Monday, February 21, 2011

Complementary and Alternative Medicine in Cancer Treatment (PDQ®

Questions and Answers About Complementary and Alternative Medicine in Cancer Treatment

1. What is complementary and alternative medicine?

Complementary and alternative medicine (CAM), as defined by the National Center for Complementary and Alternative Medicine (NCCAM), is a group of different medical and health care systems, practices, and products that are not presently considered to be part of conventional medicine. Complementary medicine is used together with conventional medicine. Alternative medicine is used in place of conventional medicine. Conventional medicine is medicine that is practiced by holders of M.D. (medical doctor) or D.O. (doctor of osteopathy) degrees and by health professionals who work with them, including physical therapists, psychologists, and registered nurses. Other terms for conventional medicine include allopathy; Western, mainstream, orthodox, and regular medicine; and biomedicine. Some conventional medical practitioners are also practitioners of CAM.[1]

This summary answers some frequently asked questions about the use of CAM therapies among the general public and about how CAM therapies are evaluated, and suggests sources for more information.
2. What is integrative medicine?

NCCAM defines integrative medicine as treatment that combines conventional medicine with CAM therapies that have been reported to be safe and effective after being studied in patients. In practice, many CAM therapies used in along with conventional medicine have not yet been well tested.
3. Are complementary and alternative therapies widely used?

Yes. Many CAM approaches are used by a large percentage of people in the general public and cancer patients.

The 2007 National Health Interview Survey reported about 4 out of 10 adults used CAM therapy in the past 12 months, with the most commonly used treatments being natural products and deep breathing exercises.[2]

One large survey of cancer survivors reported on the use of complementary therapies.[3] The therapies used most often were prayer and spiritual practice (61%), relaxation (44%), faith and spiritual healing (42%), and nutritional supplements and vitamins (40%). CAM therapies are used by 31-84% of children with cancer, both in and outside of clinical trials.[4] CAM therapies have been used in the management of side effects caused by cancer or cancer treatment.
4. How are CAM approaches evaluated?

It is important that CAM therapies be evaluated with the same long and careful research process used to evaluate conventional treatments. The National Cancer Institute (NCI) and the Office of Cancer Complementary and Alternative Medicine (OCCAM) are sponsoring a number of clinical trials (research studies) at medical centers to evaluate CAM therapies for cancer. A listing of these trials is available at the OCCAM Clinical Trials Web page.

Conventional cancer treatments have generally been studied for safety and effectiveness through a rigorous scientific process that includes clinical trials with large numbers of patients. Less is known about the safety and effectiveness of many CAM therapies. Research of CAM therapies has been slower for a number of reasons:
* Time and funding issues.
* Problems finding institutions and cancer researchers to work with on the studies.
* Regulatory issues.

Some CAM therapies have undergone careful evaluation. A small number of CAM therapies originally meant to be alternative treatments are finding a place in cancer treatment as complementary therapies that may help patients feel better and recover faster. One example is acupuncture. According to a panel of experts at a National Institutes of Health (NIH) Consensus Conference in November 1997,[5] acupuncture has been found to be effective in the management of chemotherapy -associated nausea and vomiting and in controlling pain associated with surgery. In contrast, some approaches, such as the use of laetrile, have been studied and found ineffective or possibly harmful.
5. What is the NCI Best Case Series Program?

The NCI Best Case Series Program, which was started in 1991, is one way CAM approaches that are being used in practice are being investigated. The program is overseen by NCI’s Office of Cancer Complementary and Alternative Medicine (OCCAM). Health care professionals who offer alternative cancer therapies submit their patients’ medical records and related materials to OCCAM. OCCAM conducts a critical review of the materials and develops follow-up research strategies for approaches that warrant NCI-initiated research.
6. Are NCI and NCCAM sponsoring clinical trials in complementary and alternative medicine?

NCI and NCCAM are currently sponsoring or cosponsoring various clinical trials to study complementary and alternative treatments for cancer. Some of these trials study the effects of complementary approaches used in addition to conventional treatments, while others compare alternative therapies with conventional treatments. Current trials include the following:
* Electroacupuncture to treat delayed chemotherapy -induced nausea and vomiting in patients diagnosed with pediatric sarcoma, neuroblastoma, nasopharyngeal carcinoma, germ cell tumors, or Hodgkin lymphoma (NCT00040911).

* Effect of Coenzyme Q10 on doxorubicin blood levels in women undergoing treatment of breast cancer (NCT00976131).

* Flaxseed in postmenopausal women with hot flashes with a history of cancer (NCT00956813).

* Reiki/energy healing in prostate cancer patients (NCT00065208).

* Yoga for fatigue in breast cancer survivors (NCT00727662).

Patients who are interested in taking part in these or any clinical trials should talk with their doctor.

Several clinical trials databases offer patients, family members, and health professionals information about research studies that use CAM. Clinical trials can be found by searching the following:
* The NCI’s PDQ Clinical Trials Database, which can be searched by using criteria such as cancer type, type of trial, geographic region, trial sponsorship, and/or drug name. This information is also available by calling the NCI’s Cancer Information Service (1–800–4–CANCER [1–800–422–6237]; TTY: 1–800–332–8615).

* The NCCAM Clinical Trials Web page, which can be searched by the type of treatment or disease.

* The OCCAM Clinical Trials Web page, which provides links to NCI’s PDQ Clinical Trials Database.

* The Clinical Trials.Gov Web page, which can be searched by the type of medical condition or intervention.

7. What should patients do when using or considering complementary and alternative therapies?

Cancer patients using or considering complementary or alternative therapy should discuss this decision with their doctor or nurse, as they would any therapeutic approach. Some complementary and alternative therapies may interfere with standard treatment or may be harmful when used with conventional treatment. It is also a good idea to become informed about the therapy, including whether the results of scientific studies support the claims that are made for it. Some resources for this information are provided in Question 9.
8. When considering complementary and alternative therapies, what questions should patients ask their health care providers?
* What benefits can be expected from this therapy?
* What are the risks associated with this therapy?
* Do the known benefits outweigh the risks?
* What side effects can be expected?
* Will the therapy interfere with conventional treatment?
* Is this therapy part of a clinical trial? If so, who is sponsoring the trial?
* Will the therapy be covered by health insurance?

Further information on evaluating CAM therapies and practitioners is available from NCCAM.
9. What federal agencies can provide more information about CAM therapies?

Patients, their families, and their health care providers can learn about CAM therapies from the following government agencies and resources:

NCCAM
* NCCAM is the federal government’s lead agency for scientific research on CAM. NCCAM is dedicated to exploring complementary and alternative healing practices in the context of rigorous science, training CAM researchers, and disseminating authoritative information to the public and professionals.

* The NCCAM Clearinghouse provides information on NCCAM and on CAM, including fact sheets, other publications, and searches of federal databases of scientific and medical literature. Publications include the following:
o Are You Considering CAM?
o Selecting a CAM Practitioner
o Paying for CAM Treatment

* The Clearinghouse does not provide medical advice, treatment recommendations, or referrals to practitioners.

NCCAM Clearinghouse
Post Office Box 7923
Gaithersburg, MD 20898–7923
Toll-free in the United States: 1–888–644–6226
International: 301–519–3153
Callers with TTY equipment: 1–866–464–3615
Fax-on-Demand service: 1–888–644–6226
E-mail: info@nccam.nih.gov
Web site: http://nccam.nih.gov

NCI
* OCCAM

NCI's OCCAM coordinates the activities of NCI in the area of complementary and alternative medicine. OCCAM supports CAM cancer research and provides information about cancer-related CAM to health providers and the general public on the NCI Web site.

* NCI Cancer Information Service

U.S. residents may call the NCI Cancer Information Service toll free at 1–800–4–CANCER (1–800–422–6237) Monday through Friday from 9:00 am to 4:30 pm EST. Deaf and hearing-impaired callers with TTY equipment may call 1–800–332–8615. A trained Cancer Information Specialist is available to answer your questions.

* PDQ

NCI’s PDQ, a comprehensive cancer information database, contains peer-reviewed summaries of the latest information about the use of CAM in the treatment of cancer. Each summary contains background information about the specific treatment, a brief history of its development, information about relevant research studies, and a glossary of scientific and medical terms. CAM summaries can be found on NCI's Web site.

U.S. Food and Drug Administration (FDA)

The FDA regulates drugs and medical devices to ensure that they are safe and effective. This agency provides a number of publications for consumers, including information about dietary supplements.

U.S. Food and Drug Administration
5600 Fishers Lane
Rockville, MD 20857
Telephone: 1–888–463–6332 (toll free)
Web site: http://www.fda.gov
FDA’s Dietary Supplements Web page: http://www.cfsan.fda.gov/~dms/supplmnt.html

Federal Trade Commission (FTC)

The FTC enforces consumer protection laws and offers publications to guide consumers. The FTC also collects information about fraudulent claims.

Consumer Response Center
Federal Trade Commission
CRC–240
Washington, DC 20580
Telephone: 1–877–FTC–HELP (1–877–382–4357) (toll free)
Callers with TTY equipment: 202–326–2502
Web site: http://www.ftc.gov

CAM on PubMed

CAM on PubMed, a database accessible via the Internet, was developed jointly by NCCAM and the NIH National Library of Medicine (NLM). It contains bibliographic citations (from 1966 to the present) to articles on CAM published in scientifically based, peer-reviewed journals. These citations are a subset of NLM's PubMed system, which contains more than 11 million journal citations from the MEDLINE database and additional life science journals important to health researchers, practitioners, and consumers. CAM on PubMed also displays links to many publisher Web sites, which may offer the full text of articles.

References

1. White JD: Complementary, alternative, and unproven methods of cancer treatment. In: DeVita VT Jr, Hellman S, Rosenberg SA, eds.: Cancer: Principles and Practice of Oncology. 6th ed. Philadelphia, Pa: Lippincott Williams & Wilkins, 2001, pp 3147-57.

2. Barnes PM, Bloom B, Nahin RL: Complementary and alternative medicine use among adults and children: United States, 2007. Natl Health Stat Report (12): 1-23, 2009. [PUBMED Abstract]

3. Gansler T, Kaw C, Crammer C, et al.: A population-based study of prevalence of complementary methods use by cancer survivors: a report from the American Cancer Society's studies of cancer survivors. Cancer 113 (5): 1048-57, 2008. [PUBMED Abstract]

4. Kelly KM: Complementary and alternative medical therapies for children with cancer. Eur J Cancer 40 (14): 2041-6, 2004. [PUBMED Abstract]

5. NIH Consensus Conference. Acupuncture. JAMA 280 (17): 1518-24, 1998. [PUBMED Abstract]

Friday, December 24, 2010

Placebos Work -- Even Without Deception

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For most of us, the "placebo effect" is synonymous with the power of positive thinking; it works because you believe you're taking a real drug. But a new study rattles this assumption.

Researchers at Harvard Medical School's Osher Research Center and Beth Israel Deaconess Medical Center (BIDMC) have found that placebos work even when administered without the seemingly requisite deception.

The study is published December 22 in PLoS ONE.

Placebos -- or dummy pills -- are typically used in clinical trials as controls for potential new medications. Even though they contain no active ingredients, patients often respond to them. In fact, data on placebos is so compelling that many American physicians (one study estimates 50 percent) secretly give placebos to unsuspecting patients.

Because such "deception" is ethically questionable, HMS associate professor of medicine Ted Kaptchuk teamed up with colleagues at BIDMC to explore whether or not the power of placebos can be harnessed honestly and respectfully.

To do this, 80 patients suffering from irritable bowel syndrome (IBS) were divided into two groups: one group, the controls, received no treatment, while the other group received a regimen of placebos -- honestly described as "like sugar pills" -- which they were instructed to take twice daily.

"Not only did we make it absolutely clear that these pills had no active ingredient and were made from inert substances, but we actually had 'placebo' printed on the bottle," says Kaptchuk. "We told the patients that they didn't have to even believe in the placebo effect. Just take the pills."

For a three-week period, the patients were monitored. By the end of the trial, nearly twice as many patients treated with the placebo reported adequate symptom relief as compared to the control group (59 percent vs. 35 percent). Also, on other outcome measures, patients taking the placebo doubled their rates of improvement to a degree roughly equivalent to the effects of the most powerful IBS medications.

"I didn't think it would work," says senior author Anthony Lembo, HMS associate professor of medicine at BIDMC and an expert on IBS. "I felt awkward asking patients to literally take a placebo. But to my surprise, it seemed to work for many of them."

The authors caution that this study is small and limited in scope and simply opens the door to the notion that placebos are effective even for the fully informed patient -- a hypothesis that will need to be confirmed in larger trials.

"Nevertheless," says Kaptchuk, "these findings suggest that rather than mere positive thinking, there may be significant benefit to the very performance of medical ritual. I'm excited about studying this further. Placebo may work even if patients knows it is a placebo."

This study was funded by the National Center for Complementary and Alternative Medicine and Osher Research Center, Harvard Medical School.

Wednesday, December 8, 2010

Mindfulness meditation found to be as effective as antidepressants to prevent depression relapse

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A new study from the Centre for Addiction and Mental Health (CAMH) has found that mindfulness-based cognitive therapy--using meditation—provides equivalent protection against depressive relapse as traditional antidepressant medication.

The study published in the current issue of the Archives of General Psychiatry compared the effectiveness of pharmacotherapy with mindfulness-based cognitive therapy (MBCT) by studying people who were initially treated with an antidepressant and then, either stopped taking the medication in order to receive MBCT, or continued taking medication for 18 months.

"With the growing recognition that major depression is a recurrent disorder, patients need treatment options for preventing depression from returning to their lives." said Dr. Zindel Segal, Head of the Cognitive Behaviour Therapy Clinic in the Clinical Research Department at CAMH.

"Data from the community suggest that many depressed patients discontinue antidepressant medication far too soon, either because of side effect burden, or an unwillingness to take medicine for years. Mindfulness-based cognitive therapy is a non pharmacological approach that teaches skills in emotion regulation so that patients can monitor possible relapse triggers as well as adopt lifestyle changes conducive to sustaining mood balance.

Study participants who were diagnosed with major depressive disorder were all treated with an antidepressant until their symptoms remitted. They were then randomly assigned to come off their medication and receive MBCT; come off their medication and receive a placebo; or stay on their medication. The novelty of this design permits comparing the effectiveness of sequencing pharmacological and psychological treatments versus maintaining the same treatment – antidepressants - over time

Participants in MBCT attended 8 weekly group sessions and practiced mindfulness as part of daily homework assignments. Clinical assessments were conducted at regular intervals, and over an 18 month period, relapse rates for patients in the MBCT group did not differ from patients receiving antidepressants (both in the 30% range), whereas patients receiving placebo relapsed at a significantly higher rate (70%).

"The real world implications of these findings bear directly on the front line treatment of depression. For that sizeable group of patients who are unwilling or unable to tolerate maintenance antidepressant treatment, MBCT offers equal protection from relapse,".said Dr. Zindel Segal. "Sequential intervention-- offering pharmacological and psychological interventions-- may keep more patients in treatment and thereby reduce the high risk of recurrence that is characteristic of this disorder.

What Zen meditators don't think about won't hurt them

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Zen meditation has many health benefits, including a reduced sensitivity to pain. According to new research from the Université de Montréal, meditators do feel pain but they simply don't dwell on it as much. These findings, published in the month's issue of Pain, may have implications for chronic pain sufferers, such as those with arthritis, back pain or cancer.

“Our previous research found that Zen meditators have lower pain sensitivity. The aim of the current study was to determine how they are achieving this,” says senior author Pierre Rainville, researcher at the Université de Montréal and the Institut universitaire de gériatrie de Montréal. “Using functional magnetic resonance imaging, we demonstrated that although the meditators were aware of the pain, this sensation wasn't processed in the part of their brains responsible for appraisal, reasoning or memory formation. We think that they feel the sensations, but cut the process short, refraining from interpretation or labelling of the stimuli as painful.”

Training the brain
Rainville and his colleagues compared the response of 13 Zen meditators to 13 non-meditators to a painful heat stimulus. Pain perception was measured and compared with functional MRI data. The most experienced Zen practitioners showed lower pain responses and decreased activity in the brain areas responsible for cognition, emotion and memory (the prefrontal cortex, amygdala and hippocampus). In addition, there was a decrease in the communication between a part of the brain that senses the pain and the prefrontal cortex.

“Our findings lead to new insights into mind/brain function,” says first author, Joshua Grant, a doctoral student at the Université de Montréal. “These results challenge current concepts of mental control, which is thought to be achieved by increasing cognitive activity or effort. Instead, we suggest it is possible to self-regulate in a more passive manner, by ‘turning off' certain areas of the brain, which in this case are normally involved in processing pain.”

“The results suggest that Zen meditators may have a training-related ability to disengage some higher-order brain processes, while still experiencing the stimulus,” says Rainville. “Such an ability could have widespread and profound implications for pain and emotion regulation and cognitive control. This behaviour is consistent with the mindset of Zen and with the notion of mindfulness.”

About the Study:
“A non-elaborative mental stance and decoupling of executive and pain-related cortices predicts low pain sensitivity in Zen meditators” was authored by Joshua A. Grant, Jérôme Courtemanche and Pierre Rainville from the Université de Montréal.

Partners in research:
This study was funded by a grant from the Mind and Life Institute with support for Joshua Grant provided by the Canadian Institutes of Health Research.

Tuesday, November 23, 2010

Homeopathic Consultations -- But Not Homeopathic Remedies -- Linked to Benefits for Patients, Study Finds

Scientists from the University of Southampton have found evidence suggesting that homeopathic consultations -- but not homeopathic remedies -- are associated with clinically relevant benefits for patients with active but relatively stable rheumatoid arthritis.

In a study published in the journal Rheumatology, the researchers found that arthritis patients significantly benefited when they received homeopathy alongside conventional treatment over a period of 6 months, but this improvement was due to homeopathy's consultation process and not its remedies.

"Although previous trials have shown homeopathy may help patients with rheumatoid arthritis, this is the first time that we have scientific evidence that these benefits are specifically due to its unique consultation process," comments lead author Dr. Sarah Brien, a senior research fellow in complementary medicine at the University of Southampton.

"Homeopathic consultations differ from those in conventional medicine in that homeopaths focus on treating the patient, whereas conventional doctors tend to treat the illness. The homeopathic consultation process improves the health of these arthritis patients based on standard rheumatology measurements and does so safely and without side effects.

"What we don't yet know is if it is possible to introduce some of the techniques or approaches used within these consultations into conventional medicine."

Researchers recruited 83 people with rheumatoid arthritis from clinics in Southampton, Poole and Winchester for the study. Each patient received a series of homeopathy consultations over a 24-week period between January 2006 and July 2008, while continuing their conventional treatment. Patients and doctors reported significant reductions in a variety of symptoms including reduced 'disease activity scores', fewer swollen joints, reduced pain and improved mood.

The team now plans to conduct more research into identifying which elements of the consultation process are most beneficial and if homeopathy is a cost-effective treatment.