A CROSS-CULTURAL LOOK AT CANCER AND ITS TREATMENT
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Presenters: Debu Tripathy, M.D., David Hess, Ph.D., P.H. Mntshali
Moderator: Barrie Cassileth, Ph.D.
Session: F1; June 11, 1999I. Abstract
This panel reviews the ways that cancer is perceived and treated in various cultures and medical systems around the world. Dr. Tripathy presents information on the clinical trial methodology to evaluate herbal therapy as a treatment for breast cancer. Dr. Hess highlights the meaning, perception and treatment of cancer from various cultures. And Mr. Mntshali discusses his perspectives on the causes and treatments of cancer in the populations he serves as a Zulu healer in Africa.
Dr. Tripathy
II. The Cancer-Related Issue Addressed
This discussion brings two cultures together: that of clinical trial methodology of Western medicine and the new interests in herbal therapy. The combination treatments of Western medicine and herbal therapy prove a challenging process to find ways to quantify the benefits of integration. This presentation will highlight some of the obstacles, difficulties and solutions in designing clinical trials by putting various herbal therapies on as equal footing as standard interventions to describe their benefits.
In understanding the co-joining of Western medicine with herbal therapies, we must look at the uniqueness of cancer.. One of the hallmarks of cancer is the genetic instability of some genes and the loss of others. Every cancer is somewhat unique with its own genetic signature, yet it is paradoxical that Western medicine approaches the uniqueness of each cancer with a monolithic treatment and standardized approach for the many types of cancers. We have just started to individualize therapy based on an individual’s genetic tumor markers and we are many years away from making this work.
Another paradox is that many forms of ancient medicine such as Tibetan and Chinese medicine have always taken a much more individual approach to treatment and diagnosis. These individual approaches have obviously not been based on molecular markers, but have been based on other attributes that an experienced practitioner should be able to utilize in a dual approach.
The Program
A. Philosophical Background
The research designs we are using for our first attempts to investigate herbal interventions are very crude and will need to be refined. There is a need for research in alternative modalities for the treatment of breast cancer. Currently, there is a high use of complementary or alternative therapies. One survey of women with advanced breast cancer in the San Francisco area revealed that 70% had utilized some form of complementary or alternative medicine (CAM). CAM use is associated with a high personal cost as third party payers do frequently not cover it.
Alternative therapies are often done in conjunction with standard therapies but are not coordinated. Medical oncologists may not be aware or interested in knowing what their patients are doing in the form of CAM. There is a lack of standardization of CAM modalities making the study of these therapies difficult. Data on effectiveness and toxicity of these therapies is minimal making it difficult to integrate into standard therapies. The lack of acceptance by the conventional community and third party payers also hinders integration of these therapies into cancer care. When trying to understand in a quantitative sense the benefits of these therapies, we must look at the type of model we will use. The conventional medical model has been the vehicle for the development of most cancer treatments including chemotherapy, hormonal therapy, and vaccines. This model has been based on a single agent approach that is well defined, identifies molecular properties of the treatment agent, has measurable outcomes, and pre-defined endpoints.
The alternative model is somewhat different in that there are complex modalities with individualized treatment plans that may vary from one person to another. The mechanisms of action at a cellular and molecular level are generally not known. The unifying theme of any model should be that there are measurable outcomes and pre-defined endpoints.
B. Details
The dual approach we are utilizing for clinical trials involves a prospective cohort study where we are following patients who are using traditional Chinese medicine as the alternative modality. Although this will not answer questions to the degree that a clinical trial would, we feel it is an important step in understanding the demographics, side effects, efficacy, and kinds of modalities. This information will then help us define more focused clinical trials with narrow, specific aims and pre-determined endpoints in a specific clinical situation. Traditional Chinese medicine (TCM) is the paradigm we have chosen to research in the treatment of breast cancer. TCM has a well defined practice with a history of centuries of practice. Many texts have been written on TCM and there is ample research in this area as well. There is conformity and reproducibility in the practice of TCM, and it is licensed in many states. Traditional Chinese medicine includes acupuncture, herbal formulas, specific means of diagnosis, and individualized dietary recommendations.
C. Research
Patients who are part of this study will see both TCM and Western medical providers. We hope to assess the feasibility of integrating the two modalities. Patients will be seen jointly by both types of practitioners. The correlation between western and TCM diagnoses will be interesting to evaluate. Western approaches look at characteristics of the tumor, hormone receptors, histologic grades, and if there is a correlation between these tumor types. These are what a TCM provider would describe in terms of the characteristics and imbalances they would utilize in diagnosis. Does a prior history of hormone therapy, oral contraceptive use, or family history relate to the TCM diagnosis? These are things we hope to investigate. Our study will be of interest because we are seeking information from three sources, the patient, the Western medicine physician and the TCM physician. The patient will give of us information concerning quality of life issues, symptoms, attitudes and preferences, as well as costs, compliance, disease status, and survival. The TCM provider will give us information concerning the points being used for acupuncture, the diagnosis, and herb and dietary recommendations. The Western physician will provide us will lab, CAT scan, and other test results.
This information will help us in several clinical trials we are developing or have in progress. Currently we are evaluating TCM as an intervention for the side effects of chemotherapy in women with breast cancer. The chemotherapy for breast cancer is very regimented and uniform. This makes it easy to see a treatment effect for herbal interventions given to alleviate the side effects of chemotherapy. Women receiving chemotherapy frequently have side effects making this study very useful. Finally, many TCM providers have provided us with consistent information for the treatment of side effects, so consensus further strengthens our study.
Although a standardized herbal treatment is contradictory to TCM, we were required to develop a standard herbal therapy in order to get FDA approval for our study. We have tested our herbs for bacteria and heavy metals, and now have a manufacturer formulating the herbs for the study. The study is placebo controlled and randomized so we can evaluate the side effects and actual improvement.
Another study we are undertaking involves the use of Tibetan medicine to treat advanced metastatic breast cancer. This phase I and II clinical trial study is exciting but difficult in that we had to develop some standardized treatment to evaluate our interventions from a research perspective. But Tibetan medicine is similar to TCM in that it is also individualized to each patient. The ethics of doing a study with only Tibetan medicine had to be evaluated. We are having a traditional Tibetan practitioner who has treated other breast cancer patients provide care for the patients of our study. He has approximately 15 different preparations he uses for treatment. In order to get approval for our study, we had to ask him to narrow down the number in order to meet FDA guidelines for investigational new drugs.
The patients entering this study will be followed by Western practitioners for toxicities and tumor progression. Patients enrolled will have metastatic breast cancer with minimal or no symptoms and no imminent organ failure. They will have a physical exam, CT scans, and X-rays after which they will undergo a Tibetan medical exam. They will be followed monthly for side effects and blood work and evaluated for tumor progression every three months with the time to disease progression as the end point.
These are starting points to critically look at herbal therapy in defined clinical situations. We are going to have to be innovative in developing research alternatives that are appropriate to the CAM modalities while maintaining scientific integrity.
Dr. Hess
II. The Cancer-Related Issued Addressed
This section will address some background concepts of cancer treatment and CAM therapies across cultures. We will also address the cultural origins of cancer and the variation in conventional treatment across cultures. Parts of the discussion will address the social status of certain treatments as well. Conventional and unconventional treatments are determined by their status of acceptance by the biomedical sciences model, regulatory agencies, and third party payers. Likewise, unconventional therapies in one country may be accepted as conventional therapies in another country. An understanding of these definitions of complementary and alternative therapies is important to this discussion. The British medical system defines complementary therapies as treatment in addition to conventional treatment, and alternative therapies are those done in place of conventional treatment.
Efficacy is an important issue for patients. It is important to distinguish the target of intervention from the practitioner’s vantagepoint. Do practitioners believe that the intervention affects the body or the mind-energy spirit? Does the mode of intervention affect the patient through words, symbolism, ritual, or through physical manipulation agents? These questions help to clarify the therapy from the point of view of the practitioners in understanding their cultural traditions.
Another concern is patient safety. It is important to distinguish between toxic and non-toxic therapies in terms of side effects, and whether those side effects are reversible. Reversibility is important, as there are patients who have chosen surgery because it is relatively non-toxic even though it is irreversible. Conversely, patients have chosen not to undergo chemotherapy because of the side effects, despite the side effect’s reversibility.
The final concern is that of Western verses non-Western and Biomedical verses non-biomedical treatment. An example of Western therapy that is non-biomedical is that of chiropractics which has a subtle energy theory. An example of a non-Western Biomedical therapy is that of Japanese immune system therapies. Understanding that the field of biomedicine does not always correspond to Western medicine is important culturally.
There are four basic concepts of non-biomedical therapies: humoral, subtle energies, mental disciplines, and spirits therapies of which the most important is the humoral concept. Humoral based medicine was popular among the Romans, Greeks, Islamic, and then Western medicine up through the 19th century. It is again becoming popular in the West through the importation of Asian therapies (i.e. Ayurvedic and Chinese medicine).
Humoral therapy involves distinguishing the different humors in the body such as yellow bile verses phlegm. These humors are aligned with sex, seasons, and basic elements of the earth such as fire, air, and water. Treatment involves restoring balance of these humors through the application of herbal or dietary treatments that cause sweating, bleeding, urination, etc., to balance these humors.
The 19th century brought about a new series of alternative therapies. Graham (maker of the Graham cracker) and Kellogg (cereal maker) created diet therapies that were a revolt against the humoral therapies of leeches and heavy metals typical of the treatment of that time. They remained within the humoral system until the germ theory emerged at the end of the century.
Subtle energies and spirits are other concepts. They cannot be measured directly and are not reducible to electromagnetic radiation. Rituals associated with these energy therapies are shamanism, sorcery, exorcisms and other ritual healing sources.
The mental disciplines are the final non-biomedical therapies concept. They are more easily integrated into Western medicine and include meditation, prayer, visualization, and interventions that focus mental energies on specific goals or objects.
There are also a wide variety of therapies by region of origin. Many are coming from Asia, and particularly East Asia. A significant number of cancer patients use these therapies, especially Chinese herbal therapies. Other areas of origin include Europe, the Middle East, the Americas, and Africa.
III. The Program
A. Philosophical Background
This wide selection of regional CAM therapies for cancer patients dissatisfied with Western biomedical approaches becomes very difficult to sort through. They are difficult to evaluate from a research and patient point of view. In choosing therapies, one must consider the patient’s needs at all levels including financial, spiritual, and biomedical. The patient must also evaluate referral and information providing organizations. These organizations charge significant sums for write-ups of treatments. Practitioners from the different CAM modalities should be evaluated. Modalities, methods, and therapies need to be examined for appropriateness. And finally, policies that outline therapeutic choice need to be examined.
The randomized clinical trial is the gold standard of evaluation and generates the best and surest evidence. But it does create biases by channeling the way one evaluates therapies that are consistent with the typical Western biomedical approach. For example this approach favors short term therapies and tends to locks cancer patients into a single protocol. Short term endpoints are often used and sometimes favor tumor regression as a surrogate endpoint that creates a bias in terms of more toxic therapies. It also tends to favor standardized treatments and single agents, not the flexible approaches and total programs used in many CAM practices.
B. Details
The research that we have been doing is a hierarchical model of thinking about evidence. We have types of evidence that are ranked in order of how valuable they can be for patients and clinicians in assessing a therapy. If the safety of the treatment or intervention is relatively known and secure, clinicians are more willing to go down in hierarchy to incorporate that intervention into practice. This is a slightly more flexible model to evaluate CAM approaches to cancer therapy.
There are some diet therapies that are often used in the United States as treatments for cancer. The macrobiotic diet is an East Asian system that is explicitly humoral in its use of Yin and Yang and the classical use of humoral categories. Foods are classified in their ability to balance the Yin and the Yang. Cancers are similarly classified and the aim of treatment is to move the more Yin cancers to the Yang side through food and visa versa. This diet is based on cooked foods with a heavy grain portion with soups and sea vegetables included. It is consistent with an East Asian diet that is epidemiologically linked to lower cancer rates.
Evaluation of a macrobiotic diet is limited. There is some limited work on the soy portions of the vegetables in the diet. There are retrospective studies that have not been published, making the diet difficult to evaluate. Some concerns are that the diet has a high sodium content, large amounts of cooked foods, it lacks fatty acids, allows frying, has a high carbohydrate content, rejects some vegetables thought to have anti-cancer properties, and has possible nutritional deficiencies especially in late stage patients.
C. Mechanisms of Action
The Gierson diet was founded by Max Gierson, a German Jew forced to leave Germany during the Nazi era. His diet therapy is drawn from humoral components cited by Hippocrates and involves peristaltic detoxification by enemas and special soups. There is a heavy German component to the diet as evidenced by the use of potatoes, dairy products, and grains. There is question whether the diet components are pulled from nutritional science or from cultural components.
The Gierson diet has been better evaluated. Juicing, a part of the diet, has glycemic control problems. Another concern is an addiction to caffeine from the required coffee enemas. Compliance issues are problematic for patients because of the difficulty of consuming raw foods and raw juices.
IV. Comments
Reviewing culture as a shaping factor is useful in evaluating not just CAM therapies but also conventional oncology practices. Germany, until recently, had safety regulations only for drugs. Herbal therapy is taught in Germany medical schools. The German holistic oncology society is larger than the conventional medical society. Germany also has had a long and upstanding tradition of CAM therapy usage where medical practitioners are allowed to practice a wide variety of CAM therapies. There is much more integration of this therapy with conventional therapy in oncology practice.
France has a lower use of surgery, especially on the gender related organs. The French pioneered breast conserving therapies for breast cancers and are far ahead of the United States for lumpectomies. There is a strong interest in immune therapies and a much higher reliance on radiation than in the U.S. and U.K. This shows that as one crosses cultures, the mixes of conventional therapies change. The U.K. has an economizing style, there are fewer drugs and fewer surgeries. This system is known for a more "hands-off" approach to cancer care. he United States favors aggressive approaches to diagnosis, surgery, evaluation, and drug dosing. Military metaphors often are part of the language of diagnosis and treatment in this culture and serve to illustrate this aggressive approach.
Examining illness disclosure across cultures, the Anglo-Saxon cultures are at the forefront in truth and disclosure of diagnosis. Occasionally, this approach is thought of as abrupt as evidenced by one patient who received a diagnosis of cancer on her answering machine on Christmas Eve. Disclosure is often not made to patients in other countries, but instead to their families. Clinicians discuss therapies and treatments with families, and the family chooses whether to disclose the disease. Japan is a culture typical of this approach.
Different cultures have different integration policies concerning CAM and conventional treatments. Since the 1930’s Germany has sanctioned CAM therapy practitioners although medical physicians only legally practice certain modalities. The CAM providers are licensed through a state exam that demonstrates only that they know the law concerning their practice. The system is very open with minimal standards and schooling. There is a long standing acceptance of coverage by private and national health insurers.
The French model is very common in southern Europe and Latin America. It is based on the Napoleonic code tradition that forbids any medical practice unless it is permitted by law. Homeopathic medicine is also much more widely accepted among the French medical profession. The medical profession can only practice healthcare with some clearly defined exceptions. Supplements are more heavily regulated and pharmacists have a much broader scope of practice than their counterparts in the United States. They are allowed to prescribe medications and give injections. The Asian countries have various policies concerning integration of CAM and conventional therapies. In China, the traditional practitioners are very prominent. In Japan, East Asian medicine is widely available for the upper class and is now included in the national health insurance. In India, CAM practice is very strong. In 1975 there were more Ayruvedic medical schools than conventional medical schools.
The United States is the odd country in its integration policies. Whereas many cultures incorporate global perspectives in treatment, the U.S. still has few policies that dictate how to address the integration of CAM and conventional treatment.
Mr. Mntshali
II. The Cancer-Related Issue Addressed
The Traditional Healers organization is 50,000 strong with members that represent traditional healers throughout the world trying to bridge the gap between traditional and modern therapies. The organization promotes collaboration between old and new forms of medicine. It is sustained by grants and donations from groups such as USAid, Unicef, Red Cross and other charities.
In Africa, cancer is considered an old disease that can grow everywhere in the body. It causes several symptoms and has an African name, which implies that the disease "eats everywhere." Cancer symptoms are similar to those of abscesses, foreign bodies, sores, and infections. When trying to treat cancer, it is important to examine and diagnose patients thoroughly, as cancer has many causes and types. Some cancers are caused by impure blood, lack of nutrition in the blood (inadequate consumption of fruits and vegetables), or sorcery (someone who wishes you evil). Other causes include eating poisonous food, excessive alcohol consumption, and germs from poisons that adhere somewhere in a weak body part where it grows to become cancer.
Heritage is a cause of cancer. African culture believes that inherited causes of cancer can come from a number of familial sources. The sins of ancestors can be causes of cancer. If forefathers have committed acts of crime such as killing, the price for those sins may be cancer in later generations of the family. Another means of acquiring cancer is if the trait is passed on. Ancestors may have had cancer that might explain a current diagnosis of cancer among a family member.
Cancer by sources of heritage is a widespread problem among Africans, and people throughout the world. Many people are being told that their cancer is incurable. Africans are being told that their cancers are caused by the deities or evil spirits brought about by the wrongs of their ancestors.
Treatment of this type of cancer requires many interventions. One intervention involves a ritual to locate the spirit of the dead person inflicting the cancer that previous ancestors have killed, and asking the spirit for the solution to curing the cancer. Reparations must be offered including asking for forgiveness for the ancestors who have inflicted the harm. Often, after this ritual is performed and forgiveness is accepted, the cancer patient is at peace and able to take medication to treat the disease. Patients and practitioners find that medications are more effective when forgiveness is sought.
Since cancers can be caused by inadequate intake of fresh vegetables and wild fruits, Africans in urban areas have increased cancer rates because of the inaccessibility to appropriate foods. Urban markets often have good produce but it may be overcooked or unhealthily prepared. People in urban areas consume more sugar and salt, and have jobs that do not require physical exertion.
The rural areas have abundant fruits and vegetable. Also, the people of the rural areas perform more physically demanding work in the fields and forests where fresh air is more abundant. Children go into the forests and collect the fruits and vegetables that are rich in nutrients. The physical exertion coupled with better dietary intake makes them less prone to cancer.
III. The Program
The treatments for cancer discussed here are treatments used by traditional healers in Africa. After the specific type of cancer is diagnosed, the use of a special herb of a tree that is made into a powder for use as a laxative. This laxative is meant to purify the blood, which is the first treatment of cancer. After the blood is purified, then the source of cancer can be much more easily treated.
IV. Comments
The Traditional African Healer organization is holding a conference in Johannesburg on August 16 through August 20, 1999. After years of imprisonment in Africa, many healers will showcase their abilities at this conference to help care for African patients with cancer, AIDS and diabetes through the use of herbal treatments and traditional healing.
V. Audience Questions
There has been great effort at fighting cancer, but there appears to be little research on the immune systems and its ability to fight cancer. What is the research?
Dr. Tripathy: There is some evidence that the body is able to mount an immune response. There is not a lot of evidence that shows how great that immune response is. There are vaccines in trials and genetic alterations of cancer cells to test their susceptibilities to vaccines. Historically, these approaches have not been successful. Some of the intent of herbal therapies has been to stimulate the immune system.
Mr. Mntshali, one of the causes of cancer is the sins committed by ancestors. Are there particular rituals or practices to ameliorate those sins and break the cycle so it does not continually happen generation after generation?
We are trying to train doctors who can treat this problem. When we find these types of patients, the best thing is to go to the home and do the purification ritual there and purify every family member and the home. It may be home strife that causes disease. So purifying the homestead may treat a number of problems that contribute to the disease.
Dr. Hess, did you have the opportunity in your fieldwork to track cancer patients and did you know of any rituals that worked for cancer patients?
Most alternative healing was for psychological problems. It was really hard to assess because there were concurrent conventional therapies performed so it was difficult to determine from where the treatment effect came.
Dr. Tripathy, what drove you to decide a single agent clinical trial verses a group of Tibetan agents or having a randomizing arm whereby patients are seen by a Tibetan healer?
The trials we do have some individualization and multiple treatment agents. If we can understand the mechanism by which some of these therapies work, we can build upon our hypotheses. Of course there may be some treatments that only work in combination, and only have empirical data from centuries of use without any scientific explanation. One of the concerns is that because we may not be able to scientifically find ways to identify the efficacy of some treatments they may be overlooked. This is a dilemma where we may have to evaluate efficacy without understanding the biomechanical reasons for that efficacy.
Dr. Tripathy, where are the herbs for the Tibetan study coming from and is there a value to growing them in one place verses another?
One practitioner is growing them in India where they are processed. For the trial we received all of the herbs we would need and then had them tested for heavy metals and bacteria here in the United States so we were sure of the safety of the batch for the study.
In Tibetan medicine is there any other way of treating cancer beside using diet and herbs?
Dr. Tripathy: Many times there are herbal and dietary treatments that are combined.
Moderator: Sound and meditation are often used in Tibetan medicine. Tibetan bowls are famous for their ability to induce and sustain meditation.