TRADITIONAL and complementary medicine (T/CM) is used by many people throughout the world. Its use varies between countries, with about 60% of the Hong Kong population reporting its use and 10% in the United Kingdom, 20% in Canada and 76% in Singapore.
In countries like Vietnam and China where T/CM is an integral part of the healthcare system, about a third of patients receive traditional medicine.
Traditional medicine has maintained its popularity in the developing world and its use is rapidly spreading in developed countries. It is estimated that more than 50% of the population in Europe and North America have used complementary and/or alternative medicine at least once.
The global market for herbal medicines is estimated to be US$60bil (RM192bil) annually and is growing steadily. Traditional herbal preparations account for 30% to 50% of the total medicines consumed in China.
Popular interest
There are several reasons for the increasing popularity of T/CM. The middle- and high-income groups of the population are more health conscious and have adopted a proactive approach to their own health by seeking out different forms of self-care. Aggressive marketing, particularly with the tagline that T/CM products are “natural”, have generated its use.
The lower income group has resorted to T/CM for different reasons i.e. availability, relatively lower costs, cultural and peer influences. A major reason is that modern medicine has generated expectations that cannot be delivered consistently.
The global market for herbal medicines is estimated to be RM192bil annually and is growing steadily. - Reuters photoThere is very limited global data on the number of T/CM practitioners. In some countries like South Africa, they exceed significantly the number of doctors. The number of practitioners is comparable to that of doctors in some countries like China and India, while they are a minority in Europe and North America.
Data from a survey conducted by the Malaysian Health Ministry in 2005 revealed that 69.4% of respondents had used T/CM in their whole life and 55.6% in the preceding 12 months. Of those who used T/CM products for health problems, the modalities used were viz:
·Biologically-based therapy e.g. herbs, vitamins supplement - 88.9%
·Manipulative and body-based e.g. massage, reflexology, chiropractic - 27.0%
·Mind-body medicine e.g. hypnosis, prayer, meditation, yoga, taichi - 11.1%
·Whole medical system e.g. acupuncture, ayurveda, homeopathy, Chinese medicine - 1.9%
The Health Ministry’s Drug Control Authority reported that, as at December 31, 2007, the cumulative number of registered products comprised 18,200 traditional medicines (46.5%) compared to 11,805 prescription medicines (30.2%) and 9,098 over-the-counter medicines (23.3%).
The National Health and Morbidity Survey in 2006 provide additional information. It reported that the out-of-pocket expenditure for those above 18 years of age in 2006 was RM3.76bil, of which a whopping RM2.97bil (79%) was for health promotion, as compared to RM0.54bil (14.4%) for ambulatory care and RM0.17 bil(4.5%) for hospitalisation. Of the expenditures, 88.1% were spent at private facilities, 8.5% at government facilities and 3.4% at both.
Terminologies
The terminologies used to describe conventional (or Western) medicine and traditional and complementary medicine (T/CM) is variable. Some terms have additional meanings depending on whether they are used by the proponents or critics of T/CM.
The terms “traditional medicine” and “complementary medicine” are relatively recent terminologies for a range of healing practices that have been practised for hundreds of years, in some instances. Such practices were previously referred to as “primitive medicine” and “fringe” or “marginal medicine”.
The World Health Organization (WHO) has defined traditional medicine “as including diverse health practices, approaches, knowledge and beliefs incorporating plant, animal, and/or mineral based medicines, spiritual therapies, manual techniques and exercises applied singularly or in combination to maintain well-being, as well as to treat, diagnose or prevent illness.
“The terms complementary/alternative/non-conventional medicine are used interchangeably with traditional medicine in some countries.”
The term “complementary and alternative medicine” (CAM), which refers to the use of treatments as an adjunct to, or supplementary to, conventional medicine, is widely used. It has been defined by WHO as “a broad set of healthcare practices that are not part of that country’s own tradition and are not integrated into the dominant healthcare system.”
Some CAM practices are adaptations of traditional medicine. As CAM is a relative concept, its knowledge and practices vary between countries and are time-specific.
The Health Ministry defined T/CM (in 2001) as a form of health-related practice that excludes the medical or dental practices utilised by registered medical or dental practitioners.
The T/CM practices in Malaysia include acupuncture, aromatherapy, ayurveda, chiropractic, homeopathy, Malay medicine, naturopathy, reflexology, traditional Chinese medicine, traditional Indian medicine and yoga.
Efficacy and safety issues
Without evidence of efficacy, it is hard to judge the safety of any practice that impacts on health. This is simply because the risk of an adverse effect, which might be acceptable for an effective treatment, will be unacceptable for an ineffective treatment.
About 25% of medicines are made from plants that were initially used traditionally. Herbal medicines which have demonstrable efficacy like morphine, which is used for pain relief, and vincristine, which is used in cancer chemotherapy, are important in conventional medicine. Their use illustrates the principle that “natural” is not synonymous with innocuous, as their safety margins are narrow.
In general, the evidence of the efficacy of T/CM is limited, as most therapeutic claims remain unsubstantiated. The scientific evidence from randomised clinical trials is only persuasive for many uses of acupuncture, some herbal medicines and some of the manual therapies.
Acupuncture has been proven to be effective in relieving postoperative pain, nausea during pregnancy, nausea and vomiting due to cancer chemotherapy, and dental pain, with very few side effects.
More research is needed to determine the efficacy and safety of several other T/CM practices and products.
The unregulated or inappropriate use of T/CM products and practices has resulted in negative or dangerous effects. For instance, the herb “Ma Huang” (ephedra), which is traditionally used in China to treat respiratory conditions, and was marketed as a dietary aid in the United States, resulted in at least a dozen deaths, heart attacks and strokes.
Interactions with prescription and over-the-counter medicines have also been reported with untoward effects for the user.
The quality of manufacturing may also pose serious problems. If plants are used, the precise chemical content would depend on the variety and the growing conditions, processing, and storage. The concentrations of compounds in T/CM products may vary considerably. Although commercially grown plants can be reliably identified, plants gathered in the wild may not be. Toxic species may be substituted for innocuous ones.
Another risk is the adulteration of T/CM products with prescription medicines e.g. corticosteroids and toxic substances e.g. heavy metals like lead, mercury and arsenic.
The Health Ministry’s Drug Regulatory Control Authority (DCA), as part of its post-market surveillance programme to ensure continued compliance to safety, efficacy and quality, subjects samples of registered products to testing.
A total of 2,538 registered products were sampled in 2007. Six product batches were recalled within 72 hours and 138 product batches were recalled within 30 days, due to quality defects. The recalls involved 17 prescription medicines (12.8%), 13 over-the-counter medicines (9.8%) and 103 traditional medicines (77.4%). It is noteworthy that the recall rate for traditional medicines is disproportionate to its segment of the products registered (46.5%) by the DCA.
The scientific evidence from randomised clinical trials is only persuasive for many uses of acupuncture, some herbal medicines and some of the manual therapies. - AFP photo
Regulation
Unlike T/CM, conventional medicine is heavily regulated. There are more than 40 health laws that doctors and health administrators have to be conversant with, depending on their practice situations.
One of the reasons for this is historical, as Malaysia inherited the common law from the United Kingdom. The common law right to choose one’s own treatment for illness has hardly been controlled by statutory law. As long as one does not claim to be a doctor or practise protected disciplines like dentistry, pharmacy and midwifery, or supply prescription medicines, any one could set themselves up as a practitioner in any aspect of healthcare.
This situation is unlike that in Europe or the United States where there are few healthcare activities that are permitted without authorisation by the state.
Because T/CM practitioners do not have to submit themselves to authority, it has led to a situation where T/CM is practised without recognisable training, qualification, professional standards or indemnity coverage. In short, there is little or no accountability with T/CM products and practices, until very recently.
The Health Ministry being cognisant of the need for a stronger evidence base on the safety, efficacy and quality of the T/CM products and practices, and the need to promote therapeutically sound use of T/CM by providers and consumers, established a Standing Committee on T/CM in 1998 and launched its national policy on T/CM in 2001. The Drug Control Authority also started to register T/CM products to address safety issues.
The much publicised T/CM Bill is eagerly awaited by many doctors and health administrators. One aspect that is of interest is whether the penalties for non-compliance are similar to that in the Private Health Care Facilities and Services Act.
T/CM products
T/CM products have recently come under the purview of the Control of Drug and Cosmetic Regulations 1984, Poison Act 1952, Sale of Drug Act 1952, Advertisement and Sale Act 1956 and Protection of Wild Life Act 1972.
T/CM products registered in Malaysia have to comply with the safety requirements of the Health Ministry’s Drug Control Authority. However, almost all T/CM products are registered as food supplements or vitamins, which registration requirements are much less stringent than that of prescription or over-the-counter medicines.
Whilst registration of T/CM products has ensured that they do not contain scheduled poisons and contaminants, efficacy issues have yet to be addressed. This question needs to be addressed, particularly when health promotion takes up about 79% of out-of-pocket health expenditure.
How effective are T/CM products? Are claims reflected in the reality of the situation in which the T/CM products are used? Are consumers getting value for their money? This is of particular relevance when the economic circumstances demand that there be belt-tightening.
Educational standards, registration and licensing
It is a fact that there are many T/CM practitioners who practise without qualifications or without adequate training. Of those who are trained, the length of training and the qualifications obtained vary widely. Some continue learning as apprentices or through short courses or correspondence courses.
There is a need for regulators to establish objectives of training and define core competencies in T/CM. Although many T/CM practitioners are not likely to face critical diagnostic issues or interact seriously with conventional medicine, others may have patients who choose not to consult a doctor, with some T/CM practitioners encouraging such an approach.
This issue needs to be clarified. If T/CM practitioners claim therapeutic autonomy, then they should have the benefit of a full medical education to equip them to work independently of doctors.
Some T/CM disciplines like osteopathy and chiropractic have developed and moved along the path of self-regulation in some countries, e.g. the United Kingdom and Australia. There are university degree courses in these disciplines with acts of parliament that protect their titles and provide orthodox regulation of their activities.
There are currently no formal accredited courses in T/CM offered by any institution of higher learning in Malaysia. However, there is progress in that the National Accreditation Board of the Ministry of Higher Education, in collaboration with the Health Ministry, has drafted standards and criteria for the offering of such courses. The standards recommended practices that are in tandem with internationally recognised good practices.
There were 7,154 T/CM practitioners registered with the Health Ministry as at December 2007. The criteria and implications of their registration have not found its way into the public domain yet.
Some countries require T/CM practitioners to be registered or to possess a licence to practise. Eligibility is usually determined by evidence of qualification and/or safe practice. Some countries automatically register a practitioner with a recognised qualification while others require the passing of a licensing examination. A robust and independent accreditation system is needed for automatic registration.
T/CM practice
Many T/CM practitioners practise in multiple therapeutic areas. It is important to address the issue of whether the regulations apply to the practice of a single therapy or recognise a varied range of therapies.
Standards of practice and conduct are usually spelt out in a code of conduct. The responsibility for setting standards is usually left to the professional body. The problem arises if the standards are set too low, for various reasons.
The public should be given the opportunity to pursue complaints against T/CM practitioners with the provision of codes of conduct, disciplinary procedures and sanctions. Although this is currently absent, it is the responsibility of regulators to ensure its implementation as soon as possible.
When there is an adverse event in conventional medicine, the patient and/or his representative can complain to the Health Ministry and/or Malaysian Medical Council and/or commence legal proceedings. What is the recourse for the patient and/or his representative when there is an adverse event following treatment by a T/CM practitioner? Worse still, what is the recourse if the adverse event occurred after treatment by a doctor as well as a T/CM practitioner?
The practice of T/CM by doctors is a question that some doctors have raised. The Code of Professional Conduct of the Malaysian Medical Council (MMC) prohibits doctors from employing or associating with persons who are not qualified or not registered under the Medical Act.
Any doctor who uses a T/CM product or practice has to ensure that it is evidence based and that they have been trained in the practice. Involvement in questionable practices may expose a patient to risks, and even danger, and the doctor to disciplinary proceedings by the MMC.
With increasing societal expectations for greater professional accountability in the medical profession, T/CM practitioners will need to do the same by increasing public scrutiny of their affairs.
Conclusions
Many people consult T/CM practitioners at the same time they consult their doctors. However, many do not inform their doctor for a variety of reasons. As there are efficacy and safety issues with many T/CM products and practices, it is in the interest of the patient for communication between doctors and T/CM practitioners to be enhanced.
There are many aspects to be addressed in the regulation of T/CM which have, to date, flourished without any accountability. It is hoped that the regulation of T/CM will enable the Health Ministry to achieve its objective of ensuring quality and safe use of T/CM practices and products to attain optimal potential in healthcare delivery.
Dr Milton Lum is Chairperson of the Commonwealth Medical Trust. This article is not intended to replace, dictate or define evaluation by a qualified doctor. The views expressed do not represent that of any organisation the writer is associated with. The views expressed are those of the writer and readers are advised to always consult expert advice before undertaking any changes to their lifestyles. The Star does not give any warranty on accuracy, completeness, functionality, usefulness or other assurances as to the content appearing in this column. The Star disclaims all responsibility for any losses, damage to property or personal injury suffered directly or indirectly from reliance on such information.
