Godwin has expressed his opinion about the study. He's been honest and straightforward. That's fantastic! For myself, I don't have an interest in pressing him to assess the intentions or motivations of those who conducted the trial.
Yes, all we can say is the intentions and motivations of patients and activists when criticizing the trial.
To
@Mike Godwin, I'd like to clarify the two issues, that are often misportrayed:
1. This prominent group of UK psychiatrists who are being criticized, have long been involved in the field, but have never bothered to really listen to the concerns of patients and ultimately never built any trust with the community. These researchers are not being criticized because merely because they are psychiatrists or psychologists conducting research in this field.
In contrast, in the USA there are researchers that have also done CBT trials, namely Fred Friedberg and
@Leonard Jason who are generally well respected in the community. The difference is that they listen to patients and make an effort to build trust.
2. Patients are not criticizing the trial "because it suggests a psychological etiology", we're criticizing it because the therapies are mostly ineffective in treating patients, but yet they are promoted as the next best thing to a panacea - "the only evidence based therapy for CFS". Patients do not care about the philosophy of mind-body dualism, patients are not saying that psychology cannot effect the body and vice versa. When patients say "CFS or ME is not psychological", we are saying that psychological factors are not the central perpetuating factors and that psychological therapies have so far failed to help a large majority of patients for their underlying condition. That is not to say CBT cannot be helpful for dealing with other problems, such as some forms of depression or anxiety but that is not the argument that most people are making.
Yes CBT and GET have been shown to effectively modify cognitions of CFS patients and alter questionnaire responses, albeit temporarily. But these therapies have so far failed to demonstrate meaningful objective improvement in objective outcomes that matter most to patients. Namely patients being more active, reducing the defects in neuropsychological performance (due to brain-fog/poor concentration due to faitgue), or gaining employment, all of which have not been shown to improve in trials.
If psychological treatments truly had the efficacy claimed by these researchers (or as widely quoted in the media) it would be fantastic!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!
Most patients agree that the design of the trial is flawed when it comes to the outcome measures.
Firstly, the questionnaires used in the field are of low quality. The biggest issue is that the questionnaires seem to be designed for researcher convenience and have patients have never been asked whether these questionnaires are actually clear/meaningful/accurate representations of patient experiences.
See the review here:
https://www.ncbi.nlm.nih.gov/pubmed/21590511
Secondly, the PACE trial was unblinded and only showed changes on subjective questionnaires in the short term. When there are such improvements, but there is no change on objective measures of functioning (regardless of whether objective measures were measured or overlooked in the trial design) and the difference between the randomised groups disappears at long term follow up, should we even conclude that the therapy was efficacious?
The fact is that meta-analyses of subjective outcomes in unblinded clinical trials have shown a high degree of bias. Incidentally, that bias is of a similar magnitude to the effect on questionnaires in the PACE trial.
