Published May 2, 2018
Published research led by Jeffrey M. Lackner, PsyD, professor of medicine in the Division of Behavioral Medicine, shows that self-administered therapy by irritable bowel syndrome (IBS) patients provided long-lasting relief.
In the largest federally funded non-drug clinical trial for IBS, patients with the most severe and persistent symptoms achieved robust and sustained relief by learning to control symptoms with minimal clinician contact.
Led by Jacobs School of Medicine and Biomedical Sciences researchers in collaboration with colleagues at New York University and Northwestern University, the randomized study was published online before print in Gastroenterology.
The research is a product of 20 years of funding from the National Institute of Diabetes, Digestive and Kidney Diseases (NIDDK) of the National Institutes of Health, and one of the largest clinical medicine trials not including a drug arm.
It reflects a longtime partnership between researchers at UB and NYU, who pooled their respective expertise and talents to test a novel treatment platform for delivering treatment that required many doctor visits.
Of 436 patients recruited at UB and Northwestern, 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.
“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 Lackner, lead author on the study.
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, and diarrhea or constipation or both. Medical and dietary treatment have a disappointing track record of relief for many patients.
Afflicting between 10 and 15 percent of adults worldwide, most of whom are female, the condition creates a public health burden that causes pain, isolation and frustration, all of which impair quality of life.
The treatment consists of 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 developed by Lackner in a previous NIH grant.
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 explains. “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 directs the Department of Medicine’s Behavioral Medicine Clinic, where he and his colleagues treat patients with a variety of painful disorders.
Beyond the personal toll, Lackner says, the economic burden of IBS in the U.S. is estimated at $28 billion annually.
“These findings will be welcomed by many women and men,” he notes, “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.”
This treatment will help address a major barrier to quality health care faced by those living in rural areas, Lackner adds, because now these patients will have access to a state-of-the-art treatment once only available in metropolitan areas.
According to NYU Silver School of Social Work Professor James Jaccard, PhD, a key investigator on this research program since its inception in 2000, “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.”
“By integrating perspectives and research methods from medicine and the behavioral sciences, it illustrates the power of team-oriented and multidisciplinary approaches to reducing health care disparities in vulnerable populations.”
While IBS affects mostly women, Lackner says this study is noteworthy because 20 percent of the patients were male, 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,” he says.
Lackner adds that the study’s strength is underscored by the fact that both patients and the gastroenterologists, who evaluated patients and were unaware of which treatment patients were assigned, reported similar rates of symptom improvement as patients.
“One measure of the strength of clinical-trial findings is when two data sources report similar data about an endpoint,” he explains.
“In our study, there was striking similarity between the treatment response reported by patients and ‘blind’ assessors,” Lackner adds. “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.”
The research holds special interest for Emeran Mayer, MD, PhD, professor in the David Geffen School of Medicine at UCLA and executive director of the G. Oppenheimer Center for Neurobiology of Stress and Resilience, an internationally known expert on the interactions between the digestive and nervous systems and women’s health.
“This study clearly established the clinical value of a mind-based intervention for IBS,” Mayer says. “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,” he says. “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 study is titled “Improvement in Gastrointestinal Symptoms After Cognitive Behavior Therapy for Refractory Irritable Bowel Syndrome” and was funded by the NIDDK.
Co-authors from the Jacobs School are:
Chang-Xiang Ma, PhD, associate professor of biostatistics in UB’s School of Public Health and Health Professions, is also a co-author.
Other co-authors are from Northwestern University, New York University, Icahn School of Medicine at Mount Sinai and the NIDDK.