Melatonin, an endogenous sleep regulating hormone, has long been mooted as a potential therapy for this condition. Endogenous melatonin production is known to decrease as a person ages, therefore it has been hypothesised that treatment with this hormone may be efficacious in treating insomnia in the elderly. However results from studies have often proved contentious, with a lack of consistency in the results seen in differing age groups exposed to melatonin therapy.

Results from a recently published randomized controlled trial in BMC Medicine have now shed new light on this controversial subject. The researchers examined the use of prolonged release melatonin (PRM) in sufferers of primary insomnia across a wide range of ages. Their results showed that PRM is particularly effective and well tolerated in patients aged 65 years and over, with the treatment response increasing and being sustained over a 6 month period.

When the National Institute for Health and Clinical Excellence (NICE) first reported on the benefits and value for money of obesity surgery eight years ago, less was known about the dramatic effects of such surgery on associated co-morbidities such as diabetes, sleep apnoea and even cancer.

We now know that bariatric surgery not only has the capacity to induce major weight loss in the long term, but also ‘cure’ diabetes in 84% of cases, sometimes within days, resulting in patients no longer needing costly treatments with drugs such as insulin. Sleep apnoea syndrome – thought to account for 300 deaths on the road each year where patients fall asleep at the wheel – enters remission, and over a seven year period, cancer death rate is halved in patients who have had surgery compared to those who did not.

Even with a rapid expansion of surgical services across the UK, ESCO highlights today that not all patients who are eligible and willing to undergo surgery will be able to receive treatment. There are currently 230,000 people who are eligible under the NICE guidelines and willing to have the surgery in the UK, yet this year only 6,000 patients will actually receive surgical treatment.

Dr Carel Le Roux, warns; “Weight loss surgery is not ,as many people believe, an ‘easy option’ or ‘quick fix’ for patients. In some ways the surgery makes patients’ lives much harder than before as they have to make lifestyle changes that require many adjustments and a great deal of support. In treating the associated chronic illnesses, weight loss surgery helps to make people healthier and more functional, while dramatically reducing the need for and cost of healthcare provision.”

Procoralan® (ivabradine), a drug costing less than £10 a week has been proven to improve survival of patients with heart failure according to new research presented at the European Society of Cardiology (ESC) meeting.  The new research (SHIfT sudy*) showed that the drug, ivabradine, significantly reduced the risk of death from heart failure by 26%, and the risk of hospitalisation was also significantly reduced by 26%. The benefits were seen even though the heart failure patients were already taking currently recommended treatments.

Professor Martin Cowie, Consultant Cardiologist and specialist in heart failure at the Royal Brompton Hospital is the UK lead investigator for the study. He comments, “This evidence represents a significant clinical breakthrough in the management of heart failure and is incredibly important information for patients with this condition. We now know that more lives can be saved and improved simply by adding ivabradine to their current treatment in order to take some of the strain off the heart. It is vital that the results of this study are implemented and ivabradine is used as part of standard heart failure treatment as soon as possible. I will be ensuring that patients under my care are able to benefit as soon as possible.”

London Cardiology Expert shows a 26% reduction in hospitalisation and death from heart failure Procoralan® (ivabradine), a drug costing less than £10 a week has been proven to improve survival of patients with heart failure according to new research presented at the European Society of Cardiology (ESC) meeting.  The new research (SHIfT sudy*) showed that the drug, ivabradine, significantly reduced the risk of death from heart failure by 26%, and the risk of hospitalisation was also significantly reduced by 26%. The benefits were seen even though the heart failure patients were already taking currently recommended treatments.

Expert Comment on New Heart Drugs

Commenting on the heart drug trial, Professor Avijit Lahiri says, “There are group differences in event rates, higher for Plavix than the trial drug Ticagrelor, I am certain that given the sample size this would become a significant difference, thus it can be surmised that there were more ‘severe’ patients in the Plavix arm, and so the question is – could these in some way alter the the balance of results?

I am certain that Plavix is not the ultimate treatment, and Ticagrelor appears more effective in this large clinical trial. It will be interesting to see how bleeding side effects pan out with increasing experience i.e. if it is more effective, there may also be greater bleeding. This side-effect was not shown in the present trial, which is a plus! Ticagrelor will be welcomed as an effective new treatment in ACS. It will also be useful to know whether the other non-bleeding side effects such as drug rash, are also reduced compared to Plavix.

Expert Comment on New Heart Drugs Commenting on the heart drug trial, Professor Avijit Lahiri says, “There are group differences in event rates, higher for Plavix than the trial drug Ticagrelor, I am certain that given the sample size this would become a significant difference, thus it can be surmised that there were more ‘severe’ patients in the Plavix arm, and so the question is – could these in some way alter the the balance of results? I am certain that Plavix is not the ultimate treatment, and Ticagrelor appears more effective in this large clinical trial. It will be interesting to see how bleeding side effects pan out with increasing experience i.e. if it is more effective, there may also be greater bleeding. This side-effect was not shown in the present trial, which is a plus! Ticagrelor will be welcomed as an effective new treatment in ACS. It will also be useful to know whether the other non-bleeding side effects such as drug rash, are also reduced compared to Plavix.

About hypertension

Hypertension includes the following conditions:

Chronic hypertension. Hypertension that is present at the booking visit or before 20 weeks or if the woman is already taking antihypertensive medication when referred to maternity services. It can be primary or secondary in aetiology (i.e. there in the first place, or subsequent to becoming pregnant).

Gestational hypertension. New hypertension presenting after 20 weeks without significant proteinuria.

Pre-eclampsia. New hypertension presenting after 20 weeks with significant proteinuria

Severe pre-eclampsia. Pre-eclampsia with severe hypertension and/or with symptoms, and/or biochemical and/or haematological impairment.

Eclampsia. A convulsive condition associated with pre-eclampsia.

HELLP syndrome. Haemolysis, elevated liver enzymes and low platelet count.

Significant proteinuria. This is when the urinary protein:creatinine ratio is greater than 30 mg/mmol or a validated 24-hour urine collection result shows greater than 300 mg protein.

In addition, the guideline also defines mild, moderate and severe hypertension as:

Mild hypertension – diastolic blood pressure 90–99 mmHg, systolic blood pressure 140–149 mmHg.

Moderate hypertension – diastolic blood pressure 100–109 mmHg, systolic blood pressure 150–159 mmHg.

Severe hypertension – diastolic blood pressure 110 mmHg or greater, systolic blood pressure 160 mmHg or greater.

There are a number of factors which increase the risk of hypertension during pregnancy. These are categorised into moderate and high risk factors. Moderate risk factors include:

• A first pregnancy
• Older mothers-to-be (aged over 40 years)
• A Body Mass Index (BMI) over 35 at first antenatal visit
• A family history of pre-eclampsia
• Multiple pregnancy

Women at high risk of developing hypertension may have been previously diagnosed with hypertension during an earlier pregnancy or have a condition which may cause hypertension, such as chronic renal disease or diabetes.

Celebrities who have experienced a form of hypertension while pregnant include Sophie Ellis-Bextor, Melinda Messenger, Jane Seymour and Darcey Bussell CBE. They all developed pre-eclampsia during at least one of their pregnancies.

Accurately measuring proteinuria requires a urine sample. Women seeking a more accurate and dignified method of providing a urine sample can do so using a Peezy, which is now available via the NHS.

UK Herbal Forum has warned that the European Union may find its pharmacy store shelves filled with illegal herbal products if companies don’t register their products under the Traditional Herbal Products Medicinal Directive (THMPD).

The Directive become law in 2004, giving herbal products making medicinal claims across the EU bloc seven years to register their products by submitting a supporting dossier. With that deadline of April 30, 2011 less than a year away, concern is growing that a swathe of products that may be perfectly legal under national laws will find themselves on the wrong side of the THMPD.

The UK has been the most active member state by far in terms of product registrations, with the UK Medicines and Healthcare products Regulatory Agency (MHRA) approving 69 products so far out of 152 applications received. None have as yet been rejected. The 69 approvals have featured 27 different herbs from valerian to sage, black cohosh, St John’s Wort and Echinacea. Thirty one applications have been lodged so far in 2010. A list of the latest registrations can be found here.

Registrations are known to have occurred in Germany, the Netherlands and Slovenia but at low numbers. UK Herbal Forum members include the British Herbal Medicine Association, the UK Council for Responsible Nutrition, the European Herbal Practitioners Association, the UK Health Food Manufacturers Association and the Proprietary Association of Great Britain.

MDMA (3,4-methylenedioxymethamphetamine, also known as Ecstasy), may one day offer hope for individuals with posttraumatic stress disorder (PTSD), even people for whom other treatments have failed. Clinical trial results out today in the Journal of Psychopharmacology, published by SAGE, suggests that MDMA can be administered to subjects with PTSD without evidence of harm and could offer sufferers a vital window with reduced fear responses wherepsychotherapy can take effect.

Before MDMA became used recreationally under the street name Ecstasy, hundreds of psychiatrists and psychotherapists around the world administered MDMA as a catalyst to psychotherapy. MDMA was criminalized in the U.S. in 1985 (it had been illegal in the UK since 1977).  Several decades later, this study is the first completed randomized, double-blinded clinical trial to evaluate MDMA as a therapeutic adjunct in any patient population.

Belmont, MA-based Rick Doblin, Ph.D., President of the Multidisciplinary Association for Psychedelic Studies (www.maps.org, a non-profit psychedelic and medical marijuana research and educational organization that sponsored the study), together with South Carolina-based psychiatrist Michael Mithoefer, MD and colleagues, conducted a pilot Phase II clinical trial with 20 patients with chronic PTSD persisting for an average of over 19 years. Prior to enrolling in the MDMA study, subjects were required to have
received, and failed to obtain relief, from both psychotherapy and psychopharmacology.

Participants treated with a combination of MDMA and psychotherapy saw clinically and statistically significant improvements in their PTSD – over 80% of the trial group no longer met the diagnostic criteria for PTSD, stipulated in the Diagnostic and Statistical Manual of Mental Disorders IV (DSM-IV-TR) following the trial, compared to only 25% of the placebo group. In addition, all three subjects who reported being unable to work due to PTSD were able to return to work following treatment with MDMA.

The trial centered on two eight-hour psychotherapy sessions scheduled about 3-5 weeks apart, where 12 subjects received MDMA, and eight took a placebo. Subjects were also given psychotherapy on a weekly basis before and after each experimental session. A blinded, independent rater tested each subject using a PTSD scale at baseline, and at intervals four days after each session and two months after the second session. The clinical response was significant – 10 of the 12 in the treatment group responded to the treatment compared with just two of the eight in the placebo group. During the trial, the subjects did not experience any drug-related Serious Adverse Events (SAEs), nor any adverse neurocognitive effects or clinically significant blood pressure or temperature increases.

After the two-month follow-up, subjects in the placebo group were offered the option to participate in the treatment process again, to receive MDMA on an open-label basis, acting as their own controls. Seven of the eight placebo subjects elected to receive MDMA-assisted psychotherapy, with successful treatment outcomes similar to the subjects initially randomized to MDMA. PTSD involves exaggerated and uncontrolled fear responses. To treat these, psychotherapists need to help sufferers revisit traumatic experiences. But patients often suffer intolerable feelings when they revisit the trauma, or numb themselves emotionally, resulting in the psychotherapy having little effect. The goal of using MDMA is to temporarily reduce fear and increase trust without inhibiting emotions, especially painful emotions, allowing these patients a window where psychotherapy for their PTSD is effective.

MDMA’s pharmacological effects include serotonin release, 5HT2 receptor stimulation and increase in levels of the neurohormones oxytocin, prolactin and cortisol.

Importantly, this trial involved concentrated periods of patient-therapist contact (31 hours over two months) including two all-day therapy sessions and overnight stays in the clinic. “These are not usual features of psychotherapy practice in the outpatient setting,” says Michael Mithoefer. MDMA-assisted psychotherapy would require special clinics equipped for longer treatment sessions and overnight stays if an MDMA-based treatment were approved. “This method also involves patient preparation and close follow-up to support further processing of emotions and integration of cognitive shifts that may occur,” Mithoefer adds, stressing that these are vital for safety and therapeutic effect.

Measures like these may prove a price worth paying, however, to alleviate the debilitating effects of PTSD on sufferers in future.

The authors caution that the study does have limitations – for example they did not look at gender and ethnic factors in their sample selection. Another important limitation was that most participants and trial investigators guessed accurately whether they were in the treatment or the placebo group. The placebo had no psychoactive effect and investigators could detect raised blood pressure and other symptoms in the MDMA group. A long-term follow-up to the study just published, evaluating subjects an average of about 40 months post-treatment, is underway.

The investigators have now received the go ahead from the U.S. Food and Drug Administration (FDA) for a protocol for a three-arm, dose-response design that they expect will result in successful blinding. This new study is for U.S. veterans with war-related PTSD, most from Iraq and Afghanistan and a few from Vietnam.  MAPS is currently sponsoring MDMA/PTSD Phase 2 pilot studies in Switzerland and Israel, and is working to start additional pilot studies in Canada, Jordan and Spain.

The safety and efficacy of 3,4-methylenedioxymethamphetamine-assisted psychotherapy in subjects with chronic treatment-resistant posttraumatic stress disorder: the first randomised controlled pilot study by Michael C. Mithoefer, M.D., Mark T. Wagner, Ph.D., Ann T. Mithoefer, B.S.N., Lisa Jerome, Ph.D., and Rick Doblin, Ph.D. is published today (19th July 2010) in the Journal of Psychopharmacology.

The Journal of Psychopharmacology is published by SAGE, on behalf of the British Association for Psychopharmacology.

A treatment manual by the study’s sponsor, the Multidisciplinary Association for Psychedelic Studies on this topic can be found here.

MAPS’ Investigator’s Brochure, reviewing and summarizing the entire published scientific literature on MDMA and Ecstasy, can be found here.

I am delighted that the NHS is beginning to embrace the Cyberknife radiosurgery system.

What is concerning me is the situation which has arisen, whereby some Trusts are willing to refer NHS patients for assessment at Cyberknife Centre and others flatly refusing. This is as bad, if not, worse, than the drug postcode lottery and I now find myself being again, patronised and dismissed as a busy body by MPs, journalists and health professionals. There needs to be some kind of uniformity regarding this, particularly because, by the end of 2011, there will be at least three Cyberknife systems in the NHS.

I intend to continue my quest for fairness re this issue. I find it obscene and unacceptable for non-medical personnel in the NHS to be making decisions on matters they really do not know enough about. Cyberknife is here to stay, thank goodness and I am sure it will go from strength to strength!

GP’s have always been known to be responsible as the ‘gate-keepers’ to the NHS with reference to their role to refer patients appropriately. The White Paper fundamentally describes how new policy will attach ‘accountability’ to that responsibility, and involve patients in the decision.

The new guidelines describe how more information on hospital performance will be available to inform choice, and clearly patients will also want more information on individual consultants and the latest treatment options. Nick Clegg says that the plan is for: “Patients to have more control”.

The Biggest Difference is Patient Information

The Chief Executive of The King’s Fund, Professor Chris Ham commented: ‘Today’s White Paper represents one of the biggest shake ups of the health system since the NHS was established. The ambitions it sets out for a more patient-focused, clinically-led NHS are the right ones”.

According to the author of one of the papers, the science backing a variety of weight loss supplements is lacking. “The market for these is huge, but unlike for regulated drugs, effectiveness does not have to be proven for these to be sold,” said Dr Thomas Ellrott, head of the Institute for Nutrition and Psychology at the University of Göttingen Medical School, Germany. “Few of these supplements have been submitted to clinical trials and the landscape of products is always changing, so we need to put them through rigorous scientific evaluation to determine whether they have any benefit,” he said.

However, the manufacturers of weight management dietary supplement products who were contacted by NutraIngredients.com still stressed the ‘robustness’ of the science backing the efficacy of their products.
Placebo-controlled Weight Loss

Dr Ellrott’s study was a randomized, placebo controlled, partly blinded eight-week trial, where 189 overweight or obese individuals were given either a weight loss supplement in doses recommended by the manufacturers, or a placebo. The nine supplement products tested were purchased at pharmacies in Germany. Labelled active ingredients were: Polyglucosamide, cabbage powder, Konjak extract, sodiumalginate-complex, bean concentrate, selected plant extracts, L-Carnitine, fibre formulation and Guarana seed powder.
First Systematic review of all scientific literature

The second study, led by Dr. Igho Onakpoya of Peninsula Medical School at the Universities of Exeter and Plymouth, UK, claims to be “the first systematic review of all existing systematic reviews of clinical trials on weight loss supplements.”
Literature searches were conducted in five electronic databases to identify all relevant articles on nine popular slimming supplements. These include: chromium picolinate, Ephedra, bitter orange, conjugated linoleic acid (CLA), calcium, guar gum,

The coalition government has signalled its intention to put patients at the centre of the NHS and to start an information revolution by publishing more information about quality and outcomes.  While patients want to be more involved in decisions about their care and to be supported to make informed choices, professionals are often too busy to do this, do not see this as their role, and believe that patients want them to make decisions for them.  How will professionals be motivated and supported to put patients first and involve patients more in decisions?  Will patients and professionals be able to make use of the information to drive improvements in care?