No Reduction of Severe Fatigue in Patients With Postpolio Syndrome by Exercise Therapy or CBT

[Kyla]

http://www.ncbi.nlm.nih.gov/pubmed/26253175#

No Reduction of Severe Fatigue in Patients With Postpolio Syndrome by Exercise Therapy or Cognitive Behavioral Therapy: Results of an RCT.

Koopman FS1, Voorn EL2, Beelen A2, Bleijenberg G3, de Visser M2, Brehm MA2, Nollet F2.
Author information

• 1University of Amsterdam, Amsterdam, The Netherlands s.koopman@amc.uva.nl.
• 2University of Amsterdam, Amsterdam, The Netherlands.
• 3Radboud University Medical Centre, Nijmegen, The Netherlands.

Abstract
BACKGROUND:
People with postpolio syndrome (PPS) commonly experience severe fatigue that persists over time and negatively affects functioning and health-related quality of life (HRQoL).

OBJECTIVES:
To study the efficacy of exercise therapy (ET) and cognitive behavioral therapy (CBT) on reducing fatigue and improving activities and HRQoL in patients with PPS.

METHODS:
We conducted a multicenter, single-blinded, randomized controlled trial. Over 4 months, severely fatigued patients with PPS received ET, CBT, or usual care (UC). The primary end point (fatigue) was assessed using the subscale fatigue severity of the Checklist Individual Strength (CIS20-F). Secondary end points included activities and HRQoL, which were assessed with the Sickness Impact Profile and the 36-Item Short-Form, respectively. End points were measured at baseline and at 4, 7, and 10 months.

RESULTS:
A total of 68 patients were randomized. No differences were observed between the intervention groups and UC group for fatigue (mean differences in CIS20-F score = 1.47, 95%CI = -2.84 to 5.79, for ET versus UC; and 1.87, 95%CI = -2.24 to 5.98, for CBT versus UC), activities, or HRQoL.

CONCLUSIONS:
Our results demonstrate that neither ET nor CBT were superior to UC in reducing fatigue in severely fatigued PPS patients. Further research should investigate explanations for the lack of efficacy of these 2 currently advised approaches in clinical practice, which may provide clues to improving treatment aimed at reducing fatigue in PPS.

 

[adreno]

Further research should...not waste more time on this.

Fixed.

 

[A.B.]

multicenter, single-blinded, randomized controlled trial.

Maybe this is why CBT failed to "work" as it usually does? I'm wondering why it suddenly fails when it seems to "work" for almost anything.

 

[alex3619]

Magical thinking is alive and well it seems. This is, in my opinion, what the philosopher of science Lakatos calls a waning research program. Its stagnant, achieving nothing, but they still go at it. Next time they will get it right. Next time they will score big. Next time they will hit the jackpot. Oh, wait, that's gambling addiction. Hmmm, is there a difference?

 

[Scarecrow]

Maybe this is why CBT failed to "work" as it usually does? I'm wondering why it suddenly fails when it seems to "work" for almost anything.

Excuse me for being a bit thick but how can you single blind this? I can understand it being blinded to the data analysers but surely both patients and therapists must have had a clue as to what was going on? The article is behind a pay wall.

 

[alex3619]

Maybe this is why CBT failed to work as it usually does? I'm wondering why it suddenly fails when it seems to work for almost anything.

Its also probably not controlled in the strict sense. They have a comparison group, which is probably not quite the same thing.

There is no way to deliver sham treatments in these things. It cannot be done. I would also like to know what they mean by single blinded. Did they mean that the people interpreting the results did not know which group a patient was in?

No psych study using this format can ever be gold standard - double blinded randomized placebo controlled trial. They can however use objective outcome measures. This is probably the only way this kind of study can achieve high reliability.

 

[A.B.]

Excuse me for being a bit thick but how can you single blind this? I can understand it being blinded to the data analysers but surely both the patients and therapists had a clue as to what was going on? The article is behind a pay wall.

The only way I can make sense of this is that researchers filled out questionnaires for the patients while asking them the questions in the questionnaire, while being unaware of the treatment the patients had received.

... which might be a very good explanation as to why the usually good results are absent

 

[Esther12]

The only way I can make sense of this is that researchers filled out questionnaires for the patients while asking them the questions in the questionnaire, while being unaware of the treatment the patients had received.

... which might be a very good explanation as to why the usually good results are absent

Maybe some independent researcher assessing fatigue levels. Interesting.

 

[JaimeS]

Did they mean that the people interpreting the results did not know which group a patient was in?

That is likely. They were given a stack of survey responses that were numbered and lettered, but they had no idea which patient was in which group. It is single-blinded because of course the patient knows what they are receiving in terms of treatment.

-J

 

[Effi]

I would also like to know what they mean by single blinded. Did they mean that the people interpreting the results did not know which group a patient was in?

single blinded = of or relating to an experiment or clinical trial in which the researchers but not the subjects know which subjects are receiving the active medication or treatment and which are not: a technique for eliminating subjective bias, as the placebo effect, from the test results.

So it's ok if the researchers are biased I guess. How else would they be able to massage the findings to get the outcome they want? *cheeky*

 

[Effi]

Further research should investigate explanations for the lack of efficacy of these 2 currently advised approaches in clinical practice, which may provide clues to improving treatment aimed at reducing fatigue in PPS.

I've been seeing this more often lately, studies connected to the lack of efficacy of CBT, and then subsequently studies that explain why it's not working. The outcome being somewhere along the lines of: can't blame everything on the patient, but instead blaming the partner, family or the general social environment of said patient, for their too high/too low/otherwise faulty expectations. Anyone else notice this?

 

[JaimeS]

This is not single-blinded if both parties know exactly what they're doing!

Full text is on Research Gate - downloaded there already, I didn't even need to ask for it.

It was, in fact, the investigator who was blinded, not the patients.

Patients were randomized to 1 of 3 treatment arms: ET, CBT, or UC. Randomization was stratified by center.... An independent investigator performed the randomization. The investigator responsible for the inclusion and the 2
experimenters who performed the outcome assessments were blinded to the group allocation.

No Reduction of Severe Fatigue in Patients With Postpolio Syndrome by Exercise Therapy or Cognitive Behavioral Therapy: Results of an RCT. Available from: https://www.researchgate.net/public...ognitive_Behavioral_Therapy_Results_of_an_RCT [accessed Aug 21, 2015].

 

[JaimeS]

Also, for CBT, no differences were found for any of the exploratory end points compared with UC, except for a lower score on the emotional coping domain of the CISS-21 at long-term follow-up for CBT when compared with UC (−2.77, 95% CI = −5.16 to −0.38).

No Reduction of Severe Fatigue in Patients With Postpolio Syndrome by Exercise Therapy or Cognitive Behavioral Therapy: Results of an RCT. Available from: https://www.researchgate.net/public...ognitive_Behavioral_Therapy_Results_of_an_RCT [accessed Aug 21, 2015].

This essentially reads: at the end of CBT, people were more emotionally damaged by the therapy than were controls.

-J

 

[Effi]

This essentially reads: at the end of CBT, people were more emotionally damaged by the therapy than were controls.

sounds about right

btw one of the participating universities (Radboud) is a very big fan of 'it's all in the mind'. They even prescribe CBT to fatigued cancer patients in remission (up to 40% of patients in remission feel fatigued!). They say that the fatigue these people feel has no link whatsoever to the the treatment they received, no matter how agressive it was or how long they had to endure it. They say it is caused by feelings of sadness, too much or too little exercise, bad sleeping habits, etc. So I'm not sure what their agenda might be behind this study. Could be anything, really...

 

[JaimeS]

They say that the fatigue these people feel has no link whatsoever to the the treatment they received, no matter how agressive it was or how long they had to endure it. They say it is caused by feelings of sadness, too much or too little exercise, bad sleeping habits, etc.

Link, please! I want evidence of this horribleness.

Though keep in mind these guys are saying that CBT and its ilk do not actually work. I should think they are going against their evil overlords.

[Edit: never mind; I found where they prescribed CBT to cancer patients; they mention it in the article. Wow.]

-J

 

[Effi]

Link, please! I want evidence of this horribleness.

It's in Dutch: https://www.radboudumc.nl/Zorg/Afdelingen/nkcv/Pages/Vermoeidheidnakanker.aspx

I google translated the most important part (with a few touch ups by moi):

There has not yet been much research on the factors which affect fatigue after cancer. It seems that medical factors (type of cancer, type / intensity treatment etc.) do not affect this fatigue. Probably the fatigue starts either during or as a result of the treatment.

Over time, however, there are other factors that contribute to fatigue symptoms persisting.

Fatigue long after treatment for cancer has ended, may be associated with gloom, with fear of the recurrence of cancer, too much or too little activity, sleep problems or lack of understanding from the environment. These factors or a combination of these play a role in the persistence of the fatigue. These factors may vary for different patients.

It's pretty much the same story that they tell about cfs - there could be a biomedical stressor, but the persistance of the fatigue is pretty much caused by our own little selves.

 

[A.B.]

In total, 490 patients were invited to participate. Of these 490 patients, 129 did not respond, 200 declined to participate, and 93 were excluded. The major reasons for exclusion were not being severely fatigued and having comorbidities. From June 2009 to September 2012, 68 patients were enrolled.

Few patients (13%) who are sufficiently fatigued and without comorbidities were actually interested in participating in this study.

One patient allocated to ET withdrew consent after the pretreatment assessment; hence, the ITT sample consisted of 67 patients (22 in UC, 22 in ET, and 23 in CBT). Sociodemographic and polio characteristics of these 67 patients are shown in Table 1. In all, 51 patients were included in the per-protocol analyses (22 in UC, 14 in ET, and 15 in CBT).

Compared to the control intervention, exercise therapy and cognitive behavioural therapy have a problem with patients dropping out. Figure 1 tells us a bit more about that. In the ET group, 1 patient withdrew consent, 8 did not complete the treatment. In the CBT group, 5 did not start with the treatment, and 3 did not complete treatment. The reasons given seem relatively innocuous but it's strange how the control intervention didn't have the same problems.

These therapies are clearly not popular among patients (what else is new?).

 

[JaimeS]

@Effi ,

&*%$(*&(*$

Sorry, but a keyboard smash was the only thing that could accurately capture the horribleness.

Let's start from the supposition that they are generally correct. Look, I'm sure that there are people with serious illness who really worry a lot about it coming back. They should clearly seek psychological help for such an unreasonable and pathological way of thinking. I mean, their fears are totally unfounded. It's not like cancer could ever come back: once you're cured, you're cured. Everybody knows that.

It's equally pathological to give your body time to heal. Every doctor knows that there are only two states: at death's door and entirely well. There is no 'recovery period'; there is no 'regaining one's strength'. Once you've been declared cancer-free, you should be at work, preferably later that day.

Okay, okay, / sarcasm.

I'm amazed at how much of psychology is still purely Freudian. This idea of psychological treatment for normal human response to trauma and illness is really weird. (Freud did not believe that neuroses could exist in the mentally well - you were either entirely mad or completely sane.) But of course, if they didn't pathologize everything, they could be out of a job.

Meanwhile, due to the fact that cancer treatment isn't a walk in the park, I'm surprised there isn't something called 'post-cancer fatigue syndrome'. I'm sure that the immune system is pretty well smashed afterwards, and may never recover. But note that nothing I argued above assumes this to be the case.

-J

 

[A.B.]

Meanwhile, due to the fact that cancer treatment isn't a walk in the park, I'm surprised there isn't something called 'post-cancer fatigue syndrome'. I'm sure that the immune system is pretty well smashed afterwards, and may never recover. But note that nothing I argued above assumes this to be the case.

Coincidentally, I recently read that psych studies on cancer patients also have big problems finding enough interested participants. The commonly held belief that cancer patients are generally terrified is wrong. Most cancer patient also view their psychological reaction to their circumstances as normal and not something that has to be treated. The remaining patients that are so few it can be hard to recruit enough for a study. Unfortunately I don't remember the title of the article, but that was the gist of it.

 

[Seven7]

I think we have to do the following. Get a CBT proponent, give them the Flu, then get another CBT proponent and start the session.

Flu therapist: I feel like $hit
Therapist 2: Nope, is all in your head. You need to improve your take on the flu. Have better attitude.
Flu therapist: FU! you are telling me this join pain is in my head and that I have to push through this tiredness.
Therapist 2: yeap go to work and move on, have better attitude.
Flu therapist: (I just wonder what the result would be).

THIS IS SO INSANE. In what world can you convince a person w MOno like or flu feeling that is all in your head. I think we need to submit every CBT proponent to it while they suffer the worst virus of their live. And that is giving them only one symptom!!!! While we have all the other crap: the lack of sleep, tingling, inability to be vertical, diarrhea, running on -30% of blood and so on!!!!