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

Abstract
Introduction

Traditional Chinese Medicine
TCM intervention for surgery

Post-operative acupuncture
TCM and radiation treatment
Traditional Chinese Medicine in the Treatment of Breast Cancer - Part One
Traditional Chinese Medicinein 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

References


Abstract
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Traditional Chinese medicine (TCM)is becoming increasingly popular in many medical contexts, particularly among patients with cancer. TCM encompasses a range of modalities including herbal medicine, acupuncture, medical qigong, dietary recommendations and meditation (daoyin ). In contrast to standard chemotherapeutic and hormonal regimens used for the adjuvant treatment of early stage breast cancer, very little data from controlled clinical trials has been generated using TCM modalities in relationship to the outcomes of recurrence or survival,or even overall quality of life and safety. As we previously reported 1 , the objectives of TCM modalities are manifold - the reduction of therapeutic toxicity, improvement in cancer-related symptoms, improvements in the immune system, and even a direct anti-cancer effect. The primary basis of TCM rests upon empirical evidence and case studies, as well as its theoretical principles.In some cases, laboratory or clinical data lend support to these modalities. Although TCM practices are based on ancient medical tenets founded on centuries of experience, and documented through oral and written texts, its direct relationship to breast cancer treatment in an integrative setting is very young. There is still a paucity of evidence in the clinical setting, which limits firm conclusions about the effectiveness or safety of most TCM approaches to breast cancer. This review will summarise the application of certain TCM modalities in the therapy of early stage breast cancer.


Introduction
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Cancer affects one in three individuals in the Unites States and most patients seek initial evaluation and therapy in the modern conventional setting. Most oncologic therapies are based on evidence from randomised trials showing improvements in outcomes, particularly survival. However the use of TCM is becoming increasingly prevalent both where few conventional therapeutic or ameliorative options exist and also because standard oncologic therapies have side effects that can significantly affect patients' short and long term quality of life. A review of surveys of cancer patients from around the world showed the average prevalence of complementary and alternative medicine (CAM) use was 31%, with the most common types cited being dietary treatments, herbs, homoeopathy, hypnotherapy, imagery/visualisation, meditation, megavitamins, relaxation and spiritual healing 2 . In China many hospitals that have cancer wards offer TCM treatments alongside Western treatments, although there is no formal study addressing the use of TCM among cancer patients. Colleagues in China estimate that in rural areas almost all patients take herbal medicine when treated for cancer,while in urban areas that number is estimated to be 50%-60%, with increase of use in more advanced stages of the disease. A population-based study conducted in San Francisco, California showed that 72%of women with breast cancer used at least one form of complementary or alternative medicine,and one third used two forms 3 . The types of approaches used included dietary therapies (26.6%, including megavitamins), spiritual healing (23.7%), herbal remedies (12.9%),physical methods (14.2%),and psycho- logical methods (9.2%).4 The use of herbal medicine among women with ovarian cancer was 51% while only 12% of the women used trained herbalists for guidance. 5 Use of CAM was more common in younger women, more educated individuals, and among women with advanced stages of cancer; about half of the patients reported the usage of CAM modalities to their physicians. The complete abandonment of conventional therapy accompanying the use of alternative approaches is not very common despite the fact that conventional and alternative medicine in the Western world are almost never administered in a coordinated fashion. 6 Most formally trained medical oncologists tend to avoid making recommendations in the areas of alternative medicine and are generally reluctant to integrate their treatment plan with a discipline that is foreign to their training and not represented in the scientific literature. Yet at the same time, increasing awareness of CAM,coverage by the lay press and intense presence through electronic media, especially via the internet, has amplified cancer patients' interest in and pursuit of CAM. A recent analysis of over 1,000 CAM studies for breast cancer published in the mainstream biomedical literature however revealed few controlled,well designed studies with adequate endpoints. 7

Several TCM modalities have been highlighted for discussion of their potential study and applicability in the area of adjuvant therapy for early stage breast cancer. Of these, special emphasis is placed on herbal medicine and acupuncture given their prevalent use in China and by Western practitioners.


Traditional Chinese Medicine
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Traditional Chinese Medicine (TCM) serves as a useful yet complicated model of CAM therapy in a variety of medical settings.TCM consists of herbal medicine that is usually administered as a combination or formula,as well as acupuncture. Therapy is typically individualised on the basis of a TCM diagnosis of imbalance of the body measured by various parameters including yin,yang,qi,blood and body fluids. TCM diagnoses generally do not follow standard Western pathophysiologic classifications of disease. The tradition of TCM has evolved and been passed down for centuries and several well recognised texts and training institutions exist; hence, there is a fair degree of standardisation of diagnostic and therapeutic practice. Furthermore, TCM practice is licensed and regulated in most US states. Given the widespread use of TCM on the West coast of the United States, our research program has focused on this modality for clinical investigation in several settings for breast cancer. Although a significant body of research has been conducted in China into the ability of TCM to treat cancer, many of the studies are of poor quality, lack proper control groups, fail to describe the specific methods of the study and omit information about the statistical significance of the results. An overview of both acupuncture and herbal medicine studies in specific cancer-related settings is presented here as it applies to the potential for the study of TCM in early stage breast cancer in conjunction with and following chemotherapy or radiation therapy.


TCM intervention for surgery
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Surgery is by far the most effective treatment for early breast cancer and all women diagnosed with early breast cancer will undergo surgery as the main treatment for the disease. Currently women face several surgical options when encountering breast cancer diagnosis: lumpectomy with or without axillary lymph node excision (axillary clearance) or sentinel node excision,or modified radical mastectomy. Surprisingly there is no significant survival benefit to mastectomy over lumpectomy followed by locoregional radiotherapy. In recent years women who are diagnosed with large breast tumors, for whom lumpectomy is impractical for cosmetic reasons, have undergone neo-adjuvant chemotherapy, prior to surgery, in order to attempt to reduce the tumour size and conserve the breast. There is no significant difference in survival between women who undergo neo-adjuvant chemotherapy followed by surgery and women who undergo modified radical mastectomy 8-16 .

From a TCM point of view surgery is considered as an externally inflicted wound that results in damage to the smooth flow of qi and blood, gives rise to qi deficiency and blood stasis and results in both accumulation of blood in the vessels and in inability of the Spleen qi to contain qi and blood. Anaesthesia disturbs the functions of the hun (ethereal soul) and po (corporeal soul) in commanding the distribution and correct response of qi and blood. While under normal circumstances the body would have reacted with pain and strong survival response elicited by a combination of voluntary and involuntary reactions, the artificial disturbance of anaesthesia on the the hun and po results in irregularity in the normal course of the flow of qi, resulting in shen disturbance, qi deficiency and blazing of yin fire. The resulting symptoms such as pain, bruising, immobility, nausea and vomiting are part of that syndrome.

Although chemotherapy may induce nausea and vomiting as well, the type of symptoms and the duration of the symptoms encountered by women will be different. Post operatively the symptoms of nausea and vomiting tend to be shorter in duration: from a few hours to 3 days. The mechanisms of nausea and vomiting induction are not very clear. Many brain areas seem to be affected (area postrema, nucleus tractus solitarius and central pattern generator)and they are all mediated by abdominal vagal afferents.

Pre-operative acupuncture
Several issues can be addressed by TCM pre-and post- operatively.In preparation to surgery,acupuncture has been shown to reduce nausea and vomiting and pain. 17 Simple points like Hegu L.I.-4, Taichong LIV-3, Zusanli ST-36 and Neiguan P-6 have been used successfully for this purpose.

Contraindicated herbs with anaesthesia
Several anecdotal reports can be found in the literature of suspected negative interaction between anaesthesia control and herbs 18-19 and suggest that some caution should be practised.The following pharmacological categories are recommended to be used with caution:

Anticoagulants
Bai Zhu (Rhizoma Atractylodis Macrocephalae)
Dan Shen (Radix Salviae Miltiorrhizae)
Chuan Xiong (Radix Ligustici Wallichii)
Antithrombics
Dang Gui (Radix Angelicae Sinensis)
Hong Hua (Flos Carthami Tinctorii)
Jiang Huang (Rhizoma Curcumae)
Yi Mu Cao (Herba Leonuri Heterophylli)
CNS stimulating effect
Jin Yin Hua (Flos Lonicerae Japonicae)
Ma Huang (Herba Ephedrae)
Ren Shen (Radix Ginseng)
Coronary vasodilating and flow increasing
Bai Guo Ye (Folium Ginkgo Bilobae)
Bai Shao (Radix Paeoniae Lactiflorae)
Bu Gu Zhi (Fructus Psoraleae Corylifoliae)
Ji Xue Teng (Radix et Caulis Jixueteng)
Hypertensives
Sheng Jiang (Rhizoma Zingiberis Officinalis Recens)
Chen Pi (Pericarpium Citri Reticulatae)
Wu Yao (Radix Linderae Strychnifoliae)
Platelet aggregation inhibitors
Ge Gen (Radix Puerariae)
Shan Zhu Yu (Fructus Corni Officinalis)
Yan Hu Suo (Rhizoma Corydalis Yanhusuo)
Yin Yang Huo (Herba Epimedii)

Post-operative acupuncture
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Therapeutic and reconstructive surgeries bring on a variety of unwelcome conditions, including pain, anaesthesia-induced nausea,short-term diminished mobility, bruising and fatigue. TCM can be used to accelerate wound healing, increase peripheral blood circulation to aid the supply of nutrients and blood cells to the wounded area, aid nerve regeneration, reduce scarring, enhance the immune system and prevent lymphedema (swelling of the arm that can occur after the lymphatic vessels are severed by surgery).

A preliminary study of post surgical nausea,vomiting and pain,conducted at Duke University 17 showed that acupuncture is slightly more effective than the most commonly used antiemetic, ondansetron (Zofran).40 women undergoing breast surgery (augmentation, reduction or mastectomy) requiring general anaesthesia were studied. The surgery lasted 2-4 hours. The results can be summarised as follows:

Symptom Placebo Zofran Acupuncture
Incidence of nausea at 2 hrs. post-op 69% 36% 23%
Incidence of vomiting at 2 hrs. post-op 23% 7% 7%
Incidence of nausea at 24 hrs. post- op 61% 57% 38%
Incidence of vomiting at 24 hrs. post- op 46% 28% 23%
Incidence of pain at 2 hrs. post-op 77% 64% 31%

On the surface the results seem more than slightly better for the acupuncture treatment, but the number of women treated in this study was too small to derive a statistically significant conclusion.

Other than postoperative nausea,vomiting and pain, acupuncture is very useful to relieve postoperative constipation. Points like Shangjuxu ST-37,Xiajuxu ST-39, Yanglingquan GB-34,Zhigou SJ-6,Neiguan P-6,Tianshu ST-25, Qihai REN-6 and Qihaishu BL-24 seem to be very effective, especially when stimulated strongly. Acupuncture can be complemented with some herbs that stimulate bowel motility like Da Huang (Rhizoma Rhei)and Huang Lian (Rhizoma Coptidis).20-22 Gui Zhi Jia Shao Yao Tang (Cinnamon Twig Decoction plus Peony)may also be used. Post-operative herbal interventions to help wounds heal and stimulate platelet aggregation herbs such as Huang Qi (Radix Astragali) are used 23 , whilst herbs that inhibit granulation,such as Ba Ji Tian (Radix Morindae Officinalis)24 , should be avoided.

The application of herbal medicine after surgery takes into consideration the post-surgical syndrome, as described above, as well as the disease itself and the opportunity to initiate prevention of recurrence. Strengthening qi and fluids,regulating blood and reducing heat and toxins are the therapeutic principles employed.

Breast Cancer Post-Operative Formula
Herb name Dose in grams
Xia Ku Cao (Spica Prunellae Vulgaris) 15
Dang Gui (Radix Angelicae Sinensis) 10
Zhu Ling (Sclerotium Polypori Umbellati) 15
Shan Ci Gu (Bulbus Shancigu) 6
Jin Yin Hua (Flos Lonicerae Japonicae) 12
San Qi (Radix Pseudoginseng) 1.5
Huang Qi (Radix Astragali) 15
Tai Zi Shen (Radix Pseudostellariae Heterophyllae) 15
Gua Lou (Fructus Trichosanthis) 20
Fu Ling (Sclerotium Poriae Cocos) 15
Zi He Che (Placenta Hominis) 12
Bai Shao (Radix Paeoniae Lactiflorae) 10
Tian Men Dong (Tuber Asparagi Cochinchinensis) 15
Bai Hua She She Cao (Herba Oldenlandiae Diffusae) 15
Ren Shen (Radix Ginseng) 5
Zhi Mu (Radix Anemarrhenae Asphodeloidis) 12


TCM and radiation treatment
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Radiation is another prevention method for early breast cancer.The application of high energy beams through the breast tissue and local lymph nodes reduces the probability of local recurrence. 25-28 Radiation exerts its cell inhibitive effect through the creation of a high concentration of free radicals that create high local oxidative stress. The oxidative stress causes irreparable DNA damage and results in cell death. Since the cell death caused by radiation is not selective to cancer cells the whole radiated area is affected and the body responds to it with strong inflammatory reaction. The main side effects of radiation are fatigue accompanied by agitation and insomnia. TCM views radiation as an extreme external attack of heat and dryness which,as with sun exposure, damages the yin fluids and the Spleen qi, with local accumulation of heat, fire and toxins. Inhibition of the Spleen's ability to transform pure from impure and to propel the vapour from food results in a complex picture of heat-fire dryness above,stagnation of heat toxins locally and deficient damp-heat below.

In order to increase the cell killing effect of radiation and control its local side effects,one needs to increase oxygenation to cells,and promote peripheral blood flow 29-34 .

Herbs that are commonly used during radiation

Anti-hypoxic effect (increase cell oxygenation):
Dang Shen (Radix Codonopsis Pilosulae), Hong Hua (Flos Carthami Tinctorii), Bai He (Bulbus Lilii), Yin Yang Huo (Herba Epimedii).
Microcirculation improving effect:
Chuan Xiong (Radix Ligustici Wallichii), Dang Shen (Radix Codonopsis Pilosulae), Pu Huang (Pollen Typhae), Yi Mu Cao (Herba Leonuri Heterophylli).
Antihistaminic effect (can reduce itching ,anti inflammatory effect can reduce swelling and redness in the breast and skin):
Bai Zhi (Radix Angelicae),Qin Jiao (Radix Gentianae Macrophyllae), Jin Yin Hua (Flos Lonicerae Japonicae), Huang Qin (Radix Scutellariae Baicalensis).
Radiation sensitising effect:
Ren Shen (Radix Ginseng), Ling Zhi (Ganoderma Lucidum), Gui Pi Tang (Restore the Spleen Decoction), Hong Hua (Flos Carthami Tinctorii).
Two herbs [Shu Di Huang (Radix Rehmanniae Glutinosae Conquitae)and Rou Gui (Cortex Cinnamomi assiae)]can inhibit radiation effect; when given to animals they increase their survival 32

Burns and skin protection
To prevent radiation burns and rashes apply Aloe-Vera gel (fragrance-free,above 96%pure; fresh Aloe juice or leaf is superior) on the skin 2-3 times a day. If an itchy, red, rough sensation starts to develop apply Ching Wan Hung ointment, once or twice a day. Beware that it stains everything. For more severe burns apply the following formula externally: Da Huang (Rhizoma Rhei)30, Di Yu (Radix Sanguisorbae Officinalis)30, Hong Hua (Flos Carthami Tinctorii)20, Chuan Xiong (Radix Ligustici Wallichii)15, Long Kui (Herba Solani Nigri)20, Han Shui Shi (Calcitum) 12, Shi Gao (Gypsum)12. In cases of blistering and pus add Huang Bai (Cortex Phellodendri).

Grind the above ingredients to very fine powder and mix with boiling water to make a light paste. Apply to burns with gauze, twice a day and leave on the skin for 30-60 minutes.

Fatigue
From the TCM perspective, radiation-induced fatigue is due to accumulation of heat toxin causing dryness and therefore disturbing the yin fluids. This in turn causes yin vacuity blazing fire. The symptoms are extreme fatigue accompanied by agitation and insomnia. This usually does not start until the third week into radiation therapy. Weekly acupuncture treatment relaxes this sort of agitation and comprehensive herbal therapy attempts to counter the damage to the fluids and the inflammation.

Scarring
Scarring from radiation is different from that of surgery. Since the radiation exposure covers a large area, the beams pass through and scatter to areas in the interior of the body, mainly the lungs and, if the cancer was in the left breast, to the heart. Though radiation technology has improved significantly in the last decade, preventing heart and lung fibrosis is important. Again the herbs we use are those that increase microcirculation, decrease collagen activity and promote the breakdown of scars, protecting the body from pulmonary fibrosis caused by radiation: Dan Shen (Radix Salviae Miltiorrhizae),Yu Jin (Tuber Curcumae) and Ji Xue Teng (Radix et Caulis Jixueteng).




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