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July 15, 2002

Traditional Chinese Medicine in the Treatment of Breast Cancer - Part One
Isaac Cohen, LAc, OMD, Mary Tagliaferri, MD, LAc & Debu Tripathy, MD

Abstract
Introduction
Method

Prevention: the treatment of breast cysts
The Treatment of Breast Cancer
Conclusion
Traditional Chinese Medicine
in the Treatment of Breast Cancer - Part One

Traditional Chinese Medicine
in the Treatment of Breast Cancer - Part Three


Formularies (Part Three) Traditional Chinese Medicine
in the Treatment of Breast Cancer

Tables and Studies - Traditional Chinese Medicine
in the Treatment of Breast Cancer

(Part 3) References

This is part one of a series of five articles designed to explore the integration of traditional Chinese medicine (TCM) in the treatment of breast cancer. Part one will detail the results of clinical trials from China. Part two will detail specific TCM and western medicine (WM) treatments for early stage breast cancer. Part three will discuss secondary prevention of breast cancer and part four will outline TCM pattern differentiation for breast cancer pathogenesis. The series will relate what is known scientifically as well as the authors clinical experience and current understanding of the disease. It will start with dry facts and culminate with the experiential and speculative.

Abstract
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The treatment of breast cancer involves multiple disciplines, and current recommendations are based on modern tenets of biology and pharmacology along with a growing body of evidence based literature. Despite advances in screening, surgery, adjuvant radiation and systemic therapy and novel biologically targeted therapies, there are limitations to their benefits, especially in advanced disease. Complementary therapies including Oriental medicine have enjoyed a growing popularity as a less intensive and more natural approach to achieving health or improving quality of life. However, definitive literature in this area is scant and therefore has not been integrated into the mainstream medical community. Traditional Chinese medicine (TCM) may serve as a useful model for scientific inquiry since there is a standardised system of diagnostics and therapies, and this discipline is practised worldwide. Still, the holistic and individualised nature of TCM presents challenges to rigorous clinical testing, and as a result, most published work in this field is in the form of anecdotal reports or uncontrolled series. Among the components of TCM, herbal or botanical agents possess complex biological activities that could affect many aspects of carcinogenesis such as cell growth and proliferation, host-tumour interactions, immune function and differentiation. Despite a fairly extensive series of laboratory studies detailing many biological effects of botanical agents, few clinical trials have been completed to test specific hypotheses regarding the mode of action of TCM. Most TCM therapies have been empirically applied in a series of patients with descriptive results provided. The summaries of a few studies highlighted in this review can provide some evidence of safety but generally do not possess the design and results to verify clinical effectiveness. Nevertheless, the theory of TCM coupled with laboratory studies and safety information can serve as the basis for the design of more definitive trials of TCM for specific indications in breast cancer. There is increasing interest and growing opportunities for investigative approaches that could ultimately verify or reject TCM and specific botanical agents. Some of these initiatives in the area of breast cancer prevention and treatment are outlined.

Introduction
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Many individuals with breast cancer seek alternative approaches to prevent recurrence and for the treatment of metastatic disease. Alternative approaches to medicine are widely used in the United States and throughout the world to treat a broad spectrum of conditions as well as to maintain wellness. It is estimated that one in two (46.3%) Americans currently use alternative therapies and make 629 million visits to alternative medicine practitioners each year. 1,2 Despite widespread use, complementary and alternative medical approaches have not undergone rigorous clinical testing to measure outcomes. Consequently, while more patients are seeking alternative medicine, there is little in the medical literature to determine if these therapies can be used safely, improve quality of life or provide a therapeutic benefit.

Botanical agents were once the most significant medicinal substances employed by physicians. According to a WHO survey, 80% of the world population still rely on herbal medicine as their primary source for therapy.3 In the Western world, approximately 25% of currently prescribed drugs were first identified in higher plants4 and over half of the 50 most popular drugs today are derived from plant material.5 Over 60% of chemotherapeutic agents used in the treatment of cancer today are derived from natural substances6 and some of the most popular drugs are still fractionated from plant material.7

Chinese medicine employed treatments for cancer for over two millennia. The book The Rites of the Zhou Dynasty (1100- 400 BCE) refers to physicians specialising in the treatment of swellings and ulcerations or necrosis and ulcerations. These terms are still utilised in the modern practice of traditional Chinese medicine to denote the study and treatment of tumours that are both benign and malignant.8

Early Chinese medical texts described different types of breast tumours and discussed their clinical appearance, physiological origin and severity.8-11 Over 100 names were recorded for tumours in early medical literature. Most of these terms represent conditions that would be regarded as early cancerous conditions in the Western medical literature. The most frequently cited term for breast cancer was breast rock12. In the Yellow Emperors Classic of Internal Medicine (written circa 250 BCE), the first clinical picture of breast cancer was described. The prognosis was estimated to be approximately ten years after diagnosis and the process of progression, metastasis and death was detailed. 9

There are hundreds of anecdotal case reports of breast cancer cures using traditional Chinese medicine (TCM) as a sole therapy.13-15 Chinese medicine is useful in all stages of the disease to augment the benefits of conventional treatments, to prevent recurrence and metastasis in early stages of breast cancer, and to promote health, improve quality of life and prolong life in advanced stages.16-29

Method
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A wide literature search was conducted through the National Medical Libarary, the library of Shanghai University of Traditional Chinese Medicine and the library of Beijing Medical University. Key words used in the search were: breast cancer, TCM, acupuncture and herbal medicine. The search was conducted for all citations in these categories from 1984-2000. Most citations were either personal experiences and case reports of individual physicians, or of laboratory experiments using herbal medicine. For this review we accepted only controlled clinical trials or case controlled studies. Original sources were obtained mostly in the Chinese language by our collaborator Li Ping Ping M.D., Director of TCM Research Center at the Beijing Medical University, Cancer Research Institute, Beijing, P.R.C. and were translated by Shelley Oachs, M.Sc., L.Ac., a professional medical translator and licensed acupuncturist in San Francisco, California. Most of the studies reported in this review lack the accepted rigor required by Western medical journals yet the results are compelling and deserve further attention.

Prevention: the treatment of breast cysts
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Although the number of cases of breast cancer has increased dramatically over the last decade in China30 the risk of being diagnosed with breast cancer or dying from breast cancer is still five times higher in Western countries than in China.31,32 Some of the differences are attributed to difference in body mass, age of onset of menstruation, length of menses and nutritional factors such as soy and green tea consumption.33 There are many case reports from China detailing effective treatments of breast disorders using herbal medicine and acupuncture. Some of these disorders are considered to increase the risk of breast cancer incidence.

In the Western world 7% of women develop palpable breast cysts.34 Studies that included only or mainly women with palpable breast cysts have shown that those women are at an increased risk of developing breast cancer.35-38 The risk was age dependent but was independent of the type of cyst found.39 Dixon et al. showed that the overall standardised incidence rate of breast cancer in patients with palpable cysts was 2.81 (95%) when compared to the risk in the overall population. For women under 45 years old, the risk for developing breast cancer was the greatest at 5.94 (2.97- 10.63), with significant trend for decrease in relative incidence rate with age. The standardised risk was highest in the first year after aspiration of the cyst, 7.02 (3.73-12.00) but was still raised after five years, 2.68 (1.84- 3.76). Though there is no study that correlates the reduction or disappearance of palpable breast cyst with the reduction of breast cancer risk, one can speculate such a correlation.

Five studies including 757 women (participation in the studies was as follows: n=389, 90, 50, 128, 100) aged 13-55 with a history of chronic fibrocystic breast disorder (FBD) and discrete palpable lump treated with Chinese herbal medicine that were discovered in our literature search are hereby summarised. FBD was defined by the presence of pain, cysts and distinct lumps, and patients enrolled in the studies were treated for one to six months. The average total effective rate, defined as complete resolution of lumps, pain and cystic changes for at least three months following herbal treatment, was 68.4% (518 women). When the 159 women who had partial effect defined by marked improvement of greater than 50% were included, the total effective rate of the herbal treatment was 89.4% (677 women). The herbal formulas used in the trials varied (see Table 2) and their therapeutic classification was defined according to TCM tenets.40

In a sixth trial, 120 women with discrete benign breast lumps were treated with traditional Chinese herbs. Radiological assessment (X-rays, ultrasound, thermography) were used for evaluation and diagnosis. Various herbal formulas (see Table 3) were administered according to differentiation of symptoms and signs based on the diagnostic principles of TCM. The age range was 20-62 years, with an average age of.41 Seven women were reported to be unmarried and 113 were married (denoting seven women were not sexually active). The patients were only permitted to take herbs that were prescribed in the clinical trial. In order to standardise the dose, the herbs were encapsulated and administered to the study subjects. A total of 46/120 (38.3%) women had complete resolution of the lumps for at least 3 months; 56/ 120 (46.6%) had greater than 50% reduction of the lumps, 12/120 (10%) had less than 50% reduction and 6 (5%) had no improvement. One treatment course comprised three months of herbal therapy. Complete resolution of symptoms after one course of treatment (three months) was experienced by 36/120 (30%) women and 10/120 (8.7%) had a complete resolution after 6 months. No adverse side effects were experienced by the participants.41

Results from a clinical trial of 96 women with breast lumps showed acupuncture and herbal medicine were effective in resolving the breast lumps and pain associated with fibrocystic syndrome.42 The participants were prescribed a single herbal formula (Modified Er Xian Tang, below) and they received acupuncture treatments at various locations on the Stomach and Liver channels, and the Governing and Conception vessels. Of the 96 women, 58 (60.4%) had complete resolution of the lumps after three months follow-up, and 17 (17.7%) were markedly improved. The total effective rate of the trial was 78.1%. The selection of the acupuncture points was based on combining points traditionally used for breast disorders and points that have shown to regulate specific reproductive hormone levels. The authors noted that the serum hormone analysis before and after the trial showed a regulation of the hypothalamus-pituitaryovarian axis. There was a decrease in serum estradiol and an increase in serum progesterone and testosterone. The authors speculate, on the basis of animal and human experiments, that acupuncture regulates hormonal function via neurohormonal and nervous reflex effects. This theory implies that the insertion of needles at specific acupuncture points can result in a secretion of neuro-chemicals or synaptic stimulation that have a down stream effect on secretory glands and cellular hormone receptors. In many of the clinical trials, modulation of oestrogen, progesterone and FSH were detected after the stimulation of acupuncture points.

Modified Er Xian Tang

Xian Mao (Rhizoma Curculiginis Orchioidis) 10g, Yin Yang Huo (Herba Epimedii) 12g, Chai Hu (Radix Bupleuri) 12g, Dang Gui (Radix Angelicae Sinensis) 15g, Bai Shao (Radix Paeoniae Lactiflorae) 10g, Gou Qi Zi (Fructus Lycii Chinensis) 10g, Lu Jiao Jiao (Colla Cornu Cervi) 15g, Zhi Gan Cao (Radix Glycyrrhizae Praeparatae) 5g. One bag a day in water decoction. Thirty bags to one treatment course.


Increased mammographic breast density is an important surrogate marker of increased breast cancer risk. Increased breast density is seen more in younger, premenopausal women and women who use HRT.43-46 Women who consume more soy products have lower overall mammographic breast density.47 Mandelson et al.48 report that after adjustment for age at index mammogram (the mammogram used for the study), menopausal status, use of HRT and body mass index (BMI) the odds ratio (OR) for interval cancer (getting cancer within five years of dense mammogram) among women with extremely dense breasts is 6.14 (95%) comared to women with extremely fatty breasts. When only retrospective review of index mammogram were considered, without adjusting to age, which is one of the most significant risk factors for breast cancer, the OR increased to 9.47 (95%). A study of 460 women with benign breast lumps and increased breast density treated with herbs reported a good effect on the resolution of lumps and reduction of density. The women in the trial ranged in age from 19-58, with an average age of 38.5; 79.6% were between the ages of 28-45 years and 20.4% were 46-58 years old. Among those enrolled in the study, 206 of the women suffered from bilateral breast lumps and increased density, 148 had the symptoms on the left only and 106 had symptoms on the right. All the patients were followed for six months after the end of the treatment.

The patients were classified into three groups according to TCM pattern differentiation and were given a single herbal formula (Xiao He Ling Formula, below). Of the 460 women, 108 (23.5%) showed complete response. Complete response was defined as the complete disappearance of lumps and shadows with X-ray and infra-red ray assessments. A total of 222/460 (48.3%) women showed marked improvement (greater than 50% reduction) and 96/460 (20.9%) of women showed some improvement (defined greater than 50% reduction of density but less than 50% reduction of the mass).49

Xiao He Ling Formula Wu Gong (Scolopendra Subspinipes), Yan Hu Suo (Rhizoma Corydalis Yanhusuo), Chuan Sha Jia (Squama Manitis Pentadactylae), Quan Xie (Buthus Martensi), Yu Jin (Tuber Curcumae).

Unfortunately none of the above data has been directly correlated to a reduction in the incidence of breast cancer. Patient follow-up was relatively short and no information about the incidence or risk of breast cancer was reported.

The Treatment of Breast Cancer
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Breast cancer is currently treated with surgery, adjuvant and neo-adjuvant chemotherapy of short duration (3-6 months), local irradiation, biological agents and long-term hormonal therapy (up to 5 years). The effects of those treatments have been defined and characterised widely through large randomised controlled clinical trials in the past decades. The use of clinical trials methodology helped oncologists clarify the actuarial usefulness of the treatments employed and therefore strategise the treatment in accordance with both clinical and molecular findings. The use of adjuvant chemotherapy has shown a significant decrease in both the rate of recurrence and in mortality. In their meta-analysis of breast cancer adjuvant chemotherapy clinical trials, The Early Breast Cancer Trialists Collaborative Group reported that adjuvant chemotherapy produced significant proportional reductions in breast cancer recurrence for both women under the age of 50 (35% reduction) and for women 50-69 years of age (20% reduction).

The recurrence reduction was chiefly observed in the first 5 years of follow-up. Mortality was significantly reduced for women under 50 (27% reduction ) and among women 50-69 years of age (11% reduction). The difference in survival grew throughout the first 10 years. For women under 50 years old with node-negative disease the 10 year absolute survival benefit was 7% (from 71%-78%) while for women with nodepositive disease the 10 year absolute survival benefit was 11% (from 42%-53%). For women 50-69 years of age with node negative disease the 10 year absolute survival benefit was only 2% (from 67%-69%) while for those women with nodepositive disease the 10 year absolute survival benefit was 3% (from 46%-49%)50. Since most women who are diagnosed with breast cancer are older than 50 years of age51 the mortality benefit is less statistically significant for the majority of women diagnosed with breast cancer.

The current trend in China is to integrate, or combine, Western therapies with TCM in the treatment of breast cancer. There are no available statistics on the proportion of women using this approach. Our collaborators in China estimate that about 70%-80% of women diagnosed with breast cancer in the metropolitan areas, where Western medicine (WM) is favoured, are using the combined approach at some point during their treatment of breast cancer while a very small fraction of women use TCM as a sole therapy (private conversations with Dr. Li Ping Ping and Dr. Yu GQ, President emeritus of All China Society of Cancer Prevention and Treatment with Integrated TCM and WM). The treatments employed by the TCM physicians are aimed at controlling side effects and toxicities attributed to cancer therapies, improving quality of life, preventing recurrence and prolonging survival.52-54

Conclusion
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The results reported in this survey are very compelling. A direct effect of integrated WM and TCM on both recurrence- free survival and overall survival are noted. Though we tried to include only well documented studies, they all suffer from many major methodological and reporting flaws that leave many questions to a critical reader rather than clear answers. It has already been noted by several researchers that clinical reports from China tend to produce only positive results.67,68 Compared to trials published in England where 75% gave the test treatment superior results to control, the results in China were 99% superior to controls.67 The reports generally suffer from writers bias. Botanical/herbal medicine is one of the more popular complementary and alternative medical approaches used by cancer patients. Chinese herbal therapy is a treatment modality widely sought by breast cancer patients.69,70 Many women diagnosed with breast cancer use Chinese herbal therapy both as anti-cancer agents as well as to alleviate the side effects of chemotherapy and of the cancer itself. Traditional Chinese medicine (TCM) is also well suited to investigation using a Western clinical model because there is a high degree of conformity about both diagnoses and treatments among practitioners, extensive texts exist to facilitate research, and practitioners are licensed to dispense herbs in many US states. Therefore, it is essential that a scientifically sound methodology be developed to evaluate the specific benefits and risks associated with Chinese herbal therapy for breast cancer.

For reasons of space,this series has been extended to five parts. Part three will discuss the use of Chinese medicine in the context of chemotherapy; part four will discuss secondary prevention of breast cancer, and part five will outline the TCM differentiation for breast cancer pathogenesis.

About the Authors

Reprinted by permission from
Journal of Chinese Medicine Number 68 February 2002.
(Part One) Traditional Chinese Medicine in the Treatment of Breast Cancer
www.jcm.co.uk


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