Exercise therapy beneficial for some ME/CFS patients new Cochrane report says

[Snow Leopard]

This has probably been posted before, but I just noticed it...

I wish I could swim... or dance.

 

[Valentijn]

I wish I could swim... or dance.

I prefer to think big.

Synchronized swimming, dawg!

 

[Bob]

If I could swim, cycle and/or dance, I'm not sure that I'd need exercise therapy for my 'fatigue'! So, what's the point of these studies'? What am I missing?

 

[Bob]

@Dolphin pointed out that all of the studies in the review recruited using Oxford or Fukuda/CDC, so post exertional malaise wasn't a required feature in the patients they studied. They studied chronic fatigue. (Perhaps that explains how the patients could dance, cycle and swim!) However, the NICE guidelines in the UK do require PEM. (The wording is slightly vague, but PEM is required for a diagnosis in the UK.) So the Cochrane review is not relevant to a UK ME/CFS patient cohort, as they studied a different cohort, or a mixed or overlapping cohort at best.

And it's always worth remembering the very large National Outcomes Database study, in which England's specialist ME/CFS clinics failed to improve physical function using CBT or GET as the main intervention. The difference in outcomes between that study and the Cochrane review might partially be explained by the cohorts. (I'm sure other biases in the exercise studies play a large part in the difference as well.)

 

[Dolphin]

@Dolphin pointed out that all of the studies in the review recruited using Oxford or Fukuda/CDC, so post exertional malaise wasn't a required feature in the patients they studied. They studied chronic fatigue. (That explains how the patients could dance, cycle and swim!)

Another view of course is that most didn't necessarily dance, cycle and swim. We are not given data that they did actually do these things. We saw in the PACE Trial no improvement in the fitness test which would be an odd result if people were exercising regularly. Similarly final scores at end of PACE Trial for 6-minute walking test still very poor and not what one would expect if most people were regularly dancing, cycling and swimming.

But it is frustrating that should loose definitions are used. Perhaps small numbers of people do get quite active and this can convince professionals that everyone else could do it.

Anyway, you make some interesting points but I just wanted to pick up on that point.

 

[Snow Leopard]

If I could swim, cycle and/or dance, I'm not sure that I'd need exercise therapy for my 'fatigue'! So, what's the point of these studies'? What am I missing?

You're missing out.

 

[Bob]

Another view of course is that most didn't necessarily dance, cycle and swim. We are not given data that they did actually do these things. We saw in the PACE Trial no improvement in the fitness test which would be an odd result if people were exercising regularly. Similarly final scores at end of PACE Trial for 6-minute walking test still very poor and not what one would expect if most people were regularly dancing, cycling and swimming.

But it is frustrating that should loose definitions are used. Perhaps small numbers of people do get quite active and this can convince professionals that everyone else could do it.

Anyway, you make some interesting points but I just wanted to pick up on that point.

Ah, I haven't read the full paper, but my assumption from the wording was that some patients could dance/swim/cycle from the beginning of the studies; It didn't occur to me that the treatments may have enabled participants to dance/swim/cycle. So I may have misinterpreted. My earlier comments should be viewed from the point of view of the participants being able to dance/swim/cycle at the beginning of the studies. If I misinterpreted the text then my comments aren't helpful.

 

[Seven7]

@Sidereal I have my 2 cents, do not shoot me this is just my experience. I have crashed 3 times due to excercise, so I will give you my experience.
1) I will NOT move on upwards without excercise (top number of scale).
2) TOO much or the WRONG KIND is contraproductive and will crash me.

Results: I have learned that I have to combined what my Excercise for CFS said + what my post Excercise said and I can improve.
So, Start low and slow based on AT, mine is at 115, I will do 3 sets (5min on 5min off) under my AT then increase slowly every 2 weeks (this is personalized based on my oxigen test). If symptomatic, stay or go down. if ok, go up another set.
POTs: I ignore the push parts, so I added to my CFS instruction DO NOT do standing excercise to begin with, do vertical or recumbant bike (swimming anything that will not fight gravety). Focus in streghting where pooling occurs, For me legs and Core.

So if I follow this rules I can progress (go slowly from a 70% to a 80%....)
If I do not excercise I am less symptomatic but my good days platoo. Vs if I excercise my top number improves. I do get more symptoms but I add a rest period (horizontal) after excercise I will be ok.

The one I have not figured is when I overdoo I can undo ALL PROGRESS. So the increase is better done SLOWLY and be sure 100% I can increase intensity

 

[Dolphin]

Ah, I haven't read the full paper, but my assumption from the wording was that some patients could dance/swim/cycle from the beginning of the studies; It didn't occur to me that the treatments may have enabled participants to dance/swim/cycle. So I may have misinterpreted. My earlier comments should be viewed from the point of view of the participants being able to dance/swim/cycle at the beginning of the studies. If I misinterpreted the text then my comments aren't helpful.

Ok. No, the reference to dancing* is simply from the list of options some patients were given as a way to exercise in some studies just one study (FINE Trial). The FINE Trial started off as being on the severely affected although I think all weren't. But the average baseline SF-36 PF score was 29.84 and they finished at 43.27 so one wonders how many actually did dancing.

*initially I had searched for dancing but then gave the list of the three but that is not correct i.e. cycling and swimming are mentioned with other interventions.

 

[Snow Leopard]

so one wonders how many actually did dancing, swimming and cycling.

Since there is no data to show that such activities did actually occur, it could be considered merely a suggestion.

 

[Dolphin]

Since there is no data to show that such activities did actually occur, it could be considered merely a suggestion.

Yes. But perhaps because of the way it is presented, readers might think they were actually done in one or more trials as Bob assumed. For example, this is from the abstract:

Seven studies used variations of aerobic exercise therapy such as walking, swimming, cycling or dancing provided at mixed levels in terms of intensity of the aerobic exercise from very low to quite rigorous, whilst one study used anaerobic exercise.

 

[MeSci]

Marques M, De Gucht V, Maes S, Leal I. Protocol for the “four steps to control your fatigue (4-STEPS)” randomised controlled trial: a self-regulation based physical activity intervention for patients with unexplained chronic fatigue. BMC Public Health 2012;12:202. [DOI: 10.1186/ 1471-2458-12-202]

Is Maes a common name? Not heard of S Maes before. I see that one is on 'unexplained chronic fatigue'.

 

[MeSci]

I wish I could swim... or dance.

I wish I could cycle again...I gave my bike away years ago after finally accepting that I was not going to be able to ride it again in the foreseeable future. I had kept hoping until then.

 

[Bob]

Ok. No, the reference to dance/swim/cycle is simply from the list of options some patients were given as a way to exercise in some studies just one study (FINE Trial). The FINE Trial started off as being on the severely affected although I think all weren't. But the average baseline SF-36 PF score was 29.84 and they finished at 43.27 so one wonders how many actually did dancing, swimming and cycling.

Thanks for the info.
Yes, you can't do much dancing/swimming/cycling with a SF-36 PF score below 50!

BTW, I'm pretty sure that the fine trial included a good proportion of moderately affected patients in the end. But I'm going from memory which isn't reliable. But certainly it wasn't only severely affected.

 

[Dolphin]

Marques M, De Gucht V, Maes S, Leal I. Protocol for the “four steps to control your fatigue (4-STEPS)” randomised controlled trial: a self-regulation based physical activity intervention for patients with unexplained chronic fatigue. BMC Public Health 2012;12:202. [DOI: 10.1186/ 1471-2458-12-202]

Is Maes a common name? Not heard of S Maes before. I see that one is on 'unexplained chronic fatigue'.

Don't know. But doubt it is Michael Maes based on what he has written.

 

[Effi]

Is Maes a common name? Not heard of S Maes before. I see that one is on 'unexplained chronic fatigue'.

Don't know. But doubt it is Michael Maes based on what he has written.

It's Stan Maes, Professor Clinical and Health Psychology at Leiden University in the Netherlands. He seems to focus on (self-)management of chronic illnesses (like heart disease, RA or CFS). List of published work here.

 

[Dolphin]

Looks like responses can be sent and should be replied to:

http://editorial-unit.cochrane.org/sites/editorial-unit.cochrane.org/files/uploads/14532_Final Print Ready.pdf

Edit. Not exactly clear where they should be sent. Anxiety, Neurosis and Depression Group?

Looks like this is it:

Cochrane Depression, Anxiety and Neurosis Group
Contact us



CCDAN Editorial Base Office
+44 (0)117 331 0172
contact@ccdan.org

Centre for Academic Mental Health, University of Bristol
Oakfield House, Oakfield Grove
Bristol, BS8 2BN
United Kingdom


Co-ordinating Editor: Dr Rachel Churchill

Managing Editor: Jessica Sharp

Trials Search Co-ordinator: Sarah Dawson

Just thought I'd bump this up.

 

[Bob]

Re making submissions, if you go to the webpage where the Cochrane review is published (i.e. click here), on the right-hand side, under 'article tools', you can click on 'submit comments'. I assume that's the way to submit a comment.

 

[Bob]

I've just noticed that physical function at follow up is not a statistically significant improvement. -16.33 [-36.74, 4.08]

See Analysis 1.6 which is on page 69 in my PDF copy.

That ties in nicely with the objective data available elsewhere and the large UK National Outcomes Database study which found no improvement in physical function in England's specialist clinics.

The language in the review seems a bit slippery about it (see bold text below):

"Pooling of the three
remaining trials (621 participants) showed a mean improvement
on the SF-36 physical functioning subscale that was 16.33 points
higher for exercise than for treatment as usual (95% CI -4.08 to
36.74; Analysis 1.6), but heterogeneity was excessive (I² = 96%, P
value < 0.00001); therefore little or no difference cannot be ruled
out."

So, in these non-blinded studies, at high risk of bias, the subjective symptom of fatigue was improved, slightly, but physical function was not significantly improved at follow up.

 

[Dolphin]

For what it's worth (some might not agree with about the PACE Trial for example but they don't cover the recovery criteria which is where the biggest problem was I think it's fair to say):

Selective reporting
Two studies (Wearden 2010; White 2011) referenced published protocols, and when we checked these against the published results, we found that reporting was adequate. In one study (Wearden 1998), trial investigators reported numerical data for only one subscale (health perception) of the Medical Outcomes Survey (MOS) scale (Ware 1992), for which data favour the intervention group; no numerical data were given for the five other subscales, nor for another scale (anxiety), as data were “similar in trial completers.” It was not possible to check the other studies for selective reporting bias; therefore their risk of bias is considered unclear.

@biophile has drawn my attention to the "Criteria for judging risk of bias in the ‘Risk of bias’ assessment tool (8.5 The Cochrane Collaboration's tool for assessing risk of bias)"
http://handbook.cochrane.org/chapte...a_for_judging_risk_of_bias_in_the_risk_of.htm

I found:

SELECTIVE REPORTING

Reporting bias due to selective outcome reporting.

Criteria for a judgement of ‘Low risk’ of bias.

Any of the following:

• The study protocol is available and all of the study’s pre-specified (primary and secondary) outcomes that are of interest in the review have been reported in the pre-specified way;
  
  
• The study protocol is not available but it is clear that the published reports include all expected outcomes, including those that were pre-specified (convincing text of this nature may be uncommon).

Criteria for the judgement of ‘High risk’ of bias.

Any one of the following:

• Not all of the study’s pre-specified primary outcomes have been reported;
  
  
• One or more primary outcomes is reported using measurements, analysis methods or subsets of the data (e.g. subscales) that were not pre-specified;
  
  
• One or more reported primary outcomes were not pre-specified (unless clear justification for their reporting is provided, such as an unexpected adverse effect);
  
  
• One or more outcomes of interest in the review are reported incompletely so that they cannot be entered in a meta-analysis;
  
  
• The study report fails to include results for a key outcome that would be expected to have been reported for such a study.

Criteria for the judgement of ‘Unclear risk’ of bias.

Insufficient information to permit judgement of ‘Low risk’ or ‘High risk’. It is likely that the majority of studies will fall into this category.

The Cochrane review gave the PACE Trial, White et al. a low risk of bias grade for "Selective reporting (outcome bias)" (see Figure 2, page 15).

This doesn't seem like the right allocation given none of the 3 primary outcome measures in the PACE Trial were analysed as promised:

Primary outcome measures – Primary efficacy measures
Since we are interested in changes in both symptoms and disability we have chosen to designate both the symptoms of fatigue and physical function as primary outcomes. This is because it is possible that a specific treatment may relieve symptoms without reducing disability, or vice versa. Both these measures will be self-rated.

The 11 item Chalder Fatigue Questionnaire measures the severity of symptomatic fatigue 27], and has been the most frequently used measure of fatigue in most previous trials of these interventions. We will use the 0,0,1,1 item scores to allow a possible score of between 0 and 11. A positive outcome will be a 50% reduction in fatigue score, or a score of 3 or less, this threshold having been previously shown to indicate normal fatigue 27].

The SF-36 physical function sub-scale 29] measures physical function, and has often been used as a primary outcome measure in trials of CBT and GET. We will count a score of 75 (out of a maximum of 100) or more, or a 50% increase from baseline in SF-36 sub-scale score as a positive outcome. A score of 70 is about one standard deviation below the mean score (about 85, depending on the study) for the UK adult population 51,52].

Those participants who improve in both primary outcome measures will be regarded as overall improvers.

Also:

Adverse outcomes
Adverse outcomes (score of 5–7 of the self-rated CGI) will be monitored by examining the CGI at all follow-up assessment interviews 49]. An adverse outcome will be considered to have occurred if the physical function score of the SF-36 28] has dropped by 20 points from the previous measurement. This deterioration score has been chosen since it represents approximately one standard deviation from the mean baseline scores (between 18 and 27) from previous trials using this measure 23,25]. Furthermore, the RN will enquire regarding specific adverse events at all follow-up assessment interviews.

Data was never published on those who scored a CGI of 5. Nor do I believe was data ever published on people who dropped by 20 points from the previous measurement (they did scores of 20 or more at two consecutive measurements and also an extra paper on decreases of 8 or more).

I think it would be good if one or more people submitted comments highlighting the problem with the outcome reporting particularly for the efficacy measures.