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Types of Clinical Trials
Problems With Clinical Trials
Why Is There So Little Research?
The Way Forward
The Placebo Response
Holistic Links
INTRODUCTION
Although the popularity of many complimentary therapies may be widespread, it is not generally based on a broad understanding of what these therapies can offer. Complimentary medicine seems to be largely taken on trust. Given its popular status, there is a somewhat surprising and possibly troubling lack of research on the subject. To a large extent even the most basic questions remain unanswered. Which complementary therapies are effective? Are they as safe and natural as claimed? More complex issues are even more difficult to resolve. Do complementary therapies promote health or prevent illness? Could they reduce medical expenditure? Is there a "scientific basis" for their action?
Much more research into complementary therapies is needed. Some conventional research methods, however, are not ideally suited to evaluating the benefits of these therapies because they do not take into account the patient's participation in the healing process.
TYPES OF CLINICAL TRIALS
Different types of clinical trials, originally devised to test pharmaceutical drugs and treatments in conventional medicine, are now being used to investigate complementary therapies. A controlled clinical trial compares at least two groups of patients: an experimental group that receives the treatment, and a control group that does not. This does not necessarily determine whether a procedure or medication "works", however, since any treatment, even taking a medical history, tends to have therapeutic effect. To take this into account, the placebo controlled clinical trial was devised, in which both groups are given seemingly identical treatments, but the treatment of the control group is inactive (See Placebo Response). For the treatment to be deemed to have worked, patients in the experimental group must perform significantly better than those taking the placebo. Researchers also try to include as many people as possible in the trial to balance out any personal factors, such as one patient being more ill than another, and to reduce the likelihood of therapeutic benefits being attributed to chance.
Further risks of bias are ruled out by assigning patients at random into both groups, and the randomized controlled trial has been the gold standard in scientific research since the 1950s. Taking this one step further, the ultimate type of research trial is the "randomized double-blind" study, in which neither the patient nor the practitioner knows if the treatment is real or a placebo. The aim of this method is to ensure that nay improvement in the treated group has not been influenced by individual attitudes, such as a practitioner's strong belief in the efficacy of a treatment.
Clinical trials are sometimes evaluated with what is known as a systematic review or meta-analysis, in which the results of a number of trials are combined. Small trials that remain inconclusive themselves may, when linked with trials that are designed better, yield more significant results. In complementary medicine, there are few possibilities for meta-analyses until more trials of therapies are available, but in the 1990s several reviews of this type did produce evidence that homeopathic treatments, acupuncture and manipulative therapies have clinical benefits.
There is little incentive for commercial funding of research into herbal medicine due to the lack of profitable patents to acquire, since many plant remedies have been used for hundreds of years and are widely available.
PROBLEMS WITH CLINICAL TRIALS
The use of randomized controlled trials to investigate complementary therapies can be problematic. Critics point out that randomization neglects a patient's right to choose, and that the success of complementary therapies depends to a great degree on the knowledge, skills, and attitude of the practitioners. In many cases - particularly for mind-, body-, and movement-oriented therapies - treatment is more complex than a simple administration of pills, and it can be hard to select a "blinded" control treatment. How do you give a placebo massage, or even placebo acupuncture, not to mention placebo psychotherapy? Clinical trials also contradict the desire of many patients to participate in the healing process, a vital factor in many complementary therapies.
The Evidence & Research cited in the therapies and diagnostic sections:
MoonDragon's Alternative Health Therapy: Touch & Movement Therapies
is based on the best scientific research available: the 1,500 randomized controlled trials (not all double-blind) on the database of the Research Council for Complementary Medicine in the UK, which has worked with the Office of Alternative and Complementary Medicine of the National Institutes of Health in the US. The findings suggest that some complementary therapies can be analyzed in this way and may be clinically effective, but there is a lack of research. Researchers in conventional medicine have yet to show great interest in complementary medicine, nor have complimentary practitioners had much interest in research. Much of the research so far has been by health care providers practicing complementary therapies.
WHY IS THERE SO LITTLE RESEARCH?
Unlike drug trials, funding for complementary medicine research is scant. Drug companies are not likely to invest, since there are few financially attractive patents to acquire; most herbal remedies, for example, have been in use for centuries. Nor do complementary practitioners wanting to carry out research have the backing of universities, hospitals, statisticians, and full-time research staff - all elements that create a research environment for conventional medicine. As complementary therapies develop their own professional bodies and academic groups, the facilities to carry out research will grow and coherent programs will develop.
Ailments studied in conventional research may not be representative of those commonly treated by complementary medicine. Postoperative nausea, for example, has been studied because it can be easily gauged and a hospital-based researcher has access to a large number of patients, but it is not a condition for which complimentary therapies are often used. Chronic fatigue syndrome, on the other hand, is often helped by complementary medicine, but is unlikely to be treated in hospitals and cannot be quantified easily.
It will always be difficult to make general statements about the efficacy of complementary medicine, because therapies differ so much, and because so much depends on the approach and skill of the practitioner. Even if a definite statement could be made about one therapy, it might only apply to one condition; for example, a therapy shown to be effective for irritable bowel syndrome may not be proved to work for any other ailment.
Adapting research conclusions into practical knowledge is also far from simple. For example, a placebo controlled trial of homeopathy might find this therapy more effective than a placebo for migraines, but it fails to indicate whether homeopathy would be more effective than another approach for the same condition. There are scientifically rigorous ways of researching complementary therapies that take account of individuality and relationships, but they are often more complex than randomized controlled trials.
THE WAY FORWARD
It is important to not that many conventional treatments - most surgery and physiotherapy, for example - have never been subjected to clinical trials. Moreover, only a quarter of studies reported in leading medical journals are estimated to be based on randomized controlled trials. If complimentary and mainstream medicine are to integrate more closely, and new approaches are to be evaluated, thorough research is needed, and a way to apply clinical trials must be found.
Finding a scientific explanation for the principles behind many complementary therapies is one of the most difficult issues. For example, there is no anatomical basis for the existence of acupuncture meridian, nor a biochemical explanation of how homeopathic remedies could work. Although the use of acupuncture in conventional pain management took a great leap forward when it was discovered that endorphins (a body's natural opiate, a morphine-like substance produced naturally by the body to relieve pain) could be released during treatment, this kind of research depends on high technology, and there is limited funding.
"If the present popularity of complementary medicine is to be more than yet another passing fashion, it is essential to cultivate an atmosphere of constructive criticism, informed debate, and balanced views... those who are inspired by an attitude of constructive criticism will surely turn out to be the true champions of complementary medicine."
By Professor Edzard Ernst of the University of Exeter; UK: Complementary Medicine: An Objective Appraisal
THE PLACEBO RESPONSE
A placebo (from the Latin for "I will please") is an inactive medication or treatment given to a patient in place of a genuine drug or medical technique. In clinical trials, new treatments are tested against a placebo, which may be a sugar pill or meaningless procedure. Because patients expect it to work, the placebo may have a therapeutic effect. This is in fact the self-healing response, which conventional doctors often dismiss because placebos are not an intervention. However, it is highly significant that, when given a placebo, around 30% or people in clinical trials feel much improvement; some researchers say this can rise to as much as 90%. The opposite also appears to be true - patients receiving insensitive treatment from practitioners often feel worse - a "nocebo" effect. How a treatment is given, by whom, and in what setting, is clearly important, but little is understood about the physical and psychological processes involved. All treatments, however, particularly surgical procedures, do have a large placebo component. Immune system research has shown how patients' expectations and feelings can influence healing processes, and the mind/body relationship in all illness, especially long-term disease, has a major effect on the outcome of health problems.
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