Protocol Effects of the Qigong Tuina therapy on patients with Chronic fatigue syndrome: study protocol for a randomized controlled trial 2025 Yao et al

[Andy]

Abstract

Background
Chronic fatigue syndrome (CFS) is a chronic disease characterized by fatigue, complex symptoms and long duration. It incurs significant economic costs every year. Qigong Tuina therapy (QTT), a traditional Chinese therapy, is skilled in the treatment of fatigue. The objective of this study is to observe the effectiveness of QTT in treating patients with CFS.

Methods
A randomized controlled trial will recruit 128 patients with CFS. The patients will be allocated randomly in a 1:1 ratio to either the QTT group or the cognitive behavioral therapy (CBT) group. The interventions for both groups will be carried out once per week for 8 weeks. Then a 4 weeks follow-up will be conducted for all patients after the intervention. The primary outcome will be the changes in the Multidimensional Fatigue Inventory (MFI-20). Secondary outcomes will be measured by the 36-Item Short Form Health Survey (SF-36), Pittsburgh Sleep Quality Index (PSQI), Hospital Anxiety and Depression Scale (HADS), and functional magnetic resonance imaging (fMRI). The data will be analyzed at the baseline, 4 weeks into the intervention, at the end of the intervention, and 4 weeks after the intervention. The safety of interventions will be assessed after each treatment session.

Discussion
The trial aims to establish whether QTT is not inferior to CBT for CFS patients. This study provides vital information for an alternative and complementary therapy aimed at patients afflicted with CFS.

Open access

 

[EndME]

Nice way to show the ineffectivity of CBT, but will it be interpreted that way?

 

[Utsikt]

CBT is a common intervention for CFS [7]. It can identify and adjust maladaptive behaviours and beliefs, leading to a decrease in symptom severity and improvement of functional capacity. However, involving professional counselors in the process proves to be challenging and expensive, making CBT a difficult approach to promote.

Yeah, that’s the challenge with CBT..

 

[Utsikt]

The study is a single-center, randomized, assessor- and statistician-blinded, parallel-controlled trial.

At least they make an effort to blind what can be blinded.

Patients will be informed of the benefits that can be derived from the treatment as well as the risks that may be associated with it and they can terminate participation at any time.

I highly doubt they will give a neutral assessment of the risks..

Participants that meet the following criteria will be included.

1. I.
   According to the NICE guidelines for 2021 [1], all of the following 4 symptoms need to be present at the same time and last for at least 3 months:

So they are aware of NICE, yet they chose CBT that isn’t recommended? Those are some nice cherries..

On CBT:

The treatment involved progressive exposure therapy, graded activity programs, and addressed the severity and environmental specificity of cognitive fatigue, as well as its effects and outcomes. Other techniques used were cognitive rest, exercise to alleviate stress, and dietary adjustments to relieve fatigue.

 

[Utsikt]

No mentions of the threshold for clinical significant changes in the methods section.

The design, conduct, reporting, and dissemination plans of this research were carried out without the involvement of any patients or members of the public.

It shows..

Evidence suggests that fatigue is closely linked to functional alterations within specific regions of the brain [33]. These changes affect the brain's ability to carry out cognitive and motor functions, finally lead to somatic symptoms. On the other hand, somatic symptoms such as fatigue and insomnia can in turn affect a person's mind, exacerbating anxiety and depression, for example. Therefore, adjusting the mind and body at the same time is the key to treating CFS.

 

[Utsikt]

Existing therapies mostly concentrate on one kind of symptom management, for example, CBT, which allows individuals to appreciate their condition, adjust their way of life and decrease their energy expenditure, consequently, reducing fatigue [34].

Sharpe M. Cognitive behavior therapy for chronic fatigue syndrome: efficacy and implications. Am J Med. 1998;105(3, Supplement 1):104S–109S.

At the time of submission, recruitment for the trial has been started. The first participant was included on 16 March 2024. The study is scheduled to end in December 2025.

Publishing the protocol almost a year after the study started. Good job!

 

[rvallee]

Nice way to show the ineffectivity of CBT, but will it be interpreted that way?

So far the formula has been that when two useless things are found to be equally ineffective, they are asserted to be equally effective. Which is true, 0=0.

Given the corner the industry have painted themselves into, I'd assume this will go this way again. After all, in systematic reviews they simply get combined under some vague label like "behavioral interventions". No one seems to care much about actual efficacy, an we are long past the point after which medicine has accepted alternative medicine pseudoscience that it doesn't matter anymore, GET may as well be just as effective as erotic fingerpainting for all that any of this matter.

 

[Hutan]

Existing therapies mostly concentrate on one kind of symptom management, for example, CBT, which allows individuals to appreciate their condition, adjust their way of life and decrease their energy expenditure, consequently, reducing fatigue [34].

34. Sharpe M. Cognitive behavior therapy for chronic fatigue syndrome: efficacy and implications. Am J Med. 1998;105(3, Supplement 1):104S–109S.

That's a strange conclusion - the authors seem to think that CBT aims to have people decreasing their energy expenditure and reducing fatigue. I'm sure that's not what Sharpe had in mind. It begs the question - what on earth will the CBT arm of this trial be attempting to convince its participants of?

 

[Utsikt]

It begs the question - what on earth will the CBT arm of this trial be attempting to convince its participants of?

This is the summary of week 6-8, after the gaslighting. Nothing about reduced energy usage, unless that’s what they mean by ‘cognitive rest’.

«The treatment involved progressive exposure therapy, graded activity programs, and addressed the severity and environmental specificity of cognitive fatigue, as well as its effects and outcomes. Other techniques used were cognitive rest, exercise to alleviate stress, and dietary adjustments to relieve fatigue.»

Also, notice the past tense. It seems like the protocol was written after the trial.