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06 August, 2003
Complementary and Alternative Medicine Alternative medicine is big business. Americans spent approximately $27 billion (out-of-pocket) on alternative medicine in 1997, and a national survey indicated that nearly 42.1% of Americans have tried some sort of alternative medicine in 1997, that was up from 33.8% in 1990 (Eisenberg DM et al, 1998: uid=9820257; Stokstad E. Science 288, 1568-70: 2000). A total of 1539 adults in 1991 and 2055 in 1997 responded in the survey. The increase in alternative medicine use and expenditures between 1990 and 1997 was attributable primarily to an increase in the proportion of the population seeking alternative therapies. The therapies increasing the most included herbal medicine, massage, megavitamins, self-help groups, folk remedies, energy healing, and homeopathy, and the therapies were used most frequently for chronic conditions, including back problems, anxiety, depression, and headaches.
Alternative medicine is rather vaguely and expediently defined. It may be defined as treatments and practices not commonly taught in medical schools, or not generally used in hospitals. According to NIH's National Center for Complementary and Alternative Medicine (NCCAM), alternative medicine is a group of diverse medical and health care systems, practices, and products that are not presently considered to be part of conventional medicine. While some scientific evidence exists regarding some of these therapies, for most there are key questions that are yet to be answered through well-designed scientific studies such as whether they are safe and whether they work for the diseases or medical conditions for which they are used. Further among these therapies, complementary medicine is referred to as the ones used together with conventional medicine. An example is aromatherapy to help lessen a patient's discomfort following surgery. Alternative medicine is medicine used in place of conventional medicine. An example is a special diet to treat cancer instead of undergoing surgery, radiation, or chemotherapy that has been recommended by a conventional doctor. Finally, conventional medicine is medicine as practiced by medical doctors or doctors of osteopathy and by their allied health professionals, such as physical therapists, psychologists, and registered nurses. Thus more recently medicine other than conventional medicine (Western medicine) is collectively referred to as complementary and alternative medicine (CAM). In addition, rather ambiguous terms may be found to refer to CAM such as unconventional, non-conventional, unproven, irregular medicine or health care and dietary supplements.
What are major CAM types? Here NCCAM CAM classification is quoted as follows:
1. Alternative Medical Systems
These systems are built upon complete systems of theory and practice that have evolved independently and earlier in the history than conventional medicine. Examples: homeopathic medicine, naturopathic medicine, traditional Chinese medicine and traditional Indian Ayurveda.
2. Mind-Body Interventions
These are a variety of techniques designed to enhance the mind's capacity to affect bodily function and symptoms. Some techniques, such as patient support groups and cognitive-behavioral therapy, are being integrated into conventional medicine. Other examples: meditation, prayer, mental healing, and other therapy means such as art, music, or dance.
3. Biologically Based Therapies
These therapies in CAM use substances found in nature, such as herbs, foods, and vitamins. Examples: dietary supplements, herbal products and scientifically unproven natural therapies. Some substances are being integrated into conventional medicine, as they have been proven scientifically and molecularly for their efficacies.
4. Manipulative and Body-Based Methods
These are based on manipulation and/or movement of one or more parts of the body. Examples: chiropractic or osteopathic manipulation, and massage.
5. Energy Therapies
Energy therapies involve the use of two types of energy fields:
i) Biofield therapies: Manipulation of energy fields that are claimed to surround and penetrate the human body. Such fields have not yet been scientifically proven. The biofields are presumably manipulated or radiated by applying pressure or by placing the hands through/toward these fields. Examples: qi gong, Reiki, and therapeutic touch.
ii) Bioelectromagnetic-based therapies: Use of electromagnetic fields, such as pulsed fields, magnetic fields, alternating current or direct current fields.High-profile scientists in conventional medicine condemn that CAM is psudoscience and resembles even "witchcraft". It is true that CAM therapies are more or less unproven in terms of concepts and techniques in modern biomedical sciences. However, it may be asked why so many Americans invest on such "unproven" therapies. CAM therapies may be effective or even superior to conventional medical treatments for some health conditions as claimed by keen advocates of CAM, and/or the popular use of CAM therapies may reflect problems that the conventional medicine can not yet give solutions.
Who use CAM? Again in a national survey of 1035 individuals randomly selected in USA (Austin JA, 1998: uid=9605899), it was found that dissatisfaction (or unfavorable feeling) with conventional medicine was not a major reason for CAM use. In fact, only 4.4% of those surveyed relied mainly on CAM therapies. The use of CAM therapies by cancer patients, for instance, was not associated with perceived distress or poor compliance with conventional medical treatment (Sollner W et al, 2000: uid=10951352). Rather, inclination to holistic medicine, health maintenance of organic nature and philosophical view to life were main reasons for such use. Patients of high education, progressive cancer status and active coping behavior tended to use CAM. These users combine CAM therapies with conventional medical treatments. Conventional medical doctors are aware that their patients use CAM therapies, in particular outpatients. As an appreciable and increasing number of patients combine the use of CAM therapies with conventional treatments, conventional medical doctors should be better ready to offer reliable information to their patients, in particular additional and/or complementary efficacy and possible hazardous interactions between drugs and CAM remedies (Hsiao AF et al, 2003: uid=12794548).
The popular use of CAM has led US government to increasingly support rigorous CAM research and development, to train medical researchers in the use of CAM and to disseminate information to the public and medical professionals, regarding which CAM modalities work, which do not, and why. Such information would protect CAM users from possible hazardous effect and provide the best use of CAM for health conditions. In addition, it would be possible in some cases to integrate scientifically proven CAM therapies into conventional medicine. In 1992, Office of Alternative Medicine (OAM) was earmarked into existence with the budget of US$2.0 mn. OAM was elevated to be a National Center for Complementary and Alternative Medicine (NCCAM) in 1999 with $50.0 mn budget that further increased to be $114.1 mn in 2003. Now NCCAM is a Collaborating Center for Traditional Medicine designated by the Pan American Health Organization/World Health Organization for the period 2003-2007 and engages in international collaborative efforts with WHO centers. Currently, NCCAM sponsors clinical trials in CAM projects such as acupuncture for knee arthritis, Ginkgo biloba to prevent dementia, glucosamine and chondroitin sulfate for knee arthritis, St. John's Wort for depression, shark cartilage for lung cancer, Gonzalez Protocol for pancreatic cancer, and saw palmetto extract in benign prostatic hyperplasia. There are also increasing number of research projects supported by NCCAM.
In many CAM therapies, it is difficult to standardize treatments due to inconsistency of product quality, active ingredients undefined, and bioavailability, shelf life and basic toxicological data unavailable. CAM products may not be tested, for instance, in double-blind, randomized placebo-controlled trials in the regular protocols of clinical trials for therapeutic regimens in conventional medicine. Of course standard protocols for testing conventional medical treatments may not always be applicable to CAM therapies such as body massage and energy healing. Concepts and techniques of modern biomedicine may not yet be ready to approach and evaluate some CAM therapies practiced over centuries and even thousands of years, and it would be desirable to develop new protocols to comparatively evaluate CAM products among themselves and with conventional medicine. In cancer field, US National Cancer Institute's PDQ (Physician Data Query) Adult Treatment Editorial Board has developed a classification system to allow the ranking of human cancer treatment. In the system, cancer studies are evaluated according to statistical strength of the study design and scientific strength of the treatment outcomes (endpoints) measured. This classification system has been adapted to allow the ranking of human studies of CAM treatments for cancer. The adapted CAM strength classification system should define the levels of evidence for particular CAM therapies for human cancer, and be preferably applicable to CAM practices and treatments for other human health conditions.
The above classification system newly adapted for CAM is quoted briefly here from NCI's PDQ . Essentially, a combined level of evidence score is calculated for each qualifying study by joining the score for statistical strength of study design with the score for strength of the endpoints measured. These scores range, in decreasing order of strength, from 1iA to 3iiiDiii. Refer to NCI's PDQ for details.
Strength of Study Design (Evidence score 1i - 4)
A numeric scale from 1 to 4 is used to indicate the statistical strength of the study design, with 1 assigned to studies having the strongest design and 4 assigned to studies having the weakest design. The various types of study design are described below in descending order of strength:
1. Randomized controlled clinical trials:
Studies in which participants are assigned by chance to separate groups for the comparison of different treatments. Neither researchers nor patients can choose the group to be placed. At the time of a trial, there is uncertainty about which of the treatments is best. These trials can be "double-blinded" or "nonblinded". Double-blinded trials have a stronger study design.
i. Double-blinded: Neither the patients nor the researchers know which patients are receiving the therapy under study or the comparison (control) treatment.
ii. Nonblinded: The researchers and the patients know what treatment is being given.
2. Nonrandomized controlled clinical trials:
Studies in which participants are assigned to a treatment group based on criteria that may be known to the researchers, such as the patient's birth date, chart number, or day of clinic appointment. With this type of study design, there is less confidence that the group receiving the treatment under study and the control group are comparable.
3. Case series:
Studies that describe results from a group or series of patients who all received the treatment that is being investigated. These studies have a weak design, due, in part, to the absence of a control group. Different types of case series, in descending order of strength, are as follows:
i. Population-based, consecutive case series: The study population is well-defined and is either the entire population of interest or a representative random sample of the larger population from which it is drawn. The study subjects receive treatment in the order in which they are identified by the researchers.
ii. Consecutive case series: Studies describing a series of patients who were not limited to a specific population and who received treatment in same order in which they were identified by the researchers.
iii. Nonconsecutive case series: Studies describing a series of patients who were not limited to a specific population and who do not represent a consecutive series of patients identified and treated by the researcher.
4. Best Case Series:
From a larger series of patients, only the cases that appear to have benefited from the treatment under study are reported. These studies have the weakest design. These Best Case Series are of their extremely weak study design, and given a score for strength of study design only. No combined level of evidence score is given.
Strength of Endpoints Measured (Evidence score A - Diii)
A progressive alphabetic scale is used to indicate the scientific strength of endpoints measured, with the letter A assigned to the strongest endpoint that can be measured and the letter D assigned to the weakest endpoint. Commonly measured endpoints in human cancer treatment studies are listed below in descending order of strength:
A. Total mortality (death rate):
The proportion of the study population that died. Overall survival is the inverse of total mortality.
B. Cause-specific mortality:
Death from a specified cause in the population under study, for example, death from cancer versus death from side effects of therapy versus death from other causes. The inverse value is disease-specific survival.
C. Carefully assessed quality of life:
Quality of life is an extremely important endpoint to patients but a very subjective endpoint. Questionnaires, psychologic tests, etc are used.
D. Indirect surrogates:
These are measures that substitute for actual health outcomes, and they are subject to investigator interpretation. In descending order of strength, indirect surrogates include the following:
i. Disease-free survival: Length of time no cancer was detected after treatment.
ii. Progression-free survival: Length of time disease was stable or did not get worse after treatment.
iii. Tumor response rate: The proportion of patients whose tumors responded to treatment and the degree or extent to which the tumors responded.In the above classification system, not all human studies on CAM may be classified. Only those reporting therapeutic endpoints such as tumor response, improvement in survival, or measured improvement in quality of life, are considered. In addition, individual case reports are not classified because important clinical details are often missing, the evidence from them is generally weak scientifically, and there is an increased probability that similar results may not be obtained with other patients. Reports of case series are excluded when the description of clinical findings is incomplete for proper assessment and interpretation. However, the classification system described above should offer assistance in evaluating the strength of the evidence associated with particular CAM treatments.
The question may arise whether or not CAM therapies that are commonly used now have enough clinical data that enable the strength classification by the above-mentioned system. Some CAM remedies can be studied to the extent that active components are defined at molecular level and integrated into conventional therapeutics. This process of investigation may also offer chance of discovering novel drugs for conventional medicine. However, for most CAM remedies currently in use, clinical findings are based only on individual best case reports , the scientific evidence of which is so weak and similar results may not be reproduced for other patients. In point of fact, CAM is more or less preventive, and Government medical insurance policy does not usually cover preventives, except for a very limited cases. This results in the lack of enthusiasm among pharmaceutical companies to invest on CAM research and development and in the absence of clinical data for rigorous evaluation. Of course conventional medical therapeutics require horrendous cost for their development, and health insurance coverage is a must for drug developers. While it would be desirable that CAM therapies are classified according to well defined and acceptable system such as the above-mentioned one, most CAM therapies in use would not ready to be classified due to the above reasons. Efforts should be made among CAM advocates as well as Government and public organizations to sort out CAM therapies by commonly accepted protocols and put CAM on the table for comparative evaluation, and to inform the public and medical professionals for their best use in individual health conditions. Some CAM advocates and high-profile scientists may have political and scientific antagonism over the use of CAM in contemporary medical arena but they should join together to find truth still hidden in CAM, as the population of CAM users ever increases year by year in 21st century.
High-profile scientists in biomedicine claim that conventional medicine is evidence-based. New scientific findings in biomedical research are usually starting leads to novel diagnostic means and/or therapeutics which are followed by extensive pre-clinical and clinical trials for evaluation before approval of their clinical use. A microbial infection may be taken care of by a specific antibiotic to cure the resulting disease. However, human deleterious health conditions are caused more or less by multiple aberrations in gene functions, metabolic processes and physiological interactions. Most complex diseases such as neurodegenerative and vascular ones still await for their evidence and mechanism of occurrence, and for these diseases conventional medicine is often unable to assure the patient of the outcome and provides only probable results while warning possible complications. It might be said that conventional medicine is sure of perfect outcomes of the treatment only in 10% or so of the ailments under care. Treatments frequently have side effects such as allergies, vomiting and headaches, and patients are obliged to accept these side-effects as part of the treatment. Conventional medicine often fails to take care of resulting lowered quality of life of the patient. Patients may be left in a situation of confusion and frustration. Thus conventional medicine is still largely experience-based and explores multiple regimens for a single human health condition, by trial and error, in an effort to possibly get best conceivable outcome. Therefore, there are still many aspects of human health conditions where conventional medicine is unable to cope with. This is particularly so when and where mind-body relationships are involved.
In CAM classification described above, biologically-based therapies are most likely to be integrated into conventional medicine, as they may be approached by concepts and techniques of modern biomedicine and active molecules and mechanisms are elucidated. However, in other classification categories (alternative medical systems, mind-body interventions, manipulative and body-based methods, energy therapies), modern science would not be able to investigate the claimed benefits in many of the practices and therapies that are appreciated over centuries and even thousands of years. Some therapeutic practices in these categories might be in the domains of religion and probably forever unapproachable by science. For others that sustained the appreciation of their efficacy for a long period of time in human history, the lack of scientific approaches at the moment should not deny their value, or receive unwarranted criticism of being pseudoscience and "witchcraft". Better understanding of additional benefits by conventional medical practioners would likely position these traditional CAM therapies in combination with conventional treatments.
In CAM therapies, psychological orientation and spiritual traditions of the patient appear to play an important role. Once persuaded by one way or another, users get convinced that their CAM is good for them and have almost religious faith in it. This is partially because CAM practitioners try to give users (patients) confidence and assurance in CAM therapies, and they are aware professionally that direct care of patients and spiritual commitment are important in promotion of patient's health and well-being. In fact, many CAM remedies as described above in each classification could act through psychological orientation and coping attitude of the patient. In mind-body interventions, an example may be found in cancer patients whose social and psychological stress modifies immune components involved in the regulation of tumor growth, including the reduction of NK cytotoxicity and T- cell responses (Andersen BL et al, 1998: uid=98089056), and in that supportive group therapy and training programs in basic coping skills such as stress management, relaxation training, thought monitoring and changing, mental imagery and goal setting significantly increase survival duration and time from recurrence to death in breast cancer patients (Spiegel M and Moore R, 1997: uid=97414103; Cunningham AJ et al, 1999: uid=10335561; also go to Stress and Immunomodulation commentary. Thus stress-reducing "mind and behavior" therapy appears to be effective. Positive placebo effect in conventional medicine is also well known in this line. Placebo resembles as much as possible the treatment being studied in a clinical trial, except that the it is inactive. It could be a sugar pill, a sham procedure without active treatment quality, and more recently placebo can be interaction between a patient and a doctor, or patient's expectation to happen from the care. These examples all testify the importance of psychological and behavioral role in medical therapies that are most likely to involve neuroimmune pathways now being newly unravelled.
Conventional medicine generally treats suspected lesions in a targeted manner. The treatment itself could be a major stressor (stress-causing stimulus). In cancer treatment for instance, surgical removal of lesions, chemotherapeutic attack to tumors and radiotherapy over the suspected area may be very major and strong stressors that lead to the disruption of neuroendocrine-immune systems of the patient. There is yet no quantitative assessment means of each stress-inducing treatment for potential immunomodulation that reduces the body defense capability. However, CAM therapies in the categories that reduce stressor effects should be considered before, during and after the conventional treatment in order to gain active coping attitude of the patient under stress, to enhance quality of life and chance of recovery by boosting the psychological well-being. CAM therapies usually target the whole body rather than part as by conventional medicine and once carefully and appropriately employed should complement and/or synergistically promote the welfare of the patient (user). Perhaps this is where conventional medicine meets CAM in a friendly mammer.
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