Cognitive behavioural therapy for irritable bowel syndrome: 24-month follow-up of participants in the ACTIB randomised trial, 2019, Everitt et al

Andy

Andy

Retired committee member
Authors also include McCrone, Chalder and Moss-Morris.
Background
Irritable bowel syndrome (IBS) is common, affecting 10–20% of the adult population worldwide, with many people reporting ongoing symptoms despite first-line therapies. Cognitive behavioural therapy (CBT) is recommended in guidelines for refractory IBS but there is insufficient access to CBT for IBS and uncertainty about whether benefits last in the longer term. Assessing Cognitive behavioural Therapy for IBS (ACTIB) was a large, randomised, controlled trial of two forms of CBT for patients with refractory IBS. ACTIB results showed that, at 12 months, both forms of CBT for IBS were significantly more effective than treatment as usual at reducing IBS symptom severity in adults with refractory IBS. This follow-up study aimed to evaluate 24-month clinical outcomes of participants in the ACTIB trial.
Methods
In the ACTIB three-group, randomised, controlled trial, 558 adults with refractory IBS were randomly allocated to receive either therapist-delivered telephone CBT (telephone-CBT group), web-based CBT with minimal therapist support (web-CBT group), or treatment as usual (TAU group) and were followed up for 12 months. Participants were adults with refractory IBS (clinically significant symptoms for ≥12 months despite being offered first-line therapies), recruited by letter and opportunistically from 74 general practices and three gastroenterology centres in London and the south of England (UK) between May 1, 2014, and March 31, 2016. Primary outcome measures were IBS Symptom Severity Score (IBS-SSS) and Work and Social Adjustment Scale (WSAS), assessed in the intention-to-treat (ITT) population with multiple imputation. This study was a non-prespecified naturalistic follow-up and analysis of the participants of the ACTIB trial at 24 months assessing the same outcomes as the original trial. Outcome measures were completed online by participants or a paper questionnaire was posted, or telephone follow-up undertaken. The ACTIB trial is registered with the International Standard Randomised Controlled Trial Number registry, number ISRCTN44427879.
Findings
24-month follow-up of outcomes was achieved for 323 (58%) of 558 participants: 119 (64%) of 186 in the telephone-CBT group, 99 (54%) of 185 in the web-CBT group, and 105 (56%) of 187 in the TAU group. At 24 months, mean IBS-SSS was 40·5 points (95% CI 15·0 to 66·0; p=0·002) lower in the telephone-CBT group and 12·9 points (−12·9 to 38·8; p=0·33) lower in the web-CBT group than in the TAU group. The mean WSAS score was 3·1 points (1·3 to 4·9; p<0·001) lower in the telephone-CBT group and 1·9 points (0·1 to 3·7; p=0·036) lower in the web-CBT group than in the TAU group. A clinically significant IBS-SSS change (≥50 points) from baseline to 24 months was found in 84 (71%) of 119 participants in the telephone-CBT group, in 62 (63%) of 99 in the web-CBT group, and in 48 (46%) of 105 in the TAU group. In total 41 adverse events were reported between 12 to 24 months: 11 in the telephone-CBT group, 15 in the web-CBT group, and 15 in the TAU group. Of these, eight were reported as gastrointestinal related, five as psychological, and six as musculoskeletal. There were no adverse events related to treatment.
Interpretation
At 24-month follow-up, sustained improvements in IBS were seen in both CBT groups compared with TAU, although some previous gains were reduced compared with the 12-month outcomes. IBS-specific CBT has the potential to provide long-term improvement in IBS, achievable within a usual clinical setting. Increasing access to CBT for IBS could achieve long-term patient benefit.
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Open access, https://www.thelancet.com/journals/langas/article/PIIS2468-1253(19)30243-2/fulltext
 
I think the biggest issue is that the control (Treatment as Usual) isn't good enough. Treatment as Usual could easily have been 'very little care'. In contrast, the 'CBT' treatments weren't just the hand-wavy brain-gut axis and addressing unhelpful thoughts. There was solid stuff like working on good diet. The regular followup probably helped people stay motivated about taking medication and fibre products.

The core CBT content of the two treatment groups was similar, based on an empirical cognitive behavioural model of IBS
and versions of this model tested in previous smaller RCTs. It consisted of education around the brain–gut axis, behavioural techniques to improve bowel habits, developing stable healthy eating and exercise patterns, addressing unhelpful thoughts, managing stress and emotions, focusing on reducing symptoms, and preventing relapse.

Participants randomised to the telephone-CBT group received a detailed self-management CBT manual including homework tasks and recording sheets and were offered six 1-h telephone sessions with a CBT therapist at week 1, 2, 3, 5, 7, and 9. They also received two 1-h booster sessions at 4 months and 8 months (a total of 8 h of therapist support).
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So, there may well be some limited benefit in having a coach who helps you follow what good advice there may be for managing IBS. But does it need to have the magic of CBT added? We still don't know. Is it better than having IBS patients attend support groups or participate in online forums?

The other issues I've seen so far are
  • the very high loss to follow-up,
  • and, related to that, a lot of imputation of missing data being done. Having seen the mess Crawley et al created with imputation in one of their papers, I think it would be worth poking into that.
  • subjective outcomes
 
Just by the way:
Only ten (5%) of 187 participants from the TAU group accessed Regul8 despite all TAU participants being sent an access link at 12 months.
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So, in the year after the trial was over, only 10 out of 187 participants in the Treatment as Usual group felt that it was worth even accessing the online CBT course. And that's just accessing it, having a look at it, not completing it.

You'd think if this was something fairly effective, word would have got around and the controls would have been lining up for the treatment.
 
Again subjective outcomes in an open label trial, without any adequate control.

No wonder this larger group of researchers are so defensive of such as PACE and of this methodology for evaluating CBT. So much research and so many reputations rely on it.

What happened to a general acceptance forty years ago that if you have methodological problems in particular research approaches, often an issue in clinical research, the best way forward is to seek confirming evidence from different and varied experimental designs and sources, not double down on the one problematic approach?
 
Hutan said:
there may well be some limited benefit in having a coach who helps you follow what good advice there may be for managing IBS. But does it need to have the magic of CBT added? We still don't know. Is it better than having IBS patients attend support groups or participate in online forums?

The other issues I've seen so far are
  • the very high loss to follow-up,
  • and, related to that, a lot of imputation of missing data being done. Having seen the mess Crawley et al created with imputation in one of their papers, I think it would be worth poking into that.
  • subjective outcomes
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This is one of the issues I have with FND. They treat it with physio and CBT to persuade patients that there is no actual disease.

A Doctors Perspective: FND Treatment Options
Written by Professor Mark Edwards
In illness in general there are not many different treatment options. There are medical treatments (drugs), surgical treatments, physical treatments (physiotherapy, occupational therapy, rehabilitation) and cognitive/psychological treatments (e.g. cognitive behavioural therapy (CBT), psychotherapy). There are in addition complementary medical treatments such as acupuncture, therapeutic massage, hypnosis, homeopathy.
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There seems no reason to think that the psychological treatments add anything. Personally I would not class therapeutic massage as a complementary treatment. They treat frozen shoulder by manipulation under anaesthetic and I found that massage helped my body remember where it should be by moving it in ways I could not manage myself.
 
24-month follow-up of outcomes was achieved for 323 (58%) of 558 participants
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Don't even need to read further than this. Dropout rates of this order make the results impossible to interpret.

developing stable healthy eating
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Ah, there it is. Obviously. But it would be too complex to properly account for difference in eating habits. How many participants who improved had a horrible diet to begin with? There are far too many factors involved to ascribe any benefits to therapy itself when it includes modifying eating habits, which are obviously a primary aspect of reducing, though not treating, IBS. A control arm with nutritional advice (and possibly some financial support to sustain since eating healthy is more expensive) would have been necessary, without one nothing can be concluded.

Typical garbage from the usual CBT brigade.
 
Hutan said:
Just by the way:


So, in the year after the trial was over, only 10 out of 187 participants in the Treatment as Usual group felt that it was worth even accessing the online CBT course. And that's just accessing it, having a look at it, not completing it.

You'd think if this was something fairly effective, word would have got around and the controls would have been lining up for the treatment.
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"The bastards don't want to get better"

Or something like this.

Why don't people like our treatments? Clearly they are wrong because we are obviously right.
 
CBT, TM, and yoga never helped my IBS. I will say again...probiotics help my IBS. We have seen a number of studies that show disordered gut bacteria appears to play a significant role in IBS. The following are just 2 such studies:


"Gut dysbiosis and irritable bowel syndrome: The potential role of probiotics."

RESULTS:
IBS is a common disease for which no resolutive therapy is presently available. In recent years, strong evidence of a possible relationship between modifications of the gut microbiota composition and development of IBS has been collected. Moreover, the evidence showed that attempts to treat acute infectious and post-antibiotic gastroenteritis with some probiotics were significantly effective in a great number of patients, leading many experts to suggest the use of probiotics to address all of the clinical problems associated with IBS.

CONCLUSION:
The available data are promising, but presently, a precise definition of which probiotic or which mixture of probiotics is effective cannot be made. Moreover, the dose and duration of treatment has not been established. Finally, we do not know whether probiotic treatment should be different according to the type of IBS. Further studies are needed before probiotics can be considered a reliable treatment for IBS.

https://www.ncbi.nlm.nih.gov/pubmed/29291933



"The gut microbiome and irritable bowel syndrome

Abstract
Irritable bowel syndrome (IBS) is one of the most common functional gastrointestinal disorders encountered in clinical practice. It is a heterogeneous disorder with a multifactorial pathogenesis. Recent studies have demonstrated that an imbalance in gut bacterial communities, or “dysbiosis”, may be a contributor to the pathophysiology of IBS. There is evidence to suggest that gut dysbiosis may lead to activation of the gut immune system with downstream effects on a variety of other factors of potential relevance to the pathophysiology of IBS. This review will highlight the data addressing the emerging role of the gut microbiome in the pathogenesis of IBS and review the evidence for current and future microbiome based treatments"

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6039952/
 
And avoiding FODMAPs. Several years ago I saw a piece at Medscape titled "Why telling your IBS patients to just eat more fiber may be bad advice." I immediately clicked because I had long since noticed that certain foods that were high fiber, i.e. apples, were painful to eat. Finally someone had figured it out--at least in my case. Avoiding FODMAPs eliminated most of my IBS symptoms, combined with a couple of probiotics (added years later when I began having increased loose-stools). My gastroenterologist has been using it with many of her patients for years now. See oldish paper explaining it here.

One of the big problems with IBS is that it may well be multiple diseases/conditions that are being lumped together (thanks, in part, to people like Chalder et. al.). There is a clear subgroup that responds well to a lower-FODMAP diet but not all IBS patients do. At the end of the day, we define this disorder based on symptoms, not any biomarker. How do we know those symptoms are all describing the same condition? Given the prevalence of the condition -- 10-20% of the general population -- I find it hard to believe it would be the same thing in all of those people.

The kicker, in my case, is a couple of weeks ago I woke up constipated for the first time in years. After a few days of it not resolving and increasing my FODMAP intake, I finally went and picked an apple from one of the columnar apple trees I have on my balcony (bought around the time I was just learning about FODMAPs). Have been eating apples now just about every day since. Gonna try some milk this week. Go figure. My best crazy speculation at what might be happening is something hormonal as I've probably been in peri-menopause for about a year now. A friend of mine noted that she was suddenly able to eat things she'd not been able to eat for years after menopause. But note, it's just that: crazy speculation. The reality is, who the hell knows why?
 
24-month follow-up of outcomes was achieved for 323 (58%) of 558 participants
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This is disastrous and completely disqualifies the trial of any conclusions. When nearly half of participants are so disappointed in what they saw that they don't bother responding, that's a sign that you screwed up.

It's seriously remarkable that you can find in the same paragraph that CBT is a recommended treatment but that there is no evidence for its efficacy. This is not even close to be OK, yet so typical of BPS, selling the treatment for years before putting it to the test and then simply using the fact that it had been used for years as a good enough reason to continue despite evidence showing it is useless.

The whole edifice of EBM needs to be torn down, it is so heavily abused it puts the entire field of medicine at risk. Well, actually it's the patients that are put at risk but then if you never ask the question you can claim otherwise, typical BPS BS.

Edit: apparently I repeat myself. Whatever.
 
Not directly related to ACTIB, but should be filed under the same "heads we win, tails we win, we win" in the "eating our cake and having it too" cabinet.

You see, the horrible pandemic lockdown of FEAR FEAR FEAR is what causes Long Covid, but also the peace and quiet of not having to deal with stress outside the house means it's basically like a vacation that solves many "mental health" problems. Or both. Or whatever. It's not as if people eat differently at home or anything like that. Also that FEAR FEAR FEAR was going to cause an epidemic of suicides, or so the leading experts on the topic said, many have talked of a pandemic of mental health crisis. But it also did the opposite. Science is basically whatever you want it to be, I guess.


IBS patients' symptoms improved under COVID-19 lockdown orders
https://www.eurekalert.org/pub_releases/2021-05/ddw-ips051821.php

Bethesda, MD (May 23, 2021) -- Patients' irritable bowel syndrome (IBS) symptoms unexpectedly improved when they were under COVID-19 stay-at-home orders, reaffirming the gut-brain connection in functional gastrointestinal disorders, according to research that was selected for presentation at Digestive Disease Week® (DDW) 2021.

"One of our main hypotheses was that these patients were going to be worse because of pressure and stress due to COVID-19," said Juan Pablo Stefanolo, MD, a lead author on the study and a physician with the Neurogastroenterology and Motility section, Hospital de Clínicas José de San Martín, Buenos Aires University, Argentina. "We think the results have something to do with people staying at home. They were not exposed to outside stress, and at home they were able to avoid food triggers."

Pandemic lockdown orders in Argentina created a unique opportunity for researchers to study the impact of pandemic stressors and reduced social interaction on 129 IBS patients whose pre-pandemic data had already been collected through an earlier research project. The patients were re-assessed during the lockdown with the same online survey that included multiple validated measures of IBS severity, anxiety and depression, along with questions about co-occurring illnesses, including heartburn, regurgitation, indigestion, chronic fatigue, fibromyalgia and nonmigraine headaches.

During the lockdown in Argentina -- one of the longest lockdowns in the world -- the number of patients experiencing severe IBS fell sharply from 65 to 39. The mean Irritable Bowel Syndrome Severity Scale score for the group also fell 66 points, from 278 to 212 on a 500-point scale. IBS symptoms of pain, distention, stool consistency, anxiety, somatization, fibromyalgia and chronic fatigue symptoms all improved during the lockdown.​

A whole 11% uh? On a very imprecise scale, of course. That is veeeery impressive.

Not a small organization either: "Digestive Disease Week® (DDW) is the largest international gathering of physicians, researchers and academics in the fields of gastroenterology, hepatology, endoscopy and gastrointestinal surgery".
 
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