by Sasha Nimmo
University of Sydney’s Dr Sonia Lee looked at selective reporting in Myalgic Encephalomyelitis and chronic fatigue syndrome research. The study found psychosocial trials on ME and CFS are more likely to engage in selective reporting – meaning they are a waste of research funds and time – than cellular trials.
The small study “confirms the concerns raised by ME/CFS groups that psychosocial interventions are harmful, and present questionable therapeutic benefits no different to a placebo”.
Dr Lee appraised the bias of three trials, evaluating the methods of psychosocial versus celluar studies. The biases examined were study design, selection and measurement. The three studies were:
- PACE: psychosocial interventions (GET, CBT, and Adaptive Pacing Therapy) to represent psychosocial trends (White et. al., 2011)
- A neural study (NS) on post-exertion malaise after GET to represent cellular trends (Cook et. al., 2017).
- A gut study (GS) on profiling gut microbial differences in ME/CFS individuals (Giloteaux et. al., 2017)
These three studies were chosen due to their popularity (measured by altmetric scores) to represent ME and CFS research trends. The PACE trial is especially important to evaluate due to the criticisms and condemnation of the trial. The PACE trial is still influential in the treatment of patients around the world today, including UNSW’s Fatigue Clinic.
“As clinical trials become more complex, there is increasing concern selective reporting is harder to detect, and unforeseen complexities may escalate between the oversight bodies that monitor research integrity (eg. issues of research misconduct) versus the autonomy which allow research communities to freely conduct their own research. This review seeks to demonstrate these complexities in Chronic Fatigue Syndrome (CFS).”
Biological trials were five times more likely to address biases compared to PACE and twice as likely to be supported by evidence compared to PACE.
The celluar studies were also criticised for being weak in data, pointing out the need for consistency in research by clearly defining ME and CFS, applying a diagnostic criteria subject to a systematic evaluation.
Dr Lee is from the Sydney School of Public Health, University of Sydney, Australia. Here is the full preprint paper, which has not been peer-reviewed.