Complementary medicine was the subject of a special session on September 16. The chairman Dr Steven Kayne welcomed the audience to the session, but said they would be disappointed if they were there to find out how complementary medicine worked. Ms Joanne Barnes (centre for pharmacognosy and phytotherapy, School of Pharmacy, University of London) addressed complementary medicine in pharmacy, Dr Michael Berry (school of pharmacy, Liverpool John Moores univesrity) spoke about education in complementary medicine, and Professor Edzard Ernst (department of complementary medicine, University of Exeter) addressed the evidence base in the area
Introducing the session, the chairman Dr Steven Kayne (community pharmacist, Glasgow) said that the value of the market for complementary medicine was increasing rapidly and "there was no doubt that pharmacists are going to be involved". He outlined the holistic approach in complementary medicine, by which each individual was considered unique and where therapies took into account an individual's physical, mental and spiritual make-up. The response by health care professionals to the explosion of interest in complementary medicine had been reactive rather proactive, he said. There had been a reluctance on the part of health care professionals to accept complementary medicine, largely because of the lack of scientific research in the area, but also because of professionals' lack of knowledge about complementary medicine and concern over safety issues.
Ms Jo Barnes (School of Pharmacy, University of London) discussed pharmacy practice research in complementary medicine, and the implications of the increasing use of complementary therapies for pharmacy and pharmacists.
Complementary remedies
Herbalism and homoeopathy were the two therapies of most relevance to pharmacy, although there were others that involved the administration of remedies, such as essential oils used in aromatherapy and Bach flower remedies. She pointed out that traditional herbalism - the use of herbal remedies, often in combinations, in a holistic way to treat an individual's particular symptoms and characteristics - had a very different approach to that of science-based phytotherapy, which used standardised specific plant extracts with known pharmacological activity for the prevention and treatment of specific conditions.
In the UK, a report by the Mintel market research group on retail sales of complementary medicines (defined in its study as licensed herbal medicines, homoeopathic remedies and essential oils) had estimated the market for 1996 to be worth £72m, and that over 50 per cent of sales were made in pharmacies. Data from nationwide telephone surveys in the United States had shown that unsupervised use (ie, self-medication) of herbal medicine in the previous 12 months had increased significantly from 2.5 per cent of respondents in 1990 to 12.1 per cent in 1997.
Royal Pharmaceutical Society-funded study
Ms Barnes referred to a questionnaire survey of community pharmacists, funded by the Royal Pharmaceutical Society's 1997-98 Linstead fellowship, to explore their experiences with complementary remedies. Sixty-seven per cent of the 1,337 pharmacists surveyed had responded. Of these, 40 per cent reported that they had received or undertaken some type of training in complementary medicine, although types varied widely from lectures as part of the undergraduate pharmacy course to employer-provided training and private courses.
"Having undertaken some form of training does not necessarily reflect adequate knowledge or competence, as the content, relevance, quality and duration of training are all important," Ms Barnes said.
Ninety-nine per cent of respondents indicated that one or more types of complementary remedies, including vitamin and mineral supplements, were sold in the pharmacy in which they practised. Of these, 76 per cent sold herbal remedies, homoeopathic remedies (66 per cent), essential oils (73 per cent) and flower remedies (43 per cent). Eighty-one per cent of respondents had been asked by their customers for complementary remedies specifically by name in the 12 months prior to the survey, and 58 per cent had "recommended" complementary remedies to their customers in the previous 12 months when responding to symptoms. However, 70 per cent of respondents "rarely" or "never" asked patients specifically about their use of complementary remedies when counter-prescribing conventional over-the-counter medicines or when receiving reports of suspected adverse drug reactions to conventional medicines. As part of the survey, 90 pharmacists provided 107 reports of suspected ADRs to complementary remedies; around 25 per cent of these had been identified by the pharmacist.
Pharmacists' perceptions
Ms Barnes went on to mention research into British pharmacists' perceptions of and attitudes towards complementary therapies. She referred to a survey which had shown that acupuncture was the therapy that most pharmacists reported as knowing something or a lot about and that most perceived as being useful. Homoeopathy and osteopathy were the top two therapies to which pharmacists made referrals (herbal remedies were listed fifth); whereas homoeopathy and herbal remedies were used by 10 per cent and 6 per cent, respectively, of pharmacists themselves.
A US survey in 1998 had investigated community pharmacists' experiences with the use of alternative therapies by their patients with chronic illness. The study had reported that 17 per cent of such patients had been using some type of alternative therapy, and that 25 per cent had asked pharmacists for information on alternative therapies. Furthermore, pharmacists estimated that 26 per cent of known users of alternative therapies were generally non-compliant with prescribed medication regimens, and that 34 per cent and 22 per cent, respectively, periodically or permanently substituted alternative therapies for prescribed medication.
Another study described by Ms Barnes had involved a researcher who visited 29 health food shops in London, none of which employed a pharmacist. According to a defined protocol, the researcher approached a member of staff and claimed to be suffering from severe daily headaches of recent onset, ie, symptoms associated with serious pathology. Staff in 27 of the 29 shops offered some form of specific therapeutic recommendation, eg, a specific therapy, product or behaviour, yet only seven of the 29 suggested that the researcher consult a general practitioner.
Implications for pharmacy practice
Ms Barnes illustrated the fact that complementary medicine was widely encountered in community pharmacy:
Pharmacists working in other branches of the profession, such as hospital pharmacy and palliative care, might also encounter patients using complementary remedies and therapies.
Given the extent of use of complementary therapies and the availability of complementary remedies from pharmacies, pharmacists should not only be knowledgeable about the background, uses, quality, safety and efficacy of the products they sold, but should also have an awareness of other complementary therapies given that some patients would use them in place of prescription medicines.
"Other aspects of patient behaviour have implications for pharmaceutical care," Ms Barnes emphasised. For example, there was a potential for interactions to occur where conventional drugs and complementary remedies, particularly herbal remedies, were used concurrently. "It is important that pharmacists have information on patients' use of complementary remedies and therapies in order to be able to make informed therapeutic decisions," Ms Barnes said.
Improving pharmacy practice
She suggested that improvements in some aspects of pharmacy practice with regard to complementary therapies were desirable:
Ms Barnes's view was that there was a public need for a trained health care professional who could provide objective, reliable, and tailored advice and information on complementary remedies and their use alongside conventional medicines. "I believe that pharmacists could and should fill this role, indeed that they are the only healthcare professionals who can do so," Ms Barnes said. However, she outlined several steps that need to be looked at achieve this:
Concluding, Ms Barnes emphasised that complementary medicine "is an area that pharmacy cannot afford to ignore". If they did not grasp the opportunity to become the health care professionals with expert knowledge in complementary remedies, then others would, and that might not be in the best interest of the patient, she warned.
"I am not saying that pharmacists should become homoeopaths or aromatherapists, but that they should have sufficient knowledge of the background, uses, and evidence-base in complementary medicine in order to be able to advise patients appropriately," she said.
Recent milestones Ms Barnes listed several recent milestones in pharmacy and complementary medicine. These included the publication of ‘Herbal medicines - a guide for healthcare professionals' and the review journal Focus on Alternative and Complementary Therapies by the Pharmaceutical Press, the appearance of articles on complementary medicine in The Pharmaceutical Journal, and the setting up of a working group on complementary medicine by the Royal Pharmaceutical Society.
Dr Mike Berry (Liverpool John Moores University) began his presentation by considering who needed to be educated in complementary medicine. He listed doctors, complementary therapists, pharmacists, dentists, nurses and other health care professionals (eg, physiotherapists, occupational therapists) as all undoubtedly needing some education in the area. For example, there were around 4,000 aromatherapists in the UK registered with a professional body and whose training required upgrading to higher education standard, pharmacists sold OTC complementary remedies and some offered complementary health clinics attached to their premises, and appointments of nurses as clinical aromatherapists were becoming increasingly common. Different professions, however, would have different needs and consideration should be given as to the skills and knowledge required by each profession. For example, doctors would need sufficient knowledge to allow them to prescribe appropriately. Pharmacists, like herbalists, would need compounding skills if they were to return to preparing galenicals. Or, if they were to be concerned only with commercially produced complementary remedies, then they needed to be able to give appropriate advice, Dr Berry said.
Educating therapists . . .
Concentrating on educating complementary therapists, Dr Berry remarked that "it is a changing world for therapists themselves". The Universities and Colleges Admissions Service (UCAS) handbook now listed 12 university degree courses in complementary medicine, representing eight different therapies, such as herbal medicine, homoeopathy, aromatherapy and traditional Chinese medicine. Courses fell into 2 categories - those that covered the philosophy of complementary medicine and its integration into health care and those that were practitioner based. Potential students needed to be sure that their chosen course met their needs.
The aims in educating therapists were several. Dr Berry used the aromatherapy course taught by his group at Liverpool John Moores university to illustrate some of the attributes that therapist courses should have. The John Moores course aimed to be clinically oriented, science-based, practice-related, and holistic in application in order to deliver therapists who had adopted a reflective, evidence-based, research-oriented approach. A key element of this approach was to encourage therapists to carry out research into their own discipline. In Dr Berry's view, the best means of training therapists was in higher education alongside other health care professionals.
Some of the issues that were becoming more important for therapists were those of research, registration and regulation, and pressures on private colleges to reach standards equivalent to those in the public education sector.
. . . and pharmacists
Moving on to the education of pharmacists in complementary medicine, Dr Berry listed the approaches that could be used. These included undergraduate teaching, postgraduate courses, preregistration training, postgraduate education, journal articles, the Centre for Pharmacy Postgraduate Education, short courses, distance-learning courses, and internet resources. However, at present there was little offered by most of these options. He said that the demise of pharmacognosy about 20 years ago had led to undergraduates and pharmacists having little understanding of phytochemistry and natural products, and that, because of this, teaching in this area was often at a basic level. Considering what it was that pharmacists needed to know about, Dr Berry listed the pharmaceutical-type remedies as being most important. These were herbal medicines, homoeopathy, Bach flower remedies, anthroposophical remedies, aromatherapy products and supplements (including vitamins and minerals, "pharmafoods" and "nutraceuticals"). Pharmacists needed to know about the uses, pharmacology, toxicity, quality, safety and efficacy of these types of remedies.
Concluding, Dr Berry said that there was a moral and ethical debate about complementary medicine: were quality, safety and efficacy proven?
The evidence base in complementary medicine was discussed by Professor Edzard Ernst (department of complementary medicine, University of Exeter). Professor Ernst described the high patient satisfaction rates that were achieved in complementary medicine, but stressed that "this does not prove efficacy". He also referred to a study carried out by his department at Exeter of general practitioners' perceptions of the effectiveness of different complementary therapies. The findings showed that GPs perceived medical herbalism to be one of the least effective therapies, which was surprising since more evidence existed for the efficacy of herbal treatments than for any other complementary therapy, Professor Ernst said.
Professor Ernst focused on homoeopathy and herbal medicine in his summary of evidence as two areas that were of most relevance to pharmacy.
Homoeopathy: a placebo?
Beginning with homoeopathy, he referred to a meta-analysis of data from all placebo-controlled trials of homoeopathic remedies to assess whether the clinical effect of homoeopathy was equivalent to that of placebo; the authors of that study had identified 89 trials which were suitable for meta-analysis. The combined odds ratio for these 89 trials was 2.45 in favour of homoeopathy; when the 26 trials of high methodological quality were considered, the combined odds ratio was reduced to 1.66, but did not eliminate the effect in favour of homoeopathy. It had been concluded from this that the clinical effects of homoeopathy were not completely due to placebo; however, the authors had also noted that there was insufficient evidence to demonstrate that homoeopathy was clearly efficacious in any single clinical condition. Professor Ernst pointed out another short-coming of this meta-analysis, namely, that it pooled together the results of trials investigating different homoeopathic remedies in different clinical conditions. This approach was not normally permitted in meta-analysis methodology.
Professor Ernst went on to describe some of his group's own work in this area. A systematic review of trials of homoeopathic remedies in delayed-onset muscle soreness (DOMS) had identified eight double-blind, placebo-controlled trials of which three had also included random allocation to treatment.
The non-randomised trials, which had involved small numbers of patients, had reported some positive results with differing regimens of homoeopathic remedies, whereas the three randomised and more methodologically rigorous trials had all reported statistically non-significant differences between the verum and placebo groups. Thus, the published evidence did not suggest that homoeopathic remedies were more effective than placebo in reducing the symptoms of DOMS, Professor Ernst concluded.
A similar approach had been used to assess all clinical trials of homoeopathic Arnica and for trials comparing homoeopathic remedies with conventional treatments. According to Professor Ernst, none of these reviews had provided convincing evidence for the efficacy of homoeopathy.
Turning to herbal medicine, Professor Ernst stated that "the test of time argument is the worst argument that can be used in support of safety or efficacy". He illustrated his point by reference to Aloe vera, a plant used in many different cultures for a diverse range of conditions, including syphilis, haemorrhoids, and as a contraceptive. "They can't all be right," he said. Furthermore, each herbal remedy must be tested on its own merit - generalisations could not be made.
Professor Ernst went on to describe several herbal remedies for which trial evidence had been subjected to systematic review or meta-analysis.
A systematic review of all randomised clinical trials of peppermint oil had included eight placebo-controlled trials. The data had shown that preparations of peppermint oil alleviated symptoms of irritable bowel syndrome significantly more than placebo did. However, several of the trials had contained methodological flaws and so the conclusion remained somewhat tentative.
A systematic review of studies of horse chestnut seed extract (HCSE) in chronic venous insufficiency (CVI) had identified 13 relevant trials - eight placebo-controlled and five comparing HCSE with syandard treatments. The data suggested that preparations of HCSE were superior to placebo and as effective as standard treatments in alleviating objective signs and symptoms of CVI.
Saw palmetto (Serenoa repens) had been the subject of a systematic review and meta-analysis. The authors had identified 10 placebo-controlled trials and two trials comparing extracts of Saw palmetto with finasteride in men with benign prostatic hyperplasia. It had been concluded that Saw palmetto improved urological symptoms and urinary flow measures to a greater extent than did placebo.
Compared with finasteride, Saw palmetto produced similar improvements in urinary tract symptoms and urinary flow, and might have a more favourable adverse effect profile.
The safety issue
Professor Ernst emphasised that it was not sufficient to consider only efficacy, but that safety also needed to be taken into account. "For any treatment, we need to ensure we are doing more good than harm," he said. Both direct risks (eg, toxicity of certain herbal remedies) and indirect risks (eg, unnecessary cost) could occur in complementary medicine, he said. There were some areas of risk, such as drug-herb interactions, that were little understood and were an important issue.
Concluding his presentation, Professor Ernst warned that conventional health care professionals should not put their heads in the sand and hope that complementary medicine would go away. "It won't go away," he said. Complementary medicine practitioners had also been guilty of putting their heads in the sand by claiming that research in complementary medicine was not necessary. However, the situation was now changing and some therapists were now realising the importance of research, he said.