Alternative medicine: the risks of untested and unregulated remedies

What is there about alternative medicine that sets it apart from ordinary medicine? The term refers to a remarkably heterogeneous group of theories and practices-as disparate as homeopathy, therapeutic touch, imagery, and herbal medicine. What unites them? Eisenberg et el. defined alternative medicine (now often called complementary medicine) as "medical interventions not taught widely at U.S. medical schools or generally available at U.S. hospitals." (1) That is not a very satisfactory definition, especially since many alternative remedies have recently found their way into the medical mainstream. Medical schools teach alternative medicine, hospitals and health maintenance organizations offer it, (2) and laws in some states require health plans to cover it. (3) It also constitutes a huge and rapidly growing industry, in which major pharmaceutical companies are now participating. (4)

What most sets alternative medicine apart, in our view, is that it has not been scientifically tested and its advocates largely deny the need for such testing. By testing, we mean the marshaling of rigorous evidence of safety and efficacy, as required by the Food and Drug Administration (FDA) for the approval of drugs and by the best peer-reviewed medical journals for the publication of research reports. Of course, many treatments used in conventional medicine have not been rigorously tested, either, but the scientific community generally acknowledges that this is a failing that needs to be remedied. Many advocates of alternative medicine, in contrast, believe the scientific method is simply not applicable to their remedies. They rely instead on anecdotes and theories.

In 1992, Congress established within the National Institutes of Health an Office of Alternative Medicine to evaluate alternative remedies. So far, the results have been disappointing. For example, of the 30 research grants the office awarded in 1993, 28 have resulted in "final reports" (abstracts) that are listed in the office's public on-line data base. (5) But a Medline search almost six years after the grants were awarded revealed that only 9 of the 28 resulted in published papers. Five were in 2 journals not included among the 3,500 journal titles in the Countway Library of Medicine's collection. (6,7,8,9,10) Of the other four studies, none was a controlled clinical trial that would allow any conclusions to be drawn about the efficacy of an alternative treatment. (11,12,13,14)

It might be argued that conventional medicine relies on anecdotes, too, some of which are published as case reports in peer-reviewed journals. But these case reports differ from the anecdotes of alternative medicine. They describe a well-documented new finding in a defined setting. If, for example, the Journal were to receive a paper describing a patient's recovery from cancer of the pancreas after he had ingested a rhubarb diet, we would require documentation of the disease and its extent, we would ask about other, similar patients who did not recover after eating rhubarb, and we might suggest trying the diet on other patients. If the answers to these and other questions were satisfactory, we might publish a case report - not to announce a remedy, but only to suggest a hypothesis that should be tested in a proper clinical trial. In contrast, anecdotes about alternative remedies (usually published in books and magazines for the public) have no such documentation and are considered sufficient in themselves as support for therapeutic claims.

Alternative medicine also distinguishes itself by an ideology that largely ignores biologic mechanisms, often disparages modern science, and relies on what are purported to be ancient practices and natural remedies (which are seen as somehow being simultaneously more potent and less toxic than conventional medicine). Accordingly, herbs or mixtures of herbs are considered superior to the active compounds isolated in the laboratory. And healing methods such as homeopathy and therapeutic touch are fervently promoted despite not only the Jack of good clinical evidence of effectiveness, but the presence of a rationale that violates fundamental scientific laws - surely a circumstance that requires more, rather than less, evidence.

Of all forms of alternative treatment, the most common is herbal medicine. (15) Until the 20th century, most remedies were botanicals, a few of which were found through trial and error to be helpful. For example, purple foxglove was found to be helpful for dropsy, the opium poppy for pain, cough, and diarrhea, and cinchona bark for fever. But therapeutic successes with botanicals came at great human cost. The indications for using a given botanical were ill defined, dosage was arbitrary because the concentrations of the active ingredient were unknown, and all manner of contaminants were often present. More important, many of the remedies simply did not work, and some were harmful or even deadly. The only way to separate the beneficial from the useless or hazardous was through anecdotes relayed mainly by word of mouth.