In February 2011, the news media in the UK and many other parts of the world published the highly anticipated results of the 5-year long PACE trial. The £4.2 million trial that was financially supported by the UK Government studied four ME treatment options including specialist medical care (SMC), cognitive behaviour therapy (CBT), graded exercise therapy (GET) and adaptive pacing therapy (APT) with an aim to establish both their efficacy and safety. Unfortunately, the results didn’t meet the high expectations of ME advocacy groups and especially, of ME patients.
According to most ME advocacy groups, the results of the PACE trial are a major disappointment. They noted that despite millions of pounds and years of research invested into establishing the efficacy and safety of the above mentioned treatments, we are not any closer to a systematic, proven, safe and effective management of ME symptoms, and much less to finding a cure for this complicated medical condition. Advocacy groups almost unanimously agree that the most important thing the PACE trial has found is the need for further research to make the available treatments more effective and hopefully, find a cure. But what did the PACE trial actually find?
The authors of the PACE trial, which included 600 participants, concluded that of four ME treatments they studied only CBT and GET were found to be effective to a certain degree when combined with SMC as opposed to SMC alone. ATP, on the other hand, didn’t have any effect when used in combination with SMC.
The conclusions of the PACE trials are based on ratings of the study participants.
In addition to failing to bring us any closer to finding more effective and safer treatments for ME, the PACE trial has also been heavily criticised for focusing almost exclusively on fatigue while ignoring other symptoms including pain. Also, the participants were asked to rate the improvement of fatigue and mobility/physical function instead of rating the overall improvement, which according to some, made the studied treatments appear more effective than they in reality are.
The trial also received a lot of criticism for failing to include patients who are unable to leave their home and those younger than 18 years. Lastly, the findings are based on the participants’ observations which raises the question about the result’s reliability.