Protocol Comparing effectiveness of physiotherapy vs drug management on fatigue, physical functioning, and episodic disability for [ME] in [PCC]... 2024 Sarker

Andy

Andy

Retired committee member
Full title: Comparing effectiveness of physiotherapy versus drug management on fatigue, physical functioning, and episodic disability for myalgic encephalomyelitis in post-COVID-19 condition: a study protocol of randomized control trial

Abstract

Background
Physiotherapy interventions effectively improved fatigue and physical functioning in non-COVID patients with myalgic encephalomyelitis or chronic fatigue syndrome (ME/CFS). There is a research gap on the effectiveness of physiotherapy interventions versus drug management on ME/CFS in post-COVID-19 conditions (PCC).

Methods
We planned a three-arm prospective randomized control trial on 135 PCC cases with ME/CFS who are diagnosed between 20 November 2023 and 20 May 2024 from a population-based cohort. The study aims to determine the effectiveness of physiotherapy interventions as adapted physical activity and therapeutic exercise (APTE) provided in institution-based care versus telemedicine compared with drug management (DM). Participants will be assigned to three groups with the concealed location process and block randomization with an enrollment ratio of 1:1:1. The post-treatment evaluation will be employed after 2 months of interventions, and follow-up will be taken after 6 months post-intervention. The Chalder fatigue scale will measure the primary outcome of fatigue. SF-36 and the disability-adjusted life years (DALYs) will measure the secondary outcome of physical functioning and episodic disability.

Discussion
This study will address the research gap to determine the appropriate approach of physiotherapy or drug management for ME/CFS in PCC cases. The future direction of the study will contribute to developing evidence-based practice in post-COVID-19 condition rehabilitation.

Open access, https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-024-08077-x
 
"The proposed study will be a three-arm randomized clinical trial (RCT) of PCC patients diagnosed with ME/CFS according to WHO working group criteria1"

Reference given is to WHO: A clinical case definition of post COVID-19 condition by a Delphi consensus

"The sample size was calculated using the software ClinCalc [27], and the key primary outcome was determined as the score of fatigue in the Chalder fatigue scale (CFS)"
 
The key outcome of exercise in ME/CFS is restoration of physical functioning that is significantly improved even after 12 to 24 weeks of interventions [22,23,24,25]
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(Citing the PACE trial and other GET studies)

(4) diagnosing ME/CFS according to 2006 Canadian consensus criteria [29], (5) willing to participate in the trial with consent of adherence with the interventions, and (6) eligible for drug management according to the physician’s assessment. Exclusion criteria will be (1) any preexisting post-exertion symptom exaggeration,
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?? How can they ask for people who fit the CCC but exclude PEM (PESE). Or does “preexisting” here mean PESE before the covid infection?

As far as I can tell, no mention of people being possibly too severe to participate, which isn’t a good sign.
 
Yann04 said:
?? How can they ask for people who fit the CCC but exclude PEM (PESE). Or does “preexisting” here mean PESE before the covid infection?
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I think it might be the second because they say this - they expect people to experience PESE during the study.

We anticipate no adverse effect for the physiotherapy groups except minor post-exertional symptom exacerbation.
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I see the authors are based in Bangaldesh, so I assume the study will be carried out there. I hope some clinicians such as Todd Davenport will help them with better information and redesign of the study, though it may be too late. It's so full of flaws it will be useless.
 
The paper said:
Physiotherapy interventions effectively improved fatigue and physical functioning in non-COVID patients with myalgic encephalomyelitis or chronic fatigue syndrome (ME/CFS)
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No they don't. So the entire premise of this "study" is invalid. They are comparing ineffective things with other ineffective things, something that deserves to be mocked mercilessly. Might as well compare with potatoes for all that this matters. As in having potatoes deliver whatever personalized patient-centered holistic treatment they can think of. Same difference.

And a primary outcome of CFQ? Good grief, how is this junk still getting funded?

Not that it's especially worse than the usual. In fact, there is basically no significant difference between this and PACE, it's just differently inept.
 
Trish said:
I see the authors are based in Bangaldesh, so I assume the study will be carried out there. I hope some clinicians such as Todd Davenport will help them with better information and redesign of the study, though it may be too late. It's so full of flaws it will be useless.
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Yeah, I somehow feel these authors might be more open to constructive criticism than some of the UK BPS crowd. I hope someone will have the energy to send them something.
 
Amw66 said:
no objective endpoints/ measures
same old GIGO
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From what I can see there is no control group of any sort either

it’s exercise in an institution, exercise via telemedicine vs drugs.

I don’t know the exact appropriate control given the design flaws of choosing to do no objective measures etc too but my goodness this is like the forced choice between three bad therapies in theory recently if they are rubbish drugs? So in that case could be worse than comparing to ‘give nothing’ if the drugs send people backwards?
 
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bobbler said:
From what I can see there is no control group of any sort either

it’s exercise in an institution, exercise via telemedicine vs drugs.

I don’t know the exact appropriate control given the design flaws of choosing to do no objective measures etc too but my goodness this is like the forced choice between three bad therapies in theory recently if they are rubbish drugs? So in that case could be worse than comparing to ‘give nothing’ if the drugs send people backwards?
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I can’t copy quotes from this using my phone - can someone scroll down to the drug management section under methodology and do so if they get there before I’m up to looking at this another way?

I’m pretty shocked by it as there is a long list of about 8 meds many of which are hard core (and seem unusual to be all taken together by so many?) including rituximab snd hydrocortisone among two examples

also shocked by the fact they intend to allow the drug ‘controls’ to participate in the exercise programme if they want to

so where is the control?

EDIT: I've copy-pasted the quotes in the next comment. BUt the list of meds is:

azithromycin, remdesivir, favipiravir, infliximab, tocilizumab, siltuximab, hydrocortisone, rituximab, rintatolimod, and intravenous immunoglobulin

I've checked to see there isn't wording saying 'a selection from...' or something in the section itself but not read the whole paper forensically yet.

That seems unusual to take a number of 'imabs'?
 
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Here it is (my bolding on the 'drug controls can join in the exercise programme' bit):

Drug management (DM)
Participants of the drug management group will receive drug interventions as azithromycin, remdesivir, favipiravir, infliximab, tocilizumab, siltuximab, hydrocortisone, rituximab, rintatolimod, and intravenous immunoglobulin [17, 18]. The drug interventions will be directly prescribed by a physician specialized in treating PCC cases. A single brand name will be prescribed for each drug. We will communicate with the patients to ensure no adverse effects of the medications. The patient will be given a choice if they are willing to join the exercise programs; they have full liberty to join the programs even after the completion of the trial.
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and also

Treatment progression
The participants of all three groups will be performing exercise or taking their treatment for 8 weeks. The exercise group will take the interventions formally twice a week for 8 weeks with continuous monitoring. In case of any adverse effect, additional sessions will be employed depending on the opinion of the consultant physiotherapist or physician. The overall treatment for ME/CFS will be provided actively for 2 months, and after that, the treatment will stop, and there will be a 6-month follow-up.
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Participants of the drug management group will receive drug interventions as azithromycin, remdesivir, favipiravir, infliximab, tocilizumab, siltuximab, hydrocortisone, rituximab, rintatolimod, and intravenous immunoglobulin [17, 18].
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Holy cow, that's a lot of drugs. There's no way, right? I feel like this has to be poor wording choice.

Edit: I assume the "and" is supposed to be "or". And that the physician will decide which to prescribe.
 
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Sean said:
The Chalder fatigue scale will measure the primary outcome of fatigue.

What could possibly go wrong?
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Not only that but: “The original questionnaire was formulated in English. Then, a bilingual researcher who is not involved in this study project translates forward Bangla to backward English.”

As you say, what could possibly go wrong?

The whole thing reads like a satire.

Do we know who is funding this study? How could any scientifically literal person take this seriously?
 
There's a long criticism on PubPeer of this protocol that in large part echoes the points made here. The summary at the end:
In summary, this protocol features an invalid sample size calculation, an intervention group that will produce an utterly uninterpretable result and with no basis provided for the drugs used, a contradiction between the inclusion and exclusion criteria such that no patients can actually meet them, confusion as to whether this actually is a randomized trial or not, confusion as to how long the trial will run, outcome measures that appear irrelevant, and has an introduction that cites evidence that the interventions they plan to do could cause significant harm in their patients, which is instead misrepresented to suggest this evidence shows such interventions are beneficial.
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