- Medicine Information and Evidence for Policy > Medicines Policy
- Traditional Medicine > Traditional, Complementary and Herbal Medicine
(2002; 70 pages) [French] [Spanish]
2.3 Safety, efficacy, quality
Allopathic medicine is based on Western culture. Practitioners therefore emphasize its scientific approach, and contend that it is both value-free and unmarked by cultural values. TM/CAM therapies have developed rather differently, having been very much influenced by the culture and historical conditions within which they first evolved. Their common basis is an holistic approach to life, equilibrium between the mind, body and their environment, and an emphasis on health rather than on disease. Generally, the practitioner focuses on the overall condition of the individual patient, rather than on the particular ailment or diseases from which he or she is suffering.
"The quantity and quality of the safety and efficacy data on traditional medicine are far from sufficient to meet the criteria needed to support its use worldwide. The reasons for the lack of research data are due not only to health care policies, but also to a lack of adequate or accepted research methodology for evaluating traditional medicine. It should also be noted that there are published and unpublished data on research in traditional medicine in various countries, but further research in safety and efficacy should be promoted, and the quality of the research... improved."49
This more complex approach to health care makes TM/CAM very attractive to many. But it also makes evaluation highly difficult since so many factors must be taken into account. And since TM/CAM practices have developed within different cultures in different regions, there has been no parallel development of standards and methods - either national or international - for undertaking evaluation. Moreover, CAM providers may come from a cultural and philosophical background that differs radically from that surrounding the original development of a therapy. This can lead to problems of interpretation and application. Understandably, therefore, allopathic medicine practitioners in some countries have been reluctant to refer patients to CAM providers. (This in turn has made health insurance schemes unwilling to reimburse CAM treatments, effectively reducing patients' choice of health care.)
Evaluation of TM/CAM products, such as herbal medicines, is especially difficult. Accuracy of plant identification is essential, as is isolation of active ingredients. The latter is complex, though, because medicinal plant properties are influenced by the time of plant collection and area of plant origin (including environmental conditions). At the same time, a single medicinal plant can contain hundreds of natural constituents. Establishing which constituent is responsible for what effect can therefore be prohibitively expensive. Yet given the worldwide popularity of herbal medicines, a widely applicable, appropriate and effective means of evaluating herbal medicines with limited resources is urgently needed.
Research, research methodology and cost-effectiveness
It is perhaps not surprising that reviews have shown that clinical trials have been few, small and inadequately controlled. The Cochrane Complementary Field (see Chapter 4) found that articles indexed as "alternative medicine" formed only 0.4% of the total number of MEDLINE-listed articles for the period 1966 - 1996. (However, the annual total was steadily increasing during this period and the growing proportion of reports of randomized clinical trials (RCTs) suggested a trend towards an evidence-based medicine approach.) Only some of the RCTs reported included costs (incurred for the therapy in question, and including cost of consultation, materials used, etc.). In fact, very few reliable and full economic analyses of TM/CAM have been made.
Figure 11. Good evidence of efficacy exists for some herbal medicines - but too often evaluation is inadequate
Source: based on data in Herbal Medicines: an Evidence-based Look. Therapeutics Letter, Issue 25, June - July 1998.
The failure to support research in this area over recent years has resulted in a lack of data and development of methodology for evaluating the safety, efficacy and quality of TM/CAM. Yet there are indications that at least some commonly used alternative therapies - for instance, some herbal medicines, manipulative therapies and behavioural stress-reduction techniques, such as transcendental meditation - can provide effective management for chronic disease (Box 2). Box 3 indicates some of the more detailed cost-effective analysis that is beginning to be undertaken. More firm evidence along these lines would be of enormous assistance in presenting arguments for greater recognition and application of TM/CAM. Indeed, it will be a prerequisite if access to TM/CAM is to be promoted and extended, and rational use of this type of health care ensured.
Herbal medicines and acupuncture are the most widely-used TM/CAM therapies. Reports of investigations of their clinical efficacy have been published in prestigious international scientific journals. The efficacy of acupuncture in relieving pain10 and nausea,50 for instance, has been conclusively demonstrated and is now acknowledged worldwide.
For herbal medicines, some of the best-known evidence for efficacy of a herbal product, besides that for Artemisia annua for the treatment of malaria, concerns St John's wort for the management of mild to moderate depression. Patients usually experience fewer side-effects than when treated with antidepressants, such as amitriptyline. Such findings have inspired research worldwide to establish the efficacy of other extensively-used TM/CAM. In laboratory settings, plant extracts have been shown to have a variety of pharmacological effects, including anti-inflammatory, vasodilatory, antimicrobial, anticonvulsant, sedative and antipyretic effects.10 However, almost no randomized-controlled studies have been carried out to investigate the practice and treatment delivery of herbal practitioners in their everyday work. This also applies to most other TM/CAM therapies.
Regarding non-medication therapies, the 1999 British Medical Journal series on CAM commented that randomized controlled trials have provided good evidence that both hypnosis and relaxation techniques can reduce anxiety, and prevent panic disorders and insomnia. Randomized trials have also shown hypnosis to be of value in treating asthma and irritable bowel syndrome, yoga to be of benefit in asthma, and tai ji in helping elderly people to reduce their fear of falls.10
STUDYING CAM COST-EFFECTIVENESS IN PERU
A study undertaken by Peru's National Programme in Complementary Medicine and the Pan American Health Organization compared CAM practices to allopathic medicine practices, as used in clinics and hospitals operating within the Peruvian Social Security System.
The relative effectiveness of CAM was evaluated in terms of:
Treatments were compared for selected pathologies, of the same degree of severity, as registered in case histories and/or clinical evaluations.
A total of 339 patients, 170 being treated with CAM and 169 with allopathic medicine were followed for one year. Treatments for the following pathologies were analysed: moderate osteoarthritis; back pain; anxiety-based neuroses; light or intermittent asthma; peptic acid disease; tension migraine headache; exogenous obesity; and peripheral facial analysis.
The conclusions (95% significance) can be summarized as follows:
Ensuring safety and quality at national level
Low levels of research activity have also slowed development of national standards for ensuring the safety and quality of TM/CAM therapies and products. In particular, lack of technical guidance and information has hindered development of regulation and registration for herbal medicines. This in turn has slowed development of, for example, national surveillance systems for monitoring and evaluating adverse events. The fact that only 3% of 771 cases of counterfeit drugs reported to WHO by April 1997 involved herbal medicines might be a reflection of this low level of monitoring, rather than an indication that adverse effects from herbal medicines are few.52
Table 8. Key needs in ensuring the safety, efficacy and quality of TM/CAM
At national level:
At global level:
Determining research needs
The 6th report from the Committee on Science and Technology to the House of Lords cites a number of problems relating to CAM research in the United Kingdom. They can be taken as applying to research problems in the field in general. The Committee found a poor research infrastructure and concluded that research is often of poor quality because research ethics are not well understood, sound methodology is lacking, resources are in short supply and researchers are unwilling to evaluate evidence. A summary of key needs in ensuring the safety, efficacy and quality of TM/CAM is given in Table 8.
Some priority areas for research are outlined in Table 9.
Table 9. Priority areas for research
• Effects of each individual therapy: efficacy, safety and cost-effectiveness.
• Research into mechanisms of action of individual therapies, including patterns of response to treatment.
• Research into TM/CAM genre itself, including social research into motivation of patients seeking TM/CAM and usage patterns of TM/CAM.
• Research into new research strategies which are sensitive to the TM/CAM paradigm.
• Research into efficacy of diagnostic methods used.
• Research into implementation and effects of TM/CAM in specific health care settings.
Source: House of Lords, 2000.16