Here's part of a letter that I've sent to a UK patient charity...
I'm posting it on here in case anyone wants to make use of any of it...
If anyone wants to, then please feel free to cut and paste or use it in any way...
I haven't studied the paper very intensely yet, so there may be important stuff that i've either missed out, or that i've slightly misinterpreted...
But I'm pretty sure that i've got the details accurate.
If anyone notices any mistakes, then please could you let me know so I can correct them.
Or if it could be improved on, then please comment or rewrite.
I know it could be better written but my brain isn't working well this month...
I've focused on questioning the validity and interpretation of the data, more than the validity of the methodology and patient selection criteria etc.
____________________________________________
I am very worried about the results of the PACE Trial, and I am worried that the spin put on the results is going to cause immense damage to our community, possibly setting back the understanding of our disease, and it's representation in the media, by many years.
I believe that there are many ways in which the trial was manipulated in order to get the results which the authors desired. Such as using unofficial diagnostic criteria, and abandoning the use of actometers (the only objective measurement being used) during the trial.
Also, a lot of spin has been put on the results by the authors. Only 16 to 60% of the patients were helped by CBT or GET in the trial, depending on which figures you look at in the paper and how they are interpreted. And of those patients helped, they only experienced about a 10% reduction in fatigue levels. Personally, I would call this a 'small' reduction, and not a 'moderate' reduction, as the authors call it. I would describe a 'moderate reduction' as something around 35 to 65%, not 10%.
I've looked up 'moderate' in the dictionary, and it means 'not extreme'. So a 'moderate reduction in fatigue levels' means 'not an extreme reduction in fatigue levels'. I don't think that this accurately reflects the very small reductions that were recorded in the study. I think that 'small reductions in levels of fatigue' would be a more accurate description.
It also seems that the statistical data were skewed to a particular outcome in the first place. Because so many of the original fatigue scores were originally very high, as recorded on the Chalder scale, they only had one direction in which to go, which was downwards. Any of the participants who originally recorded very high fatigue scores, or the highest score, and then later experienced higher fatigue levels would not have been able to go above the highest score of 33. For this reason, the statistics were not a fair portrayal of the actual events as they were projected to go downwards even if only random deviation was recorded in the statistics. If a patient can't record a higher level of fatigue during the study, then this skews the wider results because the general fatigue levels are statistically projected to trend downwards anyway. As some patients improve, and some patients get worse, only the improving scores can be recorded because the worst (highest) scores are at maximum levels already. The use of the Chalder scale is unhelpful in this way, as the baseline average scores were so high (e.g. 28.2 out of 33 for GET.) Thus, I think that the results of the trial may not be a fair representation of events. Without access to the raw data, it is impossible to see how many patients recorded near-maximum fatigue levels throughout the study. Also, if patients recorded a maximum baseline score of 33, then it is impossible to monitor or record any deterioration in those patients.
I also think it is extremely damaging for the ME patient community to be told that 'pacing' is not helpful. This is untrue anyway. The study used a hitherto unknown, and unheard of, therapy named Adaptive Pacing Therapy (APT), especially formulated for the study, which clearly had little effect in the study. But APT is not at all similar to the intuitive form of pacing that patients use. APT is prescriptive, systematic and formulaic, and is clearly unhelpful, unlike 'pacing' which is intuitive and flexible and is very helpful for patients. Patients in the APT group on the study were also told that they would never get better, but had to accept their illness as it was, whereas patients receiving CBT and GET were told that they would get better using these therapies. This surely must have skewed the results, as patients with higher expectations, hope and motivation due to being told that their therapy would lead to an improvement in their health, may well be motivated to record better results when answering questions about their fatigue levels, when compared to a group who were told that they would never get better.
The fact that some patients could walk an extra 45 meters in a 6 minute time period (as compared to the Specialist Medical Care [SMC] only group), but still recorded high levels of fatigue (20.6 out of 33 on the Chalder scale after 52 weeks) does not seem like a successful outcome of the study to me. These results seem to tell us very little except that ME is clearly not a psychological disease, and cannot be effectively treated with psychological interventions. The fact that no patients were cured by this trial is very telling about the nature of the therapies on offer to our community, and about the nature of the disease. The poor results also tell us that the symptoms of ME are not caused by mental or physical deconditioning, or maladaptive behavioural patterns or maladaptive cognition, because all of the best psychological therapies on offer failed to actually cure any patients. The CBT and GET in the trial probably did no more for ME patients than they would to motivate any other section of the population.
In the GET group, 93% of patients experienced 'non serious' adverse events, and 9% experienced 'serious' adverse events. Also, 9% of the CBT group and 6% of the GET group recorded 'serious deterioration' in the trial. These results suggest that these interventions are not at all 'harmless' as they have been presented by the authors. The therapies cannot be described as 'harmless', like the authors are portraying them, when so many adverse events and 'serious deteriorations' have been recorded. The CBT group also recorded very similar adverse events as the GET group. We can imagine how these therapies would cause far more damage to patients, with far worse consequences, when administered outside the close controls of a very expensive clinical trial, carefully overseen by the 'best' experts in the field.
In the CGI figures in table 5 of the published paper, 58% to 60% of patients recorded either negative or minimum change in the CBT and GET groups. Conveniently for the authors, no separate figures were recorded for total negative change (which includes the minimal negative change data). Even so, these figures do not look either impressive or safe. For both the GET and the CBT groups, only 16% extra patients recorded 'positive change', as compared to the SMC-alone group (i.e. only 16% extra patients in the CBT and GET groups were helped as compared with the SMC-only group.)
______________________________________________
