Protocol Efficacy of patient education and duloxetine, alone and in combination, for patients with multisystem functional somatic disorder:... 2024 Jespersen+

Full title: Efficacy of patient education and duloxetine, alone and in combination, for patients with multisystem functional somatic disorder: Study protocol for the EDULOX trial

Fink is also an author.

Abstract

Background
Multisystem functional somatic disorder is characterized by specific patterns of persistent physical symptoms with a complex biopsychosocial etiology. The disorder can lead to disability and personal suffering. Current treatment options require specialized settings, therefore patients often wait a long time to receive specific treatment.

Patient education is considered important in most treatment programs, but has only been investigated sparsely as a stand-alone treatment. Pharmacological treatment is limited to tricyclic antidepressants in low doses with no antidepressant properties. Duloxetine has been found effective in single organ functional disorders. As a treatment for multisystem functional somatic disorder, duloxetine could reduce symptoms and treat comorbid anxiety and depression. It may furthermore enhance the effect of patient education through a hypothesized effect on cognitive functioning. The purpose of the EDULOX trial is to study psycho-EDUcation and duLOXetine alone and in combination.

Methods
This is a nested study design. The parent trial “EDULOX1” (n = 424) will compare a patient education program with enhanced usual care in an open-labelled, randomized controlled trial. In addition to this, eligible participants will furthermore receive either duloxetine or active placebo in the nested, double-blinded, randomized controlled trial, “EDULOX2” (n = 212). Patient and clinician reported outcomes will be collected through questionnaires.

Conclusion
The EDULOX trial may establish evidence for treatments applicable for the majority of patients with multisystem functional somatic disorder. If effective, duloxetine would be a more tolerable pharmacological treatment option that can target comorbid depression and anxiety, and potentially boost the effect of patient education.

Open access, https://www.sciencedirect.com/science/article/pii/S1551714424001071

 

"Functional somatic disorders (FSD) are characterized by specific patterns of persistent physical symptoms with a complex etiology involving a multiform interplay between physiological, psychological, and sociocultural factors [1,2]. Patients with FSD are prevalent in all medical settings and may receive diagnoses such as fibromyalgia, chronic fatigue syndrome, irritable bowel syndrome, and other functional somatic syndromes (FSS) depending on which medical specialty they consult"

 

This looks eerily like the 1960s/70s. If women complained too much, they were prescribed tranquillisers.

I was given them for ME, my mother was given them because she had ulcers throughout her stomach, and a neighbour a few doors down was given them (without examination) for cervical cancer. That's just the ones I knew about, who knows how many more there were.

What makes me angry is that things like this could start happening again, every bit as frequently as they used to. The underlying reasons might be different, but the risk to patients is the same.

 

It's repetition ad nauseum.

No need to repeat. The evidence base for efficacy of duloxetine in FMS is modest but can help a bit for some (pain and mood). It's not a cure - takes the edge off pain at best. Many patients don't tolerate it well. Patients put on weight often too.

As for CFS antidepressants of various varieties have been trialed over the years to null effect. Unlikely to start miraculously working now

The underlying belief that so called lump everything together as "Multisystem functional somatic disorder" is unsatisfactory on multiple levels for many reasons covered here in depth previously.

It strikes me as grasping at straws to desperately try and rename things we don't understand as if no one will notice: consciously or unconsciously using the cognitive bias of substitution. Humans will often not notice if someone confidently (halo effect) answers another question to the one posed, especially if the question being posed (please doc can you tell me what's wrong with me?) causes discomfort, alarm, upset and cognitive dissonance in the person expected to respond (confidently and competently).

Most handy heuristic to allow for a simple response to troubling challenge to professional competency, it must be a "complex biopsychosocial etiology." Which we know means all things to all people (apart from this crew who know that they think it is all in the head but just haven't the metal to fess up). The duplicity here is glaring and obvious to some but it is accepted by many (patients and clinicians) with cognitive ease.

Easier apparently than a discomforting honest response: "We/I simply do not know...." In reality much less stressful this honesty lark For everyone. The lack of honesty and duplicity really is a professional dead end. Fragile and sad.

 

Duloxetine has some very nasty side effects. It seems to be one of those drugs developed for one thing, found to be largely toxic and useless and then tried out in other situations, where it is found to be largely toxic and useless.

Sort of scraping the barrel until it leaks and the wine drips out.

 

Sounds like false repurposing the FDA-approved for FM drug duloxetine.

According to Daniel Clauw, MD, an expert in FM research, these FDA-approved FM drugs: duloxetine, pregabalin, and milnacipran (solo or in some combination) are for the most part ineffective and/or have overwhelming side effects.

According to him, the drugs are taken chronically by 12-13% of patients who initially try them.

 

In relation to Duloxetine, this might be of interest :

https://www.patientslikeme.com/treatment/duloxetine

I was prescribed this once then found out that it had one of the worst records of all SSRIs as far as Antidepressant discontinuation syndrome was concerned. I only took one tablet before deciding I didn't want to risk it.

It turned out that my depression/anxiety was caused by severely deficient iron, I wasn't suffering from a mental illness.

 

This endless loop of identical useless trials doesn't even pass the plausibility test. It's not even plausible that this should work, it has no possible value and will not inform anything, but they get away with it because 'pragmatic', while claiming to target etiology, for which they have no basis. Biopsychosocial is completely generic, literally any illness fits the model and this is why it's always "not otherwise explained by another diagnosis".

 

Symptom (to doctor and society) simplified as ‘moaning’?
Treatment = what ‘deals with’ making them go away?