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The other course

  • 14/09/1996

The other course one of the problems facing the world today is effective and affordable healthcare for its five billion-odd inhabitants. The prohibitive costs that Western or allopathic school of medicine (which often involves serious side effects) engenders is increasingly turning people towards the haven offered by alternative medical systems. The term "alternative" medicine refers not just to traditional medical systems like ayurveda, but also to practices, techniques and systems that are contrary to contemporary scientific viewpoints or bureaucratic priorities of the dominant professionalised healthcare system.

The World Health Organization (who) estimates that four billion people - 80 per cent of the world"s population - presently use herbal medicine, which is a major component of all indigenous people"s traditional doctoring as also of ayurvedic, naturopathic and other Oriental medical systems. The question is: are these systems effective, or are they shams aimed at people disillusioned with conventional treatment? The imminent need, therefore, is to examine their effectiveness by subjecting them to rigorous scientific testing.

Ironically, it is in the us - the stronghold of modern medicine - that most such efforts are underway. For instance, an independent panel of the National Institutes of Health (nih), usa, has found that behavioural and relaxation therapies were best for treating chronic pain (as in migraine and arthritis) and insomnia. The nih, the premier research institution in the country, comprises 24 separate institutes, centres and divisions that focus on specific diseases or areas of healthcare and research support; the office of alternative medicine (oam) is one of them.

Congressional beginnings Set up in 1992 by the us Congress to evaluate prominent alternative therapies, the oam, along with other nih institutes, has funded 42 exploratory grants on complementary, alternative and unconventional medicine (cam). The therapies under research are as diverse as prayer-healing and bioelectromagnetic medicine. The areas for which these therapies are supposedly effective are equally diverse - from acquired immunodeficiency syndrome (aids) to attention deficit hyperactivity disorder (adhd).

The office has also set up 10 clinical research centres in universities like Harvard and Stanford. Each centre has its own area of specialisation for which it evaluates research opportunities, develops a research agenda and executes the objectives on the agenda over a period of three years.

The oam was the brainchild of former Congressperson Berkely Bedell, who was cured of lyme disease and prostate cancer by alternative therapies. Bedell convinced his close friend senator Thomas Harkin, a budgetary overseer of the nih in the us Congress, of the need for such an office. In 1992, the Congress set up the oam under the nih Appropriations Bill, sponsored by senator Harkin, with a budget of us $2 million.

The constitution of oam was largely the result of a deep-rooted disillusionment with conventional medicine. A 1992 survey by The New England Journal of Medicine had found that one out of every three us citizens was using unconventional therapies for various ailments, and that total expenditure on such therapies was as much as us $14 billion annually. Even though many unconventional practices have not been validated by the us scientific community, many unconventional drugs are approved for sale (mainly because they do not have any proven adverse side effects) by the us Food and Drug Administration (fda).

Many health maintenance organisations (hmos) - organisations that provide comprehensive healthcare to voluntarily enrolled people in a particular geographic area by member-physicians, and that are financed by fixed pre-determined advance payments - provide coverage for alternative therapies as they are far cheaper than conventional allopathic medicine. The nation"s first government-subsidised naturopathic health clinic was recently set up in King County, Washington state.

The Congressional mandate establishing oam had stated that the office"s aim was to "facilitate the evaluation of alternative medical treatment modalities for the purpose of determining their effectiveness and to help integrate effective treatments into mainstream medical practice". However, the immediate reaction of the scientific community to the move had been one of scepticism. Some scientists likened the establishment of oam to setting up of an office for astrology. Others contended that the office was diverting resources from valuable research to mainstream medicine. Yet others were afraid that the office would promote quackery under political pressure. The oam"s activities have been criticised by proponents of alternative medicine as well, who accuse it of displaying scientific bias against alternate practices by subjecting them to over-rigorous testing. But Howard Shaffer, who is with the division of addiction at the Harvard Medical School and has studied hatha yoga as a therapy for illicit drug use under an oam grant, says, "If you look at the history of science, every path of scientific inquiry has received those queries. Science is always an intellectual query against conventional methods."

The criticisms notwithstanding, the scientific community does welcome scrutiny of alternative practices on the whole. Shaffer says, "Health problems produce so much anxiety that people engage in therapies that are not viable whether they are mainstream or alternative. I am interested in therapies that are viable whether they are alternative or mainstream." But evaluating alternative treatments is not an easy task.

Politic moves
Despite the prevailing scepticism, the nih had conducted tests in "alternative" treatment even before the oam was formally set up. The National Institute of Drug Abuse had used acupuncture to treat addicts and the National Cancer Institute has tested thousands of natural substances for effectiveness against aids and cancer.

The oam"s first full-time director, Joseph Jacobs, resigned in September, 1994, charging that proponents of alternative medicine and their Congressional supporters were trying to dilute the organisation"s scientific standards. During Jacobs" tenure, he and other oam officials were pitted against alternative medicine proponents including Bidell Wiewel, who were part of an 18-member panel of external researchers, on questions of how and where research was to be conducted.

In setting up the office, politicians had been looking for magic cures for diseases like cancer and were, therefore, pushing forward their favourite therapies which were to be evaluated through field studies; they wanted researchers to collect just anecdotal accounts from practitioners of "alternate" therapies and see whether the claims were valid without making any efforts to control the data-gathering process. But for a therapy to be scientifically acceptable, it has to be subjected to stringent clinical trials.

With the replacement of senator Harkins, after the Republicans gained majority in the last elections, much of the politicking seems to have stopped. For years, the fda has raided health food stores, manufacturers and even doctors" offices for untested or unapproved products. For this reason, Jacobs" plan to create a network of university-based research centres was quashed by Wiewel and others, who charged that proponents of conventional medicine would seek to eliminate alternative therapies driven by their own biases. Even today, conventional physicians do not recommened, or are legally forbidden to recommend their patients to alternative practitioners. Kedar Prasad, who is studying the effectiveness of antioxidant vitamins in treating melanoma (funded by oam) at the University of Colorado Health Sciences Center, says, "Doctors have no training in nutrition so they tell their patients that vitamins don"t do any good. Much of the scientific resistance (against alternative medicine) is due to a lack of knowledge."

Many major hospitals like Johns Hopkins (Maryland) have centres for complementary management of therapies. Currently, the focus is on complementary rather than alternative medicine (patients are treated with a variety of therapies which complement each other). For example, Prasad points out that cancer patients can be given vitamin supplements as vitamins can destroy free radicals and also stimulate the immune system. "People," says Bala Manyam, who is a professor at the Southern Illinois University School of Medicine and is studying ayurvedic herbals as a remedy for Parkinson"s disease, "make the mistake of comparing one treatment to another. Physicians should keep an open mind. We are not perfect. Apply all the systems in healing."

Technical quagmire
There are technical difficulties too in evaluating alternative medicine. Many practitioners of alternative medicine are against double-blind tests, which reflect the mainstream approach to finding a single-drug cure. Instead, they claim to follow a holistic approach in which the person"s overall mental and physical states, diet and lifestyle are taken into account.

One of the basis on which conventional medicine rejects the effectiveness of "alternative" medicine is on the grounds that it has a placebo effect (placebos have had success rates of over 70 per cent in some cases). But many alternate therapies work due to psychological interaction between the practitioner and the patient, which may produce the placebo effect. "A biological system," Manyam says, "is an interaction of the physical body, mind and the soul or spirit. It is wrong to say the body alone is sick; the mind is also sick. When healing, the body interacts with the mind. Cosmopolitan (conventional) medicine searches for a causative factor for an infection. Finding a causative agent does not mean that it makes a person sick. A prominent scientist has said that Mycobacterium tuberculae is an inessential cause of tuberculosis."

Mind-body interactions have not yet been studied in any considerable detail. Acupuncture stimulates nerve endings which triggers the release of chemicals like endorphins, that interact with the brain. Recently, it was found that the sooner a mother is discharged from hospital after giving birth, the lesser chance she has of getting infected. This is because when a mother is separated from her family"s support, her body"s resistance to infection goes down.

One for the record
Though unconventional medical practices are being studied in universities and institutions throughout the world, especially in the us and Europe, there is no central body anywhere that evaluates all such practices. Therefore, one of oam"s first objectives was to record and classify all unconventional practices currently in use. A series of workshops were held from June 1992 onwards in which scientists, health administrators and statisticians formed working groups with alternative medicine practitioners to define the scope of the alternative system and to drum out the ways in which they can be scientifically studied.

A report was finally published by the office in March, 1995, in which alternative practices were classified under six categories:

• mind-body interventions
• bioelectromagnetic applications in medicine
• alternative systems of medical practice
• manual healing methods
• pharmacological and biological treatments and
• herbal medicine
The report also contains guidelines for researchers to conduct research on alternative medicine systems.

It has been observed that alternative medical practitioners do not have rigorous training in modern scientific practices, and hence they lack the expertise to carry out meaningful research. The oam funds a post-doctoral research programme in order to attract more qualified research investigators to the field. The office also funds two exploratory centres that provide training and funding of small pilot studies to evaluate alternative therapies. The criteria for evaluating promising cam therapies are: safe and long-term effectiveness; low cost; person-centered and comprehensive therapy; and scientific rigour and contextual sensitivity.

The oam has an international programme through which it wants to build on the experience of other countries that have conducted researches in alternative medical practices over several years. It also wants to standardise approaches to such research so that studies in other countries may be recognised and are not redundantly duplicated in the us. The office has established contact with institutes in China, India, Vietnam, Japan, Australia and countries in Europe, Africa and South America. However, it has not actually collaborated yet with practitioners in India.

Positive note
Public interest in the oam is phenomenal. The office averages over 1,000 enquiries a month from the general public, in addition to over 40 from the media every day. But many scientists and academicians do not share the same enthusiasm. In a recent article in The New York Times, two physics professors charged the nih of buying snake oil with the citizens" tax money. But the oam points out that many studies have already been conducted on cam practices by other institutions in the nih and elsewhere.

Research has demonstrated the beneficial effects of herbal products such as gingko (Gingko biloba) in treating dementia arising from circulation problems; palmetto preparations for benign prostatic hypertrophy; and extracts of capsicum for arthritis. Fourteen randomised controlled trials have shown that hypericum (commonly known as St John"s wort) is effective in treating depression. Some smallscale but highly specialised studies have shown that arthritis can be cured using acupuncture, homoeopathy, vitamin supplements, herbal products and diet therapies.

This is where the oam"s focus differs from mainstream scientific research, which limits itself to finding a single cure. The oam, with its person-centered research, focuses on finding integrative approaches to treating a disease. Chronic pain, asthma, drug addiction, vascular disease, heart failure, embolisms, diabetes, high blood pressure and other conditions have been evaluated usually in small trials, with a variety of alternative and complementary approaches such as nutritional, mind-body and behavioural interventions, acupuncture, homoeopathy and prayer and mental healing. If this approach succeeds, it would change the aspect of medical research fundamentally.

However, it will be difficult to realise this objective given the current system of grant approval by the central nih grant approval section. The allegation is that the section has a closed mind. "Here lies the biggest problem in evaluating alternative medicine in a conventional framework," says Manyam.

Scientists aver that the concept of holistic medicine is unattractive because of the non-patentability of herbal or other preparations in which the active ingredient is not isolated. At a recent science writers" association meet on the future of research in alternative medicine, one of the speakers had said: "The evaluation of complementary and alternative medicine will require flexibility, creativity and rigour in research application. It will require the best of molecular and cellular biology, basic science research, surveys and epidemiological approaches, detailed case reports and best case series, multidisciplinary and cross-level research, randomised and placebo controlled trials, prospective parallel outcome studies, cost-benefit evaluation, research summaries, meta analyses, and direct comparisons of complex therapeutic systems. In all cases, the importance of objectivity, rigour, clarity of research goals and the reduction of bias must be paramount. If such quality research in complementary and alternative medicine is supported and effectively carried out, it may solve many of our most burdensome and difficult problems in medicine. It is the optimal goal of the office of alternative medicine to foster both rigour and realism in cam research. It is the vision of the office of alternative medicine to bring together the best of healing and the best of science."

In evaluating the various alternative therapies, the oam is assessing techniques developed by diverse cultures, only to be slighted by modern biomedicine. The realisation that modern scientific practice does not have all the answers is itself a radical achievement. "But," cautions Shaffer, "it is a mistake to think that oam will bring about more acceptence of alternative practices. More research has to be done, though a lot of the research done is good." Prasad emphasises the need for dialogue between conventional and alternative medicine practitioners. He believes that "in 10 years, this field will become much more respectable simply because people have been talking to each other."

What is ironic as well as deplorable in all this is that this research has had to be initiated in the country which is the fountainhead of Western medicine, and not in nations like India or China which boast of some of the most powerful systems of alternative medicine. If research proves that these systems are effective, then it may even succeed in bringing the people of the world closer culturally.

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