A recent analysis of national survey data reveals that over 1.6 million American adults use some form of complementary and alternative medicine (CAM) to treat insomnia or trouble sleeping(*) according to scientists at the National Center for Complementary and Alternative Medicine (NCCAM), part of the National Institutes of Health. The data came from the 2002 National Health Interview Survey (NHIS) conducted by the National Center for Health Statistics of the Centers for Disease Control and Prevention.

In 2002 the NHIS, an in-person, annual health survey, included over 31,000 U.S. adults aged 18 years and older. A CAM supplement to the survey asked about the use of 27 types of CAM therapies, as well as a variety of medical conditions for which CAM may be used, including insomnia or trouble sleeping. Survey results show that over 17 percent of adults reported trouble sleeping or insomnia in the past 12 months. Of those with insomnia or trouble sleeping, 4.5 percent - more than 1.6 million people - used some form of CAM to treat their condition.

'These data offer some new insights regarding the prevalence of insomnia or trouble sleeping in the United States and the types of CAM therapies people use to treat these conditions,' said Dr. Margaret A. Chesney, Acting Director of NCCAM. 'They will help us develop new research questions regarding the safety and efficacy of the CAM therapies being used.'

Those using CAM to treat insomnia or trouble sleeping were more likely to use biologically based therapies (nearly 65 percent), such as herbal therapies, or mind-body therapies (more than 39 percent), such as relaxation techniques. A majority of people who used herbal or relaxation therapies for their insomnia reported that they were helpful. The two most common reasons people gave for using CAM to treat insomnia were they thought it would be interesting to try (nearly 67 percent) and they thought CAM combined with a conventional treatment would be helpful (nearly 64 percent).

In addition to looking at the data on CAM use and insomnia, the researchers also looked at the connection between trouble sleeping and five significant health conditions: diabetes, hypertension, congestive heart failure, anxiety and depression, and obesity. They found that insomnia or trouble sleeping is highly associated with four of the five conditions: hypertension, congestive heart failure, anxiety and depression, and obesity.

Other key points reported in the analysis include:
• Nearly 61 percent reporting trouble sleeping were women versus about 39 percent men.
• Insomnia peaks in middle age (45-64 years old) and a second increase appears in people 85 and older.
• African Americans and Asians appear less likely to report trouble sleeping or insomnia than whites.
• Those with higher education also are less likely to report insomnia or trouble sleeping.

* Pearson NJ, Johnson LL, Nahin RL. Insomnia, Trouble Sleeping, and Complementary and Alternative Medicine: Analysis of the 2002 National Health Interview Survey Data. Archives of Internal Medicine, 2006; 166:1775-1782

On September 6, 2005, the U.S. Food and Drug Administration (FDA) announced that, at its request, U.S. Marshals seized quantities of Ellagimax capsules, Coral Max capsules, Coral Max without Iron capsules, and Advanced Arthritis Support capsules distributed by Advantage Nutraceuticals L.L.C. of Fort Walton Beach, Florida, valued at approximately $55,000.00.

The products are alleged to be in violation of the new drug and misbranding provisions of the Federal Food, Drug and Cosmetic Act.

Although these products are labeled as 'dietary supplements', they are being promoted with claims typically associated with drug products. These claims are evident in the products' labeling, including various promotional literature, an audio cassette tape, and two Internet Web sites owned and used by the firm. The FDA advises consumers to consult with their physician if they are taking these products.

Advantage Nutraceuticals' labeling promotes and markets these products for serious disease conditions, including but not limited to cancer, arthritis, fibromyalgia and seizures.

FDA considers these products to be unapproved new drugs, and the agency takes seriously its responsibility to protect Americans from dangerous unapproved drugs. Before a new drug product may be legally marketed, it must be shown to be safe and effective and approved by FDA. Drug product labeling must also include adequate directions for use, which the seized products' labeling does not provide.

Following an investigation of the firm's marketing practices, FDA advised Advantage Nutraceuticals that the claims related to prevention or treatment of diseases in many of its products' labeling make these products subject to regulation as drugs. Despite FDA's warnings, the firm failed to take sufficient steps to come into compliance with the Act. During subsequent inspections, FDA inspectors found that the offending claims were still being made.

LCTA's magazine, Dragons Tale has been awarded the prestigious Pearl Award for Media Excellence. The Award presented at a ceremony on Thursday 28th September 2006, acknowledges Dragons Tale’s contribution to the promotion of Chinese medicine and responsible best practice in the UK.

'LCTA has worked hard to promote Chinese medicine in the UK through Dragons Tale – something which was long overdue. Many congratulations to all at LCTA on receiving this award,”' commented William Ong of The Pearl Foundation. The Pearl Awards were established by the Pearl Foundation in 2004 to recognise and celebrate Chinese achievements in multi-cultural Britain.

The US Food and Drug Administration (FDA) has warned three firms, RoTech Healthcare, Inc., CCS Medical, and Reliant Pharmacy Services, to stop manufacturing and distributing thousands of doses of compounded, unapproved inhalation drugs nation-wide.

Responsible officials at firms that do not properly address violations identified in FDA warning letters risk further enforcement, including injunctions that prevent further violations and seizure of their products that violate the law.

The three firms warned by FDA say that they produce inhalation drugs as part of the practice of pharmacy compounding. Traditional pharmacy compounding typically involves pharmacies preparing drugs that are not commercially available, such as a unique medicine for a patient who is allergic to an ingredient in a FDA-approved drug.

This kind of compounding follows a physician's decision that his or her patient has a special medical need that cannot be met by FDA-approved drugs. FDA normally permits traditional pharmacy compounding and the agency's action is not targeting this practice.

Inhalation drugs are used to treat diseases including asthma, emphysema, bronchitis, and cystic fibrosis. These are potentially life-threatening conditions for which numerous FDA-approved drugs are available. Compounded inhalation drugs may be distributed to patients in multiple states, and patients and their doctors may not know that they are receiving compounded products. FDA urges consumers using inhalation drugs to discuss their medications with their physicians and verify with their pharmacists that the medications they received are what their physicians ordered.

'Compounded inhalation drugs are not reviewed by the FDA for safety and effectiveness, often are not produced according to good drug manufacturing practice, and typically are not sterile. This may expose patients to unnecessary risk,' said Dr. Steven Galson, Director of FDA's Center for Drug Evaluation and Research. 'To avoid these risks, we encourage patients to use FDA-approved drugs whenever possible.'

FDA believes that, in compounding mass amounts of inhalation drugs, a number of pharmacies go well beyond traditional compounding. FDA is aware of certain pharmacies compounding millions of doses of inhalation drugs per year. These compounded drugs often simply copy FDA-approved, commercially available drugs, and any differences from FDA-approved drugs do not appear to be related to patients' medical needs.

Consumers and health care professionals should notify FDA of any complaints or problems associated with compounded drugs. These reports may be made to MedWatch, FDA's voluntary reporting program, by phone at 1-800-FDA-1088 or online at www.fda.gov/medwatch/report.htm.

Warning Letter to Rotech Healthcare, Inc., Orlando, FL
http://www.fda.gov/foi/warning_letters/g5964d.htm
Warning Letter to CCS Medical, Clearwater, FL
http://www.fda.gov/foi/warning_letters/g5963d.htm.

Following an investigation by the Medicines and Healthcare products Regulatory Agency (MHRA), Richard Underhill (48) of Church Cookham, Hampshire, pleaded guilty on 28 September 2006 at Guildford Magistrates Court to one offence relating to the possession of Kamagra gel, with intent to place on the market. Mr Underhill was remanded on unconditional bail to Guildford Crown Court for sentencing. A date for sentencing will be set shortly.

MHRA enforcement officers visited Mr Underhill’s home address on 20 December 2004. The officers believed that a website called www.kamagrasales.com was operating from his home, supplying and selling Kamagra gel. This product is used to treat erectile dysfunction and is unlicensed in the UK. Mr Underhill told the officers that the website was no longer operating and that the products had been disposed of. However, following an inspection of the premises, a cardboard box containing a large quantity of ‘Kamagra jelly’ sachets was found in the garden shed. These products were seized, along with documentation and computer equipment.

This case arose following an MHRA investigation into Christopher Wayne Davies, former resident at Dennison Barracks, Hermitage, Berkshire. Mr Davies was fined £800 on 6 March 2006 at West Berkshire Magistrates Court after pleading guilty to three offences for the illegal sale and supply of unlicensed erectile dysfunction medicines over the Internet. Mr Davies had obtained these medicines from Mr Underhill via his website.

Two men and a woman from south London pleaded guilty to offences relating to the illegal sale and supply of steroid creams following an investigation by the Medicines and Healthcare products Regulatory Agency (MHRA).  

Hassan Akhtar (49), Mubashir Akthar (25) and Nasira Akhtar (46), of London SW16, pleaded guilty to offences under the Medicines Act 1968 and Trade Marks Act 1994 at Inner London Crown Court on 25 September 2006. A date for sentencing at this court is scheduled for 25 October 2006.

Enforcement officers from the MHRA, together with Lambeth Trading Standards Officers, visited a hair product and cosmetic shop called Ace Afro Hair and Beauty in Brixton on 16 February 2006. During the visit a number of steroid based creams were seized. These steroid creams, used to treat conditions such as eczema and acne, were unlicensed medicines.

Mr Mubashir Akthar and Ace Afro Hair and Beauty had previously been fined £14,000 and costs in November 2005 in a joint investigation by the MHRA and Southwark Trading Standards for similar offences at Tower Bridge Magistrates Court. On 22 July 2004, the MHRA and Southwark Trading Standards Officers visited Ace Afro Hair and Beauty in Peckham. A large amount of unlicensed steroid creams were once again seized.

Two scientific papers have been released that demonstrate both the effectiveness and safety of red clover for the treatment of menopausal symptoms, particularly hot flushes.

The Journal of Obstetrics & Gynecology of Canada published a paper in April, authored by eight internationally renowned women's health experts, which demonstrated that, for many women, along with lifestyle changes, the use of clinically tested over-the-counter natural supplements like red clover, marketed under the brand name Promensil, should be among the first lines of defense in the treatment of the symptoms of menopause. This represents the first time scientists have come to a consensus suggesting dietary supplements as among the first lines of defense in the treatment of the symptoms of menopause.

‘Hot flushes are the leading reason menopausal women seek treatment during menopause,’ said Dr. Lila Nachtigall, MD, professor of obstetrics and gynecology at New York University's School of Medicine, and the lead author of the paper. ‘In our research, we found a growing trend away from prescription hormone therapy (HT) in women with mild to moderate symptoms and an increasing trend toward lifestyle modifications and complementary therapies.’

The study proposes an algorithmic method of treatment, where various treatment options are used over time based on whether a woman is suffering from mild, moderate or severe menopausal symptoms. Treatments start at lifestyle changes, such as exercising, avoiding caffeine and quitting smoking, then escalate to alternative therapy supplements, particularly Promensil because of its safety and effectiveness as shown in numerous clinical trials. HT may be considered in extreme cases.

While declining levels of oestrogen at menopause give rise to the visible acute symptoms, there are also more long-term, or invisible, effects associated with decreases in oestrogen that woman need to be aware of, including heart disease, breast cancer and osteoporosis.

According to Nachtigall, ‘Some women who choose no treatment option at all may be putting their bodies at risk for the negative ancillary effects not only from the stress and anxiety caused by menopause symptoms, but also from long term post-menopausal health issues, including osteoporosis and cardiovascular disease.’

In addition to alleviating the symptoms of menopause, studies have found that red clover also has positive effects on invisible symptoms as well. In fact, one such study, published in the March edition of the European menopause journal, Maturitas, showed in a randomised, double-blind, placebo-controlled trial, that not only did red clover not contribute to endometrial thickness - a potential indicator of increased risk to cancer - it was actually instrumental in reducing thickness.

Additional studies have shown the red clover in Promensil to be effective in promoting cardiovascular health (lowering bad cholesterol levels and improving arterial compliance), reducing breast tissue density (another possible indicator of increased risk to cancer), and also in reducing the rate of bone loss.

The antioxidant content of tea could mean that drinking three or more cups a day could reduce the risk of a wide range of health problems, ranging from cancer to heart disease, and may even be healthier than water, says a review from the BBC.

‘Drinking tea is actually better for you than drinking water. Water is essentially replacing fluid. Tea replaces fluids and contains antioxidants so its got two things going for it,’ reviewer Dr Carrie Ruxton from Nutrition Communications told the BBC.

Interest in tea have mostly focusses on green tea, with consumption linked to a wide range of health benefits, including lower risk of certain cancers, weight loss, and protection against Alzheimer's.

The health benefits have been linked to the polyphenol content of the tea. Green tea contains between 30 and 40 per cent of water-extractable polyphenols, while black tea (green tea that has been oxidised by fermentation) contains between 3 and 10 per cent.

The four primary polyphenols found in fresh tealeaves are epigallocatechin gallate (EGCG), epigallocatechin, epicatechin gallate, and epicatechin.

But Dr. Ruxton and her co-authors from King's College London report that black tea also had positive effects on general health.

‘We found some research showing that black and green tea contained similar amounts of antioxidants but different types. This can be expected as they come from the same plant but go through different processing,’ Dr. Ruxton told NutraIngredients.com.

‘Antioxidant activity in the blood is similar too so one could assume that both types of tea confer heart health benefits,’ she said.

The review, sponsored by the Tea Council and published on-line in the European Journal of Clinical Nutrition (doi: 10.1038/sj.ejcn.1602489), searcher databases for relevant epidemiological and clinical studies that were published between 1990 and 2004.

In terms of cardiovascular disease, the reviewers report that ‘clear evidence was found’ to link drinking three of more cups per day could reduce the risk.

Cancer risk did seem to be reduced in experimental (in vitro and animal studies) said the reviewers, but these results were not backed up by epidemiological evidence, they said.

A small note of caution however was noted by the observation that a non-effect or slight increase in risk of colorectal cancer with consumption of black tea.

The researchers also tackled the old wives' tale that drinking tea leads to dehydration, due to the diuretic caffeine content of the beverage. This was not backed up by the science, said the reviewers, with normal levels of hydration maintained when the tea contained less than 250 mg per cup.

‘Studies on caffeine have found very high doses dehydrate and everyone assumes that caffeine-containing beverages dehydrate. But even if you had a really, really strong cup of tea or coffee, which is quite hard to make, you would still have a net gain of fluid,’ Dr. Ruxton told the BBC.

The reasons for these benefits was proposed to be related to the antioxidant action of tea polyphenols, wrote the reviewers.

‘There was sufficient evidence to show risk reduction for CHD at intakes of more than three cups per day and for improved antioxidant status at intakes of one to six cups per day,’ concluded the reviewers.

‘A maximum intake of eight cups per day would minimise any risk relating to excess caffeine consumption. Black tea generally had a positive effect on health.’

Web: http://www.nutritionfocus.org/

Breda Gajsek, Principal of BCNH gives her views: 'I prefer to call it complementary medicine as its role is to complement orthodox medicine, not to substitute it. Millions of us have turned to complementary medicine when orthodox medicine failed to deliver or help to resolve chronic conditions such as IBS or eczema.

My view is that many complementary therapies, including nutrition have an important role to play in prevention of disease. The NHS is mostly focused on the treatment of disease, rather than disease prevention. One has to question, how much the government, and NHS could save if complementary therapies and nutrition were an integral part of a preventative healthcare strategy in this country. Many people in the U.K. have experienced long-term and even life long benefits of complementary medicine, without any side effects.

I have tried homeopathy, herbalism, osteopathy, reflexology, hypnotherapy, spiritual healing and reiki to name but few, and each one of them helped me in its own way. Improving my own diet through Nutritional Therapy had the most profound effect on my personal health and well-being. It has helped me to overcome a heart condition and given me a new lease of life.

Complementary medicine is not and never will be a substitute for orthodox medicine. The way forward has to be to work together, so we can deliver the best possible results for the patients and potentially save NHS lots of money in the long run.

Many in the conventional medicine arena fail to embrace the many reported benefits of complementary therapies, asserting such treatments are unproven or not validated. Rigorous clinical trials are very expensive to run, and all too often funding is only available from pharmaceutical companies, who have little or no interest in funding trials on nutrients that they can not patent.

Complementary medicine is however getting smarter and many courses and therapies are now evidence based. In fact there is a wealth of research out there that confirms the importance of nutrients and a healthy diet - people and the medical establishment need to be made aware of it.

Training courses such as our BSc (Hons) in Complementary Therapies (Nutritional Health) is part of bringing this into the mainstream - ultimately working to change attitudes amongst the medical establishment. I truly look forward to the day that nutrition and preventative health care is an integral part of the NHS strategy.

Breda Gajsek
Principal BCNH
Web: http://www.bcnh.co.uk

The World Health Organisation (WHO) welcomes the announcement that Michael Bloomberg, mayor of New York City, will contribute US$125 million to a new Worldwide Stop Smoking Initiative. This contribution will help to end the tobacco epidemic, and translate the principles of the WHO Framework Convention on Tobacco Control into real action and implementation on the ground.

‘Tobacco use currently kills about five million people every year, and the number will be doubled if the current trend continues,’ said Dr Anders Nordström, Acting Director-General of WHO. ‘However, there is now a global momentum to reverse that, with many countries both wealthy and poor taking action to restrict tobacco use, and support those who need help stopping. This contribution will help to increase this momentum.’ Through policy guidelines, global monitoring and technical support to government decision makers and legislators, WHO supports country-level efforts to pass and implement effective legislation that increases tobacco tax, bans tobacco advertising, makes health warning labels mandatory on tobacco products, prevents cigarette smuggling and protects the public from exposure to tobacco smoke through bans that create 100% smoke-free environments.

The WHO Framework Convention on Tobacco Control is one of the most widely endorsed treaties in UN history, with more than 130 countries having ratified.

‘Recently, philanthropists have announced major contributions that will directly benefit global public health,' added Dr Nordström. ‘The World Health Organisation welcomes this movement, which stands to save and improve millions of lives.’

Looking at your shadow (the shorter it is, the more dangerous UV radiation is), and covering up with hats, sunglasses and sunscreen, are among the practical tips for children contained in a new guide on the ozone layer for primary school teachers.

The OzonAction Education Pack, launched globally on 15th September in English, French and Spanish, contains an entire teaching and learning programme, based on basic knowledge, practical skills and participation, to enable children to learn about simple solutions to protect the ozone layer and safely enjoy the sun.

‘While we have hope that the atmosphere is healing and that the Montreal Protocol is working, we are still facing serious challenges,’ said Achim Steiner, UN Under-Secretary General and Executive Director of the United Nations Environment Programme (UNEP). ‘Children should be aware of the huge risks that a weakened ozone layer poses to human health and the environment and they must know that much remains to be done. We must give them the means to protect their own future, and education is certainly key in this regard,’ he said.

The pack, produced jointly by the United Nations Environment Programme (UNEP), the United Nations Educational, Scientific and Cultural Organisation (UNESCO) and the World Health Organisation (WHO), was released to co-incide with the International Day for the Preservation of the Ozone Layer on 16th of September. This year's theme is ‘Protect the Ozone Layer, Save Life on Earth’.

‘The OzonAction Education Pack will help schoolchildren to become aware of the simple protection steps that reduce solar UV health risks, and these become even more important as ozone layer depletion leads to intensified UV radiation on Earth,’

said Dr Anders Nordström, Acting Director-General of WHO. ‘The severe health effects such as melanoma and other skin cancers are largely preventable through reduced sun exposure. UV protection thus becomes an important component of the global efforts towards cancer prevention.’ The ozone layer plays a crucial role in the protection of life on Earth from harmful effects of ultraviolet radiation. While some solar UV radiation is necessary for bone health and also may help to prevent certain chronic diseases, excessive sun exposure causes immediate and long-term health problems.

Sunburn - which can be severe and blistering - is an acute health problem, while skin cancer and cataract leading to blindness are the most severe long-term health effects. WHO estimates that about 1.5 million DALYs are lost every year due to excessive solar UV radiation. One DALY is equivalent to one lost year of life in full health.

The OzonAction Education Pack is also linked to the UN Decade of Education for Sustainable Development, which is led by UNESCO.

‘The United Nations Decade of Education for Sustainable Development (2005-2014) aims to integrate the values inherent in sustainable development into all aspects of learning to encourage changes in behaviour which will enable a more viable and fairer society for everyone,’ said Koïchiro Matsuura, Director-General of UNESCO. ‘During this Decade, education for sustainable development will help to make citizens better prepared to face the challenges of the present and the future, and to orient decision-makers in their efforts to create a viable world.’

UNEP, UNESCO and WHO are jointly promoting the OzonAction Education Pack to countries around the world and encouraging Environment, Education and Health Ministries, schools and teachers to adopt it as part of the primary school curriculum.

The signing of the Montreal Protocol on Substances that Deplete the Ozone Layer on 16th September 1987 is now celebrated every year as the International Day for the Preservation of the Ozone Layer.

The development of the Education Pack was led by the OzonAction Branch in UNEP's Division of Technology, Industry and Economics and it was financially supported by the Multilateral Fund for the Implementation of the Montreal Protocol.

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