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?

He writes here about Knee Replacement Surgery.

“This review of studies is extremely comprehensive and there is no reason to believe that its conclusions do not apply to the situation in the UK” said Professor Nick Finer, honorary professor at the Department of Medicine, University College London. “It confirms what we see with our patients on a daily basis – the link between excess weight, a poor diet containing excessive sugary drinks, and cardiovascular disease. Of course the links between diet, obesity and disease are complex but especially for children, consumption of sugar-sweetened beverages is un-neccessary and exposes them to health risks.”

Professor Avijit Lahiri says: “We only ignore this warning at serious risk to the community. There are 196 million diabetics in the world, in 2020 there will be 400 million! 70-80% will die a premature ‘cardiac’ death. The commonest cause of death in the World will be due coronary heart disease fuelled by Metabolic Syndrome, diabetes and obesity combination. Obesity and hyperlipaedimia is also increasing in children and this will lead to development of early T2 diabetes.

Governments all over the world should focus on low sugar containing, low fat healthier food. Many of these ‘developing’ countries saw increased mortality from child birth, infections, starvation and war; this will change to mortality from coronary heart disease driven by diabetes and metabolic syndrome in the next decade. I therefore support the data presented, and I am of the opinion that these high risk individuals should be screened early for silent coronary atherosclerosis and vascular disease.“