Among all the therapies that are called ‘complementary’, phytotherapy is the one that can draw on the most scientific support. This book is constructed largely on the foundation of published literature. It is clear that there is now a sufficient case to construct a rational therapeutic system from the older traditions. However, in spite of this and the presence in medicinal plants of many pharmacologically active constituents, the most persistent doubt expressed by the medical world is whether whole herbs actually work in practice.

Most published material on phytomedicines is based on laboratory research rather than on observed effects in humans of realistic doses. There is still a relative paucity of top-quality controlled clinical studies of the whole herb. Moreover many good clinical studies show only a modest effect beyond placebo. Critics also point out that pharmacological constituents in most herbs are at relatively low levels in a final therapeutic dose, that the complexity of constituents is at least as likely to reduce as to potentiate activities, and that traditional reputation is often clouded by plagiarism and inappropriate transmission.

On the other hand, most herbal practitioners will attest to consistent therapeutic performance and will also have accounts of dramatic responses from their patients, where genuinely powerful pharmacological effects have followed consumption of herbal prescriptions, often after conventional treatments had failed. They will also point to the essential features of clinical trial data as denying precisely that which they value most about their therapy – the individualisation of treatment and response. As an example, experimental data consistently deny the possibility of appreciable diuretics among plant remedies, yet substantial diuresis in individual patients is one of the most familiar treatment reactions in practice. Such experiences are enough to convince most practitioners that herbal medicine is a serious alternative to conventional drug treatment with few of the adverse effects.

Any move in the stand-off between the sceptics and the believers is, however, likely to include a full discussion of the placebo effect.

Honesty can be painful to all health practitioners: it is likely that most benefits seen in taking any therapy are not produced directly by the treatments themselves. This is the main conclusion reached after taking into account the substantial literature about placebo.

The term ‘placebo effect’ itself is not wholly appropriate for this discussion. It derived originally from observations in double blind clinical studies where the treatment was compared with a dummy pill made to look as close as possible to the treatment, with neither the patient nor the practitioner aware of which was which. Early observations were that a significant proportion of subjects in such studies who were taking the dummy nevertheless got better. Initial impressions in the 1940s and 1950s, when such rigorous studies became more common, were that figures varied from trial to trial, but it appeared that about a third of subjects were likely to be ‘placebo responders’. This behaviour was put down, in the psychosomatic model emerging at the same time, as reflecting a particular suggestibility on the part of that proportion of the population. As a result the placebo response has been seen to be a non-serious event, not something to be confused with real medicine and at worst a confounding nuisance in establishing therapeutic efficacy for treatments.

Many doctors and other practitioners became used to thinking that about a third of their patients would get better whatever they were given and many thought they knew who they were! After discounting this element they were pleased to feel that any further improvement in their patient population was a result of therapeutic efficacy and skill. Herbal practitioners have therefore been able to confirm to themselves that there must be much more to account for the evidence before their eyes.

Both practitioners and sceptics must review their opinion about the placebo effect in the light of overwhelming later evidence. The last 50 years have completely overturned early prejudices. In brief, it is now possible, after analysis of the clinical trial literature, to confirm that:

The first real shock to the herbal practitioner is that those ‘conditions and circumstances’ where placebo responses have been recorded as particularly high include many of those covered by herbal and other complementary treatments. There is support for the cynic’s case that the success of herbal tradition over centuries, especially that drawn from close-knit early societies (where placebo responses were likely to be particularly high because of stronger peer pressures and belief systems), could be due to benefits other than the treatment itself.

The shock also applies, however, to conventional medicine and especially surgery, where placebo responses, as evidenced by examining data from non-controlled clinical studies of surgical interventions which were later found to be valueless, are among the highest recorded.² The simple instruction from a doctor carries enormous ‘placebo’ impact.¹² In whole industries, such as those promoting antidepressant drugs, the impact of placebo relative to treatment response has probably been systematically understated.¹³

Among both conventional and complementary healthcare practitioners there is an understandable feeling that cures having nothing to do with the treatment so skilfully provided are something of an embarrassment and even a challenge to one’s choice of vocation. Thus the placebo effect is one of the least discussed phenomena in clinical medicine. Yet it is by far the most powerful factor of all.

The way through this potential difficulty is to reconsider what the placebo response means.

When a moderate cut is sustained, one assumes it will heal itself. A cold or bout of influenza will generally get better on its own. The only treatment for serious trauma like broken bones or operation wounds is to put the tissues back together and leave them for natural healing to occur.

No one doubts that self-repair is a vital phenomenon. Nevertheless, medicine has moved away from the classic principle that all healing is self-healing, that the vis medicatrix naturae, the healing power of life, is the only healer and that the physician should do no more than help it on its way. Exasperation at the slow and uncertain pace of natural healing, the realisation that one can save lives and health by stepping in with something direct and powerful, has led to the discovery of healing bullets. The modern success in this venture has allowed medicine to forget the fundamental principle that ultimately no drug or surgery actually heals: its value is in reducing pain and distress, returning an acceptable function and at best enabling spontaneous repair to occur when it had previously been prevented.

There is no problem with the modern strategy in many clinical cases; it is certain that it can save lives and protect health in ways inconceivable to prescientific medicine. Nevertheless, there is another strategy that may be more appropriate in many other clinical conditions, a therapeutic approach with the primary objective of supporting self-repair. This could be most appropriate in facing the challenge of chronic diseases, the broad range of indeterminate syndromes, along with the numerous minor self-limiting symptoms that make up the vast majority of the family practitioner’s caseload.

What researchers have labelled as the placebo effect in their clinical trials may be described as an improvement in self-repair. That it was merely the effect of being recruited into the clinical study and being given a dummy treatment (the main feature of most clinical trials is the increased attention that subjects receive for their condition) is surely evidence of how little it can take to mobilise this self-repair. Dismissing placebo healing as just suggestibility is to miss the point; as shown above, placebo healing can occur in any subject when the circumstances are right.

Indeed, some medical practitioners have got the point. There is a long unspoken tradition of non-specific prescribing, with vitamins, laxatives, aspirin and, unfortunately, antibiotics to keep the patient happy (placebo means ‘I please’), although actual prescription of placebos as such usually breaches ethical and legislative codes.

Many researchers prefer to use the term ‘non-specific effects’ to describe contributions to improvements in clinical studies that are not caused by the treatment in isolation. As well as the placebo effect itself, they include the natural course of the illness (‘getting better anyway’ is something ‘control groups’ of non-treated patients are supposed to quantify in the better organised clinical trials but even here confusion reigns about hidden ‘placebo effects’¹⁴), ‘spontaneous remission’ (generally used to describe recovery that cannot otherwise be explained), a trend for improvement (‘regression to the mean’) due to the fact that people tend to get recruited to studies (and come to obtain treatment) when they are at their worst. All these phenomena are aspects of self-repair. A shift in terminology so that the generally prejudicial ‘placebo effect’ becomes ‘non-specific effects’ will be welcome.

In reflecting on practice experience with the full impact of the placebo literature in mind, one could easily become dismayed at the difficulty in separating possible herbal treatment effects from non-specific effects. Nevertheless, one is quickly reminded of the peculiar properties of herbal remedies; time and again one sees in practice changes that are characteristic of the remedies, rather than fitting any preconceived notion of a placebo response. Changes in physiological functions, in digestion, bowel performance, expectoration, diuresis, circulation and many others can often be invoked. There is enough evidence to support the view that many herbal remedies have appreciable effects on various organ and tissue functions, much of which is considered throughout this book.

If this is the case and the objectives of treatment are to better mobilise self-repair functions, then herbal remedies could have unique prospects for this job. If non-specific responses are manifestations of such mobilisation then, to put it simply, the role of the herbal practitioner is to improve such responses. No one needs to feel their vocation is challenged if they acknowledge the large contribution of non-specific factors in their professional performance. It may even be possible to develop research questions that test the hypothesis that herbal remedies have unique prospects for mobilising the self-repair functions.

Whatever the argument for or against the benefits of herbal medicine, this has been driven more by prejudice on both sides than by the evidence. It is time to review the status of research so far and pose new, more appropriate methods for the future.

Judging by the substantial markets for herbal products in the developed world, let alone the vast use in traditional cultures, a great many people have already found herbal medicines useful. Compared with the experience of most modern drugs, the human use and approval of most herbal remedies is phenomenal. The requirement by the medical and scientific establishment for research to ‘prove’ that herbs are effective is not found among the population at large. It is apparent that most ordinary people are content to rely on their impressions of the world to get by in it.

Knowledge within traditional medicine has also generally been in the form of received wisdom moulded to the individual needs and prowess of each practitioner. Such means of acquiring healing skills seem temperamentally suited to most practitioners, herbal and conventional, even today. Their interest in inquiry for its own sake, with secure truths up for constant possible refutation, is understandably secondary to their concern to survive in practice. In the case of herbal medicine, adherents understandably tend to give it the benefit of doubt. The view that: ‘What worked for our grandparents is good enough for me, and at least it is natural’ probably generates a casual approach about research. It is also possible to question the validity of the research forum and only to play it as far as absolutely necessary (so that the rights to supply herbs are not restricted by law).

Moreover, in spite of the public indifference to the evidence base, they do want to be assured that someone is looking after them. They therefore assume the questions are being asked by those who ought to do it. The physician and the regulators are charged with the job of making sure that medicine is safe and effective. There are internal reasons why some practitioners may be willing to submit to the rigours of the research method: a simple pride in the therapy might generate the challenge ‘If what you say is so valuable and powerful then it should be able to stand up for itself in any forum’.

There are, however, practical problems in pursuing good clinical research in herbal medicine:

Even with these difficulties, conventional double blind randomised clinical trials can sometimes be completed, although the track record so far is patchy. The controlled trial is a notably flexible instrument and clinical trial data at least involve rigorous observations of human use of plants: of the forms of research available they are by far the most valuable in making clinical judgments. For now there are many hundreds of well-conducted random-assigned, double blind controlled studies, and even systematic reviews of these, at least for the proprietary products on the market. The monographs in this text also include well-conducted clinical trials for products based on valerian, feverfew, ginger, saw palmetto and others. These studies show that the conventional methodology is very powerful and can be suited to understanding herbal remedies in some contexts at least. They also show that even such unremarkable plants, when researched thoroughly, can demonstrate efficacy beyond the placebo.

It is also important to counter some practitioner resistance to clinical trials. Some have decried them as inherently unethical, in denying a proportion of patients the most useful treatment. However, the researcher goes into a controlled clinical study professionally neutral to the outcome: the point is that until the study is complete there is no ‘most useful treatment’. Second, no study in a developed country could proceed without painstaking adherence to the principle of informed consent and to other reassurances that the interests of the subject are paramount. The ethics committees that legally review all orthodox study protocols are charged to represent the interests of the subjects (and this includes rejecting studies that are not sufficiently well designed to actually answer the question). Indeed, medical researchers may point out in their terms that administering a remedy that has not been proven by good-quality research is itself unethical. This may not be an argument for herbal practitioners to pursue too far!

Moreover it should be recognised that OTC herbal use far outstrips practitioner prescription, probably by a factor of more than 20:1 even in Europe.¹⁹ For researching OTC label indications for single medicinal products, in which individual responses to remedies are not the critical issue, the double blind controlled clinical trial is clearly the most applicable method. In addition, as the ‘patient’ is in many cases not being diagnosed professionally and is determining his or her own treatment and prognosis, self-assessment questionnaires are often an appropriate measure of progress. These are not expensive to administer. This is often ‘out-patient’ medicine. Research costs can be saved as close clinical supervision need not be always be necessary throughout the trial.

Unfortunately clinical research on herbs has often also been of indifferent methodological quality. Modern studies, even those otherwise highly rated, can be undermined because they neglect basic precautions against the very variable quality of herbal products. In a surprising proportion of clinical trial papers the herbal product used is not quantified, stabilised or verified.²⁰ Other studies may not relate to the herbal remedy as such but to its chemically-defined ingredients.

Perhaps future hopes for a new injection of investment in clinical research lie with the moves towards sustainable economic development in countries around the world. Renewed interest in the potential of indigenous medical traditions, in some cases linked to emerging economies, has increased research activities in a wider range of plants.²¹ At best, standards developed for herbal research in Europe can be exported to improve the quality of investigation elsewhere and to new products linked to sustainable ‘free trade’ arrangements. There is still a hunger for beneficial natural medicines. If there is any substance in the promise, new ways will be found to service that demand. This phenomenon has already begun, as evidenced by the clinical data being generated in India and China, of which this book contains many examples.

So the practical applications of the conventional controlled clinical trial to herbal practice are mixed. It would be helpful to develop other techniques to explore how herbs affect human beings. There have fortunately been some considerable efforts in constructing appropriate methodologies of sufficient weight.²² These include looking at different outcome measures, applying rigorous observational studies and monitoring individual case studies.

In the review earlier in this chapter, the tendency to use herbs to support individual self-repair rather than simply to target disturbances was raised as prompting different research questions.

Traditional views of herbal remedies emphasise their primary influence on transient body functions, e.g. they are classed as diaphoretics, expectorants, circulatory stimulants, diuretics, digestive stimulants, laxatives and so on. These effects, contrary to common beliefs about the effect of herbal remedies, can occur very quickly after treatment. The requirement is to devise a process by which such properties can be substantiated.

By working with either healthy individuals or, more appropriately, cohorts of patients, it should be possible to monitor functional changes after administering herbal remedies. Recent advances in electronic biochemical monitors provide the possibility of following changes in liver function and blood levels of various markers very simply. Moreover, monitoring changes in blood flow to various organs with thermal imaging or cutaneous thermocouples is a most elegant way of pursuing one of the persistent traditional claims for herbal medicines, that they affect the circulation to heat or cool various tissues, organs or functions. With such advances in non-invasive monitoring technologies it is possible to conceive of important trials in human subjects, in both observational and controlled studies.

Rather than pursue isolated effects from isolated chemical entities it may be better to chart several changes within individuals, using such parameters as are relevant, useful and non-invasive. Emphasis would shift to the simultaneous recording of several parameters of change. It is precisely the interdependence of synchronous events that leads to their exclusion from conventional trials as distracting variables. Acceptance of these variables as important data is a key feature of such work and must therefore profoundly change the nature of the information gathered. Instead of trying to eliminate all variables that might cloud the specific issue in question (‘Is it drug A that reduces inflammation in this organ or other factors?’, for example), the aim of the ‘functional assay’, as it might be called,* is ideally to define all factors which determine the medicinal substance’s influence on the course of disease (‘What, in fact, is drug A likely to do in this individual?’). The task would in some ways resemble homeopathic ‘proving’; in other ways it might take advantage of modern computerised and multilevel diagnostic techniques known as ‘metabolic profiles’.

Any conclusions drawn from such complex information would be qualitative rather than quantitative: relationships may be induced rather than causes analysed. The process will resemble anthropological rather than conventional medical research. It could however augment the collation of exhaustive case stories as described below. The demonstration of transient effects would not always lead to predictable changes in pathologies, representing as these do the somatic accumulation of various, previous functional disorders. However, many clinical presentations are wholly functional (e.g. acute inflammations, asthma, migraine, digestive disorders and the whole range of psychosomatic disorders). Even in the worst case, knowing the functional impact of a herbal remedy would be a most useful guide to its use in clinical practice. (See also later in this chapter under Human phytopharmacological research.)

These latter multiple measurements lead the discussion on to the role of observational studies as a whole in assessing the impact of herbal remedies.

There are many ways in which rigorous, though uncontrolled, observations can illuminate therapeutic events. Although it is difficult to establish cause and effect in observational or field studies or specifically to separate specific from non-specific treatment effects, there are a number of ways that observational studies could productively be used in herbal research.

Performance and effectiveness of a therapy overall can be measured with various outcome measures, including the whole range of clinical or biochemical measures, patient questionnaires or analysis of records. This information can inform those who are determining health policy or the allocation of resources (a good observational study could demonstrate that herbal medicine was a sufficiently cost-effective strategy in the management of interstitial cystitis, for example, to enable a clinical group to bid for public health funding for treatment of the condition). Of course, only limited evidence of efficacy can be obtained; however, if a herb were to be given to one group of patients with a condition while another group with the same condition was observed as a matching control, then any clear improvement in the first group will suggest follow-up research.

There is another way in which observational studies are a highly appropriate method for herbal medicine. A persistent tradition (see Chapter 1) is that herbal medicines may support self-corrective functions in the body: only by looking globally at the body’s responses could this be confirmed. Following the earlier discussion about self-repair and the supportive role of the practitioner of herbal medicine, as well as the review of the self-organisation found in living complex systems in Chapter 1 and the therapeutic principles that arise (p. 15), then it is apparent that different research methodologies are required. These should:

All this suggests observational rather than controlled studies. Non-invasive monitoring of physiological functions, as in the ‘functional assay’ above, may be applied, perhaps coupled with patient self-rated questionnaires, clinical observations of overall behaviour and epidemiological methods, to establish as far as possible what actually happens to living patients when they do or do not use treatments.

In effect observational studies accrue as sequential single accounts or ‘n=1 studies’. The criteria for validity of single case studies have been well reviewed by Reason and Rowan²³ and by Aldridge.²⁴ A good design can be very rigorous. It includes providing as many points of view on the event as possible, clarifying operational definitions, and recycling observed data around the researchers (including the patient as co-researcher) for checking and possible refutation. As well as applying qualitative research methodologies it is possible to conduct double blind, placebo-controlled studies in a series of such individual case studies with each patient being his or her control. These could allow for a useful database of reliable case histories to be assembled over the years, as both an educational and research exercise.

In an ideal study design, data about a particular treatment could be drawn from:

The account of each participant can be compiled individually and then cross-checked and combined at a case conference so as to produce a final consensus report of the treatment. Each such report can be examined by the coordinating researcher or assistant, applying a form of grounded inquiry similar to that originally proposed by Diesing in the social sciences.²⁵ In other words, themes of disturbance and incapacity are elicited by formal contents analysis of the original material, and are then used to construct the working case story, both steps being subjected to re-evaluation by all co-researchers. As each case is thus graphically characterised, it can be used for comparative purposes with other cases to see whether a pattern occurs and can be sustained.

Inherent validity in even rigorous consensual research is, of course, no greater than when a number of people agree among themselves that ‘all swans are white’ (to use Popper’s image), but it can still be argued that this is a fair basis on which to base practical predictions and applications (it would be considered very sound intelligence in the business world). It has the advantage that all conclusions are based on real experiences and can more thoroughly be applied to meaningful clinical application.

Such rigorous exercises are best conducted in the environment of a training clinic where there is likely to be a more overt climate of inquiry and debate and extra administrative labour. Routine collection of patient and clinical data at a teaching clinic is feasible, for example, including self-rating questionnaires for general health and target conditions, perhaps combined with a number of other non-invasive observations, compared with general remission rates. Modern database technology and touch-screen inputs facilitate routine data collection and can allow meaningful collation, retrieval and analysis.

Raising the benefits of using observational, single case studies of pattern recognition rather than reducing events to the single mechanism leads inevitably to one of the oldest and surest currencies in human intercourse: the story or narrative.

Stories have a terrible time in medical research. They are often called anecdotes and studiously ignored. One common truism is: ‘the plural of anecdote is not data’. Traditional use evidence for plant medicines, for example (see below), is generally discounted for the purposes of medical research as no more than a series of unconnected anecdotes, not generalisable to the human condition. The story it is argued is only a personal experience, hopelessly tied to the particular circumstance of that person, time and place. Scientific facts need to be removed from the idiosyncratic and are only valuable when they can be applied to a wider population. Medical researchers have generally been the more confident the more they can quantify the probability that what they observe is not due to ‘chance’. An individual account remains just that, of little relevance to the rest of us.

However, in clinical medicine there is growing interest in extracting evidence that arises from actual experience of healthcare interventions, the ‘narrative evidence base’. In such an approach each person, patient or research subject is a character living their story, the evidence about each event is obtained by ‘living through’ rather than ‘knowledge about’ these characters, the patient’s own words and account are the data and the message is in that story.²⁶ In the narrative evidence base even the derided anecdote has a role. Such evidence can inform clinical and health policy decisions by illuminating the positive and negative consequences of these decisions and the public’s eventual compliance with, and outcome of, treatment.

Beyond that, the concept of narrative rather than raw data as a unit of measure chimes well with conclusions drawn from observing the behaviour of complex dynamic systems (above and in Chapter 1), especially in the biological and physiological sphere. One can here see life and health as emergent phenomena from systems built on self-similar fractal geometries, where, as described in the field of biosemiotics, organisms extract ‘meaning’ from the available script, the elements that constitute them.²⁷ Only a narrative could describe such a phenomenon.

That most human experience of healthcare is ignored is a rebuke to the modern research focus. There is a Sufi story about Nasrudin, who when asked why, when he had lost his key inside his house, he was looking for it in his garden, replied ‘because there is more light here’. Perhaps in looking for evidence where there is more light, where the instruments work, the modern scientist is looking for one key in the wrong place. Those most involved in everyday clinical work are perhaps more likely to agree that at the end of the encounter, when the clinical decision is made, it is the individual ‘story’ that counts most.²⁸ Human experience is an accretion of billions of stories. Each is meaningful. The challenge is to find rigorous approaches to learn from them.

The value of narrative is finally at its most acute in addressing the great bulk of herbal evidence base. The persistent theme running through any discussion on the efficacy of herbal medicine is that it has been used over centuries and millennia. It is claimed with some justification that at least some value will have been distilled out by this vast store of human bioassay data, especially as there would have been little room for sentiment and idealism in the life-and-death situations that prevailed through most of herbal use.

However, the record of traditional use can appear as little more than a hotchpotch of folk fancies. The review of historical methodologies highlights some limitations, but the power of cultural placebo alone, as discussed above, renders any individual observation almost worthless. What is needed is the identification and extraction of themes, a structure for assessing traditional claims. Fortunately this is possible.

Clinical insight into the traditional record leads to the realisation that, from the very earliest and most primitive accounts of herb use, humans classified the plant material into relatively consistent pharmaceutical categories. The classification was based on subjective properties of taste or appearance and the immediate impact they made on consumption. These categories, encountered repeatedly in the ethnobotanical records, became the basis of core therapeutic principles in the classic texts of China, India, Graeco-Roman Europe, Islam and almost all other written traditions. The pharmaceutical principles of traditional medicine provide a potentially robust correlation with modern herbal research, provided the latter can be linked to these phytochemical subgroups, as is done in Chapter 2 of this book. In other words, provided both the scientific and the traditional data relate to the same common elements in comparable contexts. By way of example, a recent study compared three independent ethnomedicinal floras.²⁹ Similarities of usage could be interpreted as independent discoveries, and therefore likely to be an indicator of efficacy. Data from the literature were compiled about the ethnomedicinal floras for three groups of cultures (Nepal, New Zealand and the Cape of South Africa), selected to minimise historical cultural exchange. Ethnomedicinal applications were divided in to 13 categories of use. Regression and binomial analyses were performed at the family level to highlight ethnomedicinal ‘hot’ families and general and condition-specific analyses were carried out. Several ‘hot’ families (Anacardiaceae, Asteraceae, Convolvulaceae, Clusiaceae, Cucurbitaceae, Euphorbiaceae, Geraniaceae, Lamiaceae, Malvaceae, Rubiaceae, Sapindaceae, Sapotaceae and Solanaceae) were recovered in common in the general analyses. Several families were also found in common under different categories of use. Although profound differences were found in the three ethnomedicinal floras, common patterns in ethnomedicinal usage were observed in widely disparate areas of the world with substantially different cultural traditions.

Modern ethnopharmacological studies show countless examples where pharmacological activity can be demonstrated in traditional remedies and practices. In effect, the traditional reputation provides the ‘human bioassay data’, the clinical evidence preceding the preclinical studies, rather than the other way around as is usual in modern pharmaceutical research. This phenomenon has been described as ‘reverse pharmacology’.³⁰ These correspondences may lift the findings of laboratory research into a real clinical context.

If laboratory or preclinical research has a new role in substantiating traditional use, it also has its own rationale that should now be considered.

Laboratory studies account for the vast majority of published papers on herbal remedies. However, their relevance to human use is clearly often doubtful and the preclinical information provided in the monographs in this book should be viewed from this perspective. They often also include extraction or isolation of ‘active principles’ and exposure to tissues in forms and at doses very different from what could be seen in human consumption. Nevertheless there are fundamental technical questions raised in building a case for herbal therapeutics that could be usefully addressed. The following reviews highlight areas of preclinical research that really could benefit clinical practice.

There is now an abundance of preclinical and clinical research on medicinal plants (as evidenced by the content of this book). However, the reader can sometimes mistake the clinical relevance or importance of a published study, or misinterpret its findings. In order to appropriately interpret a herbal scientific study, or the body of work on a particular herb, the following four information filters are proposed:

If the information passes these filters then it can be assessed as having relevance to the safe and/or effective human use of the plant under investigation.

Questions that might be asked concerning identity are as follows:

In terms of relevance of the research to normal human use, some of the following questions are relevant:

Reliable data are paramount. Poorly designed trials certainly do not inform the efficacy debate for herbal products. Relevant questions include:

Phytoequivalence defines the transferability of herbal data (clinical or traditional) from one herbal product to another. It is a vital concept because clinicians do not use ‘herbs’ in their clinics, they use herbal products. A clinician might seek to reproduce the known clinical properties of a herb (as informed by either tradition or clinical trials), hereby denoted as ‘the reference study’ with a specific product in his or her practice. Relevant questions to ask include:

See also Appendix E on herbal clinical trials and how to read them.

There is a substantial evidence base for the use of herbal medicines. However, much of the research data has been generated to find pharmaceutical leads rather than inform clinical decisions. There is scope for integration of the evidence and better research in the future, though only if two conditions are met.

Fundamentally, research provides new information and is absolutely necessary in order that the field of phytotherapy evolves to meet the new clinical challenges of the 21st century. But by far the best reason for doing research is that it provides the best education, for herbal students and practitioners alike. Many of the project ideas are feasible for student clinics associated with undergraduate degree training programmes. Being trained to ask questions of their working environment is the best way to produce effective practitioners, able to adapt to different circumstances and avoid formulaic and lazy practice. At its heart research is a process by which it is possible to develop the professional ideal of critical acumen, to select, sort and clarify the information available about a healing technique, to answer the fundamental question: ‘Is this treatment likely to make the patient well or is it not?’ As Carl Rogers put it:

Or as Oliver Cromwell is said to have cried: ‘By the bowels of Christ, I beseech ye, bethink yourselves that ye may be mistaken’.