Published May 24, 2010
Nearly one-third of patients with irritable bowel syndrome (IBS) who underwent a novel behavior treatment developed by a UB behavioral scientist achieved significant relief within four weeks of beginning treatment.
These patients, called “rapid responders” maintained their improvement at a three-month follow-up, despite reporting more severe IBS symptoms when they started the treatment.
Results also showed that the amount of “face time” spent with a therapist during the 10-week treatment regimen didn’t have an effect on rapid response.
The study is published in the May 2010 issue (Vol. 8, No. 5) of Clinical Gastroenterology and Hepatology.
“These results are important, because conventional wisdom states that benefit from behavioral treatments is tied to the amount of treatment patients receive,” says first author Jeffrey Lackner, PsyD, associate professor in the Department of Medicine, UB School of Medicine and Biomedical Sciences, and director of its Behavioral Medicine Clinic.
“In some patients this assumption does not prove to be true,” he continues. “Regardless of whether patients received two or four sessions of behavioral treatment, a significant proportion rapidly achieved significant relief of severe IBS symptoms and maintained these gains for at least three months.”
Irritable bowel syndrome is a chronic, debilitating disorder affecting 25 million people in the U.S.—14-24 percent of women and 5-19 percent of men. In the past, there had been no reliable, satisfactory medical treatment for the full range of IBS symptoms, which can cause severe physical and psychological distress and deprive sufferers of their quality of life.
Lackner is principal investigator on an $8.9 million, seven-year, multi-site clinical trial funded by the National Institute of Diabetes, Digestive and Kidney Diseases to test the treatment, which proved effective during his pilot study. The UB trial is the largest IBS clinical trial conducted to date, and one of the largest behavioral trials without a drug component funded by the NIH.
The current study involved 71 participants from its UB site who were randomized to receive either four one-hour sessions with a behavioral therapist over 10 weeks, 10 one-hour sessions over 10 weeks or to a “wait” group, which served as a control.
Researchers were interested in knowing if patients who showed significant improvement soon after beginning treatment maintained that improvement at three months after the 10-week intervention, and if so, how these rapid responders were different from the non-rapid responders.
Lackner says they found a strong connection between participants’ beliefs about their IBS symptoms and their rapid response and maintenance of improvement.
“Rapid responders were more likely to attribute their symptoms to their own specific behavior, express more confidence in their ability to make specific behavior changes necessary to control IBS symptoms and have stronger motivation to participate in a self-management program,” says Lackner.
“One might assume that the therapist-directed, time-intensive and highly structured weekly cognitive behavior therapy would be more likely to promote a more rapid response. That turned out not to be the case.”
In addition, 92.5 percent of rapid responders showed an enduring benefit that lasted well over three months with little evidence of deterioration.
“This suggests that rapid response is a relatively robust, clinically meaningful and enduring clinical phenomenon,” says Lackner. “The enduring nature of the response to treatment argues against the idea that the results are due to placebo.”
He continues: “The study has implications for designing clinical trials that test the effectiveness of medical therapies. Generally speaking, the approach has been to test two treatments side by side. This horse race approach is useful, but may not provide information about the more pressing question of: which treatment works best for which patient?
“Our study suggests that what goes on during treatment may be more important to understanding the course of outcome than factors such as the severity of their illness, age, gender and education level. Generally speaking, these variables are not reliable predictors of outcome.”
Additional authors on the paper from UB are Gregory D. Gudleski, PhD, Susan S. Krasner, PhD, Catherine D. Powell and Leonard A. Katz, MD, and Laurie Keefer, PhD, from Northwestern University.