Trial By Error: CBT and Irritable Bowel Syndrome

I am slowly getting back to my efforts to highlight Mahana Therapeutics’ continuing misrepresentation of its new web-based cognitive behavior therapy program for irritable bowel syndrome. In January, the start-up company that it had licensed the program from King’s College London, based on a high-profile study published last year in Gut, a BMJ journal.

The deal seems to represent the triumph of hype over facts. Even a cursory reading of the study results should have noticed that the web-based program did not produce clinically significant benefits over standard treatment in reducing symptom severity at 12 months. I had temporarily put aside my pursuit of this issue, for understandable reasons. But I have taken it up again. Earlier today, I sent the following letter to Hazel Everitt, the corresponding author of the Gut study, who is a GP and a professor of primary care research at the University of Southamptom, England.
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https://www.virology.ws/2020/05/05/trial-by-error-my-letter-to-ibs-studys-corresponding-author/
 
Blog on Medium

The Benefits of Prescription Digital Therapeutics for Gastrointestinal Conditions
..people living with chronic gastrointestinal (GI) conditions, who historically haven’t had success using medications, may deeply benefit from a PDT.

That’s why I joined Mahana Therapeutics, a digital healthcare startup in San Francisco and London launched by patients for patients. I value its mission to support people living with chronic health conditions and find great purpose in contributing to products that have the potential to impact their lives in meaningful ways.

We’ve made a commitment to developing evidence-based Cognitive Behavioral Therapy (CBT) PDTs for people with Irritable Bowel Syndrome (IBS) and Inflammatory Bowel Disease (IBD) and are well on the way to delivering on our promise.
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Our initial focus is to design CBT-based programs to treat IBS and IBD. Mahana’s clinical innovation team, led by Megan Oser, Ph.D., researches, develops, and designs CBT interventions and clinical trials for GI conditions. This is no easy feat, which is why Mahana has called upon Alice Sibelli, Ph.D., who was instrumental in helping to develop the original Parallel™ program (formerly known as Regul8) for IBS in the United Kingdom
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Mahana’s advisors, including Rona Moss-Morris, Ph.D.; Emeran Mayer M.D.; Carlo di Lorenzo M.D.; Miranda van Tilburg, Ph.D.; Tonya Palermo, Ph.D.; Lee Ritterband Ph.D.; and Rona Levy, Ph.D.; among others, are leaders in gastroenterology and psychology. They’ve become an insightful sounding board for some of Mahana’s most important decisions along the way and bring a great depth of knowledge to our team.
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Together, we’ve made major strides in a short amount of time. This includes the development of Parallel™, Mahana’s first product, based on an 8-week, clinically-validated, minimal-contact digital program for people with IBS.
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Code: 
https://medium.com/mahana-therapeutics/the-benefits-of-prescription-digital-therapeutics-for-gastrointestinal-conditions-86304debb883


Parallel:
Parallel™
A New Way To Address IBS

We’re developing an 8-week, clinically validated, digital program for people living with Irritable Bowel Syndrome.
https://www.mahanatx.com/treatments/parallel
 
This is Just the Beginning

PDTs [Prescription Digital Therapeutics] are the future of healthcare. They have the potential to substantially impact people’s health and well-being in a way that some medications simply can’t. They’re also poised to redefine healthcare in a more meaningful, personalized way. People living with GI conditions deserve to live happy, healthy, normal lives, and Mahana is eager to help them meet this reality.
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Now there is a threat if I've ever heard one..
 
That’s why I joined Mahana Therapeutics, a digital healthcare startup in San Francisco and London launched by patients for patients.
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'by patients for patients'
Is this yet another case of a business set up by an individual who is convinced a particular therapy helped them and are dead set on turning it into a money spinner, despite there being only very shaky evidence from one poor quality trial that it has any effect. A combination of missionary zeal and money making is a powerful incentive to brush off any scrutiny of their so called science.
 
The psychosocial woo is spreading.

Funding awarded for Mayo scientist's research on irritable bowel syndrome

https://www.con-telegraph.ie/2020/0...entists-research-on-irritable-bowel-syndrome/
The researchers at APC Microbiome Ireland SFI Research Centre and Departments of Psychiatry & Neurobehavioural Science and Anatomy & Neuroscience at University College Cork are partners in the grant ‘Development, dIagnosis and prevention of gender-related Somatic and mental COmorbiditiEs in iRrItable bowel syndrome in Europe’ (DISCOvERIE) which is valued at €6 million overall.
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IBS is a very common gastrointestinal (GI) disorder characterised by abdominal pain, excess gas and diarrhoea or constipation, predominantly seen in young and middle-aged females. The experience of illness in a significant number of patients with IBS is greatly complicated by the additional presence of psychiatric symptoms such as anxiety or depression, as well as conditions such as fibromyalgia and chronic fatigue syndrome.
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The DISCOvERIE consortium is distinguished by its innovative and disruptive approach to finding new solutions. This is particularly visible in the focus on age and sex/gender-related differences, and lifestyle factors that we believe will support a better diagnostic approach in clinical practice and facilitate the development of novel therapeutic options.

The Clarke and Cryan labs have a long-standing interest in stress-related gut-brain axis disorders and their role in this important project will be focused on understanding the common biological pathways which lead to the concurrent presence of both gastrointestinal and psychiatric symptoms in IBS.
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I am still unclear about the actual reasoning behind psychogenic intestinal gas and diarrhea. But then again I am not a Sir Regius Professor of Bonhomie so what the hell do I know.
 
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article in Life Hack
5 Reasons IBS is Psychological
While functional disorders including irritable bowel syndrome (IBS) can have serious physiological symptoms, they seem to have no biological cause. Those with IBS tend to exhibit distinct patterns of thinking, which seem to contribute to the disorder. A common explanation for IBS comes from Deary, Chalder, and Sharpe and points to a vicious circle linking symptoms to catastrophic belief to heightened anxiety which reinforce perception of symptoms and strengthens this cognitive process. Research has shown that altering thinking patterns in IBS patients can also alter the symptoms. Here are 5 psychological features of IBS and tips on reducing them.
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https://www.lifehack.org/articles/lifestyle/5-reasons-ibs-psychological.html

5. Comorbid conditions
About 50% of IBS patients also suffer from another psychiatric disorder, while those with inflammatory bowel disease are no more likely than the rest of the population to have a psychiatric disorder.
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so many things wrong with this.
but if Deary, Chalder and Sharpes say it it must be right(?) even tho they propose the same theory for just about any ailment. Although it makes a thing about the fact that IBD patients are not as likely to have a psychiatric disorder, this hasn't stopped RMM et al from now aiming their sights on IBD patients.
 
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Sly Saint said:
5 Reasons IBS is Psychological
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While functional disorders including irritable bowel syndrome (IBS) can have serious physiological symptoms, they seem to have no biological cause.
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Based on my own personal experience, I know that "IBS" can be cured. I needed surgery to deal with immense amounts of scarring and adhesions from delayed and botched surgery in my early teens. Once that was done (it only took roughly 30 years), my IBS problem was 95% cured.

Doctors see IBS as a mental health problem - but they constantly ignore the fact that the bowel has two surfaces - an inside and an outside. If there is a problem with the outside you're stuffed, possibly for life.
 
Sly Saint said:
5 Reasons IBS is Psychological
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Info on the author :
Jamie is currently at Oxford studying Experimental Psychology. With interests ranging from behavioral economics to pentathlons, she is always looking for a new perspective on things. jamierosenstein.wordpress.com linkedin.com/in/jamiehrosenstein
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With an author like that there is simply no chance that physical health problems would ever be considered as a cause of IBS. And what about people with undiagnosed IBD? It can take decades to get a diagnosis of that, all the while being dismissed as suffering from IBS. I know someone who was discovered to have severe Crohn's Disease in his early 50s. He lost a big chunk of his bowel as a result. His daughter had the same problem and had been diagnosed and treated for it since childhood. But it never seemed to occur to doctors that the man might have the same condition as his daughter.
 
Recent study: atypical food allergies and IBD.

www.gastrojournal.org/article/S0016-5085(19)34636-0

Background & Aims
Confocal laser endomicroscopy (CLE) is a technique that permits real-time detection and quantification of changes in intestinal tissues and cells, including increases in intraepithelial lymphocytes and fluid extravasation through epithelial leaks. Using CLE analysis of patients with irritable bowel syndrome (IBS), we found that more than half have responses to specific food components. Exclusion of the defined food led to long-term symptom relief. We used the results of CLE to detect reactions to food in a larger patient population and analyzed duodenal biopsy samples and fluid from patients to investigate mechanisms of these reactions.
Methods
In a prospective study, 155 patients with IBS received 4 challenges with each of 4 common food components via the endoscope, followed by CLE, at a tertiary medical center. Classical food allergies were excluded by negative results from immunoglobulin E serology analysis and skin tests for common food antigens. Duodenal biopsy samples and fluid were collected 2 weeks before and immediately after CLE and were analyzed by histology, immunohistochemistry, reverse transcription polymerase chain reaction, and immunoblots. Results from patients who had a response to food during CLE (CLE+) were compared with results from patients who did not have a reaction during CLE (CLE–) or healthy individuals (controls).
Results
Of the 108 patients who completed the study, 76 were CLE+ (70%), and 46 of these (61%) reacted to wheat. CLE+ patients had a 4-fold increase in prevalence of atopic disorders compared with controls (P = .001). Numbers of intraepithelial lymphocytes were significantly higher in duodenal biopsy samples from CLE+ vs CLE– patients or controls (P = .001). Expression of claudin-2 increased from crypt to villus tip (P < .001) and was up-regulated in CLE+ patients compared with CLE– patients or controls (P = .023). Levels of occludin were lower in duodenal biopsy samples from CLE+ patients vs controls (P = .022) and were lowest in villus tips (P < .001). Levels of messenger RNAs encoding inflammatory cytokines were unchanged in duodenal tissues after CLE challenge, but eosinophil degranulation increased, and levels of eosinophilic cationic protein were higher in duodenal fluid from CLE+ patients than controls (P = .03).
Conclusions
In a CLE analysis of patients with IBS, we found that more than 50% of patients could have nonclassical food allergy, with immediate disruption of the intestinal barrier upon exposure to food antigens. Duodenal tissues from patients with responses to food components during CLE had immediate increases in expression of claudin-2 and decreases in occludin. CLE+ patients also had increased eosinophil degranulation, indicating an atypical food allergy characterized by eosinophil activation.
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Edit: formatting
 
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Gaspard said:
Recent study: atypical food allergies and IBD.

www.gastrojournal.org/article/S0016-5085(19)34636-0/fulltext?referrer=https%3A%2F%2Fwww.mdedge.com%2Fgihepnews%2Farticle%2F203792%2Fibd-intestinal-disorders%2Fatypical-food-allergies-common-ibs
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A problem is that many learn that this just simply doesn't happen (okay, I can't speak for all but in Norway doctors learn very little about nutrition and food, and us dieticians-to-be often get the story this does not happen). As an example, if you don't have celiac then you cannot have a response to gluten. Only today there was a newspaper opinion piece in Norway with an allergist claiming a lot of food allergies are just fashionable and not real. Gah :banghead: It's one step forward then three back with these people. "It's not the protein, it's the fermentable sugar! It's proven by this study on 30 people!" (never mind the muffin they used to test if someone reacted to gluten had other stuff in it that could mess with the results, but hey...)

Then again, the supervisors for my bch thesis on impaired epithelium integrity said they got interested in the subject after reading it, "leaky gut" and other immune reactions than IgE after food intake is easier to talk about now (until one of the old-school people comes along) :thumbup:
 
It would seem the helping professions are no longer about serving the community / patients but about getting satisfaction / inspiration / colleague approval / awards to build up personal self-worth.

It's the age of the guru and they are holding professional 'love-ins.' Keep the positivity. Don't use critical thinking / analysis / or objectivity it's way too negative.
 
Snowdrop said:
It would seem the helping professions are no longer about serving the community / patients but about getting satisfaction / inspiration / colleague approval / awards to build up personal self-worth.

It's the age of the guru and they are holding professional 'love-ins.' Keep the positivity. Don't use critical thinking / analysis / or objectivity it's way too negative.
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No kidding it's become a mutual admiration society. It's actually one step beyond the ivory tower in how detached from the real world it all is. The only criticism leveled is at anyone criticizing the circle jerk of toxic positivity. It's basically going full spiritual, may as well just make The Secret the only medical textbook.
 
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