From the AGA Journals

Home-based CBT significantly improved IBS symptoms

 

Key clinical point: Primarily home-based CBT significantly reduced self-reported and gastroenterologist-assessed symptoms of IBS.

Major finding: The intervention required 60% less clinician time and was at least as effective as 10 sessions of conventional CBT, according to responses to the Clinical Global Impressions Improvement Scale. CBT also significantly outperformed the education control (P less than .05).

Study details: Two-center, single-blinded randomized trial of 436 patients with IBS per Rome III criteria.

Disclosures: The National Institutes of Health provided funding. The researchers reported having no conflicts of interest.

Source: Lackner JM et al. Gastroenterology. 2018 Apr 24. doi: 10.1053/j.gastro.2018.03.063.

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Minimal-contact CBT works well for IBS

Treating the myriad symptoms of irritable bowel syndrome (IBS) patients remains a great challenge in clinical practice. A bigger challenge is the management of IBS patients who are refractory to medical therapy, which commonly includes a combination of pain, bowel, and psychiatric medications. In this very well designed and executed study, Lackner and his colleagues randomized refractory IBS patients with moderate to severe symptoms to three therapeutic arms: standard cognitive-behavioral therapy (CBT), minimal-contact home-based CBT, and IBS education. The authors demonstrated that 4-session home-based CBT was as efficacious as 10 sessions of standard CBT and both were significantly more efficacious than IBS education in global improvement of IBS symptoms. The superior effect of both types of CBT was maintained over a period of 6 months post treatment.


There are several important conclusions from this pivotal trial. First, the study further cemented the therapeutic value of CBT in the management of IBS patients, especially for those patients who are refractory to the currently available medical therapy. Because of the size of the study and the rigorous design, it is probably the best evidence we currently have about the value of CBT in IBS. Second, minimal-contact home-based CBT is as effective as standard CBT in controlling the full range of IBS symptoms. The former may be preferred by IBS patients, who are not available or may not be compliant with repeated clinic visits for standard CBT sessions. Standard CBT is typically lengthy and expensive. The minimal-contact home-based CBT option has the benefit of being more accessible and less costly, and most importantly, it does so in a way that does not compromise the therapeutic value of symptom relief.


The exact duration of symptom control that can be achieved post CBT and the value of other psychological interventions in IBS patients remain to be elucidated.

Ronnie Fass, MD, is a professor of medicine at Case Western Reserve University, Cleveland, as well as the medical director of the Digestive Health Center and director of the division of gastroenterology and hepatology, head, esophageal and swallowing center at MetroHealth Medical Center, also in Cleveland. He has no conflicts of interest.


 

FROM GASTROENTEROLOGY

Primarily home-based cognitive-behavioral therapy improved irritable bowel syndrome symptoms at least as much as conventional CBT, cut clinician time by 60%, and significantly outperformed educational sessions in a multicenter clinical trial reported in the July issue of Gastroenterology.

Acutely, primarily home-based CBT produced a mean 61% improvement in self-reported symptoms on the IBS version of the Clinical Global Impressions Scale, versus 44% for the educational control group (P less than .05), wrote Jeffrey M. Lackner, PsyD, of the State University of New York at Buffalo and his associates. Blinded gastroenterologists reported improvements of 56% and 40%, respectively (P less than .05). The superiority of the minimal-contact CBT program held up at 6 months and equivalence tests found it “at least as effective as standard CBT,” the researchers wrote.

IBS is a major area of unmet clinical need that costs the United States some $28 billion annually. Clinicians and patients lack both reliable biomarkers and “uniformly effective” therapies, the investigators noted. In recent years, severe adverse events have greatly restricted the availability of otherwise promising Food and Drug Administration–approved therapies, such as Lotronex (alosetron hydrochlorine), which has been linked to ischemic colitis and fatal cases of ruptured bowel, and Zelnorm (tegaserod maleate), which has been associated with myocardial infarction, stroke, and unstable angina.

In contrast, face-to-face CBT is safe, efficacious, and guideline recommended for IBS. However, uptake is limited by cost, stigma, geography, and a shortage of certified providers, the researchers noted. They enrolled 436 patients with IBS based on Rome III criteria and randomly assigned them to one of three interventions. The standard CBT group received 10 weekly, 60-minute, face-to-face CBT sessions on brain-gut interactions, symptom triggers and monitoring, muscle relaxation, worry control, problem-solving, and relapse prevention. The primarily home-based CBT group covered the same topics but attended only four clinic sessions and was provided home study materials. Finally, the education group attended four sessions with background information on IBS and the role of stress, diet, and exercise.

Baseline characteristics were comparable among groups, as were dropout rates (9% overall). In all, 89% of patients completed at least 8 of 10 standard cognitive-behavioral therapy sessions or at least three of four home-based CBT or educational sessions. Six months after the interventions ended, primarily home-based CBT continued to outperform education (blinded gastroenterologist-reported improvements, 58.4% and 44.8%, respectively; P = .05 for difference between groups).

Equivalence tests indicated that the minimal-CBT intervention was at least as effective as standard CBT, and improvements were not primarily the result of concomitant medications, according to the researchers. Nonetheless, only 42% of patients who benefited from CBT achieved remission, defined as no or mild IBS symptoms on the gastroenterologist-administered Clinical Global Impressions Scale. Unremitted patients might benefit from combining CBT with medical therapies that target both “central and peripheral mechanisms of IBS,” the investigators said.

The three interventions produced comparable acute and longer-term improvements on the IBS Symptom Severity Scale, which emphasizes sensory symptoms and therefore might be a less sensitive endpoint than the Clinical Global Impressions Scale, the researchers noted. Nonetheless, CBT produced some of the strongest absolute symptomatic improvements ever reported for IBS. “To put these data in context, treatment response of FDA-approved pharmacological agents using global IBS symptom improvement scales range from 17% to 40%,” the researchers wrote.

The National Institutes of Health provided funding. The investigators reported having no conflicts of interest.

SOURCE: Lackner JM et al. Gastroenterology. 2018 Apr 24. doi: 10.1053/j.gastro.2018.03.063.

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