Pilot Study in Clinical Trial of 20 cases of Cancer Patients Receiving Chinese Herbs and Acupuncture During Chemotherapy and Radiotherapy

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1 Pilot Study in Clinical Trial of 0 cases of Cancer Patients Receiving Chinese Herbs and Acupuncture During Chemotherapy and Radiotherapy Doreen G.F. Chen, Brian G. Chen EastWest Integrated Care Center, New York, USA Abstract: A preliminary prospective study of the beneficial effects of Chinese herbs and acupuncture on 0 cases of cancer patients suffering from side-effects of chemotherapy or radiotherapy, particularly focus on alleviating the fatigue symptom. The statistic P value <0.000 for the alleviation of fatigue symptom indicated the appreciative effect of Chinese medicine in improving the quality of life for cancer patients undergoing chemotherapy or radiotherapy. According to the Chinese medical theory, fatigue, is considered to be Qi (energy) iciency and can be addressed and treated. The purpose of this study is to encourage and to promote Chinese medicine in the integration of Western medicine in the treatment for cancer, which yield better results in improving survival rate and improving the quality of life for cancer patients. Key words: Traditional Chinese Medicine (TCM), Western Medicine (WM), Chemotherapy (CT), Radiotherapy (RT), Energy (Qi), Blood (Xue) INTRODUCTION Purpose: to study the beneficial effects of Chinese herbs and Acupuncture for patients who suffer from the side-effects of chemotherapy and radiotherapy. Particular symptoms studied are fatigue, pain, nausea, depression and anxiety. Goal: to illustrate that Chinese herbs and Acupuncture can alleviate some side effects of chemotherapy and radiation, particularly focus on fatigue, so as to improve the quality of life for cancer patients. MATERIALS & METHODS Method: 0 cases have been collected for prospective study, and they include any victim of cancer at any stage of cancer (Table I). No restrictions have been placed on age, sex or race. These patients are all undergoing varying courses of chemotherapy and radiation, some pre- or post-surgically. There is no randomized or control group being used in this study. These patients have been referred to EeatWest Integrated Care Center (EWICC) by their oncologist, or from Moss Report, even some came on their own to seek help from Chinese medicine. Every patient has an initial visit at EWICC, which consists of a comprehensive consultation based on Traditional Chinese Medicine (TCM) theory and principle to establish a diagnostic pattern of imbalance and set up a treatment strategic protocol. Then the patient receives acupuncture treatments with application of the Qi lamp on a weekly basis and takes the Chinese herbal tea or capsules on a daily basis. Patients should receive this standard treatment for at least 8 weeks, preferably up to

2 weeks. Those who receive less than 4 weeks of treatment will be excluded from this study. This study monitors following mentioned symptoms and records the pulse and tongue signs on a biweekly basis: Age <40 Western Breast Diagnosis Primary 6 Metastasis Stage I Table. TCM and WM diagnosis and treatment in 0 cancer cases Lung 5 I-II Ovarian II Lymph oma IIA >70 Colon II-III Pancr eatic II 5 Mela noma IIIB Sinus III-IV Leuke mia IV 0 Chinese Diagnosis Western Treatment TCM treatment Qi 8 Qi Stag. Rad. Acup. 8 Blood 7 Phlegm Accum. Chemo. 8 Herbs 0 Yin 9 SP Damp Accum. Surgery 7 Both 8 LU Yin 4 Tai Chi LU Qi 0 Other* 4 K Yin w/heat LV Yin K Yang *Yoga, meditatio n Blood stasis Symptoms: Fatigue, pain, nausea, depression and anxiety are the five main subjective symptoms being evaluated. We are using a numeric scale of 0-0 in reference to a verbal scale according to the standards established by the National Cancer Institute, for example: Table : Fatigue Scale Numeric Verbal None Mild (increased fatigue over baseline but not altering activities) Moderate (decreased performance status, difficulty performing activities) Severe (loss of ability to perform activities) Table : Pain Scale Numeric Verbal None Mild (doesn t bother normal activities) Moderate (interferes with normal activities) Severe (reduced activities) Bedridden (total bed rest) Bedridden (worst imaginable pain which cannot be tolerated) Signs: vital signs, mental clarity, facial complexion and body weight are all recorded. Based on TCM diagnostic techniques, the tongue picture and the quality of the pulse are

3 also examined. This is done to determine the TCM Diagnostic pattern of imbalance and TCM treatment strategy. Lab reports: collected data from peripheral blood tests include WBC, RBC, Hgb, Plt, Liver enzymes (SGOT, SGPT), and tumor markers (CA 5 and CEA), if necessary and available for reference. Statistics analysis: using the 0-0 scale, information regarding the five subjective symptoms of the 0 cases were collected before, during and after the 6- week period of treatment, and compiled in order to arrive at the P value. Charts -5 demonstrate the process. The full black line on the charts indicates the Mean, and the P value is at the bottom of each chart. Chart : Study on Chinese Medicine for Fatigue Radio-therapy for Cancer Patients Chart : Study on Chinese Medicine for Pain Radio-therapy for Cancer Patients Chart : Study on Chinese Medicine for Stress Radio-therapy for Cancer Patients Chart 4: Study on Chinese Medicine for Depression Radio-therapy for Cancer Patients Chart 5: Study on Chinese Medicine for Nausea Symptom during Chemo or Radio-therapy for Cancer Patients

4 RESULTS The P value of the first three symptoms is <0.005, depression in chart 4, p<0.05, indicating that the symptoms have been significantly alleviated in cancer patients following administration of Chinese herbs and Acupuncture. Certain side-effects, such as nausea and pain, can be controlled by anti-emetic and pain-killing medications. Fatigue, however, is a subjective multi-dimensional symptom associated with a broad spectrum of physiological disorders. It is not well addressed by the western approach and patients can suffer severely with this symptom. In Chinese medicine, fatigue is considered to be Qi iciency and can be treated according to this basic TCM principle. Therefore the Chinese herbal formulae and Acupuncture have a positive impact on the patients' symptoms and improving their quality of life while they undergo chemotherapy and radiotherapy. Herbal Formulae: the formation of our herbal formulas come from extensive laboratory research and clinical observation collected from China and from our own clinical experiences in New York. We have found that cancer patients receiving chemotherapy or radiotherapy suffer largely from depletion of the body's Yin and Qi (energy), Blood and Yang are also depleted in some cases. As a result, the patterns of imbalance in cancer patients primarily present in iciency. Only few cancer patients present in excess patterns of heat and dampness. Based on this, and on the fact that the purpose of the pilot study is to alleviate the side-effects of chemotherapy and radiotherapy, especially for the symptom of fatigue, our treatment strategy is to select herbs to replenish or tonify Qi, Yin, Blood and Yang. We also use the Qi lamp and acupuncture to restore the Qi (energy) and Xue (Blood) flow and balance along different meridians. Our basic herbal formula is comprised of Huang Qi (Astragalus Membranaceus), Nu Zhen Zi (Ligustici Lucidum), Shan Yao (Chinese Yam), Sheng Di Huang (Raw Rehmania). Mai Men Dong (Ophiopogonus), Shan Zhu Yu (Dogwood Fruit), and others. If a patient's Qi is very low, we add Dang Shen (Codonopsis), Ren Shen (Chinese Ginseng) or Xi Yang Shen (American Ginseng). If the patient's Yin is very depleted, we might add Gui Ban (Hard Tortoise shell) and Bei Jia (Soft Turtle shell). Some cancer patients may even need Dong Chong Xia Cao (Cordyceps) mix powder and Ling Zhi (Gonoderma) powder in order to tonify their Qi and to strengthen their immune system. If the patient presents Blood iciency, A-Jiao and Ji Xue Teng will be added. Other patients will have additional anticancer herbs to their basic formula, such as Bai Hua She She Cao, Zhoa Shu, Ban Bian Lian and others. In most of these cases, the patients will drink raw herbal teas. These herbs are supplied by Kok Sheng Herbal distribution company in Brooklyn. If the patients prefer granules or powder over the raw form, we order from Qualiherb in California using our own base prescribed formula. The Cordyceps mix powder is comprised of Cordyceps, Dan Shen, Dang Gui. Yin Yang Huo, Gu Ya, Mai Ya, which is supplied by Professor Cheng Wen Ying, director of research in the Radiation Medicine Institute of the Shanghai Medical University. The patient will take 0grams per day.

5 DISCUSSION Many laboratory research and clinical trails have been carried out regarding the Chinese herbs in the treatment of cancer. A summarized article "Evaluator of Chinese herbs in the treatment of neoplastic diseases" written by Dr. Y. Sun(), chair of the Department of Medical Oncology of the Cancer Institute of Chinese Academy of Medical Sciences(CAMS), stated the principles of TCM in cancer therapies as follow: l ) Fu Zheng Qu Xie therapy (promote or enhance the natural host ense mechanism to eliminate the external and internal pathogenic factors): This group of herbs is used as immuno-modulator which is good in the supportive care for cancer patients and can potentially improve the long-term results when combined with chemotherapy and radiotherapy or others treatment modalities. ) Huo Xue Qu Yu therapy (activate blood circulation (ABC) and eliminate blood stasis): These ABC herbs can dissolve stagnant blood and maintain normal blood circulation. This group of herbs can be used as sensitizers to improve the sensitivity of cancer cells to chemotherapy and radiotherapy. ) Qing Re Jie Du therapy (clearing out and removing evil heat or heat toxins with ferbrifugal herbs): This type of herbs is used to eliminate the toxin of cancer and infection, to treat sores and nameless swelling, and usually is effective in relieving fever and pain in some cancer patients. 4) Ruan Jian San Jie therapy (softening and dissolution of hard masses): This group of herbs can eliminate phlegm, dissolve sludge and disperse hard masses as to treat swelling and masses. It is used to treat lymphadenopathy, goiter, abdominal masses and hepatosplenomegaly. Some of the herbs have been tested as anti-cancer agents. 5) Yi Du Gong Du therapy (combating poison with poison, acting like antidotes): This group of herbs have been proved to have anti-cancer activities in western medical technology. The Fu Zheng therapy in the treatment of cancer has been studied very thoroughly in China.(,.4,5). Astragalus Membranaceus, and Gingseng are the herbs most commonly used for Qi tonic. Dr.Y.Sun has participated in research work with Dr.G.M. Mavligit at the M.D.Anderson Cancer Center, Texas, in animal experiments and clinical trails on the immuno-modulating effects of Astragalus Membranaceus (AM) & Ligustici Lucidum(LL).(6) The work illustrates the two herbs are able to improve the function of lymphocytes and macrophages. One research work also illustrates the potential of antitumor activity mediated by ril- in low concentration is possible by the concomitant use of AM & LL. Dr.Sun and his colleagues of Cancer Institute of CAMS.(7) have isolated and studied the immuno-modulating effect of the active component from AM, polysaccharide extract Fb, in animals and in cancer patients. The local graft-versus-host (GVH) reaction and the Blastogenic Response Lymphocytes (BRL) were used as index for T cell function. The data revealed that Fb was able to augment the BRL and that the local GVH reaction of 9 cancer patients went from negative to positive. The BRL effect of Fb can further be augmented by suboptimal concentration of Con A, PHA, and PWM, and that the responses were dose dependent. The results indicated that the mechanism of immuno-augment effect of Fb, at least in part, is through the elimination of suppressive T

6 cell activity. Dr. Sun and his collaborative group in Tian Jing(8,9) have also isolated and studied the immuno-modulating effect of the active component of LL, Ligustrim (Oleanolic acid) in a double blind phase II clinical trial. The data revealed that the percentage of phagocytosis of macrophages was enhanced (P=0.0070), the delayed hypersensitivity as determined by OT test was augmented, the general condition of the majority of the cancer patients was improved, while the side-effect of Lugustrim was minimal. Furthermore, much laboratory and clinical research has been carried out regarding the Chinese herb Dong Chong Xia Cao (Cordyceps). Papers have been published on the topic by Professor Cheng Wen Ying, the Chair of the Dept of Radiomedicine of Shanghai Medical College. She has studied the effects of Cordyceps for 0 years and has recently researched cultivated Cordyceps (Cordyceps Militaris), comparing its pharmaceutical effects with natural Cordyceps (Cordyceps Sinensis). Comparisons that were made included their anti-inflammatory effects, sedative effects, anti-anorexia effects etc., and it was found that the cultivated Cordyceps has nearly the same potency as the natural version. The toxicity of both is very low: <P50 >0 g. crude drug/kg in mice (0). The two chemical components are similar, but the cost of the wild Cordyceps Sinensis is approximately 0 times higher than its cultivated counterpart. Therefore, in our clinic, we have been using the cultivated Cordyceps Militaris with a consistent quality guarantee by the supplier. According to TCM theory, Cordyceps is sweet in flavor and warm in nature, and enters the Lung and Kidney meridians. Traditionally, it has been used to nourish the Lung and Kidney to arrest bleeding and resolve phlegm. It is primarily used to nurse a patient with a weak and unhealthy condition caused by consumptive disease, and is especially good for chronically debilitated patients such as those fighting cancer. Cordyceps can enhance macrophage phagocytosis and increase production of lymphocytes, natural killer cells, interleukin, interferon and tumor necrosis factor. It is successfully being used as an immuno-modulator.() Lucid Gonoderma (Ling Zhi) has also been studied extensively in China, Japan and other countries. Western medical research has confirmed that Gonoderma can inhibit the growth of various viruses and bacterium. It can increase white blood cells and enhance the macrophages and T cell and B cell lymphocyte function. It also enhances the production of cytokine, interleukin, tumor necrosis factor and interferon. According to TCM theory and experiences, Gonoderma can tonify the Blood and Qi (vital energy) for helping chronic fatigue; tonify the Lung and Kidney for asthmatic condition; tonify the Liver and Kidney for tinnitus and deaf, and lassitude of knees and loins; it also nourishes the Heart for insomnia, palpitation and amnesia; and lastly it can strengthen the Spleen and Stomach to improve digestion. Gonoderma was documented as a superior herb in the ancient herbal compilation "Shen Nung Pen Tsao Ching". Gonoderma is a favorable herb to serve the: elderly who are debilitating and degenerating in their body function. Ginseng and Gui Ban, Bei Jia are also well documented in TCM texbook. Ginseng is a Qi tonic herb and Gui Ban, Bei Jia are Yin tonic herbs. Shan Yao nourishes the Spleen Yin and raw Rehmania nourishes the Kidney Yin.

7 CONCLUSION The herbal formula we used for this study has shown significant effect on relieving fatigue symptom and lessen the side-effects of chemotherapy and radiotherapy for cancer patients. Chinese medicinal herbs have much to contribute to the treatment of cancer, even in late stage cancer. Especially when TCM integrates with Western Medicine, together they can yield better results and improve the quality of life of cancer victims. This can only happen if the two can compromise and complement with each other, yet not conflict with each other. The future of medicine is integrative medicine. REFERENCES Pilot Study in Clinical Trial of 0 cancer patients receiving Chinese herbs and Acupuncture during CT & RT I) Sun Y, Evaluation of Chinese drugs in the treatment of neoplastic diseases, Chair of the department of Medical Oncology, Cancer Institute and Hospital, Chinese /Academy of Medical Sciences ) Zhang DZ And Hao YX., Recent progress in TCM in the prevention and treatment of the toxicity and side-effects from chemotherapy and radiotherapy. A Review Hunan Guiding J.TCMP 998,4(9): 7-9, Translated by Doreen Chen ( MD,OMD in China) President of Eastwest Integrated Care Center, New York ) Sun Y, Zhang YH, Yu GQ ct al., The Fu-Zhen principal of TCM in the treatment of cancer. Chin J Med 98,6():97-0 4) Zhao TX, A clinical study on Fu-Zheng Bu-Xue herbal syrup for cancer patients. GanSu Zhong Yi. 994,7(4): 8-0, Translated by Doreen Chen ( MD,OMD in China) President of EastWest Integrated Care Center, New York 5) Sun Y, Hong WJ, Deng J, Liu D. Feng ZK. Yin WB, Zhang YH. Observation on 0 years follow-up of cancer patents with Fu-Zheng therapy. Chin.J.lntegr.Med (): ) Sun Y. Mavligit GM, et al. Clinical and Experimental Research on Chinese Medicinal Herbs used in Fu-Zheng Therapy 7) Wang DC, Influence of Astragalus mernbranaccus (AM) polysaccharide FI on immunologic function of human peripheral blood lymphocyte. Chin J Oncol.989,(): ) Sun Y, Immune modulating effect of Ligustrum lucidum (Oleanolic acid) Results of a double blind clinical phase II trial. Chinese J. Pharmacology 990,6(): -4 9) Sun Y, Yuan RR, Wu NJ. Et al., Immune modulating effect of Oleanolic acid. Chinese J. Pharmacology ():6-0) Cheng WY, The anti-cancer effect of Cordyceps, Compile by the Department of Radiomedicine of Shanghai Medical College, Oct. 000 ) Zhao KL, Observation of the effect of immunologic function of DongChong XiaCao(Cordyceps) on cancer patients treated by chemotherapy. Proceedings of International Conference on Chinese Medicine. 987 page