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Seasonal Allergies and Complementary Health Practices
Seasonal Allergies and Complementary Health Practices
Source: National Center for Complementary and Alternative Medicine
Seasonal allergies, also called “hay fever,” are a common chronic medical problem. At least 17.7 million American adults (7.8 percent of the adult population) and 7 million children (about 9 percent of children) have seasonal allergies.
People manage seasonal allergies by taking medication, avoiding exposure to the substances that trigger their allergic reactions, having a series of “allergy shots” (a form of immunotherapy) or using various complementary approaches. According to the 2007 National Health Interview Survey, “respiratory allergy” is among the 15 conditions for which children in the United States use complementary approaches most frequently. This issue of the Digest provides information on what the science says about several complementary health approaches for seasonal allergies, such as saline nasal irrigation, butterbur, honey, acupuncture, and other practices.
Toxicology and Carcinogenesis Studies of Ginkgo Biloba Extract (CASRN 90045-36-6) in F344/N Rats and B6C3F1/N Mice
Source: National Institutes of Health (National Toxicology Program)
Under the conditions of these 2-year gavage studies, there was some evidence of carcinogenic activity of Ginkgo biloba extract in male F344/N rats based on increased incidences of thyroid gland follicular cell adenoma. The increased incidences of mononuclear cell leukemia and hepatocellular adenoma may have been related to Ginkgo biloba extract administration. There was some evidence of carcinogenic activity of Ginkgo biloba extract in female F344/N rats based on increased incidences of thyroid gland follicular cell neoplasms. Increased occurrence of respiratory epithelium adenomas in the nose may have been related to Ginkgo biloba extract administration. There was clear evidence of carcinogenic activity of Ginkgo biloba extract in male B6C3F1/N mice based on increased incidences of hepatocellular carcinoma and hepatoblastoma. The increased incidences of thyroid gland follicular cell adenoma were also related to Ginkgo biloba extract administration. There was clear evidence of carcinogenic activity of Ginkgo biloba extract in female B6C3F1/N mice based on increased incidences of hepatocellular adenoma, hepatocellular carcinoma, and hepatoblastoma.
Administration of Ginkgo biloba extract resulted in increased incidences of nonneoplastic lesions in the liver, thyroid gland, and nose of male and female rats and mice and the forestomach of male and female mice. Increased severity of nephropathy in male rats was also due to administration of Ginkgo biloba extract.
Acupuncture for Posttraumatic Stress Disorder: A Systematic Review of Randomized Controlled Trials and Prospective Clinical Trials
Source: Evidence-Based Complementary and Alternative Medicine (eCAM)
To evaluate the current evidence for effectiveness of acupuncture for posttraumatic stress disorder (PTSD) in the form of a systematic review, a systematic literature search was conducted in 23 electronic databases. Grey literature was also searched. The key search terms were “acupuncture” and “PTSD.” No language restrictions were imposed. We included all randomized or prospective clinical trials that evaluated acupuncture and its variants against a waitlist, sham acupuncture, conventional therapy control for PTSD, or without control. Four randomized controlled trials (RCTs) and 2 uncontrolled clinical trials (UCTs) out of 136 articles in total were systematically reviewed. One high-quality RCT reported that acupuncture was superior to waitlist control and therapeutic effects of acupuncture and cognitive-behavioral therapy (CBT) were similar based on the effect sizes. One RCT showed no statistical difference between acupuncture and selective serotonin reuptake inhibitors (SSRIs). One RCT reported a favorable effect of acupoint stimulation plus CBT against CBT alone. A meta-analysis of acupuncture plus moxibustion versus SSRI favored acupuncture plus moxibustion in three outcomes. This systematic review and meta-analysis suggest that the evidence of effectiveness of acupuncture for PTSD is encouraging but not cogent. Further qualified trials are needed to confirm whether acupuncture is effective for PTSD.
New From the GAO
New GAO Reports
Source: Government Accountability Office
DIETARY SUPPLEMENTS
FDA May Have Opportunities to Expand Its Use of Reported Health Problems to Oversee Products
GAO-13-244, Mar 18, 2013
Antioxidants and Health: An Introduction
Antioxidants and Health: An Introduction
Source: National Center for Complementary and Alternative Medicine (NCCAM)
Antioxidants are man-made or natural substances that may prevent or delay some types of cell damage. Diets high in vegetables and fruits, which are good sources of antioxidants, have been found to be healthy; however, research has not shown antioxidant supplements to be beneficial in preventing diseases. Examples of antioxidants include vitamins C and E, selenium, and carotenoids, such as beta-carotene, lycopene, lutein, and zeaxanthin. This fact sheet provides basic information about antioxidants, summarizes what the science says about antioxidants and health, and suggests sources for additional information.
NCCAM Clinical Digest: Stress and Relaxation Techniques
NCCAM Clinical Digest: Stress and Relaxation Techniques
Source: National Center for Complementary and Alternative Medicine
Stress is a physical and emotional reaction that people experience as they encounter changes in life. Occasional stress is a normal coping mechanism. However, long-term stress may contribute to or worsen a range of health problems including digestive disorders, headaches, sleep disorders, and other symptoms. Stress may worsen asthma and has been linked to depression, anxiety, and other mental illnesses.
Some people use various relaxation techniques to induce the relaxation response, which helps release tension and may counteract the ill effects of stress. Relaxation techniques often combine breathing exercises and focused attention to calm the mind and the body. Some examples of relaxation response techniques are autogenic training, biofeedback, deep breathing, guided imagery, progressive relaxation, and self-hypnosis.
This issue provides information on "what the science says" about relaxation techniques for several stress-related disorders, including anxiety, depression, headaches, asthma, heart disease and heart symptoms, high blood pressure, insomnia, and irritable bowel syndrome.
CRS — Medical Marijuana: The Supremacy Clause, Federalism, and the Interplay Between State and Federal Laws
Source: Congressional Research Service (via Federation of American Scientists)
As part of a larger scheme to regulate drugs and other controlled substances, federal law prohibits the cultivation, distribution, and possession of marijuana. No exception is made for marijuana used in the course of a recommended medical treatment. Indeed, by categorizing marijuana as a Schedule I drug under the Controlled Substances Act (CSA), the federal government has concluded that marijuana has “no currently accepted medical use in treatment in the United States.” Yet 18 states and the District of Columbia have decriminalized medical marijuana by enacting exceptions to their state drug laws that permit individuals to grow, possess, or use marijuana for medicinal purposes. In contrast to the complete federal prohibition, these 19 jurisdictions see medicinal value in marijuana and permit the drug’s use under certain circumstances.
Although the U.S. Supreme Court has established Congress’s constitutional authority to enact the existing federal prohibition on marijuana, principles of federalism prevent the federal government from mandating that the states actively support or participate in enforcing the federal law. While state resources may be helpful in combating the illegal use of marijuana, Congress’s ability to compel the states to enact similar criminal prohibitions, to repeal medical marijuana exemptions, or to direct state police officers to enforce the federal law remains limited by the Tenth Amendment.
Even if the federal government is prohibited from mandating that the states adopt laws supportive of federal policy, the constitutional doctrine of preemption generally prevents states from enacting laws that are inconsistent with federal law. Under the Supremacy Clause, state laws that conflict with federal law are generally preempted and therefore void. Courts, however, have not viewed the relationship between state and federal marijuana laws in such a manner, nor did Congress intend that the CSA displace all state laws associated with controlled substances. Instead, the relationship between the federal ban on marijuana and state medical marijuana exemptions must be considered in the context of two distinct sovereigns, each enacting separate and independent criminal regimes with separate and independent enforcement mechanisms, in which certain conduct may be prohibited under one sovereign and not the other. Although state and federal marijuana laws may be “logically inconsistent,” a decision not to criminalize—or even to expressly decriminalize—conduct for purposes of the law within one sphere does nothing to alter the legality of that same conduct in the other sphere.
This report will review the federal government’s constitutional authority to enact the federal criminal prohibition on marijuana; highlight certain principles of federalism that prevent the federal government from mandating that states participate in enforcing the federal prohibition; consider unresolved questions relating to the extent to which state authorization and regulation of medical marijuana are preempted by federal law; and assess what obligations, if any, the U.S. Department of Justice (DOJ) has to investigate and prosecute violations of the federal prohibition on marijuana.
S-Adenosyl-L-Methionine (SAMe): An Introduction
S-Adenosyl-L-Methionine (SAMe): An Introduction
Source: National Center for Complementary and Alternative Medicine (NCCAM)
S-Adenosyl-L-methionine (also called S-adenosyl methionine, S-adenosylmethionine, SAMe, or SAM-e in the United States or ademetionine in Europe, and also often abbreviated as SAM and AdoMet) is a chemical that is found naturally in the body. SAMe is sold in the United States as a dietary supplement. This fact sheet provides basic information about SAMe, summarizes scientific research on safety and effectiveness, and suggests sources for additional information.
Yoga Service Resource Guide
Yoga Service Resource Guide (PDF)
Source: Kripalu Center
The organizations found within these pages offer trainings, inspiration, and practical tips for bringing yoga to a wide range of underserved populations, including military veterans, trauma survivors, people who are homeless, those who abuse substances and alcohol, inmates, people with chronic conditions, children in Title I schools, and others. The teachers and directors of these organizations have all seized the opportunity to work toward a better, healthier world by following their calling: to bring the benefits of yoga and mindfulness to unserved and underserved populations.
Dietary Supplements: Companies May Be Difficult To Locate in an Emergency
Dietary Supplements: Companies May Be Difficult To Locate in an Emergency
Source: U.S. Department of Health and Human Services, Office of Inspector General
WHY WE DID THIS STUDY
The Public Health Security and Bioterrorism Preparedness and Response Act of 2002 requires certain dietary supplement companies to register with FDA. Registration in the Food Facility Registry (the registry) is intended to provide FDA with sufficient information to contact companies in an emergency. Previous OIG work identified problems with FDA’s registry. Recent recalls of dietary supplements tainted with prescription drugs, synthetic steroids, and other potentially dangerous ingredients highlight the importance of registration and adverse event contact information so that FDA can trace the source of the product. These problems raised questions about FDA’s ability to identify and contact manufacturers in a food emergency to protect public health.
HOW WE DID THIS STUDY
We analyzed a purposive sample of 127 weight loss and immune support dietary supplements. For 123 of these supplements, we determined whether the companies that produced them were registered with FDA and compared the information in the registry with information obtained during structured interviews with company representatives. We also analyzed the labels of all 127 dietary supplements to determine whether they contained required adverse event contact information.
WHAT WE FOUND
Twenty-eight percent of contacted companies failed to register with FDA as required. Of the companies that did register, 72 percent failed to provide the complete and accurate information required in the registry. Finally, 20 percent of dietary supplement labels in our sample did not provide the required telephone numbers or addresses.
WHAT WE RECOMMEND
We recommend that FDA: (1) improve the accuracy of information in the registry, (2) seek authority to impose civil monetary penalties on companies that do not comply with registration requirements, and (3) educate the dietary supplement industry about registration and labeling requirements. FDA concurred with all of our recommendations.
Dietary Supplements: Structure/Function Claims Fail To Meet Federal Requirements
Dietary Supplements: Structure/Function Claims Fail To Meet Federal Requirements
Source: U.S. Department of Health and Human Services, Office of Inspector General
WHY WE DID THIS STUDY
The Government Accountability Office and public interest groups have raised concerns about a specific type of claim-called a structure/function claim-that manufacturers may use on dietary supplement labels. Manufacturers have used these claims to promote health benefits of their products. Stakeholders have urged FDA to strengthen oversight of these claims because they are potentially misleading and may lack scientific support. FDA lacks authority to review or approve these claims before products enter the market. Manufacturers must have competent and reliable scientific evidence to show that claims are truthful and not misleading, but they do not have to submit the substantiation to FDA, and FDA has only voluntary standards for it. A manufacturer must notify FDA when it uses structure/function claims, and a product label must include a disclaimer stating that FDA has not reviewed the claim and that the product is not intended to diagnose, treat, cure, or prevent any disease.
HOW WE DID THIS STUDY
We analyzed structure/function claims for a purposive sample of 127 dietary supplements marketed for weight loss or immune system support. We reviewed the claims to determine the extent to which they complied with FDA regulations. We reviewed substantiation provided by manufacturers to describe the quantity and nature of the evidence. We also assessed the accuracy and completeness of notification letters that manufacturers must submit to FDA for their structure/function claims.
WHAT WE FOUND
Overall, substantiation documents for the sampled supplements were inconsistent with FDA guidance on competent and reliable scientific evidence. FDA could not readily determine whether manufacturers had submitted the required notification for their claims. Seven percent of the supplements lacked the required disclaimer, and 20 percent included prohibited disease claims on their labels. These results raise questions about the extent to which structure/function claims are truthful and not misleading.
WHAT WE RECOMMEND
We recommend that FDA seek explicit statutory authority to review substantiation for structure/function claims to determine whether they are truthful and not misleading. We recommend that FDA improve the notification system for these claims to make it more organized, complete, and accurate. We also recommend that FDA expand market surveillance to enforce the use of disclaimers for structure/function claims and to detect disease claims. In its comments on the draft report, FDA did not explicitly concur with our first recommendation, but said it would consider it. FDA concurred with our second and third recommendations.
Osteoarthritis and Complementary Health Approaches
Osteoarthritis and Complementary Health Approaches
Source: National Center for Complementary and Alternative Medicine (NCCAM)
Osteoarthritis (OA) is a disease that causes pain and difficulty moving joints, particularly in the knees, hips, hands, and spine. This fact sheet provides basic information on OA, summarizes scientific research on selected dietary supplements, mind and body practices, and other complementary health approaches that have been studied for OA, and suggests sources for additional information.
Lead Poisoning in Pregnant Women Who Used Ayurvedic Medications from India — New York City, 2011–2012
Lead Poisoning in Pregnant Women Who Used Ayurvedic Medications from India — New York City, 2011–2012
Source: Morbidity and Mortality Weekly Report (CDC)
Lead poisoning still occurs in the United States despite extensive prevention efforts and strict regulations. Exposure to lead can damage the brain, kidneys, and nervous and reproductive systems. Fetal exposure to lead can adversely affect neurodevelopment, decrease fetal growth, and increase the risk for premature birth and miscarriage (1). During 2011–2012, the New York City Department of Health and Mental Hygiene (DOHMH) investigated six cases of lead poisoning associated with the use of 10 oral Ayurvedic medications made in India. All six cases were in foreign-born pregnant women assessed for lead exposure risk by health-care providers during prenatal visits, as required by New York state law. Their blood lead levels (BLLs) ranged from 16 to 64 µg/dL. Lead concentrations of the medications were as high as 2.4%; several medications also contained mercury or arsenic, which also can have adverse health effects. DOHMH distributed information about the medications to health-care providers, product manufacturers, and government agencies in the United States and abroad, via postal and electronic mail. DOHMH also ordered a local business selling contaminated products to cease sales. Health-care providers should ask patients, especially foreign-born or pregnant patients, about any use of foreign health products, supplements, and remedies such as Ayurvedic medications. Public health professionals should consider these types of products when investigating heavy metal exposures and raise awareness among health-care providers and the public regarding the health risks posed by such products.
Chronic Pain and Complementary Health Practices
Chronic Pain and Complementary Health Practices
Source: National Center for Complementary and Alternative Medicine
Millions of Americans suffer from pain that is chronic, severe, and not easily managed. Pain from arthritis, back problems, other musculoskeletal conditions, and headache costs U.S. businesses more than $61 billion a year in lost worker productivity.
Pain is the most common health problem for which adults use complementary health practices. Many people with conditions causing chronic pain turn to these practices to supplement other conventional medical treatment, or when their pain is resistant or in an effort to advert side effects of medications. Despite the widespread use of complementary health practices for chronic pain, scientific evidence on efficacy and mechanisms—whether the therapies help the conditions for which they are used and, if so, how—is, for the most part, limited. However, the evidence base is growing, especially for several complementary health practices most commonly used by people to lessen pain.
This issue highlights the research status for several therapies used for common kinds of pain, including arthritis, fibromyalgia, headache, low-back pain, and neck pain.
Spinal Manipulation for Low-Back Pain
Spinal Manipulation for Low-Back Pain
Source: National Center for Complementary and Alternative Medicine (NCCAM)
Low-back pain (often referred to as “lower back pain”) is a common condition that usually improves with self-care (practices that people can do by themselves, such as remaining active, applying heat, and taking pain-relieving medications). However, it is occasionally difficult to treat. Some health care professionals are trained to use a technique called spinal manipulation to relieve low-back pain and improve physical function (the ability to walk and move). This fact sheet provides basic information about low-back pain, summarizes research on spinal manipulation for low-back pain, and suggests sources for additional information.
Usage and appraisal of educational media by homeopathic therapists: A cross sectional survey
Usage and appraisal of educational media by homeopathic therapists: A cross sectional survey
Source: BMC Complementary and Alternative Medicine
Background
During recent years the market for homeopathic education media has increasingly diversified with old (books, seminars) and new media (video-seminars, pc-programs, homeo-wiki and internet-courses). However, little is known about homeopaths’ preferences in using educational media and their requirements of this topic. Aim: This survey was designed to gain a better understanding of the usage and appraisal of educational media by homeopaths.Methods
192 homeopathic practitioners (GPs and health practitioners) at a educational conference were asked to answer a standardized questionnaire covering the topics “formal education and context of work” (9 items), “homeopathic practise and usage (24 items), “utilization of educational media” (9 items) and “favoured attributes for educational media” (11 items).Results
Out of 192 homeopaths who attended the conference, 118 completed the questionnaire (response rate 61.5 %). For their continuing homeopathic education they predominantly indicated to use books (scale value from 0=never to 2=always: 1.72) and seminars (1.54) whereas journals (0.98) and the internet (0.65) were used less often. The most favoured attributes concerning medical education media were reliability (1.76), relevance for clinical practice (1.74) and user friendliness (1.6). Less favoured attributes were inexpensiveness (1.1), graphical material (0.92) and interactivity (0.88).Conclusions
The survey illustrates the current situation of medical education media in homeopathy. Although there are parallels to earlier research conducted in conventional GPs, homeopaths are more likely to refer to classical media. New education tools should be designed according to these preferences.
Red Yeast Rice: An Introduction
Red Yeast Rice: An Introduction
Source: National Center for Complementary and Alternative Medicine
Red yeast rice is a traditional Chinese culinary and medicinal product. In the United States, dietary supplements containing red yeast rice have been marketed to help lower blood levels of cholesterol and related lipids. Red yeast rice products may not be safe; some may have the same side effects as certain cholesterol-lowering drugs, and some may contain a potentially harmful contaminant. This fact sheet provides basic information about red yeast rice, summarizes scientific research on effectiveness and safety, discusses the legal status of red yeast rice, and suggests sources for additional information.
Backgrounder — Tai Chi: An Introduction
Tai Chi: An Introduction
Source: National Center for Complementary and Alternative Medicine (NCCAM)
Tai chi, which originated in China as a martial art, is a mind-body practice in complementary and alternative medicine (CAM). Tai chi is sometimes referred to as “moving meditation”—practitioners move their bodies slowly, gently, and with awareness, while breathing deeply. This Backgrounder provides a general overview of tai chi and suggests sources for additional information.
What Every Clinician Should Know About Herb–Supplement–Drug Interactions
What Every Clinician Should Know About Herb–Supplement–Drug Interactions (PDF)
Source: Alternative and Complementary Therapies
Any items that a person takes orally on a supplemental basis–whether they be herbs, dietary supplements, other natural products, or functional foods such as energy drinks and nutritional bars–can interact with each other and with medications. We know that these interactions may have harmful or beneficial effects and can increase or potentiate lev- els of other therapeutics and/or decrease levels of other therapeutics. Dietary supplements can also interact with diagnostic test results and laboratory assays.
It is important to note that interactions caused by supplements can be hard to predict due to a lack of clinical research, compared to reactions caused by drugs, because many products are not standardized to specific ingredients or amounts, and herbal constituents may differ depending on what plant parts the constituents are derived from, for instance, petals, seeds, stems, roots, or leaves. Unlike a prescription drug, for which one can definitively draw the chemical structure graphically, measure it, weigh it, and see it under a microscope, this is more difficult when dealing with natural products.
We have all heard that “natural” does not equal “safe,” but this is really true. If something has a therapeutic action in a human body, this substance can also cause a reaction or an interaction. Supplements are not 100% receptor-specific to only have one effect and no other effects, and what might help one person might hurt another person, just like medications do.
But, remember that not all interactions are bad. Some interactions may be beneficial. An example is if one therapy in- creases the benefit of another or affects electrolyte levels or liver-function test results in a beneficial way. One therapeutic might interact with another in a good way in that it decreases a side-effect or allows a dose of another therapeutic to be lowered, and, therefore, a person experiences a lesser side-effect risk from both therapeutics. Also, a socioeconomic benefit may be, if one purchases or perhaps grows a natural ingredient in a garden, that might be more cost-effective than the alternatives. Purchasing without a prescription may keep insurance costs down over time.
I think it is critical that clinicians consider herbs and supplements as therapeutic options. But, whether we are trained about this in medical school or not, I feel that we have a professional responsibility to educate ourselves and our patients or consumers about the potential for various types of interactions.
See: Risks of Mixing Drugs and Herbal Supplements: What Doctors and Patients Need to Know (Science Daily)
The Flu, the Common Cold, and Complementary Health Practices
The Flu, the Common Cold, and Complementary Health Practices
Source: National Center for Complementary and Alternative Medicine
Each year, approximately 5 to 20 percent of Americans come down with the flu. Although most recover without incident, flu-related complications result in more than 200,000 hospitalizations and between 3,000 and 49,000 deaths each year. Colds generally do not cause serious complications, but they are among the leading reasons for visiting a doctor and for missing school or work.
To prevent or treat these illnesses, some people turn to complementary health practices such as herbs or vitamins and minerals. This issue provides information on “what the science says” about some of these practices for the flu and for the common cold, including zinc, vitamin C, echinacea, and probiotics.
