Wednesday, 21 September 2016

Key points from the analysis of the PACE trial raw data for “recovery”

Margaret Williams 21st September 2016

The following extracts are taken from:

“A preliminary analysis of ‘recovery’ from chronic fatigue syndrome in the PACE trial using individual participant data”.

(The article referred to includes: "The recovery rate is … 6.8% for cognitive behavioural therapy, 4.4% for graded exercise therapy, 1.9% for adaptive pacing therapy.")

by Alem Matthees (1), Tom Kindlon (2), Carly Maryhew (3), Philip Stark (4), Bruce Levin (5)

1. Perth, Australia.
2. Information Officer, Irish ME/CFS Association, Dublin, Ireland.
3. Amersfoort, Netherlands.
4. Associate Dean, Mathematical and Physical Sciences; Professor, Department of Statistics; University of California, Berkeley, California, USA.
5. Professor of Biostatistics and Past Chair, Department of Biostatistics, Mailman School of Public Health, Columbia University, New York, USA.

Key Points

1. There was no committee approval for the re-definition of “recovery”.

2. “Recovery” rates for CBT and GET were not statistically significant.

3. The PACE PIs originally reported “recovery” rates of 22% for CBT and GET.

4. The published “recovery” rates were based on thresholds that deviated substantially from the published protocol and were inflated by an average of four-fold.

5. In contrast to the published paper by the PIs, the recovery rates in the CBT and GET groups are not significantly higher than in the SMC (standard medical care) group alone.

6. APT (adaptive pacing therapy) was a highly modified version of “pacing” (preferred by patients).

7. 13% of participants at baseline simultaneously met the trial entry criteria for “significant disability” and the revised “recovery” criteria.

8. The Investigators excluded drop-outs, which is not recommended practice in clinical trials.

9. Logistic regression (used by the PIs) has been shown to be an inappropriate method of analysis in randomised trials.

10. The figures originally given by the PIs for the four groups were:

SMC 7% (but according to the protocol are 3%)
APT 8% (but according to the protocol are 2%)
CBT 22% (but according to the protocol are 7%)
GET 22% (but according to the protocol are 4%)

11. “Our findings therefore contradict the conclusion of White et al (2013) that CBT and GET were significantly more likely than the SMC group to be associated with ‘recovery’ at 52 weeks”.

12. “The multiple changes to the recovery criteria had inflated the estimates of recovery by approximately 2.3 to 5.1-fold, depending on the group, with an average inflation of 3.8-fold”.

13. When using the revised recovery criteria, 8% of the “recovered” participants still met trial eligibility criteria for “significant disability”.

14. “The changes made by the PACE investigators after the trial was well under way resulted in the recovery criteria becoming too lax to allow conclusions about the efficacy of CBT and GET as rehabilitative treatments for CFS”.

15. “This analysis, based on the published trial protocol, demonstrates that the major changes to the thresholds for recovery had inflated the estimates of recovery by an average of approximately four-fold”.

16. “It is clear from these results that the changes made to the protocol were not minor or insignificant, as they have produced major differences that warrant further consideration”.

17. “The PACE trial provides a good example of the problems that can occur when investigators are allowed to substantially deviate from the trial protocol without adequate justification or scrutiny”.

18. “It seems prudent that the published trial results should be treated as potentially unsound, as well as the medical texts, review articles, and public policies based on those results”.


Margaret Williams 14th September 2016

The PACE trial was instigated and carried out mostly by a group of psychiatrists well-known for teaching that ME/CFS does not exist other than as an aberrant belief: their assumption was that ME/CFS is a behavioural disorder that is amenable to behavioural interventions. The Investigators had no evidence for their assumption and despite abundant scientific evidence to the contrary, it remained their firmly-held belief. They favoured two interventions in particular: cognitive behavioural therapy (CBT), which was to “change the behavioural and cognitive factors assumed to be responsible for perpetuation of the participant’s symptoms and disability” and graded exercise therapy (GET), which was to correct the assumed deconditioning resulting from avoidance of activity.

The original (selective) results on the PACE trial were published in The Lancet in early 2011; they were accompanied by press releases from The Medical Research Council, King’s College London and Queen Mary University of London, all of which proclaimed: “Two effective treatments benefit up to 60 per cent of patients with CFS/ME”. Importantly, this figure was achievable only because the Investigators used a much less demanding definition of improvement than they had stated in their published protocol.

Following lengthy Freedom of Information (FOIA) requests, all of which were refused until the final one, the raw data from the PACE trial had to be released, following which the Investigators re-analysed their data according to their own published protocol.

Those results were different from what had been published in The Lancet to such loud acclaim (orchestrated by the Science Media Centre, of which Professor Sir Simon Wessely, one of the PACE team, was a founder member).

It revealed that the improvement figure was only 21% for the GET group and 20% for the CBT group versus 10% for those who received usual medical care alone, meaning that for every ten people treated with CBT or GET, only one person would show protocol-defined improvement. All participants received what was described as standardised “specialist” medical care (SSMC), but those receiving SSMC alone may have seen the Fatigue clinic doctor only three times for 30 minutes each time during their participation in the trial, a total of 90 minutes throughout the trial.

Hence the protocol-specified figures are that CBT and GET helped only an additional 10% of participants over usual medical care and not the widely reported 60%.

To read the rest of this article, please click –

Friday, 16 September 2016

Science links new autoimmune disease to aluminum adjuvants in vaccines

(I thought that this was of interest, as my illness was started by Hepatitis B vaccines.)

Thursday, September 15, 2016 by: Jonathan Benson, staff writer

(NaturalNews) A recent symposium on autoimmune disease that took place in France has brought to the world's attention a new disorder linked to the aluminum-based chemical adjuvants added to many childhood vaccines. Known as Autoimmune Inflammatory Syndrome Induced by Adjuvants, or ASIA, the novel disease includes a wide range of neurological and immune-associated effects, including chronic fatigue, sleeping disorders, muscle wasting and even early death.

Aluminum has long been recognized as a neurotoxin with a diverse array of metabolic reactions -- a 1990 study published in the journal BioFactors, for instance, revealed that even low-level aluminum exposure can cause a host of neurological disorders and related symptoms. But these effects have been largely ignored in the vaccine context, with untold millions of children being injected with this poison every single year.

First identified by an Israeli doctor back in 2011, ASIA has become so widespread that a significant portion of the 9th International Congress on Autoimmunity was devoted to the unveiling of a world registry for those afflicted by it. Most doctors are still unaware of its existence, which means many patients suffering from the effects of ASIA are often bounced around among different specialists until finally being sent to the loony bin.

"The main substances associated with ASIA are squalene (Gulf War syndrome), aluminum hydroxide (postvaccination phenomena, macrophagic myofasciitis) and silicone with siliconosis," reads a segment of an abstract from a recent study on ASIA published in the journal Expert Review of Clinical Immunology. "Mineral oil, guaiacol and iodine gadital are also associated with ASIA."

ASIA most common after hepatitis B vaccination

One of the world's leading authorities on autoimmune disease and the first person to identify ASIA in a clinical setting, Dr. Yehuda Schoenfeld of the Zabludowicz Center for Autoimmune Diseases in Israel discovered that symptoms of ASIA oftentimes take years to manifest. In fact, many people who develop it following vaccination begin to experience chronic symptoms over time as opposed to an acute reaction immediately following the jab.

Based on this foundational knowledge, Dr. Schoenfeld and a team of researchers learned that aluminum and other ASIA-inducing vaccine adjuvants disrupt the body's natural immune system in complex ways, which can damage not only innate immunity but also genetic expression and endocrine function. According to their analysis, both aluminum and silicone, the latter of which is typical injected into the body in the form of breast implants, are primary drivers of autoimmune disease.

"[N]ow abundant literature shows that exposure of human and animals to aluminum from various sources can have deleterious consequences on the nervous system, especially in adults," he and the team wrote in their paper, which was published in the journal Immunologic Research back in 2013.

"The time relationship between the vaccine delivery and overt disease can last from a few weeks to even years," they added.

The hepatitis B vaccine in particular, which is commonly administered to babies right out of the womb, was found to be most closely associated with incidences of ASIA. According to the data thus-far compiled in the new ASIA world database, more than 70 percent of known ASIA cases followed vaccination for hepatitis B. And 73 percent of ASIA cases overall are directly associated with aluminum delivered via vaccines, with the remaining cases associated with other delivery routes.

"That the aluminum ion is very toxic is well known," stated Christopher Shaw, chairman of the Children's Medical Safety Research Institute and a researcher at the University of British Columbia, at the recent meeting, noting that aluminum is "insidiously unsafe."

"Its toxicity was recognized as long ago as 1911 and evidence of that has only been amplified since."

Wednesday, 14 September 2016

Christian Conferences

Two Christian conferences that took place this summer now have all their talks available online -

The Metropolitan Tabernacle School of Theology was held in early July and had as it's theme "Calvary and Covenant".

From the website -

"High points of church history show that when sound doctrine joins with dedicated living, blessing and instrumentality follow. This year’s School of Theology presented the deeper glorious elements of the work of Christ on Calvary and the covenant of grace that move God’s people to a greater sense of indebtedness and gratitude, leading to consecration and service."

Audio and video recordings of all the talks are available online or to download from -

Tabernacle Cardiff had their Summer Conference from 25 - 29 July. A report on the week is here and includes -

"We thank God for this week. The preaching was from the heart and touched upon the themes of a divine visitation, the unity of the church and the gospel."

All talks from the Conference are available on the Tabernacle Cardiff YouTube channel -

Audio versions to listen to or download can be found at -

Monday, 5 September 2016

New research: distinct biological differences in M.E.

September 02, 2016

Findings of research facilitated by the Open Medicine Foundation could be set to rock the world of medicine, writes Action for M.E. Volunteer Pharmacist Emily Beardall.

Published online in Proceedings of the National Academy of Sciences of the United States of America, and reported in UK press including the Telegraph and the Economist, the study looked closely at the blood chemistry in people with M.E. with a research technique called “metabolomics.” This involves measuring the chemicals in our blood created by the different steps and by-products of metabolising, or breaking down, the energy and nutrients from our food into the chemicals that can be used for energy, hormones and building blocks of new cells.

The research found 20 abnormal metabolic processes in people with M.E.; nine in both men and women with the illness, and a further eleven which varied between gender. This means normal metabolites found in healthy people were found to be low in M.E., so the illness could be described as a “hypometabolic” disease and the body is effectively in hibernation.

The researchers suggest that many of these abnormalities might be part of the body’s own response to try to limit the spread and effect of viral or bacterial infection because cells are using alternative pathways to create the substances it needs. This is normally only seen in acute infection but this state is ongoing in M.E. patients.

What abnormalities did the researchers find?

The disrupted processes that the researchers have found affect:

- cell building blocks sphingolipids and glycosphingolipids which are used by the body to form cell membranes in brain and nerve tissue
- cholesterol, which is needed for the production of cell membranes and steroid hormones such as cortisol and aldosterone
- bile acid, which is important for normal fat digestion; not enough bile acid secreted into the bowel can lead to a “leaky gut” where nutrients aren’t absorbed as efficiently
- mitochondria, the powerhouses of cells, leading to a lower reserve of energy and an inability to replenish high-energy stores after exertion
- the body’s ability to convert vitamins from food into the form needed by cells; those affected are vitamin A and the B vitamins riboflavin (B2), niacin (B3), pyridoxine (B6), folic acid (B9), and - cobalamin (B12). These vitamins are essential for energy production, new cell development such as red blood cells, and for normal nervous system function.
- a substance normally produced by the body as an antifungal and antibacterial, called HICA

A quarter of the abnormalities found were common to all the M.E. patients but the rest varied between individuals, giving each person their own characteristic pattern of abnormalities. The authors suggest that instead of focusing on the common disrupted processes in M.E. for developing a treatment, a personalised medicine approach, ie. giving each person a treatment for their own specific metabolic abnormalities, would be more successful.

The study also uncovered five different types of triggers for the illness:

- biological infections (viral, bacterial, fungal, and parasitic infections)
- exposure to toxic chemicals
- physical trauma
- psychological trauma
- and a category of unknown triggers.

Regardless of what triggered someone’s M.E., the underlying disease process was found to be exactly the same, contributing to the distinct chemical signature found for the condition.

Such a huge amount of biological processes in people with M.E. being affected could be the game-changer so desperately needed to move research forward to find treatments and change attitudes towards M.E.

Thursday, 1 September 2016

Are Myalgic Encephalomyelitis and chronic fatigue syndrome different illnesses? A preliminary analysis.

(It seems that some of them are just starting to catch up with what we, the patients, have been saying for years!)


Considerable discussion has transpired regarding whether chronic fatigue syndrome is a distinct illness from Myalgic Encephalomyelitis. A prior study contrasted the Myalgic Encephalomyelitis International Consensus Criteria with the Fukuda and colleagues' chronic fatigue syndrome criteria and found that the Myalgic Encephalomyelitis International Consensus Criteria identified a subset of patients with greater functional impairment and physical, mental, and cognitive problems than the larger group who met Fukuda and colleagues' criteria. The current study analyzed two discrete data sets and found that the Myalgic Encephalomyelitis International Consensus Criteria identified more impaired individuals with more severe symptomatology.