February   2003  VOLUME 56: Number 2 Veterinary Ireland Journal Page CONTENTS Peer review articles are available in full as  Acrobat PDF files You will need to download the Acrobat reader    which can be got free at this web site

EDITORIAL   

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Alternative medicine

This editorial has evolved as a direct result of a phone call from a reader/potential contributor who wanted to know how we would process a contribution on complementary medicine through our traditional peer-review regimen. During the conversation it emerged that the interlocutor was not concerned about review articles devoted to the merits and demerits of homeopathy, acupuncture, herbal medicine, or any of the other forms of so-called alternative medicine. As the chat progressed it emerged that what was required was a precise answer to a refined query:  should I submit my practical observations on the use of some herbal remedies in veterinary practice, how do you propose to evaluate them and by what criteria will your scrutineers be expected to decide whether or not my paper is worthy of publication as a peer-reviewed contribution?

The immediate - and honest - answer was that the manuscript would be assessed by two competent referees not ill-disposed to complementary medicine and that the overriding criteria are set by the endeavour to ensure that each of the medicaments discussed is both efficacious and safe. On reflection, it was obvious that the answer given on the spur of the moment did not fully address the underlying anxieties from which the question arose.

In essence, the question sprung from the belief that the various systems of complementary therapy have their own basic tenets, their own paradigms entirely separate from those of orthodox medicine; therefore, orthodox research methods and conventional criteria are unlikely to be appropriate tools by which to evaluate herbal medicines.

The episode stimulated us to look at how the matter is dealt with in the medical literature; in the course of that exercise we realised that the fruits of our searches have provided information on the topic of herbal medicines that many of our readers might find useful, should members of the public consult them about the proposed EU directive on the licensing of traditional herbal medicines used by millions of its citizens. Although the draft directive does not guarantee efficacy in the same stringent way that the approval process for orthodox medicaments does, it calls for pre-marketing assessment of the quality and safety of a product. This should lead to a significant degree of standardization of the remedies and, thus, help to alleviate another source of difficulty for those of us who are more accustomed to assessing papers in accordance with the paradigm of conventional medicine. Plant remedies are complex mixtures of chemicals and, as one commentator put it, they can vary very considerably in composition, stability and biological activity "as a result of problems in identifying plants, genetic variability, variable growing conditions, differences in harvesting procedures and in processing of extracts."   

How does one interpret variations in outcome if the remedy is liable to unaccountable variability?  Statutory regulations that seek to standardize chemical composition and that insist on comprehensive labelling should make the task less daunting. However, standardization of botanical remedies can be difficult because they are complex mixtures and because the constituent responsible for the claimed effects may not be known.

Results obtained with one product may not apply to other preparations from the same plant. Therefore, ideally we would expect the author to specify how the plant was processed and what was the final composition of the product. If there were a mixture of plant extracts, we would want to know the relative proportion of each.

With regard to methodological considerations, we would require evidence of randomization and blinding, and we would expect two categories of control animals: those given placebo and those treated with recognised conventional therapy.  The treatment groups should be sufficiently large to reveal a clinically important difference, should the herbal remedy give superior results.

We would feel duty-bound to ask the author to record any suspected adverse side-effects. In that context, we would have some concern about the safety of the product. Despite the widely-held perception that the established botanical remedies of folk medicine are inherently safe for man and animal, there is a growing realisation that it is not always so; some popular products have been found to be adulterated with undeclared products of the pharmaceutical industry or by toxic heavy metals. A recent example frequently cited by those anxious to undermine the credibility of complementary medicine is a patented botanical product used (with apparent benefit) by thousands of victims of prostatic cancer, which has been found to contain diethylstilbestrol, warfarin, and indomethicin.  The product has been withdrawn from the market.  The adulteration would have been detected at a much earlier date had there been a statutory requirement to report the adverse side effects that users had accepted with resignation.

Besides the direct risks posed by adulterants, there is an indirect risk that a botanical remedy may interfere with the activity of a conventional drug. For instance, St John's wort was found to cause serious adverse effects because it hastened the degradation of many drugs, including cyclosporin, warfarin, and antiretroviral agents.  Therefore, the author should be required to reveal all of the products, complementary and conventional, administered during the trial.

At the end of the day, it is conceivable that a proponent of herbal medicines would decide that our way of evaluating manuscripts is inappropriate for papers on complementary medicine. Fair enough! We would welcome suggestions on alternative methods that would help us meet the burden of proof we require 

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