Translated from Dutch : de Pace Trial : Wordt u hier ook zo moe van? written by the Dutch medical journalist Marc Van Impe The PACE trial: do you also get so tired of this? From the very beginning it was obvious that the outcome of the UK PACE study, published in The Lancet last Friday, would be controversial. Something that one could have known. After all, we already had the RIZIV and KCE studies that were conducted in our own country, that involved 808 patients who were meticulously recruited at the so-called Reference Centres. The patients were submitted to CBT and GET. The outcomes were a disaster. 64% reported no change, 30% became worse, and only 6% said they felt better. A new study by the KCE, a year later, gave zero results. Professor Boudewijn Van Houdenhove explained this by stating that the expectations were set too high. The PACE study involved 641 patients. The expectations were equally high. The results showed the opposite. Peter White, the main author of the study, dismissed these objections. Great Britain is CBT country, and proof was obtained for what had to be proven. Let's scroll through the objections: 1. The patient selection. The study took off with a serious handicap from the very beginning: the patients were selected based on the Oxford criteria, and not based on internationally accepted CDC criteria, employed by the WHO, or the more recent Canadian criteria. That implied a lot of non- CFS/ME patients participating in the trial. Only patients suffering from psychosis, bipolar disorder, drug abuse, organic brain disease or an eating disorder were excluded (58 in total). All other patients were admitted. The mean age was 38; 77% were female, 56% met the Oxford criteria. Remarkably it turned out during the research that 47% suffered from a psychological disorder like depression, anxiety, OCD (obsessive compulsive disorder) or PTSD (posttraumatic stress disorder). 40% were taking antidepressants. 2. The patients were also biased: 70% had high expectations of GET, 71% believed in pacing (APT), en 57% believed in CBT. Only 41% believed in other, normal medical care. That is quite peculiar in a country where GET and CBT have a bad reputation yet. The patient selection surely was not objective. Sick patients who were immobilized (139), explicitly lacked motivation (143), or lived too far away from the centres, were not admitted. 3. During the trial the process was adjusted: in the original protocol activity graphs were adopted and budgeted, but these precisely were canceled. The patients however were allowed to decide themselves how and when they would report on a scale that was designed by one of the researchers. This Chalder test is not a scientifically accepted measuring instrument. * . They were divided into 4 groups: APT, CBT, GET, and normal specialist care that consisted of anti-depressants and pain medication. They received 14 therapy sessions in the course of 23 weeks, and another single session at week 36. After 52 weeks they were allowed to make their own report. The goal of the research was to change the behavioral and cognitive factors assumed to be responsible for perpetuation of the participants symptoms and disability." In other words, they wanted to change the behavioral and cognitive factors that maintained the symptoms and the handicap. In that regard, some results might have been achieved. But, the patients' health did not improve. The authors themselves stated that these treatments were only moderately effective", and that more research into more effective treatments is necessary. Effectiveness in medical terms means that a treatment reduces the symptoms, or makes them disappear. Neither happened in this experiment. Therefore, 'moderately effective' means that the only effect was a mediocre one. Peter White and others do not state in The Lancet that CBT/GET/APT are appropriate treatments, they just showed a moderate effect. Of course there were effects. Attention, help, coaching, a listening ear always yield good results. But inferring from that that 88% of the APT patients, 82% of the CBT patients, and 88% of the GET patients who were satisfied with their treatment are cured now, that -'s jumping to unjustified conclusions. When asked whether the results were positive, that only turned out to be the case in 40% of the CBT patients. 60% didn't feel any better or worse at all. All patients answered that they were still 'more than normally' bothered with fatigue and cognitive disturbances. When asked about their 'global impression of health', 40% answered it had evolved positively, while 60% stated no changes. Not one single patient stated he felt healthy again. On a score for social activities, all patients answered that they remained 'very severely impaired'. The conclusion of this research is that CBT and GET indeed do score better compared to APT (4/8 tests) and normal specialist care (6/8). It must be stressed that the latter form of care was nothing else than classical administration of antidepressants and pain medication. None of these therapies cured the patients or enabled them to (partly) pick up on their activities. If it had the intention to cure the patients, the only conclusion is that this research has failed. The authors themselves stated that CBT, GET, and APT only treated symptoms in some people, but not in all. They are very clear that these therapies should never be considered primary treatments for CFS but as adjunct treatments a CFS specialist might use if appropriate.http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(11)60096-2/fulltext We never stated anything else. The Belgian research of Riziv and KCE already proved this extensively. Moreover, earlier British research has come to the same conclusion. http://www.ncbi.nlm.nih.gov/pubmed/20418251 In other words, this was 'much todo about nothing' another time. The question is, what did they want to prove anyway? And who's to gain by doing the same research over and over again, while at the same time everyone knows the outcome. I think I'll start my own little research. Question #1. "Do you also get so tired of this?" Marc van Impe * Chalder Fatigue Scale - Do you have problems with tiredness? Do you need to rest more? Do you feel sleepy or drowsy? Do you lack energy? Do you have trouble starting things? Do your muscles have less strength? Do you feel weak? Do you have difficulty concentrating Do you find it more difficult to find the correct word? Do you make slips of the tongue when speaking? How is your memory? If the factor is less than usual in strength (0 pts)/ no more than usual (1 pt)/ more than usual (2 pts) / much more than usual (3 pts). A top fatigue score would be 33 pts and a completely unfatigued score would be 0.