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By Efrem Korngold, LAc, OMD and Harriet Beinfield, LAc Research Investigations
A literature review performed in 1998 by
the University of Texas Center for Alternative Medicine Research in
Cancer summarized many Chinese studies, including controlled trials with
human subjects, animal, and in vitro laboratory experiments.55
The studies showed the impact of medicinal herbs on: disease response,
survival outcome, immune response, reduction in adverse effects from
chemotherapy and radiation, improved recovery from surgery, better
quality of life, and alleviation of
pain. This review indicated that some patients who received Chinese
herbal medicine combined with conventional Western treatment
demonstrated significantly better survival and/or disease response than
patients receiving Western treatment alone. But often research design
has involved inadequate methodology, including the absence of
randomized, placebo or blinded controls. While the examples that follow
hardly constitute proof of efficacy, they are suggestive of benefit,
indicating that further research is desirable and necessary.
For example, in a study of 76 patients
with second-stage primary liver cancer there were no 5-year survivors in
the groups treated with chemotherapy or radiation alone, whereas there
was a 10% survival in the group treated with a combination of Fu
Zheng herbs and radiation, and a 16.7% survival in those treated
with both herbs and chemotherapy.56 Five-year survival rates
in another study of patients with liver cancer who received chemotherapy
alone were 6%, whereas when combined with the herb formula Si Jun Zi
Tang (Panax ginseng, Atractylodes macrocephela, Poria cocos, Glycyrrhiza
uralensis), 5-year survival rose to 43%.57
Herbs that are qi and yang
tonifying, that warm and strengthen the spleen and kidney,
are thought to ameliorate the adverse effects of chemotherapy and
radiation. Zhang Xinqi comments, “The leukopenia caused by chemotherapy
or radiotherapy is classified as a deficiency type of illness which is
referred to as the morbid condition showing deficiency of genuine qi,
lowered body resistance, and declining of function. Then, supplementing
qi and nourishing the blood, warming and
invigorating the spleen and kidney are the essential
therapeutic principles for remitting toxic side effects.”58
Two of the important toxin-removing herbs
used in cancer therapy are Sophora flavescens (ku shen, meaning
bitter root of miraculous effect) and Sophora subprostrata (shan dou
gen), containing matrine and oxymatrine series alkaloids that show
cytotoxic activity in vitro and antitumor activity in vivo,
(inhibit the growth of sarcoma-180 in laboratory mice). Oxymatrine
itself is 7.8 times stronger than the chemotherapeutic agent mitomycin C
in its tumor inhibiting effects, without suppressing the
immune system.59 Sophora flavescens (or
subprostrata) also increases leukocytes and promotes peripheral
immune responses. Scutellaria baicalensis (huang qin) is another
potent heat and toxin-clearing herb with anti-tumor and
immune-stimulating properties in vivo and, in vitro, that inhibits
platelet aggregation and induces apoptosis.60 And another
herb, Isatis tinctoria (ban lan gen) contains the compound
indirubin, observed by Chinese scientists to exert an effect against
chronic myelocytic leukemia (CML). It inhibits DNA synthesis in
neoplastic cells, particularly
immature leukemic cells in bone marrow, while simultaneously stimulating
immune response.61
Angelica sinensis (dang gui) is a
blood supplementing and activating herb with anti-tumor, immune
stimulating, and antiangiogenic properties that reduces vascular
permeability in vitro.62 Other potent herbs in the
blood activating category with direct cancer-inhibiting properties
are Curcuma zedoaria (e zhu), Salvia miltiorrhiza (dan shen), and
Panax pseudoginseng (tian qi). These herbs are fibrinolytic,
antithrombic, and anti-inflammatory. People with cancer often have
elevated fibrinogen levels, increasing the stickiness of the blood so
that it is more likely to
coagulate. Because the “sticky” factors in blood facilitate the
adherence of metastatic cells to healthy tissue, and because tumors are
often encapsulated within a tough fibrin coating difficult for anti-neoplastic
drugs or immune cells to penetrate, herbs that increase
microcirculation, make the blood less viscous, the fibrin coating more
permeable, and soften and disperse masses. When extracts of curcuma are
injected in mice with tumors, the tumors shrink.63
Enhancing Conventional Protocols
To overcome the adverse effects while at
the same time potentiating the desired effects of conventional
treatment, a popular biological response modifying formula called All
Inclusive Great Tonifying Decoction (Shi Quan Da Bu Tang) is
often used. It appears to restore hematopoeitic function to improve
peripheral blood counts, and increases interleukin production along with
NK cells. This formula contains Panax ginseng (ren shen),
Angelica sinensis (dang gui), Poria cocos (fu ing), Atractylodes
macrocephela (bai zhu), Astragalus membranaceus (huang qi), Ligusticum
wallichii (chuan xiong), Peonia lactiflora (bai shao), prepared
Rehmannia glutinosa (shu di huang), Cinnamomum cassia (rou gui), and
prepared Glycyrrhiza uralensis (zhi gan cao). It was found to
potentiate the therapeutic activity of chemotherapy (Mitomycin,
Cisplatin, Cyclophosphamide, Fluorouracil) and radiotherapy, inhibit
recurrence, prolong survival, and prevent or ameliorate adverse
treatment effects such as: anorexia, nausea, vomiting, hematotoxicity,
immuno-suppression, leukopenia, thrombocytopenia, anemia, and
nephropathy.
In traditional terms, the herbs Panax
ginseng (ren shen), prepared Glycyrrhiza uralensis (gan cao),
Poria cocos (fu ling), and Atractylodes macrocephala (bai zhu)
tonify qi, while Angelica sinensis (dang gui), Ligustici
wallichii (chuan xiong), Peonia lactiflora (bai shao), and prepared
Rehmannia glutinosa (shu di huang) nourish the blood, and
Astragalus membranaceus (huang qi) and Cinnamomum cassia (rou
gui) further invigorate qi and yang.64 In
another study to determine effects of this formula on white blood cell
counts, 134 patients with cancer who had previously undergone
chemotherapy and radiation therapy that resulted in
leukopenia were given the formula and 113 patients experienced an
increase of white blood counts to normal levels.65 In a study
of 58 patients with osteogenic sarcoma who were receiving either
Cisplatin and Dexamethasone (CD) or high-dose Methotrexate and
Vincristine (MV), patients were randomly assigned to the herbal arm or
observation. Those using the herb formula in the MV group experienced
improvements in white blood cell and platelet counts and there was less
transaminase enzyme elevation. Both the CD and MV groups showed
improvement in posttherapy cardiac function, less nausea and vomiting,
and fewer rashes than those in the control group.66
Whereas tumor recurrence for
post-surgical patients with bladder cancer was 65% with conventional
treatment alone, this was reduced to 33% when patients added the use of
the Chinese medicinal mushroom Polyporus umbellatus (zhu ling or
maitake in Japanese).67 In another study, those
receiving radiation alone suffered from low white blood cell and
platelet counts, but this was reversed in subjects who received Chinese
herbs: 40 patients recovered from 3450/c.mm to 5425/c.mm,
whereas in the control group without herbs, white blood cell counts
dropped significantly.68
Five-year survival for advanced nose and
throat cancer patients receiving radiation alone was 24% whereas adding
the herbal formula Yi Qi Yang Yin Tang to the conventional
protocol produced a 52% five-year survival.69 In a study of
197 patients with stage III and IV nose and throat cancers, half
received radiation in combination with the formula Yi Qi Yang Yin
Tang and half received only radiotherapy. After 3 years the survival
rates
were 67% and 33% respectively. This formula is targeted to nourish the
qi and fluids as well as clear heat and toxins and
eliminate blood stagnation.70 In yet another study of
this formula for nasopharyngeal cancer, 272 patients were treated with
radiation, half of whom received the formula. In the herb-treated group,
5-year relapse was 68% lower (12 % versus 38%), and survival rates were
also significantly improved (67% versus 48% at 5-years).71
In 285 patients with lymph node
metastases, one group received only chemotherapy with no significant
tumor shrinkage; another received only herbal medicine with only 12%
showing significant shrinkage; whereas in the group that received chemo,
radiation, and herbs, or radiation plus herbs, 75% showed significant
tumor shrinkage.72 When 70 patients with
chronic gastritis and dysplasia were divided in groups according to
traditional Chinese pattern diagnosis (hyperactive liver qi,
deficiency cold of the spleen and stomach,
deficiency of stomach yin, and damp heat in the spleen
and stomach) and treated accordingly, 84% markedly improved, 4%
responded partially, and 11% were unresponsive.73
A study at Drew University in Los Angeles
investigated the effects of medicinal mushrooms on patients with
advanced malignancies: in 2 weeks there were marked decreases in tumor
associated antigens and marked increases in natural killer cell activity
in 8 out of 11 subjects.74 In another study, patients with
primary liver carcinoma who received herbs in combination with
chemotherapy had increased numbers of NK cells.75
A study of 176 patients compared half the
subjects who received injections of Astragalus membranaceus (huang
qi) and Panax ginseng (ren shen) while undergoing
chemotherapy for colon cancer, to a control group that was not
administered herbal injections. Those receiving the herbal injections
had higher white blood cell counts, greater macrophage activity, and
increased body weight.76 A study of the herb astragalus
at MD Anderson Hospital and Tumor Institute in Houston, Texas confirmed
earlier reports by the same authors that this herb possesses
immuno-potentiating activity, correcting in vitro T-cell function
deficiency found in many cancer patients. Decades of pharmacological
research have
revealed that the polysaccharides and other compounds in Astragalus
membranaceus promote cellular (intensifies phagocytosis) and humoral
(increases function of B lymphocytes) immune function and have in vitro
anti-tumor effects on cancer cell lines.77 Research at MD
Anderson Hospital in Houston reproduced these results in a 1983 study,
demonstrating that aqueous extracts of Astragalus membranaceus in vitro
and in vivo enhanced levels of circulating lymphocytes. A second study
in 1988 confirmed and expanded the previous findings that extracts of
Chinese herbs possess potent immune restorative activity. A
polysaccharide fraction of Astragalus membranaceus (fraction 3, F-3) was
isolated as most potent. The data indicated that extracts of astragalus
could restore T-cells from immune compromised cancer patients to normal
levels of function.78 In a human trial, Astragalus
membranaceus was found to potentiate IL-2 tenfold, permitting a
smaller, less toxic
effective dose, restoring T-cell function in 9 out of 10 cancer
patients.79 Whereas the common dose of Astragalus
membranaceus is 9 to 30 grams of dried herb for non-cancerous
conditions, doses as high as 60 grams per day may be administered as an
immunostimulant. Although toxicity is low at high doses, occasionally
symptoms of over-stimulation such as insomnia, increased heart rate,
palpitations, or hypertension can occur at these high doses.80
Multiple studies on patients with stomach
cancer were conducted using the formula Pishen Fang ( Jian Pi Yi
Shen) that supplements qi and yang, has immuno-stimulating
properties, and contains: Codonopsis pilolusa (dang shen),
Atractylodes macrocephala (bai zhu), Lycium barbarum (gou qi zi),
Ligustrum lucidum (nu zhen zi), Cuscuta chinensis (tu si zi), and
Psoralea corylifolia (bu gu zhi). One study examined 81 patients
with stage III gastric cancer who received chemotherapy. Those who also
took the herbal formula experienced improved digestive and bone marrow
function, as well as increased survival. In the herbal group, 5-year
survival
was 46% compared to 20% in the chemotherapy-only group.81 In
another study, 669 late-stage gastric cancer patients who were receiving
chemotherapy were randomly divided into the herbal arm, and the control
group. Improvements in body weight, appetite, reduced nausea and
vomiting, were observed in the group that received the formula. White
blood cell counts were 7% in the herb-treated group compared to 33% in
the control group. Macrophage activity was 21% greater in the treated
group, and 5-year survival among 303 stage III and 63 stage IV patients
who received follow-up were 53% and 10% respectively. After 10 years,
47% of the stage III patients remained alive.82 Another study examined
216 postoperative stomach cancer patients at stage III, and 110 patients
at stage IV, showing that of the half who did not receive the herbal
formula, 75% were able to finish the complete chemotherapy course,
compared to 95% who received the herbs. Patients in the herb-treated
group gained weight (23% vs. 8%); fewer lost weight (6% vs. 14%); fewer
lost their appetite (10% vs. 32%); and fewer had vomiting (4% vs. 12%).83,84
In an animal study, Mitomycin C showed a
stronger antitumor effect when combined with ginseng.85
Similarly, when an extract of the mushroom Polyporous umbellatus (zhu
ling) was combined with Mitomycin C, the life span of tumor-bearing
mice was increased by 119.9%, compared to 70% in the control group
treated with the drug alone.86 Ginsenosides, the active
saponin compounds in the ginsengs, increase phagocytosis,
appetite, blood formation, accelerate the biosynthesis of DNA, and
appear to induce cancer cells to change their morphology and become more
like healthy cells. The polysaccharides in Astragalus membranaceus (huang
qi) and Panax ginseng (ren shen) and medicinal mushrooms
regulate T-cells and stimulate interferon and phagocytosis, producing
both immune-restorative and cancer-inhibiting effects.
An herbal formula used to relieve signs
of cardiac distress (palpitation, irregular, small and slow pulse,
occasional premature systole, lower-wall myocardial ischemia) secondary
to treatment with Adriamycin (doxorubicin), is called Zhi Gan Cao
Tang, or Baked Licorice Decoction, consisting of 20 gm
Glycyrrhiza uralensis (gan cao), 30 gm Rehmannia glutinosa (di
huang), 30 pieces Ziziphus jujuba (da zao), 15 gm
Zingiberis officinale (jiang), 15 gm Cannabis indica (huo ma ren),
10 gm Panax ginseng (ren shen), and 10 gm Cinnamomum cassia (gui
zhi) administered as a decoction. When cardiac function normalized
after 6 days, Adriamycin therapy resumed, and administration of the
decoction
was continued.87
Another prescription developed in modern
times, is a formula described in 1982 by Dr Hong-Yen Hsu containing
Wisteria sinensis (zi teng), Terminalia chebula (he zi), Trapa bispinosa
(ling jiao), and Coix lachryma-jobi (yi yi ren).88
Both Wisteria sinensis (he zi) and Trapa bispinosa (ling jiao)
have a history of use in China and Japan for the treatment of tumors.
Coix lachryma-jobi (yi yi ren) and Terminalia chebula (he zi)
have been used traditionally to strengthen digestive and respiratory
functions as well as to relieve infection and inflammation.89
Coix lachryma-jobi is now considered a general anti-cancer agent.
This prescription conforms to the principles of invigorating qi and
strengthening resistance (improving digestive and respiratory function)
and clearing heat and eliminating toxins (removing
infection and inflammation).
The US Food and Drug Administration
approved the first Chinese-made anti-cancer drug for Phase II clinical
human trials in 2001, to be conducted by the US biopharmaceutical
company, Oncoherb. The drug, called Kanglaite injection, is an extract
distilled from the seeds of the herb Coix lachryma-jobi (yi yi ren).
It has demonstrated efficacy against lung cancer in clinical
trials with over 200,000 cancer patients conducted in China. Studies
have indicated that it may also be useful in the treatment of other
types of cancer, including stomach and cervical cancers, and solid
tumors. The preliminary findings of research conducted in the US support
the Chinese trials. The new drug significantly improves the efficacy of
radiation therapy and chemotherapy treatments in late-stage, lung cancer
patients. It is far less toxic than existing chemotherapeutic agents and
is effective in patients for whom existing treatments did not show any
improvements.90
In the November 2001 issue of Life
Sciences, Henry Lai from the University of Washington reported on
the cytotoxic activity of artemesinin, a compound from Artemesia
annua (quing hao). Artemesinin kills human breast cancer cells in
vitro by interfering with their iron metabolism. It was first
discovered to be an effective anti-malarial agent in chloroquine-resistant
cases. Malarial parasites depend on high iron concentrations for
reproduction, as do cancer cells, and any micro-organisms. Excess iron
is associated with increased cancer notes. Breast cancer cells have
up to 15 times more transferrin receptors than healthy cells. Acute
leukemia and pancreatic cancers have also been responsive to this agent
in vitro, with no apparent adverse effects upon healthy tissue.
The Breast Cancer Fund in San Francisco is supporting this research.
Earlier studies showed that Artemesia annua and capillaries have direct
cytotoxic effects in vivo without causing immunosuppression.91
While Debu Tripathy was an oncologist at
the University of California at San Francisco (UCSF), he conducted an
on-going placebo-controlled randomized trial for women with breast
cancer, using a formula containing 21 Chinese herbs to investigate the
alleviation of common side effects of chemotherapy, namely nausea,
vomiting, fatigue, marrow suppression, risk of infection, and hair loss.92
Safety and Herb-Drug Interactions
Herb safety and herb-drug interactions
are complex and controversial issues. With the increasing use of herbs
by Westerners has come legitimate concern for potential abuse and
toxicity. The safety of a drug, herb, or food is always relative and
contextual. Safety is determined by defining the conditions under which
a substance is considered to be safe or dangerous, and weighing
potential benefits against possible short and long-term adverse effects.
Herb-drug interaction is a similar puzzle: all
substances that enter the body interact with each other, ultimately
affecting all body processes. The issue again is determining the benefit
or detriment of such interactions.
Compared to the record of approved
pharmaceutical drugs, with a few well-known exceptions such as
Aconitum carmichaelie (fu zi), Cinnabaris (zhu sha), Aristolochia
fangchi (guang fang ji), and Ephedra sinica (ma huang),
Chinese medicinal herbs are safer.93 Aconite contains
aconitine, a recognized poison, that is traditionally detoxified by
boiling and then
combined with other herbs such as Zingiberis officinale (jiang),
Ziziphus jujuba (da zao), and Glycyrrhiza uralensis (gan cao)
that further mitigate its toxicity, yielding important therapeutic
benefits. For example treated Aconite is combined with Panax
ginseng in the treatment of acute cardiac failure. Cinnabaris,
a crude ore, contains mercuric oxide and although considered unsafe by
American standards, is still utilized in small doses in China for the
short-term treatment of acute mental agitation without negative
consequences. Many Aristolochia species have recently been shown
to exert carcinogenic effects when used continuously for longer than 6
months, yet these species continue to be used in China with good results
in the treatment of cancer and nephropathy, the very conditions for
which they have been considered causative agents in the West. Ephedra
sinica (ma huang) has appropriately been used as an anti-asthmatic,
antitussive diaphoretic and vasodilating component of numerous pulmonary
and anti-arthritic formulas for centuries.
In the US over the past two decades,
Ephedra has been inappropriately
marketed over-the-counter as a natural energy and weight loss stimulant,
resulting in incidences of high blood pressure, palpitations, agitation,
and insomnia. It is unfortunate that abuse and misuse have caused herbs
such as these to become less available to professional health care
providers, and have cast a dark shadow over the credibility and safety
of Chinese medicinal herbs in general.
The hundreds of herbs that are in common
use in China and the West are rarely associated with adverse effects
that are not easily reversible. These effects are seldom serious and
include such transient reactions as: nausea, indigestion, diarrhea,
headache, dizziness, hot flashes, chills, and rashes that are rapidly
abated by discontinued use or dose reduction. The preponderance of
evidence shows that when used as an adjunct to
conventional medicine, Chinese herbs both enhance the desired effects
and mitigate the harmful ones.
Sophisticated monitoring with biological
testing, sterilization, and spectrographic analyses by manufacturers in
the United States is insuring that herbal products are free of chemical
contaminants, adulterants, pathogens, and substitutions. This heightened
awareness along with stringent standards is encouraging Chinese
manufacturers to adopt the good manufacturing practices (GMP) required
by the Food and Drug Administration (FDA) and the Federal Trade
Commission (FTC).
There is a paucity of data that describes
the interactions between pharmaceutical agents, and even less between
herbs and drugs. A few herbs and foods have well understood interactions
with drugs. Tetracycline absorption can be impeded by milk-based foods,
whereas grapefruit juice increases the blood volume of certain drugs
(antidepressants, antihistamines, antihypertensive) by inhibiting a
drug-metabolizing enzyme (cytochrome P450). Hypericum perforatum
(St. John’s Wort, tian ji huang) reduces blood levels of
protease inhibitors by increasing their metabolism, while potentiating
the effects of MAO and SSRI antidepressants by elevating seratonin
levels. Green vegetables high in Vitamin K can oppose the blood-thinning
action of drugs like
Heparin, Coumadin, or Warfarin. Because Gingko biloba (yin guo ye),
Salvia miltiorrhiza (dan shen) and Angelica sinensis (dang gui)
promote
microcirculation and inhibit platelet aggregation, they can potentiate
the effects of anti-coagulants, as can Allium sativum (garlic)(da
suan) and Zingiberis officinale (ginger, jiang).
Astragalus membranaceus (huang qi), because of its immuno-stimulating
properties, may counter the immunosuppressive action of anti-rejection
drugs like Cyclosporin. In high doses, Glycyrrhiza uralensis (licorice)(gan
cao) can mimic the action of cortisol, elevating blood pressure and
increasing fluid retention.94 These findings are based on the
use of these herbs as single agents.
When Angelica sinensis is
incorporated into a formula such as Shi Quan Da Bu Tang, which
supplements qi and blood and activates circulation, its
hematopoietic properties are enhanced and its anticoagulant properties
are reduced by the inclusion of herbs such as Rehmannia glutinosa (di
huang) and Peonia lactiiflora (bai shao), making it an
effective treatment for the anemia, bruising, and bleeding caused by
radiation and chemotherapy. One of the side effects of standard
anti-coagulant therapy is anemia. To solve this problem with Chinese
medicine, the herbs Panax pseudoginseng (tian qi) and
Millettia reticulata (ji xue teng) are used because of their triple
hematopoietic, circulation-activating, and anti-hemorrhagic properties.
Glycyrrhiza uralensis (licorice, gan cao) is ubiquitous,
appearing in countless formulas in part because of its ability to
modulate adrenal function. For example, the Decoction of Bupleurum
chinense (chai hu) and Poria cocos (fu ling, Chai Ling Tang)
contains many herbs, including Glycyrrhiza uralensis (gan cao),
and is used to aid in the withdrawal from corticosteroid dependence.95
Rather than suggesting that people stop
eating grapefruit or green vegetables, new information is broadening our
understanding of the complexity of drug-food and drug-herb combinations,
enhancing our ability to make prudent choices. Biologist Subhuti
Dharmananda, PhD, suggests, “Herb-drug interactions may be minimized by
having patients take the herbs and drugs at different times (one hour
apart to avoid direct interaction in the digestive tract; 1.5 hours to
avoid maximum blood levels of drug and herb at the same time). The
dosage of herbs that are aimed therapeutically at the same function as
the drugs (eg both are sedatives; both are hypoglycemics; both are
anti-coagulants) should be reduced to
alleviate concerns about additive or synergistic effects that are too
great. A certain level of additive effects might be desired in cases
where the drug therapy is not producing the desired response.”96
Fundamentally, Chinese medicine is
concerned with the behavior of qi. Consequently, all of the major
modalities of Chinese medicine (acupuncture, herbal medicine, dietetics,
qi gong) are employed to provoke the qi to reorder itself
once a pathological process has begun and, ideally, before it has become
clinically manifest. While Chinese medicine has developed its own
sophisticated repertoire of treatments for specific diseases, its
primary emphasis is ultimately upon restoring and preserving the healthy
function of the body.
Acknowledgments
The authors wish to thank John Boik,
Subhuti Dharmananda, PhD,
Stephen Cowan, MD, Ken Rose, Mary Tagliaferri, LAC,MD, Debu Tripathy,
MD, Issac Cohen, LAC, and Larry Baskind, MD, for their help in
contributing to this article. This article honors Elisabeth Targ, MD,
and the mysteries.
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