Sleep supplements found to contain habit-forming drug: warning
Health Canada release - Health Canada is advising consumers not to use Optimum Health Care SleePlus TCM or BYL SleePlus, because the products contain the undeclared drug clonazepam, which can be habit-forming when used for as little as a few months.
Consumers who may still have one of these products in their homes are advised to consult with a health care professional before they stop taking the pills, because of the risk of withdrawal symptoms.Optimum Health Care SleePlus TCM and BYL SleePlus have different names but are the same formulation, and both products are promoted as a sleep aid. The products are not authorized for sale in Canada.
Clonazepam belongs in the class of drugs known as benzodiazepines, which should only be prescribed by a health care professional. Clonazepam should not be used by people with an allergy to any benzodiazepines, such as Valium (diazepam), Restoril (temazepam) and Ativan (lorazepam), or those individuals affected by the neuromuscular disorder myasthenia gravis or by sleep apnea. Benzodiazepines, including clonazepam, should only be used by pregnant women if absolutely necessary and with caution by the elderly and those with a history of substance abuse. The side-effects associated with the use of products containing clonazepam vary according to the individual and can include dizziness, drowsiness, confusion, depression, loss of memory and hallucinations.
Health Canada has issued four advisories on similar products since August 2006. Eden Herbal Formulation Serenity Pills II, Salt Spring Herbals Sleep Well Dietary Supplement, Sleepees and Eden Herbal Formulations Sleep Ease Dietary Supplement were advertised as herbal health products to relieve sleeping difficulty, and were found to contain the undeclared drug estazolam, also in the class of drugs known as benzodiazepines. None of these products have been authorized for sale by Health Canada. Drugs and natural health products that are authorized for sale in Canada will have an eight-digit Drug Identification Number (DIN), a Natural Product Number (NPN) or a Homeopathic Medicine Number (DIN-HM) on the label. These numbers indicate that the products have been assessed by Health Canada for safety, effectiveness and quality.
Optimum Health Care SleePlus TCM, labelled in Chinese script, was sold to patients by Optimum Health Care, a clinic in Vancouver. BYL SleePlus was distributed to retail stores by BYL Pharmaceuticals Ltd., Vancouver. The products are being recalled; however consumers may still have the product in their homes.
Consumers who have purchased Optimum Health Care SleePlus TCM or BYL SleePlus should return it to the place of purchase. To date, no adverse reactions suspected to be associated with the use of Optimum Health Care SleePlus TCM or BYL SleePlus have been reported in Canada.
Health Canada also advises Canadians to contact the Health Products and Food Branch Inspectorate at 1-800-267-9675 if they find Optimum Health Care SleePlus TCM or BYL SleePlus for sale in Canada.
Consumers requiring more information about this advisory can contact Health Canada’s public enquiries line at (613) 957-2991, or toll free at 1-866-225-0709.
chinese medicineFDA issues manufacturing standards for dietary supplements
PRWire - The U.S. Food and Drug Administration (FDA) today released its long-awaited final regulation on good manufacturing practices (GMPs) for dietary supplements.
The rule, according to the FDA, will ensure that “dietary supplements are produced in a quality manner, do not contain contaminants or impurities, and are accurately labeled.”
“We think the final regulation is strong, but more reasonable than the proposed version. It offers a more flexible framework in meeting standards, such as testing and facility design. This will help smaller companies control costs — costs that would have been be passed along to the consumer — while still maintaining quality standards,” said David Seckman, executive director and CEO of the Natural Products Association.
“At 800-plus pages we’ll need to take a longer, more careful look at this document to fully determine its impact on the industry and consumers, but it appears that FDA took some of our concerns into account.”
The regulations establish controls throughout the manufacturing process, including packaging, labeling, and storing, to ensure quality and purity standards are met. The final rule includes requirements for establishing quality control procedures, designing and constructing manufacturing plants, and testing ingredients and the finished product. It also includes requirements for recordkeeping and handling consumer product complaints.
“With heightened consumer concern over the safety of food ingredients, particularly those coming from overseas, this new regulation should help to increase consumer confidence in the dietary supplement products they buy,” said Seckman. “Consumers want to be assured that what’s on the label is in the bottle — nothing more, nothing less — and this regulation aims to make sure that is the case.”
The regulation released today will be officially published in the Federal Register next week. In addition to the final regulation on good manufacturing practices, the agency also issued an “interim final rule” for identity testing that will allow the public and others to comment.
Information about both the final GMP regulation and interim final rule can be found on the FDA Web site.
The Natural Products Association is the industry leader in self-regulation, having established its own GMP certification program for dietary supplements in 1999. This program is based upon third party inspections of manufacturing facilities to determine whether specified performance standards are being met. These standards include many of the same specifications seen in the final regulation.
The Natural Products Association is the nation’s largest and oldest non-profit organization dedicated to the natural products industry. The association represents nearly 10,000 retailers, manufacturers, wholesalers and distributors of natural products, including foods, dietary supplements, and health/beauty aids.
Chinese medicine inconclusive in treating hyperthyroidism: review
Medical News Today - It might not be a bad idea for people with overactive thyroids to supplement their standard treatment with Chinese herbal medicine, a new review suggests. But while some of the studies supported the combination of two types of medicine, the reviewers say the quality of the research was questionable.
“Unfortunately, we cannot find a well-designed and conducted trial at this stage,” said Taixiang Wu, an associate professor at Sichuan University in China.
Hyperthyroidism occurs when the thyroid gland produces too much thyroid hormone, causing problems that can mimic the effects of a shot of adrenalin, said Jeffrey Sandler, M.D., an endocrinologist with Scripps Mercy Hospital and Whittier Institute in San Diego. “It stimulates the heart rate, can raise blood pressure, breaks down muscle and can cause weakness and weight loss.”
Increased thyroid hormone can lead to higher body temperatures and warm, moist skin as well. The cause of hyperthyroidism is typically Graves’ disease, where cells of the immune system work against the thyroid gland.
Hyperthyroidism is most common among women and the drugs used to treat it have been around for about 50 years, Sandler said. In extreme cases, doctors turn to surgery and radiation.
In this new Cochrane Library review, the researchers looked for studies that compared hyperthyroidism patients who took Chinese herbal medicine alone to those who took it in combination with Western treatments.
The Cochrane Library, a publication of The Cochrane Collaboration, an international organization that evaluates medical research. Systematic reviews like this one draw evidence-based conclusions about medical practice after considering both the content and quality of existing medical trials on a topic.
The reviewers were only able to find 13 relevant studies whose authors were available to interview. The researchers excluded 52 other studies whose authors they could not reach.
According to the reviewers, the 13 studies with 1,770 people were all of “low quality.” Types of herbal treatment varied widely, with 103 different formulations included.
None of the studies analyzed death rates, health-related quality of life or participants’ willingness to follow the regimens. And none used a “double-blinding” approach, in which both researchers and subjects are initially prevented from knowing who’s getting which treatment.
The studies indicated that combinations of Chinese herbal medicines and Western antithyroid drugs might lower relapse rates, reduce side effects and relieve symptoms of hyperthyroidism, but the Chinese treatments didn’t seem to have much of an effect on the functioning of the thyroid itself.
While understanding of hyperthyroidism is a product of modern times, Chinese doctors have presumably been treating patients with the condition for some 2,000 years, said Subhuti Dharmananda, director of the Institute for Traditional Medicine in Portland, Ore. Chinese research focused on specific treatments, however, only goes back to the 1970s and 1980s, he said.
Should hyperthyroidism patients consider combining Chinese and Western medicine? “At this point, there is no wisdom available one way or the other,” Dharmananda said. “My recommendation to people is that if they are drawn to using Chinese medicine as part of their therapy, that they find a good practitioner in their area and undertake a program of treatment to see if it helps.”
He added, “It is possible that Chinese medicine can, for example, alleviate some of the symptoms of hyperthyroidism or help maintain good health after modern treatment for the disease.”
As for the current Western treatment, “we do pretty well with what’s currently available and standard,” Sandler said.
Regarding alternative treatments, “the problem is that when you’re dealing with a disease where it’s important to have the right dosage of medication,” Sandler said. Indeed, the proper dose of one thyroid medication can range from 50 to 1,200 milligrams depending on the person, he said
“Things like herbal medicines and supplements are not reliably predictable, and the doses may vary from batch to batch or manufacturer to manufacturer,” Sandler said. “You’re dealing with a situation where there isn’t a great deal of control.”
The Cochrane Collaboration is an international nonprofit, independent organization that produces and disseminates systematic reviews of health care interventions and promotes the search for evidence in the form of clinical trials and other studies of interventions. Visit http://www.cochrane.org for more information.
Zen XX, et al. Chinese herbal medicines for hyperthyroidism. (Review). Cochrane Database of Systematic Reviews 2007, Issue 2.
Consumers warned about toxicity of traditional medicines
Reuters - About 200,000 people die in China each year from improper use of drugs, Chinese doctors and pharmacists say, and they are calling for greater efforts to educate consumers.
Mainland Chinese rely more on traditional Chinese medicines than on Western drugs and they tend to use them carelessly because of a widespread misconception that traditional medicines are not toxic or have no side effects.
“People should be told that they can’t consume drugs any way they want. There is no drug that has no side effects, they must not take drugs like they eat rice,” said Professor Jin Shiming, a committee member of the Guangdong Provincial Science and Technological Association.
Speaking at a conference on drug safety organized by the Guangdong Province Association of traditional Chinese medicine and a Chinese newspaper, Jin said nearly 200,000 people die each year from improper use of legitimate drugs. He did not explain how the panelists had calculated that number.
“All drugs have some level of toxicity. We can only cut back on the toxicity and reduce adverse reactions with accurate usage,” he said.
Jin and other experts at the seminar described patients who took excessive doses of traditional medicine in the belief that they would recover more quickly.
Traditional Chinese doctor Mei Quanxi from the Zhongshan Chinese Medicine Hospital cited a case where a man died after consuming a whole ginseng root that his wife bought him. Ginseng is used in the treatment of diabetes and sexual dysfunction.
“If you use a lot of it as a tonic, it is dangerous, which is why we have a saying that ginseng can kill,” Mei told Reuters after the conference.
Dan shen’s effect for stroke patients lacks strong evidence
Health Behavior News Service, by Bruce Sylvester - The traditional Chinese medicine dan shen (丹参, Salviae miltiorrhizae), a standard treatment for ischemic stroke in China, lacks strong scientific evidence to support such use, according a new review of studies.Nevertheless, based on the available data, dan shen treatment showed a tendency to improve short-term neurological deficits in stroke patients, say researchers at Sichuan University in Chengdu, China.
However, the short-term result “should be interpreted cautiously because of the poor methodological quality of included trials and the small numbers of patients,” said review co-author and neurology professor Ming Liu.
The review appears in the current issue of The Cochrane Library, a publication of The Cochrane Collaboration, an international organization that evaluates research in all aspects of health care. Systematic reviews draw evidence-based conclusions about medical practice after considering both the content and quality of existing trials on a topic.
Obstruction of a blood vessel supplying blood to the brain can result in ischemic stroke, which accounts for about 83% of all strokes.
In China, post-stroke use of herbal medicine is part of standard care in both Western-style hospitals and in traditional Chinese medicine hospitals. Dan shen, in various pill, tablet and injection formulations, is the herb most commonly given for ischemic stroke; its use in that context spans more than three decades.
However, few researchers have tested the herb’s effectiveness in rigorous clinical trials that approach current international standards.
The reviewers found six studies that met inclusion criteria for the review — randomized or quasi-randomized and controlled — involving 494 acute ischemic stroke patients.
The Cochrane reviewers found that methods of randomly assigning study subjects to dan shen or placebo were unclear, and that this could have led to results exaggerating a positive treatment effect by 30% to 41%. “It is therefore plausible that dan shen is truly ineffective and the apparent benefits are simply due to bias arising from the methodological weaknesses of the studies,” they say.
Since treatment and follow-up in these studies ranged from 14 to 28 days, it was not possible to assess the long-term effects of dan shen.
“We found no evidence to support the routine use of dan shen agents for ischemic stroke,” Liu said. “However, if the apparently beneficial effects on neurological impairment were confirmed in methodologically rigorous trials, it would lead to a useful treatment for stroke being identified,” she added.
Ted Kaptchuck, O.M.D., associate professor of medicine at Harvard Medical School, said, “in Chinese society, at this time, basic science and laboratory evidence seems to be enough to gain widespread acceptance and adoption for the use herbal and other medications. In the West, we think it is a long shot to go from basic laboratory evidence to demonstrated clinical efficacy in randomized trials. We are not at the point where it is clear that a traditional Chinese herb has a major role in health care.”
Liu agreed: “The designs of these trials need to be improved in the future research, not only in the clinical trials on dan shen agents, but also in trials on other Chinese herbal medicine.”
[Dan Shen agents for acute ischaemic stroke (Review). Cochrane Database of Systematic Reviews 2007, Issue 2.]
The Cochrane Collaboration is an international nonprofit, independent organization that produces and disseminates systematic reviews of health care interventions and promotes the search for evidence in the form of clinical trials and other studies of interventions. Visit http://www.cochrane.org for more information.
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