Page 2531 - Hematology_ Basic Principles and Practice ( PDFDrive )

2254 Part XIII Consultative Hematology

TABLE Integrative Therapies Domain complications that led to the reevaluation of the constituents of
156.1 PC-SPES. Although evaluations of the product showed no evidence
of any phytoestrogens in any of the eight herbal compounds at the
• Mind–body programs • Whole systems onset of the study, during the randomized clinical trial, phytoestro-
• Energy therapies • Traditional Chinese medicine gens were found, and patients began to demonstrate breast engorge-
ment. Other lots of the product did not contain phytoestrogens but
• Body based or manipulative • Ayurvedic
were demonstrated to have contaminants such as dicoumarol, and
• Natural products some individuals were noted to experience increased bruising. Inves-
tigators have attempted to overcome the standardization issue of
herbs by studying their individual proteins in in vitro models, and
others have attempted to closely monitor the constituents of the
mind–body therapies a close second. Because many patients do not herbs by protein fractionation, ensuring that the product remains
report their use of complementary therapies to their primary care constant during the research study. Most herbs and botanicals are
hematologist/oncologist, there are markedly disparate data from one not regulated by the US Food and Drug Administration (FDA),
study to another. In other countries, such as Mexico, Ireland, and potentiating issues of quality control, possible contamination, and
Canada, there is a high use of CAM therapies ranging from 42% to stability issues. The United States Pharmacopeia (USP) does verify
60% in the pediatric patients. Therapies include vitamins, minerals, the identity, strength, purity, and quality of some supplements and
reflexology, etc. 10,11 applies its USP verification label, http://www.usp.org/uspverified.
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In a review by Wesa and Cassileth, the major reason why ConsumerLab.com also performs independent testing and applies
leukemia patients use integrative therapies or remedies not prescribed its approval stamp.
by their hematologist/oncologist is in an effort to improve their
treatment outcome and to manage their symptoms. For those with
leukemia, the integrative therapies that were felt to be most beneficial REVIEW OF RESULTS OF INTEGRATIVE THERAPIES IN
included mind–body interventions such as self-hypnosis, meditation, HEMATOLOGY/ONCOLOGY PATIENTS
guided imagery, and breath awareness. Massage and reflexology
are also frequently used to decrease symptoms (see subsequent Most studies on the use of integrative therapies in hematology/
discussion on massage). Acupuncture is very beneficial for symptom oncology disorders investigate the effect on patients’ quality of life
management with minimal side effects (see later discussion of and symptomatic relief of stress, pain, fatigue, and anxiety. The results
acupuncture). discussed here will be reviewed in terms of improvement in symptoms
and quality of life, and when appropriate, the effect on immune
function and survival if investigated. In most studies, the major
RESEARCH TECHNIQUES OF INTEGRATIVE THERAPIES symptoms for which integrative therapies are used include anxiety,
neuropathy, fatigue, pain, chemotherapy-induced nausea and vomit-
Research in the United States on integrative therapies is partially ing (CINV), worsening immune system, stress, and depression.
financially supported by the NIH through NCCIH and the Office
of Cancer Complementary and Alternative Medicine at the National
Cancer Institute (NCI). Investigators have tried to apply the same Literature on Outcomes: Science, Safety, and Efficacy
research principles used to evaluate new chemotherapy programs for
leukemias and lymphomas (i.e., the traditional randomized clinical In making decisions about what integrative therapies physicians
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trial). This approach has been problematic because it is often dif- should recommend, Weiger et al suggest that decisions be based
ficult to identify the proper controls for integrative therapies such as on safety and efficacy. If an intervention is safe and effective such as
mind–body techniques, acupuncture, and massage. As a result, meta- acupuncture for CINV, it can be appropriately recommended. If a
analyses on integrative therapies reveal an abundance of pilot studies therapy is unsafe or toxic and has been demonstrated to be ineffective,
and nonrandomized clinical studies that are often criticized on the it should not be recommended, and patients should be cautioned
basis that any positive result may be attributable to the placebo about its use. For example, laetrile (Amygdalin) may contain varying
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effect. In the case of acupuncture research, sham or “fake” acupunc- amounts of cyanide, and in clinical studies has been shown to be
ture has been used as a control in which nontraditional needles are ineffective in treating cancer. Many interventions, products, and
used but not placed in the meridian spots and not stimulated. substances are safe, but their effectiveness is unknown. With these,
In randomized clinical trials of acupuncture effectiveness, compar- the physician should be cautious and recommend their use with
ing active acupuncture with “sham” acupuncture, only those who are the following proviso: if this is a substance taken orally, it should
naive to acupuncture can participate. With massage therapy, random- be evaluated as to whether it has any unfavorable interactions with
ized clinical trials have used an educational program of equivalent chemotherapy or medications that the patient is already taking or
attention time to attempt to control for the placebo effect. This has whether it interacts with a disease process such as causing hypo-
been similarly true for research on energy therapies such as reiki and glycemia in a diabetic patient. Taking one new OTC substance at a
many of the mind–body programs. time is good common sense, and patients should be told to observe
Whole-systems research is another approach taken by integrative any change in symptoms, whether they are favorable or unfavorable,
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therapists. This involves combining nutrition, physical activity, and before adding another substance to their oral regimens, especially
stress and symptom management therapies together as an interven- if there is little or nothing known about the agent. With respect
tion in evaluating quality of life measures over a period of time. This to drug–drug and drug–herb interactions, websites are available for
type of research creates many variables and is totally contrary to the professionals as well as for lay audiences. A list of these websites
current widely accepted reductionist method of research. is given in Table 156.2. Most of these websites list the various
The study of herbs and other OTC unregulated products has terms by which a given agent is known and provide information
been fraught with confounding variables, specifically the lack of on each agent’s constituents, reasons for use, evidence for safety
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standardization of the product studied. For example, PC-SPES, a or toxicity, and evidence of effectiveness. Most importantly, these
compound of eight herbs manufactured by a single company, was websites list the adverse effects of these substances and the drug–drug,
demonstrated in a pilot study in men undergoing active surveillance drug–herb, and drug–disease interactions when known. When asked
for prostate cancer to be associated with a decrease in prostate- about the use of an OTC substance that is not FDA regulated
specific antigen levels. The promising trends of this phase I and or ConsumerLab.com approved, physicians should consult one of
later a phase II study led to a randomized clinical trial of PC-SPES. the databases to ensure safety and lack of adverse interactions (see
During the phases of this randomized clinical trial, there were Table 156.2).