Body reprogramming for fibromyalgia and central sensitivity syndrome: A preliminary evaluation, 2023, Lanario et al

[Andy]

Abstract

Objectives:
Central sensitivity syndrome disorders such as fibromyalgia, provoke continued debate, highlighting diagnostic and therapeutic uncertainty. The Hyland model provides a way of understanding and treating the medically unexplained symptoms of central sensitivity syndromes using complexity theory and principles of adaption in network systems. The body reprogramming is a multi-modal intervention based on the Hyland model designed for patients living with medically unexplained symptoms. This preliminary, naturalistic and single-arm service evaluation set out to evaluate outcome after attending a body reprogramming course in patients living with fibromyalgia or central sensitivity syndrome.

Methods:
Patients diagnosed with fibromyalgia or central sensitivity syndrome were recruited. The body reprogramming courses consisting of eight sessions, each 2.5 h in length, were run at two study sites in England. Data were collected at baseline, post course and 3-months post course using questionnaires assessing symptomatology (FIQR/SIQR), Depression (PHQ9), Anxiety (GAD7) and quality of life (GQoL). Repeated measures t-tests were used, and all comparisons were conducted on an intention to treat basis.

Results:
In total, 198 patients with a mean age of 47.73 years were enrolled on the body reprogramming courses. Statistically and clinically significant improvement were observed in the FIQR from baseline to post course (mean change: 11.28) and baseline to follow-up (mean change: 15.09). PHQ9 scores also improved significantly from baseline to post course (mean reduction 3.72) and baseline to follow-up (mean reduction 5.59).

Conclusions:
Our study provides first evidence that the body reprogramming intervention is an effective approach for patients living with fibromyalgia or central sensitivity syndromes on a variety of clinical measures. Besides these promising results, important limitations of the study are discussed, and larger randomized controlled trials are clearly warranted.

Open access, https://journals.sagepub.com/doi/10.1177/20503121231207207

 

[Andy]

Conditions presenting with pain as a dominant symptom continue to pose a diagnostic and therapeutic challenge. Diagnostic nomenclature appears confusing, with overlapping clinical usage of terms including central sensitivity syndromes (CSSs),1 functional disorders, chronic primary pain, body distress syndrome, unexplained symptoms, somatic symptom disorder2 in addition to the more established diagnosis of fibromyalgia.

Fibromyalgia is a potentially debilitating condition with a prevalence of 2%–5% depending on the criteria used,5 resulting in a significant economic, emotional and clinical burden.6,7 Both patient and healthcare provider often find it difficult to describe, understand and subsequently manage fibromyalgia.8,9 Widespread pain is accompanied by multiple other symptoms including but not limited to post-exertional malaise, non-refreshing sleep pattern, perceptual sensitivities, temperature dysregulation and cognitive issues.10

Ref 10 is to this study, Evaluating soreness symptoms of fibromyalgia: Establishment and validation of the Revised Fibromyalgia Impact Questionnaire with Integration of Soreness Assessment, https://pubmed.ncbi.nlm.nih.gov/31711726/, which makes no mention of post-exertional malaise.

There has been growing recognition that medical conditions including fibromyalgia, chronic fatigue syndrome/myalgic encephalomyelitis, irritable bowel syndrome, interstitial cystitis and others, share comorbid symptoms despite having a different primary body location focus.11 The term ‘central sensitivity syndrome’ has evolved as an umbrella label for these conditions, where ‘pain’ is a dominant symptom, and ‘central sensitisation’ considered a core mechanism.12

Ref 11 is to Symptom frequency & development of a generic functional disorder symptom scale suitable for use in studies of patients w/IBS, FM and CFS, 2019, Hyland, ref 12 is to a paper from 2007 titled Fibromyalgia and overlapping disorders: the unifying concept of central sensitivity syndromes, https://pubmed.ncbi.nlm.nih.gov/17350675/, where the abstract actually says "Methods: A critical overview of the literature and incorporation of the author's own views."!

 

[Andy]

Conceptualisation models based on complexity theory have more recently been suggested for understanding CSSs such as fibromyalgia.31 One such model is the Hyland model, which is based on the principle of a comprehensive complex adaptive framework within a network system. The model argues that symptom-causing mechanisms are causally connected, forming a network that has emergent properties.32

The Hyland model introduces the theoretical constructs of ‘stop signals’ and ‘stop programs’ within the framework of this integrated mechanism.31 Stop signals are considered as adaptive symptom clusters, triggered by either biological or psychological events, designed to change and typically inhibit behaviour. Sometimes people fail to modify behaviour and respond to the stop signals due to ongoing physical, cognitive or emotional stressors. Over time, failure to respond to stop signals causes adaption within the network and a gradual potentiation of the stop signals so the symptoms ‘shout louder’ becoming eventually fixed in a heightened state of a ‘stop program’ which drive the symptoms described by patients with CSS. A layered, metaphorical narrative has been constructed from this adaptive network theory incorporating the analogy of a sophisticated computer.33

The body reprogramming (BR) therapeutic approach for fibromyalgia is designed primarily from the Hyland model.33 It is multi-faceted, developed in partnership with patients and consistent with non-pharmacological evidence-based guidelines.34 There are parallels to the recovery model with the focus on greater patient understanding of the condition and facilitating patients to take control of their own recovery rather than awaiting ‘hardware medical fixes’.
The aim of this preliminary, naturalistic, and single-arm service evaluation was to assess the impact of the BR approach for patients with fibromyalgia and CSS. To do this we conducted within-group comparisons on patient-reported outcomes (PROs) collected at pre and post course. We also investigated if any benefits from the course persisted by collecting the same PROs at 3-month post course.

 

[Andy]

I wonder what NICE guideline they would claim to be following with this.

Design
Data were collected as part of a clinic service evaluation into the impact of introducing a BR group course for patients with fibromyalgia and CSSs.

Participants
Patients aged ⩾18 years with fibromyalgia or CSS diagnosed by their primary care medical practitioner or hospital specialist who were enrolled on group community-based BR courses run by the Plymouth Pain Management Service or Cornwall Partnership NHS Foundation Trust.

Patients were ineligible to participate in a BR group if they had other medical conditions requiring active specialist input, such as autoimmune disorders, major psychiatric illness or substance abuse disorder. Further exclusion criteria included having insufficient English to benefit from a group intervention, non-acceptance of their CSS diagnosis or unwilling to take part in a group-based therapeutic intervention.

 

[Creekside]

The objective looks like word soup to me. Single arm studies seem to be essentially useless without quantitative measurements.

 

[Hutan]

Single arm studies seem to be essentially useless without quantitative measurements.

This. No controls mean the results mean nothing much. Also, the usual problem of people who are skeptical of something called 'body reprogramming' won't go near this course, so you have a group of people who are mostly open to the idea of being fixed by thinking differently and expect some improvement.

Listing the authors and affiliations - mostly a Devon/Cornwall association

Joseph Lanario - Faculty of Health, University of Plymouth
Esther Hudson - Cornwall Partnership NHS Foundation Trust, Redruth, Cornwall
Cosima Locher - Faculty of Health, University of Plymouth; University Hospital Zurich
Annily Dee - University Hospitals Plymouth NHS Trust, Plymouth
Kerry Elliot - Royal Cornwall Hospital NHS Trust, Truro, Cornwall

I haven't looked at the paper yet - it will be interesting to see the number of dropouts in the followup

 

[Trish]

I had a quick look at the patients' guide to Body Reprogramming.
http://www.bodyreprogramming.org/guide/PatientGuide.pdf

The theoretical idea seems to be that people who are perfectionists don't listen to their bodies when the are sick, and push through the body's 'stop' signals like pain and fatigue, so the body adapts by ramping up the stop signals to get us to take notice. Then when people have recovered from the infection or whatever, the signals are still ramped up, so we go on experiencing these increased pain and fatigue as 'stop' signals when we are actually well.

The treatment is a mish mash of breaking up activities with other activities, adding relaxation and mindfulness, regular exercise, sleep hygiene, healthy eating, doing things we enjoy and happy thoughts.

The inventor of the treatment is a professor who claims he cured himself from ME/CFS presumably with these treatments.

 

[Hoopoe]

Or perhaps he improved, then adopted habits that corresponded better to his new state of health, and then conflated cause and effect and proclaimed the new habits caused the recovery.

 

[Hutan]

Just noting the ongoing disappearance of ME/CFS. Now it seems that you can have fibromyalgia with PEM, presumably meaning that the NICE Guideline for ME/CFS can be ignored.

Treatment strategies should be ideally modelled on a conceptual and evidence-based understanding of the condition. Unfortunately, in fibromyalgia there is no universally agreed conceptual model to guide therapeutic direction.

Just making up a conceptual model isn't the answer to this problem though.

Psychological interventions such as cognitive behavioural therapy (CBT) are sometimes utilised, but effect size is modest and there can be recipient frustration with their recommendation.29,30

Time to move on from CBT it seems and offer essentially the same sort of treatment with a different name. Old wine, new bottles.

courses run by the Plymouth Pain Management Service or Cornwall Partnership NHS Foundation Trust.

This clinical service evaluation was undertaken at the two service sites between November 2017 and January 2020.

A clinical service evaluation. So people whose reputations and income depend on finding a good result found a good result.

Because it was a clinical service evaluation, participants did not have to give their informed consent. And yet, the authors write: "Our study provides first evidence that the body reprogramming intervention is an effective approach" - so they were trialling an unevidenced therapy on participants. The word 'harm' does not appear in the paper. So, it seems that there was no acceptance of the possibility of this unevidenced therapy causing harm, and no monitoring of harm.

 

[Andy]

We've a number of threads about Hyland and his nonsense already including

A test of the adaptive network explanation of functional disorders using a machine learning analysis of symptoms, 2018, Melidis, Hyland et al
The extra‐pulmonary symptoms of severe asthma and the polysymptomatic presentation of fibromyalgia, 2019, Hyland et al
"Body Reprogramming: Patient guide for recovery using the Hyland model"

 

[Hutan]

Twelve patients only attended one to two sessions (6%), 18 attended three to four sessions (9%), and 35 attended five to six sessions (18%). One hundred twenty-eight patients (65%) enrolled on the course attended seven sessions or more. Despite being enrolled on the course, five patients (3%) did not attend any sessions or contribute any PROM data.

Dropouts
Of the 189 patients who were enrolled in the course (having accepted the CSS diagnosis), 135 filled out the end of course questionnaires and 81 (43%) of them filled out the questionnaires 3 months after the course. That's surely an enormous winnowing out of the non-believers and people who found that they were getting worse.

And, even with that, the reported average improvement in the primary outcome is very much in the 'relatively minor improvement' category that is characteristic of ineffective treatments relying on placebo effects in subjective outcomes (e.g. expectation effect, natural fluctuation in illness, being polite to the therapist).

 

[Hutan]

I just want to emphasise the point about this being assessed as not actually being a study requiring consent from patients.

The BR therapeutic group-based course is based on a novel conceptual model for CSSs. This evaluation of its therapeutic introduction within two clinical settings offers preliminary evidence of clinical benefit in symptom interference, anxiety, depression, and overall QoL for patients with CSSs including fibromyalgia.

This is a proof-of-concept study to explore initial validation for the approach and to inform its continued development. It is a naturalistic study

The authors claim they are trying something novel and unevidenced. They can't have things both ways. If it is novel, then participants should be asked to give consent; it should be explained that there is no evidence for the therapy they are being given. And there should be careful monitoring of harms, including beyond the 3 months, and with a substantial effort to follow up with the people who dropped out.

This isn't science and it isn't ethical. I think a complaint should be made to the ethical board that approved this study.

 

[Hutan]

Comparing this study to others is difficult as not all use the FIQR/SIQR. A systematic review and meta-analysis of mindfulness-based stress reduction for fibromyalgia reports data from six studies meeting their eligibility criteria, three of which include FIQR data.46 An 8-week course of mindfulness-based mediation plus Qigong reported a significant reduction of 11.4 in the FIQR at 24 weeks follow-up.47 One study of stress reduction – cognitive behavioural treatment (SR-CBT) delivered over 10 weeks did not find a significant improvement in FIQR scores, and the third used mindfulness-based stress reduction but did not report change in FIQR scores post intervention. A more recent study of tai chi for fibromyalgia reported a significant reduction of 14.7 in the FIQR after 12-weeks of once weekly tai chi and 25.4 points after 24 weeks of 2-times weekly tai chi.48 These improvements are comparable to the reduction in the FIQRE/SIQR of 15.09 observed in this present study at 3-month follow-up.

It looks like any sort of therapy can be shown to produce a similar sort of benefit.
Even 'mindfulness-based mediation' . Is that where the participant and their body have a good chat with each other in order to resolve differences?

Two linked national surveys profiling UK healthcare services for those with fibromyalgia (PACFiND study) recently highlighted the need for innovative therapeutic models within primary and community care.49 A systematic review in 2020 failed to identify any evidence-based care models that traversed the entire healthcare system.50 The development of a robust conceptual model successfully operationalized within the environment of a ‘troublesome label’, heterogenous symptom profile and difficult patient–provider relationship, is perhaps the ‘holy grail’ of this difficult clinical arena.51,52 The translational methodology incorporating the initial ‘Hyland’ conceptual model and subsequent BR intervention, offers a potential vehicle, both for framing the explanatory narrative and providing a coherent, integrated, therapeutic approach for CSSs such as fibromyalgia.

Sorry for copying so many paragraphs, but I find the naivety displayed here amazing. Patients are upset because there is no effective care and no real understanding of what is causing their symptoms. And these people think that making up a story, a story that actually is far from new and is basically, 'you are over-sensitive, you need to get over yourself', with a few flourishes to, in their mind, make it sound all up to date and complicated ('a sophisticated computer' ) is going to fix the problem.

Derision is the easiest response to this paper. But, the authors of this paper with their weak unevidenced and harmful ideas are being let loose on people with debilitating symptoms. It's bloody awful and has to stop. Perhaps these authors have trouble hearing stop signals?

 

[SNT Gatchaman]

There has been growing recognition that medical conditions including fibromyalgia, chronic fatigue syndrome/myalgic encephalomyelitis, irritable bowel syndrome, interstitial cystitis and others, share comorbid symptoms despite having a different primary body location focus.11 The term ‘central sensitivity syndrome’ has evolved as an umbrella label for these conditions, where ‘pain’ is a dominant symptom, and ‘central sensitisation’ considered a core mechanism.

Ref 11 is Symptom frequency and development of a generic functional disorder symptom scale suitable for use in studies of patients with irritable bowel syndrome, fibromyalgia syndrome or chronic fatigue syndrome (2019, Chronic Diseases and Translational Medicine) which doesn't mention interstitial cystitis or the bladder, so does not support that statement.

 

[Sean]

Further exclusion criteria included... non-acceptance of their CSS diagnosis or unwilling to take part in a group-based therapeutic intervention.

They are not even pretending anymore, are they.

How much more blatant does this corruption of methodology and ethics have to get before the rest of medicine steps in and kicks them out of the game?

Academic freedom does not extend to this toxic garbage.

 

[oldtimer]

I couldn't make sense of the paper so I googled and found this video on a website that seems to come from Plymouth University.

It is the second of the two videos about the Hyland body reprogramming method called The Clinician's Perspective. (The first is by Hyland himself.) I found it so bizarre I think it would fit better on The Funny Side of Life thread
http://www.bodyreprogramming.org/videos.aspx
It took at least 10 minutes to buffer for me.