Review Effectiveness of non-pharmacological interventions for fibromyalgia and quality of review methods: an overview of Cochrane Reviews, 2023 Bidonde et al

Abstract

Background
Fibromyalgia syndrome (FMS) is defined as chronic widespread pain associated with sleep disorders, cognitive dysfunction, and somatic symptoms present for at least three months and cannot be better explained by another diagnosis.

Objectives
To examine efficacy and safety of non-pharmacological interventions for FMS in adults reported in Cochrane Reviews, and reporting quality of reviews.

Methods
Systematic reviews of randomised controlled trials (RCTs) of non-pharmacological interventions for FMS were identified from the Cochrane Database of Systematic Reviews (CDSR 2022, Issue 3 and CDSR 2023 Issue 6). Methodological quality was assessed using the AMSTAR-2 tool and a set of methodological criteria critical for analgesic effects. The primary efficacy outcomes of interest were clinically relevant pain relief, improvement in health-related quality of life (HRQoL), acceptability, safety, and reduction of mobility difficulties as reported by study participants. No pooled analyses were planned. We assumed a clinically relevant improvement was a minimal clinically important difference (MCID) between interventions and controls of 15%, or a SMD of more than 0.2, or a MD of more than 0.5, on a 0 to 10 scale.

Results
Ten Cochrane reviews were eligible, reporting 181 randomized or quasi- randomized trials (11,917 participants, average trial size 66 participants). The reviews examined exercise training, acupuncture, transcutaneous electrical nerve stimulation, and psychological therapies.

One review was rated moderate according to AMSTAR 2, seven were rated low and two were rated critically low. All reviews met most of the additional methodological quality criteria. All reviews included studies with patient-reported outcomes for pain.

We found low certainty evidence of clinically relevant positive effects of aerobic and mixed exercise training and for cognitive behavioural therapies (CBTs) at reducing mobility difficulties and for mixed exercise training and CBTs for improving HRQoL at the end of the intervention. Number needed to treat for an additional beneficial outcome (NNTB) values for a MCID of 15% ranged between 4 and 9. We found low certainty evidence that was clinically relevant for mixed exercise and CBTs for reducing mobility difficulties at an average follow up of 24 weeks. We found low certainty evidence of clinically relevant positive effects of mixed exercise on HRQoL at an average follow up of 24 weeks. NNTB values for a MCID of 15% ranged from 5 to 11. The certainty of evidence of the acceptability (measured by dropouts) of the different non-pharmacological interventions ranged from very low to moderate and the dropout rate for any reason did not differ across the interventions or the controls, except for biofeedback and movement therapies. All the systematic reviews stated that the reporting of adverse events was inconsistent in the studies analysed (very low certainty evidence).

Authors' conclusions
There is low certainty evidence of clinically relevant reduction of mobility difficulties and of improvement of HRQoL among individuals with FMS by aerobic and mixed exercise training and by CBTs at the end of the intervention. There is low certainty evidence that CBTs and mixed exercise training reduces mobility difficulties post-treatment and that mixed exercise training improves HRQoL at follow-up by clinically meaningful scores.

Open access, https://www.sciencedirect.com/science/article/pii/S0049017223000902

 

"The primary efficacy outcomes of interest were clinically relevant pain relief, improvement in health-related quality of life (HRQoL), acceptability, safety, and reduction of mobility difficulties as reported by study participants."

This is a bit of a guddle....

There is no evidence that pwFMS can experience pain relief. Meds at best take the edge off, that's about it. Pacing can help patients to manage their pain by pulling back from pushing through it to taking a more paced approach when they can. But there is no expectation in pain management programmes, for example, that pain relief is possible. The hint is in the title.

If the research reviewed (sorry not had time to look) is a guddle of trying to reduce pain and at the same time improving HRQoL, and increasing activity (reducing mobility issues), then this will fail. It is just not possible to achieve these aims with medical and non-pharma methods currently.

At best patient can pace (often by reviewing goals, delegating / eliminating tasks, doing things in different ways, e.g., using mobility scooters to get out and about and so on...). It is often about identifying that they are perhaps pressuring themselves to do what they did before (especially on good days), flaring up pain in an unhelpful cycle, to stop and think, and adapt and adjust. The goal is adapting and adjusting to living well despite chronic pain - which is what no one wants. Pts want to be pain free. That option does not exist currently.

Ideally, this is a discussion can occurs before referral into chronic pain services. Ideally, there is honesty and expectation management. By overselling the BPS approach as a possible cure - i.e. 'GET for FMS' / 'CBT to think your way to less pain' etc then this is wholly misleading as there is no objective evidence I'm aware of that doing more activity with FMS = less pain in pwFMS. Quite the opposite. Keeping gently active whilst being able to sustain some small scale strengthening exercises along with making choices and assertively pushing back on soaicalital nonsense, i.e., society doesn't like ambiguity and witnessing ongoing suffering, so it tends to pretend it ain't happening. And so on.

No surprise is there is a guddle in thinking there will be low quality evidence. If GET for FMS worked then for sure this would be straightforward to objectively measure. It's not been done I don't think. If anything, I think the objective measures would show reduction in activity - or at least intensity of activity.

Some brief measures like 6 min walk test, or sit to stands in 1 minute are often used - and these can be increased after pain management - but pwFMS's functioning is nowhere like age, sex matched healthy people without FMS.

 

I have only skimmed this, but only one of the 10 Cochrane reviews was rated moderate quality, the rest low, or critically low quality (go Cochrane!). I don't understand then how they can draw any conclusions at all from an overview of 10 mainly useless reviews. What do they mean when they say all reviews met most of the "additional methodological quality criteria". What are these additional criteria, and why does meeting "most" of them justify ignoring the AMSTAR 2 rating?

 

While these types of techniques can be useful for pwFMS (some exercises - usually very minimal, gentle stretching and strengthening exercises - not aerobic exercises / mindfulness, acceptance and commitment and stress reduction), they most certainly don't need "instruction by health care professionals." People are not daft - many work out how to manage themselves just fine. The vast majority of pwFMS self manage themselves. It is a minority that are seen in pain clinics and who take part in pain management programmes. And this can be because they have not had a good medical process, picked up blaming/unhelpful attitudes form medics and others in their life and are needing more support to know more about their condition to manage it well. That can take a minority of patients some time to figure out and ask for support with this. Many get on with minimal input, beyond diagnosis, just fine.

 

So the evidence for treatments in widespread usage is bad, at best, but the language used still encourages to just keep using them on the pretense that, whatever, there's evidence for some of it, even though it's bad? With some added recognition that seems to give points to trials simply for being trials that checked some bureaucratic boxes?

Especially since the pretense that those are effective is the universal excuse to do nothing more, there are zero efforts being channeled towards developing effective treatments, since the industry has been stuck in a loop of doing the exact same stuff over and over again. Which despite the attempt at improvement, is still the case with this study and AMSTAR-2, which is still spinning the same loop of perpetual failure.

And as much as they can talk about numbers-to-treat, they cannot pretend to be naïve enough and not be aware that when patients are stuck 1:1 in a consult room with an MD, they are told explicitly that those so-called treatments are fully effective for everyone, and that this means that their "illness" is psychological, even though this explicitly cannot be inferred from pragmatic trials. It's this detachment from reality more than anything that ruins everything, how a measly 1% of some heavily biased thing is hyped into a 100% safe and effective for everyone. Basically: it's the lies, the lies!

A bar set so low you can simply roll people over it, even when they're unconscious. No wonder decades go by with zero progress. You could easily arrive at the same conclusions for homeopathy, astrological projection and any ridiculous thing. And worst of all, this doesn't bother anyone. The complete lack of deliverables in healthcare outcomes, just as the complete lack of evidence used to support them, is no one's problem. Well, I guess it's the patients', who are blamed for being failed because no one can accept it and they can get away with passing it on.

Evidence-based medicine makes dysfunctional politics look sane and very high performance by comparison, since even though there is a similar level of waste and corruption, things do get delivered: housing and roads get built, electrical power gets delivered, sewerage gets treated, and so on. While here it's absolutely nothing, complete theater with nothing at all delivered other than jobs. It's so damn weird.

 

That is definitely what's needed. I still feel it's too slow for progress, but it is some suggestion of potential future progress. The halt in trial registration would be significant, and very much needed. It's one thing to speak of the future, but there is a huge mass of this in the past that has real life power over millions of people, including some happening right now. The exact same stuff. Done the same way. With the same biases. With the same intent and rationalization that "it must be true".

I really don't think there is much they can do in the future that will make it acceptable, because the only real conclusion here is that basically none of this works, and it's too much to accept. It has been sold as a done deal for decades, and argued that it means that MUS/FND/BDD/whatever is psychological, which is simply too embarrassing. It has been fought too violently, too disrespectfully.

I don't know how much it can counter the movement in the exact opposite direction, which is still very potent. The future of this discipline is being held back by those who made a career out of this easily-gamed process, and some of them can easily nip this in the bud. Cochrane has so far sided with them, as much of their non-pharmaceutical reviews suffer from all those flaws, and then some.

Could they bear retracting much of that catalogue? When a few powerful ideologues can stop the process for the exercise review? In part by being public about going to war with them? Even when Cochrane's own conclusions are that it should happen. We already have our answer to that. They're still allowing the charade of not retracting it while excusing it on a stalled "independent" process that is radio silent, and likely doing nothing at all.

It also only speaks of chronic pain. There is so much more to it, including but not exclusive to us. The whole non-pharmaceutical evidence base is invalid, as far as I'm concerned. I think that it's obvious enough to many, but so few dare call out the naked emperor. Especially since he's been obviously naked all along and people have been imprisoned and tortured over saying so.