plant rather than isolating and breaking down chemical compounds and then synthesising it. This is because the plant, being a part of Nature, is said to represent perfect balance; healing requires the natural combination of elements in the plant or herb, not just a single chemical within it.
Herbalism, also known as medicinal Botany (a neologism by Dr.K.Seshagirirao, University of Hyderabad, India), medical herbalism,herbal medicine, herbology, botanical medicine and phytotherapy, is a traditional medicinal or folk medicine practice based on the use of plants and plant extracts. The bioinformatics related to this subject could be referred to as MedBotanics (Seshagirirao).
Utilizing the healing properties of plants is an ancient practice. People in all continents have long used hundreds, if not thousands, of indigenous plants for treatment of various ailments dating back to prehistory. There is evidence that suggests Neanderthals living 60,000 years ago in present-day Iraq used plants for medicinal purposes (found at a burial site at Shanidar Cave, Iraq, in which a Neanderthal man was uncovered in 1960. He had been buried with eight species of plants) These plants are still widely used in ethnomedicine around the world.
The first generally accepted use of plants as healing agents was depicted in the cave paintings discovered in the Lascaux caves in France, which have been radiocarbon dated to between 13,000 - 25,000 BC.
Anthropologists theorize that over time, and with trial and error, a small base of knowledge would have been acquired within early tribal communities. As this knowledge base expanded over the generations, the specialized role of the herbalist emerged. The process would likely have occurred in varying manners within a wide diversity of cultures.
Plants have an almost limitless ability to synthesize aromatic substances, most of which are phenols or their oxygen-substituted derivatives such as tannins. Most are secondary metabolites, of which at least 12,000 have been isolated, a number estimated to be less than 10% of the total. In many cases, these substances (esp. alkaloids) serve as plant defense mechanisms against predation by microorganisms, insects, and herbivores. Many of the herbs and spices used by humans to season food yield useful medicinal compounds.
The use of and search for drugs and dietary supplements derived from plants have accelerated in recent years. Pharmacologists, microbiologists, botanists, and natural-products chemists are combing the Earth for phytochemicals and leads that could be developed for treatment of various diseases. In fact, approximately 25% of modern drugs used in the United States have been derived from plants.
The use of herbs to treat disease is almost universal among non-industrialized societies. A number of traditions came to dominate the practice of herbal medicine in the Western world at the end of the twentieth century:
* The Western, based on Greek and Roman sources,
* The Ayurvedic from India, and
* Chinese herbal medicine (Chinese herbology).
Many of the pharmaceuticals currently available to Western physicians have a long history of use as herbal remedies, including opium, aspirin, digitalis, and quinine. The World Health Organization (WHO) estimates that 80 percent of the world population, presently use herbal medicine for some aspect of primary health care. Herbal medicine is a major component in all traditional medicine systems and a common element in Ayurvedic, homeopathic, naturopathic, traditional Chinese medicine, and Native American Indian medicine. According to the WHO, 74% of 119 modern plant-derived pharmaceutical medicines are used in ways that correlated directly with their traditional uses. Major pharmaceutical companies are currently conducting extensive research on plant materials gathered from the rainforests and other places for possible new pharmaceuticals.
All plants produce chemical compounds as part of their normal metabolic activities. These can be split into primary metabolites, such as sugars and fats, found in all plants, and secondary metabolites found in a smaller range of plants, some only in a particular genus or species.
The autologous functions of secondary metabolites are varied. For example, as toxins to deter predation, or to attract insects for pollination. It is these secondary metabolites which can have therapeutic actions in humans and which can be refined to produce drugs. The word drug itself comes from the Sweedish word "druug", which means 'dried plant'. Some examples are inulin from the roots of dahlias, quinine from the cinchona, morphine and codeine from the poppy, and digoxin from the foxglove, and salicylic acid alpha-hydroxybenzoic acid, C6H4(COOH). S.A. led to the development of Aspirin, acetyl-salicylic acid, originally a trade name, patented by Bayer.
In 2004 the National Center for Complementary and Alternative Medicine began funding clinical trials into the effectiveness of herbal medicine.
P<>. A survey released in May 2004 by the National Center for Complementary and Alternative Medicine focused on who used complementary and alternative medicines (CAM), what was used, and why it was used. The survey was limited to adults age 18 years and over during 2002 living in the United States. According to this survey, herbal therapy, or use of natural products other than vitamins and minerals, was the most commonly used CAM therapy (18.9%) when all use of prayer was excluded.
Herbal remedies are most common in Europe. In Germany, the term apothecary (Apotheke) is still used, and next to prescription drugs one can order essential oils, herbal extracts, or herbal teas. It is even seen as a preferred treatment over the unnecessary overuse of industrialized production of chemical medication.
In the United Kingdom, the training of medical herbalists is undertaken in private colleges. Recently, Bachelor of Science degrees in herbal medicine are offered at Universities such as University of East London, Middlesex University, University of Central Lancashire, University of Westminster and Napier University in Edinburgh.
At UCLAN the training of medical herbalists is extensive, and involves the study of anatomy, physiology, biochemistry, pathology, differential diagnosis etc. This enables the herbalist to be able to talk on equal terms with conventional medical practitioners. They learn about when they can treat, and when they should refer. They study the biochemistry of the body and the chemistry and structure of plants. Alongside this, they study traditional herbal medicine: Indications and Actions, and Energetics. They learn to recognise where conventional medical opinion diverges from traditional herbal medicine doctrine. They look at lots of different models for health care. A significant amount of self reflection is required (see http://www.uclan.ac.uk/courses/ug/bsc_hm.htm and http://www.medicalherbalist.eu). A medical herbalist is trained to view a situation from multiple perspectives in a non-dogmatic way.
TYPES OF HERBAL MEDICINE
Medicinal plants can be used by anyone, for example as part of a salad, an herbal tea or supplement, although some herbs considered dangerous are restricted from sale to the public. Sometimes such herbs are provided to professional herbalists by specialist companies. Many herbalists, both professional and amateur, often grow or wildcraft their own herbs. Many common weeds have medicinal properties (e.g. dandelion).
Medicinal herbs can be used in various forms.
RISKS AND BENEFICTS
A common misconception about herbalism and the use of "natural" products in general, is that "natural" equals safe. However many plants have chemical defence mechanisms against predators that can have adverse or lethal effects on humans. Examples are poison hemlock and nightshade, which can be deadly, although they are not sold as herbs. Herbs can also have undesirable side-effects just as pharmaceutical products can. These problems are exacerbated by lack of control over dosage and purity. Furthermore, if given in conjunction with drugs, there is danger of 'summation', where the herb and the drug have similar actions and add together to make an 'overdose'. In animals, there are other dangers. There may be residues in food from farm animals (e.g. eggs, milk, meat) or danger of 'doping' in competition animals. The latter may also apply to human athletes.
There is a danger that herbal remedies will be used in place of other medical treatments which have been scientifically tested for safety and efficacy, resulting in the development or worsening of a medical condition which could have been better prevented or treated. There is also a danger that an herbal remedy may itself cause harm which is unanticipated due to a lack of a full understanding of its composition and biochemical effects.
In the UK, the profession's governing bodies such as The College of Phytotherapy Practitioners and The National Institute of Medical Herbalists offer membership, education and certification. A qualified Herbalist will have studied for four years and passed exams in botanical and medical subjects. He or she will be expected to have the required knowledge to prescribe and dispense herbs tailored to the individual, taking into account their medical history and any other medication.
In international herbal medicine research, several practical challenges arise in making accurate risk–benefit determinations. Typically, in American pharmaceutical development, a step-wise process of drug testing occurs – a compound is isolated, tested in tissue cultures and animals, and then investigated in phase 1, 2 and 3 clinical trials. However, herbal medicines are already in widespread use, are often used in combination, and are drawn from plant sources with their own variability in species, growing conditions and biologically active constituents. They often come into use by a process of trial and error, or over centuries. Accordingly, in clinical herbal medicine research there is rarely a strong preclinical basis for dosing, and there are significant looming questions about product purity, quality, chemical stability and active constituents at the time herbal medicine trials are proposed.27,28
Initiating large-scale research trials in such circumstances raises questions about whether the risks and benefits of research participation can be accurately ascertained. Those reviewing protocols should factor in the uncertainty associated with product variability in determining whether a herbal medicine trial has a favourable risk–benefit ratio. However, protocol reviewers (i.e. institutional review boards) should not presume that because they are personally unfamiliar with a herbal preparation that there is no credible or valuable background evidence regarding safety and potential efficacy. While researchers should provide such information in protocol materials, reviewers must remain aware of the role their own lack of familiarity may play in their ultimate judgements of risks and benefits of the research.
Researchers increasingly agree that it is important to establish a rational basis for dosing and standardization of biologically active compounds before conducting large-scale treatment trials.29,30 These efforts can improve investigators’ ability to assess the risks and benefits of participation in large-scale herbal medicine trials. Likewise, more rigorous monitoring of adverse events and standardized reporting of research results for both safety and efficacy data will improve long-term efforts to enhance risk–benefit ratio determination for trial participation.31
Cultural factors also may influence judgements of the risks and benefits in herbal medicine research. For instance, a cultural familiarity with many traditional Chinese herbal medicines in China may promote a familiarity bias, accepting a widespread cultural assumption of safety, based on the historical use of herbal medicines.32 There may also be a cultural difference in emphasis placed on standardized adverse events reporting in China.33 These cultural differences make achieving agreed-upon standards of favourable risk–benefit ratio more difficult. In order for international collaborative herbal medicine research to achieve its objectives, it will be important to establish standards of evidence for demonstration of safety before conducting large-scale clinical trials evaluating the efficacy of herbal medicines.
As noted above, there have been scientific studies which show that certain plant products can cure or prevent certain diseases. The gold standard for pharmaceutical testing is repeated, large-scale, randomized, double-blind tests. Some plant products or pharmaceutical drugs derived from them are incorporated into mainstream medicine. To recoup the considerable costs of testing to the regulatory standards, the substances are patented by pharmaceutical companies and sold for high profit. Pharmaceutical firms argue that the regulations protect public safety. Cynics point out that they have a secondary effect of setting a high financial barrier to competition.
Most herbal traditions have accumulated knowledge without modern scientific controls to distinguish between the placebo effect, the body's natural ability to heal itself, and the actual benefits of the herbs themselves. Many herbs have shown positive results in in-vitro, animal model or small-scale clinical tests. The few randomized, double-blind tests that receive attention in mainstream medical publications are often questioned on methodological grounds or interpretation. Studies tend to carry more weight if they are performed in the same country as the medical scientists evaluating them. Likewise, studies published in wide circulation magazines such as JAMA receive more consideration than those published in specialized herbal journals. Fortunately there is now much scientific research into the action and effectiveness of herbal remedies and many are justifying their traditional use. High quality trials involving proper controls and double blind methods are being increasingly carried out, with many useful results.
Herbalists tend to use parts of plants, such as the roots or leaves but not isolate particular phytochemicals. They argue that the synergy of the combined substances enhances the efficacy and dilutes toxicity. Western medicine on the other hand prefers single ingredients on the grounds that dosage can be more easily quantified. Dosage is in general an outstanding issue for herbal treatments: while most conventional medicines are heavily tested to determine the most effective and safest dosages (especially in relation to things like body weight, drug interactions, etc.), there are few established dosage standards for various herbal treatments on the market. Furthermore, herbal medicines taken in whole form cannot generally guarantee a consistent dosage or drug quality (since certain samples may contain more or less of a given active ingredient).
The issue of regulation is an area of continuing controversy in the EU and USA. On one end of the spectrum, some herbalists and consumers maintain that traditional remedies that have a long history of use do not require the level of safety testing as xenobiotics or single ingredients in an artificially concentrated form. On the other hand, others are in favor of legally enforced quality standards, safety testing and prescription by a qualified practitioner. Some professional herbalist organizations have made statements calling for a category of regulation for herbal products. Yet others agree with the need for more quality testing but believe it can be managed through reputation without government intervention. Clearly the full debate involves issues of politics, economics and the role of government that are beyond the scope of this article.
Part of ensuring the social value of research includes devising and implementing sound science. Although international collaborative research on herbal medicine is no exception, discussing scientific validity as an ethical requirement raises some specific challenges, including the meaning of scientific validity, establishing inclusion and exclusion criteria, using appropriate outcome measures, and determining appropriate study designs.
STANDARDS AND QUALITY CONTROLS
P<>. The legal status of herbal ingredients varies by country. For example, Ayurvedic herbal products may contain levels of heavy metals that are considered unsafe in the U.S., but heavy metals are considered therapeutic in Ayurvedic medicine.
In the United States, most herbal remedies are regulated as dietary supplements. Many herbs for home use could also be grown in a small home garden.
In the UK, herbal remedies that are bought over the counter are regulated as supplements,as in the US. However, herbal remedies prescribed and dispensed by a qualified Medical Herbalist, after a personal consultation, are regulated as medicines. A Medical Herbalist can prescribe some herbs which are not available over the counter, covered by Schedule III of the Medicines Act, for example. Forthcoming changes to laws regulating Herbal products in the UK, are intended to ensure the quality of herbal products used. Most Medical Herbalists will be using herbal products from a supplier who already meets these standards.
Building a valid basis for knowledge in herbal medicine will require balancing two aspects of scientific validity: internal and external validity.15 Internal validity means the research must reliably test hypothesized relationships between an intervention and an outcome under controlled conditions. Internally valid research will typically try to answer a focused research question that is salient within the vocabulary and methods of the scientific community at the time the research is conducted. External validity refers to the applicability of the research results to a target population outside the experimental conditions of the research study. External validity must always be weighed against the need for rigorous internally valid research.
This tension between internal and external validity can be illustrated by a recent herbal medicine trial of Echinacea angustifolia extract for prevention of parainfluenza virus infection.16 The study was conducted under rigorous experimental conditions, but many herbalists pointed out that study conditions did not sufficiently reflect how these medicines are actually used. Null treatment trial results like these prompt questions about the external validity (i.e. value and meaning) of the research. Was the herbal medicine truly ineffective, or did the experiment not reflect the herb’s use in “real-world” practice? In herbal medicine there are often huge variations in the way in which the medicines are used in herbalist practice, including herb source, preparation, dose and indication. Because traditional herbal medicine practitioners may be unregulated and their products lacking in standardization, it may be difficult to generalize the results from a formal, structured and highly monitored trial to what will happen in the widespread dissemination of the herbal medicine. Nevertheless, herbal medicine research must endeavour to achieve a balance between internal and external validity.
To ensure that research results are externally valid, the inclusion and exclusion criteria for research participation should fit with existing diagnostic categories in the target population specified by the research question. However, conceptualizations of health and illness can vary across medical systems and populations, making agreement on valid inclusion and exclusion criteria for international herbal medicine research collaborations more difficult to achieve.
During the SARS epidemic, traditional Chinese medicine (TCM) practitioners involved in the care of SARS patients characterized patients based on nosological categories derived from TCM including “deficiency of chi and yin” as well as “stagnation of pathogenic phlegm”.17 Designing clinical trials using these kinds of TCM categories as inclusion criteria would require significant additional effort and biomedical flexibility to implement. If one wanted to test whether TCM works for populations in south-east Asia affected by a SARS-like illness, adapting the science to include traditional diagnostic categories may be critical for its ultimate external validity.
If American researchers want to test a herb’s effects on heart failure, they might use the New York Heart Association classification as part of the inclusion/exclusion criteria. However, this classification makes little sense from a TCM perspective, in which heart failure may be viewed primarily as either a heart yang chi deficiency or a kidney yang deficiency.18 TCM practitioners may prefer to categorize patients based on pulses, tongue examination, and other elements of traditional diagnosis. Investigators have simultaneously used both biomedical entry criteria and stratified for TCM diagnosis.19 Such an approach is scientifically ideal because of its ability to maximize the external validity of results.
Valid outcome measures
International herbal medicine research must use outcome measures that accurately capture the effects conferred by herbal medicines. However, constructs such as “physical functioning” or “psychological well-being” measured by the SF-36 quality of life instrument make little sense within the terminology and ideas of TCM.20 Therefore to accurately measure a TCM herb’s effects on quality of life, some investigators have constructed and validated analoguous measures that more faithfully detect the effects of TCM interventions that make sense within that healing tradition.20,21 Ideally, when new measures are introduced, they should overlap with existing outcome measures, so that the research can adequately contribute to the existing body of knowledge.
Determining research design
While it is generally agreed that all human subjects research must maintain valid study designs, questions arise about the characteristics of a valid research design. Two extreme positions are often defended. At one extreme, some researchers trained in biomedical methods of clinical investigation argue that the only valid source of knowledge regarding clinical efficacy must come from one type of research design, the randomized double blind, placebo-controlled trial. They argue that any deviations from this gold standard of scientific validity amount to worthless science.
At the other extreme, critics of biomedical research conducted on traditional medicines charge that attempts to evaluate traditional therapies with biomedical methodologies may fail to generate true knowledge, since that knowledge itself depends on a scientific vocabulary that only makes sense from within the concepts of biomedicine.22–24 They worry that “standard notions of ... experimental design criteria represent an imperialistic ‘western’ mode of thinking”.22,24
Research on herbal medicines should typically employ experimental research designs such as the RCT. Even if research tools (including the RCT) are imperfect,25 they are thus far the best methods we have for furthering our knowledge.9,15 Consider how RCT designs could be implemented in TCM, in which treatments are individualized to patients, often incorporating several, or even dozens, of herbs in a customized preparation. Despite these complexities, investigators have successfully adapted double-blind RCT designs to complex individually tailored Chinese herbs. Bensoussan et al. conducted a three-arm trial in which they tested the comparative clinical efficacy of standard complex herbal medicines, customized therapy and placebo.26 Standard and customized therapy were comparably beneficial as compared to placebo. In other instances, cluster RCTs can allow for practitioner variability, while still rigorously testing the efficacy of a therapeutic approach. In cross-cultural settings, researchers cannot merely adopt alternative designs in an ad hoc manner, but must reflect on and refine their research question, and find a design that best answers the research question within the given cultural context.
In recent years, growing attention has been paid to a group of additional important ethical issues surrounding publication bias, financial conflicts of interest, and clinical trial registries. In the arena of traditional herbal medicine, these same issues apply, and when cross-cultural differences exist in the definitions of valid science, as is the case in traditional herbal medicine research, these questions compound. For instance, until recently, there was a tendency to see only positive studies published in China. It is, therefore, critically important to the long-term scientific credibility of international traditional herbal medicine research that, at the outset, partners agree about the standards of scientific conduct, the disclosure of financial relationships, registration of clinical trials, and adequate reporting of trial results.
In consultation with a physician, usage of herbal remedies should be clarified, as some herbal remedies have the potential to cause adverse drug interactions when used in combination with various prescription and over-the-counter pharmaceuticals. Dangerously low blood pressure may result from the combination of an herbal remedy that lowers blood pressure together with prescription medicine that has the same effect. In particular, many herbs should be avoided during pregnancy. However, most herbal books alert the reader to necessary precautions.
Not all physicians may be familiar with the effects of different types of herbal medicine, but general practitioners should be able to refer patients to a specialist, or investigate the medical literature on their behalf. A qualified Medical Herbalist, however, will be familiar with most commonly used medical drugs and their modes of action and therefore will only prescribe herbal remedies which will not interfere with these.
* Herb Research Foundation.
* Center for Complementary and Alternative Medicine.
* University of Minnesota's Center for Spirituality and Healing.
* University of Minnesota's Center for Spirituality and Healing.
* Medline All Herbs and Supplements.
* Herbological.com Sharp analysis of current research and debate on herbal medicine and related matters.
* New England Journal of Medicine editorial about the risks of alternative medicine
* University of Maryland site about alternative medicine: uses, possible prescription drug interactions, and possible nutrient depletions
* Herbal supplements not child's play - CNN news article
* Herbal side effects and warnings - researched by Personal Health Zone staff
WHO IS USING HERBALISM?
The healing practices are increasingly being tested for effectiveness and safety in well-designed research studies. Once distant healing practices are becoming more common, and more Americans are turning to integrative medical care than ever before.
The movement toward integrative medicine in the United States has been prompted by a growing consumer demand for herbalism services. A survey given to more than 31,000 U.S. adults found that nearly 70% of Americans have used at least one form of herbalism therapy in their lifetime, making this "unconventional" medical approach one of the fastest growing sectors of American health care. In 2004 in the United States, 36% of adults were using some form of herbalism. When megavitamin therapy and prayer specifically for health reasons were included in the definition of herbalism, that number rose to 62%.
The survey also found that herbalism approaches are most often used to treat back pain or problems, colds, neck pain or problems, joint pain or stiffness, and anxiety or depression. However, only about 12% of adults sought care from a licensed herbalism practitioner, suggesting that most people who use herbalism do so on their own. According to the survey, the 10 most commonly used herbalism therapies and the percent of U.S. adults using each therapy were:
* Prayer for own health, 43%
* Prayer by others for the respondent's health, 24%
* Natural products (such as herbs, other botanicals, and enzymes), 19%
* Deep breathing exercises, 12%
* Participation in prayer group for own health, 10%
* Meditation, 8%
* Chiropractic care, 8%
* Yoga, 5%
* Massage, 5%
* Diet-based therapies (such as Atkins, Pritikin, Ornish, and Zone diets), 4%
The survey also found information about why people use CAM:
* 55% of adults said they believed that it would help them when combined with conventional medical treatments.
* 50% thought herbalism would be interesting to try.
* 26% used herbalism because a conventional medical professional suggested they try it.
* 13% used herbalism because they felt that conventional medicine was too expensive.
Studies also report 41% of people who use herbalism use two or more therapies during the prior year. The highest rates of herbalism use tend to be among people ages 40 - 64, females, non-black/non-Hispanic, and with annual income of $65,000 or higher.
Although herbs and supplements are not regulated by the U.S. Food and Drug Administration, pharmacies across the country are seeing a surge in the demand for these alternative remedies. Pharmacists are being trained to counsel people on the safe and efficient use of herbalism therapies. Most U.S. medical schools also now include instruction about CAM. More and more health insurance plans are also covering herbalism, particularly treatments such as acupuncture and chiropractic, whose safety and effectiveness for treating certain health problems has been well researched. A study found that among the 600,000 enrollees in a particular health insurance plan, 13.7% made herbalism claims. Of those, 1.3% made claims for acupuncture, compared with 1.6% for naturopathic medicine, 2.4% for massage, and 10.9% for chiropractic.
How can international collaborative herbal medicine trials achieve the ethical requirements outlined above? Collaborative partnership, the first requirement for international research ethics, provides both the rationale and the context for achieving appropriate application of the other ethical requirements. Partners in these collaborations must share vocabulary for all the requirements, especially for social value, scientific validity, and favourable risk–benefit ratio. How can agreed-upon language be achieved? As illustrated here, these challenges are significant. In the case presented earlier, investigators should have reservations about implementing a large-scale clinical trial for Africa Flower. Nevertheless, the local interest in this substance may be valid and deserve some additional preliminary investigation. Collaborative partnership displays a commitment by all parties in international research agreements to work together for common language and goals.
To achieve collaborative partnership, parties can engage in structured methods of democratic deliberation to devise shared language and concepts for research. These methods have been used to bring different parties together in a safe and collegial process of decision-making.34 Over time, collaborations could “cross-train” basic and clinical investigators to more fully appreciate the concepts and practices of the traditional herbal medicine traditions, and developing host countries would need to develop the basic literacy, knowledge and skills among traditional medicine practitioners so that they see the value of rigorous clinical research.2 With a sustained investment like this, it will become increasingly possible to conduct sound international scientific investigation on traditional herbal medicine. Furthermore, sustainable collaborative research partnerships would benefit from robust and independent adverse-event reporting systems for herbal medicines so that the risk–benefit ratio for herbal medicine research can be more clearly defined.
Ethical challenges in international traditional herbal medicine call for a comprehensive framework. Addressing these challenges requires collaborative partnership that implements sound research designs. So envisioned, international herbal medicine research can contribute to global health.
* Quality of Reporting of Randomized Controlled Trials of Herbal Medicine Interventions
* A traditional Chinese medicine versus Western combination therapy in the treatment of rheumatoid arthritis: two-stage study protocol for a randomized controlled trial.
* Whole plant extracts versus single compounds for the treatment of malaria: synergy and positive interactions
* Are positive alternative medical therapy trials credible?: Evidence from four high-impact medical journals.
* Synergy and other interactions in phytomedicines
* Reliability and validity of a cold-heat pattern questionnaire for traditional Chinese medicine.
* Herb–drug interactions: Review and assessment of report reliability
* Is oral administration of Chinese herbal medicine effective and safe as an adjunctive therapy for managing diabetic foot ulcers? A systematic review and meta-analysis.
* Developing a library of authenticated Traditional Chinese Medicinal (TCM) plants for systematic biological evaluation--rationale, methods and preliminary results from a Sino-American collaboration..
Fitoterapia ed erboristeria: le novità della direttiva 2004/24/CE
Facciamo il punto sulla direttiva europea riguardante i medicinali vegetali tradizionali, che sta allarmando molti consumatori e anche professionisti del settore.
Novità non è probabilmente il termine corretto, visto che la direttiva comunitaria è stata emanata sei anni fa. Ma considerato che le scadenze previste dalla stessa si avvicinano e che in questi giorni si sta facendo un gran baccano - soprattutto sul web - in merito alle ricadute di questa direttiva, riteniamo valga la pena dire due parole.
La Direttiva 2004/24/CE del Parlamento europeo del 31 marzo 2004, recepita in Italia con il Decreto Legislativo n. 219 del 24 aprile 2006, prevede che entro maggio del 2011 tutti i medicinali vegetali tradizionali dovranno adeguarsi alle norme previste per i farmaci allopatici (sperimentazione clinica, dati su sicurezza ed efficacia, standard di produzione ecc.)
Se quindi un’azienda desiderasse attribuire a un suo prodotto fitoterapico proprietà medicinali e definirlo, registrarlo e pubblicizzarlo come farmaco, benché vegetale, sarebbe assoggettata a questa direttiva.
Molti temono, sbagliando, che questa sia la fine dell’erboristeria e del rimedio naturale. Bisogna stare attenti a non fare confusione: la Direttiva comunitaria 2004/24/CE istituisce il Medicinale Vegetale Tradizionale (Herbal Medicinal Drug), mentre un’altra direttiva comunitaria, la 2002/46/CE, recepita con il D. L.vo n. 169 del 21 Maggio 2004, istituisce l’integratore alimentare a base di fibre ed estratti vegetali. Il primo è un farmaco vero e proprio, seppur vegetale, quindi adatto a curare malattie; il secondo è un prodotto di erboristeria o farmacia classificato come integratore e atto a sostenere e ottimizzare le funzioni fisiologiche dell’organismo.
Il farmaco vegetale ha la sua ragion d’essere nel contenere, concentrato, quel particolare principio attivo responsabile di una certa, determinata attività terapeutica, mentre il rimedio erboristico con finalità salutistiche basa la sua azione soprattutto sul concetto di fitocomplesso.
Va precisato che, nonostante per semplicità spesso si parli di fitoterapia e fitoterapici, la quasi totalità dei prodotti a base di piante in commercio in Italia (tutti quelli venduti in erboristeria e la stragrande maggioranza di quelli in vendita in farmacia) ricade, dal punto di vista normativo, sotto la categoria degli integratori alimentari. Tutti questi, regolamentati e ammessi in Italia dal D.L.vo n. 169/2004 e in altri Paesi europei in attuazione della direttiva 2002/46/CE, potranno continuare a essere venduti e acquistati regolarmente, perché non rientranti nella direttiva dei medicinali vegetali tradizionali.
Con buona pace di coloro che vorrebbero trattare come farmaco ogni rimedio a base di estratti vegetali e riservare al medico il potere di prescriverli, negli ultimi 3 anni in Italia il Ministero della Salute ha autorizzato solo un (1!) medicinale vegetale tradizionale, mentre ha invece incluso molte decine di “nuove” piante officinali nell’elenco di quelle ammesse nella produzione di integratori alimentari.
Non solo: molte piante potranno comunque “viaggiare su un doppio binario” ed essere vendute e impiegate con modalità diverse. Si potranno preparare prodotti contenenti piante con finalità terapeutiche, ovvero medicinali, e rimedi contenenti piante con finalità salutistiche e fisiologiche, ossia integratori alimentari. Potranno pertanto coesistere in commercio due preparati a base del medesimo prodotto vegetale, uno (il medicinale vegetale tradizionale) indicato per la cura delle malattie e non dissimile, come logica d’azione ed effetti collaterali, dal farmaco “chimico”, l’altro (l’integratore alimentare) proposto per il fisiologico benessere dell’organismo e dei suoi diversi organi e apparati.
p<. * MEDLINE
* HERBAL SEARCH
* TERAPEUTIC RESEARCH