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.

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?

The development of vascular dementia, the most common form of dementia after Alzheimer’s dementia, may soon be able to be diagnosed before the first appearance of cognitive symptoms, and could be stopped or at least slowed down by targeted preventative measures. This has been demonstrated by partial results from a large-scale multinational LADIS study (Leukoaraiosis And DISability study) presented at the Annual Meeting of the European Neurological Society (ENS) in Berlin.

Disrupted connectivity

Vascular dementia develops, in contrast to Alzheimer’s dementia, through pathological changes to blood vessels as a result of high blood pressure, diabetes, high blood fat levels or smoking. While Alzheimer’s disease primarily affects memory, vascular dementia causes abnormalities of the so-called executive brain functions reliant on the connectivity of many regions of the brain – affecting for example the ability to judge the cost/benefit relation of an offer and to make appropriate decisions. White brain matter is responsible for global functioning of this sort.

Specific symmetrical changes which can be detected with high resolution magnetic resonance imaging (MRI) in white matter, the so-called leukoaraiosis, occur with increasing frequency from the age of 60 and can be associated with dementia. The results from the latest studies demonstrate that it is not leukoaraiosis severity alone, but also the exact location of its occurrence which is decisive for the prognosis. i.e. These shape changes (leukoaraiosis) and the location are a potential predictor of dementia.

Hope for early detection and new prevention strategies

“This finding deepens our understanding of vascular dementia,” says the expert.  “We can hope to build on this so that we are able in future to earlier detect and better prevent this form of mental decline which is so agonizing to those affected and their families. Further studies will demonstrate whether we can help people with leukoaraiosis in deep brain regions by aggressive treatment of the underlying diseases such as high blood pressure or diabetes to a better prognosis and prevent or at least delay the outbreak of vascular dementia.”

The development of vascular dementia, the most common form of dementia after Alzheimer’s dementia, may soon be able to be diagnosed before the first appearance of cognitive symptoms, and could be stopped or at least slowed down by targeted preventative measures. This has been demonstrated by partial results from a large-scale multinational LADIS study (Leukoaraiosis And DISability study) presented at the Annual Meeting of the European Neurological Society (ENS) in Berlin.

Disrupted connectivity

Vascular dementia develops, in contrast to Alzheimer’s dementia, through pathological changes to blood vessels as a result of high blood pressure, diabetes, high blood fat levels or smoking. While Alzheimer’s disease primarily affects memory, vascular dementia causes abnormalities of the so-called executive brain functions reliant on the connectivity of many regions of the brain – affecting for example the ability to judge the cost/benefit relation of an offer and to make appropriate decisions. White brain matter is responsible for global functioning of this sort.

Specific symmetrical changes which can be detected with high resolution magnetic resonance imaging (MRI) in white matter, the so-called leukoaraiosis, occur with increasing frequency from the age of 60 and can be associated with dementia. The results from the latest studies demonstrate that it is not leukoaraiosis severity alone, but also the exact location of its occurrence which is decisive for the prognosis.

i.e. These shape changes (leukoaraiosis) and the location are a potential predictor of dementia.

Hope for early detection and new prevention strategies

“This finding deepens our understanding of vascular dementia,” says the expert.  “We can hope to build on this so that we are able in future to earlier detect and better prevent this form of mental decline which is so agonizing to those affected and their families. Further studies will demonstrate whether we can help people with leukoaraiosis in deep brain regions by aggressive treatment of the underlying diseases such as high blood pressure or diabetes to a better prognosis and prevent or at least delay the outbreak of vascular dementia.”

The beginning of depression is the beginning of pain

Prof. Michele Tinazzi, compared the pain threshold as well as the pain tolerance of 25 patients – all with newly diagnosed and still untreated deep depression — with the a healthy control group.  80 percent of the patients reported muscle-, joint- or head-aches occurring at the same time as or after the onset of depression. In the course of the study, both patients and the control group were subjected to standardized electrical pain impulses on both hands and feet.  The results showed that in all body areas measured, pain threshold as well as pain tolerance were considerably lower among all patients with depression than among those in the control group. Those with depression were significantly more sensitive to pain, in other words.

Brain regions used in common – common therapy approach

“Our study shows impressively that the purely physiological aspect of the pain threshold and the cognitive-emotional aspect of pain tolerance – i.e. how bearable or unbearable the pain seems to me – go hand in hand”, said Dr. Sandro Zambito Marsala (San Martino Hospital, Belluno, Italy).  “The most likely reason is that processing of pain and emotion share specific regions of the brain just as they share specific neurophysiological signal transmission pathways.”  Because the latter are substantially steered by serotonin and noradrenalin circuits, it stands to reason that serotonin-noradrenalin reuptake inhibitors simultaneously combat depression and pain and could therewith substantially simplify the therapy. “This hypothesis has to be verified first, however, through additional detailed studies”, cautions Dr. Zambito Masala.

Dr John Heyworth, President of the College of Emergency Medicine said “The CEM welcomes the Secretary of State’s announcement, which is in line with the College’s long held view that the 98% standard should be reconfigured. We look forward to working with the DH to develop more appropriate, clinically relevant, quality and outcome measures that build on the improvements already achieved in our Emergency Departments and further enhance patient care.”

ASDA shoppers are worst and spending the most on unhealthy food at £18.23. The ‘healthiest’ shoppers were from Tesco, spending £16.65 on junk items. Research into shopper attitudes shows consumers often don’t realise what they are buying. Whilst many shoppers aim to stick to shopping lists and best intentions, temptation can prove to be too much.

The survey also revealed that:
- Over a third (37%) of those questioned said that every time they go to the supermarket they overspend their set budget because they are too tempted by what they see as treats (Fat fact: It
takes just 3,500 calories to put on a pound)
- 39% confessed that they expect to overspend on ‘naughty treats’ even if they didn’t plan to buy them (Fat fact: Average yearly spend on junk food equals GBP895 per person )
- A staggering 81% of people also admitted to buying additional snacks outside of the supermarket shop. (Fat fact: Just one latte a day can add up to 1 stone in weight gain and GBP600 a year)

In 2008, almost a quarter of adults (24% of men and 25% of women aged 16 or over) in England were classified as obese. In the same year, the number of prescription items dispensed for the treatment of obesity was 1.28million; this is ten times the number in 1999 (127,000).

Professor Iain Broom, Medical Director of LighterLife and a leading expert on obesity, says: “The cost of obesity, both to an individual’s health and to the NHS, is significant and growing. As a nation, this issue needs to be addressed as a matter of urgency. Too many of us abuse our bodies by choosing the wrong foods, in the wrong quantities, and in extreme situations this can lead to a dramatic reduction in life expectancy.”

Anyone concerned that their diet might be causing heart disease should read this article by Cardiologist Avijit Lahiri.