In a non-drug clinical trial for irritable bowel syndrome (IBS), patients with the most severe and persistent symptoms achieved robust and sustained relief by learning to control symptoms with minimal clinician contact, a new study shows.

Of 436 patients recruited for the study, 61 percent reported symptom improvement two weeks after home-based behavioral treatment ended compared to 55 percent in clinic-based treatment and 43 percent who received patient education. The treatment benefit also persisted for as long as six months after treatment ended.

“These findings will be welcomed by many women and men who have unfortunately been stigmatized, marginalized, and too often treated as ‘head cases’…”

“This is a novel, game-changing treatment approach for a public health problem that has real personal and economic costs, and for which there are few medical treatments for the full range of symptoms,” says Jeffrey Lackner, professor of medicine in the Jacobs School of Medicine and Biomedical Sciences at the University at Buffalo and director of its Behavioral Medicine Clinic.

IBS is a persistent and difficult-to-treat condition that is one of the most common diseases that gastroenterologists and primary care physicians treat. It’s characterized by chronic abdominal pain, diarrhea, and/or constipation. Medical and dietary treatment have a disappointing track record of relief for many patients.

Stigmatized and misunderstood

Afflicting between 10 and 15 percent of adults worldwide, most of whom are women, the condition creates a public health burden that causes pain, isolation, and frustration, all of which impair quality of life. Beyond the personal toll, the economic burden of IBS in the US is estimated at $28 billion annually, Lackner says.

“These findings will be welcomed by many women and men who have unfortunately been stigmatized, marginalized, and too often treated as ‘head cases’ merely because no definitive cause for their symptoms is identified through routine medical testing.”

The treatment will also help address a major barrier to quality health care faced by people living in rural areas, because they will now have access to a state-of-the-art treatment once only available in metropolitan areas.

“The creative development of this symptom-management approach for IBS can affect millions of people, primarily women, who suffer from this often stigmatized and poorly understood condition,” says James Jaccard, professor of social work at New York University, who has been a key investigator on the project since it began in 2000.

“By integrating perspectives from medicine and the social sciences, it illustrates the power of team-oriented and multidisciplinary approaches to reducing health care disparities in vulnerable populations.”

While IBS affects mostly women, the findings are noteworthy because 20 percent of the patients were men, many of whom are themselves reluctant to seek help. “These men are more likely to reach out for help if they can access treatment that is brief and home-based,” Jaccard says.

Brain-gut connection

The treatment includes a form of cognitive behavioral therapy (CBT) that teaches practical skills for controlling gastrointestinal symptoms, either during 10 clinic visits, or four clinic sessions in conjunction with self-study materials. Both CBT treatments focused on information on brain-gut interactions, self-monitoring of symptoms, triggers and consequences, worry control, muscle relaxation, and flexible problem-solving.

“The treatment is based on cutting-edge research that shows that brain-gut connection is a two-way street,” Lackner says. “Our research shows that patients can learn ways to recalibrate these brain-gut interactions in a way that brings them significant symptom improvement that has eluded them through medical treatments.”

Lackner adds that the study’s strength is underscored by the fact that both patients and the gastroenterologists, who evaluated patients and weren’t aware of which treatment researchers had assigned to patients, reported similar rates of symptom improvement as patients, Lackner says.

“One measure of the strength of clinical-trial findings is when two data sources report similar data about an endpoint. In our study, there was striking similarity between the treatment response reported by patients and ‘blind’ assessors. This pattern of agreement from patients and physicians shows that we see very real, substantial and enduring improvement in GI symptoms immediately after treatment ends and many months later.”

“This study clearly established the clinical value of a mind-based intervention for IBS,” says Emeran Mayer, professor in the David Geffen School of Medicine at the University of California, Los Angeles, and executive director of the G. Oppenheimer Center for Neurobiology of Stress and Resilience.

“The success of this research shows that this should be offered to patients not as a last resort but as a safe and effective first or second-line therapy. It’s very different from the pharmaceutical model where you are searching for magic-bullet medications. With current medications, you cannot treat the whole patient. The medications can improve their bowel habits, but it’s not a complete treatment for the patient with IBS.”

The researchers report their findings in the journal Gastroenterology.

Lackner oversaw the training of clinicians who work with Mayer at UCLA on the UB program. The two have been building on this work with a study of how the microbiome of IBS patients influences their response to cognitive behavioral therapy. Results from that study are forthcoming.

The researchers report their findings in the journal The National Institute of Diabetes and Digestive and Kidney Diseases of the National Institutes of Health funded the work.

Source: University at Buffalo