IBS Patients to Test Novel Treatment Program Aimed At Changing Thoughts and Responses to Symptoms

BUFFALO, N.Y. -- Irritable bowel syndrome affects between 10-to-20 percent of the population worldwide. It is the most common disease diagnosed by gastroenterologists, but there is no universally accepted medical treatment for the full range of symptoms.

Specialists in treating irritable bowel syndrome (IBS) in the University at Buffalo School of Medicine and Biomedical Sciences are set to begin a 10-week clinical trial of an innovative treatment program that centers on reducing symptoms by changing the way patients think about and respond to potential IBS episodes.

The trial is funded by a two-year, $300,000 grant from the National Institutes of Health (NIH).

Only a small group of academic facilities specialize in IBS research; UB is one of only a handful of institutions conducting behavioral-based treatment program for IBS.

Jeffrey M. Lackner, Psy.D., UB assistant professor of medicine, a specialist in IBS and lead researcher on the clinical trial, said the key malfunctions of this debilitating syndrome are disordered bowel motility, enhanced sensitivity of nerves in the gut, and psychosocial factors, the combination of which make the symptoms (diarrhea, constipation or both) particularly difficult to treat.

"Of psychological factors, the beliefs, expectations and thoughts patients hold about their symptoms appear to be particularly important in 'short-circuiting' the neural connections between the brain and gut," he said.

Earlier multidisciplinary research by Lackner and colleagues at UB found that IBS patients showed different brain activity than those who do not experience IBS in areas that control pain and strong emotions. The researchers then were able to show that patients who learned self-management skills not only reduced significantly their IBS symptoms, but showed changes in brain activity that were more similar to controls who did not experience IBS.

"In short, the treatment, called cognitive-behavioral therapy, appears to work by teaching patients to dampen activity of brain structures involved in processing pain signals and emotions that can aggravate symptoms," said Lackner.

These clinic-based programs would be too expensive for the majority of IBS sufferers: the 12-week program costs around $1,200 to deliver. The upcoming clinical trial will test whether patients can carry out much of the therapy at home, where problems are more likely to arise, and if the results will be as effective as clinic-based therapy.

Seventy-five patients will be assigned randomly to one of two groups: a "low-contact" group involving four clinic visits over three months, or a "standard" group, involving 10-12 weekly clinic visits. An additional group of patients who are on a waiting list to begin cognitive-behavioral therapy will serve as a control group.

Patients in the two study groups will undergo extensive medical and psychological evaluation at the beginning of the trial. All will learn the same management strategies, use the same manual of instructions and maintain the same personal diaries of symptoms and their thoughts and actions in response to symptoms.

Those in the low-contact group will receive 15-minute phone calls periodically to address any problems. The wait-list group will keep a daily log of GI symptoms.

At the end of the trial, researchers will determine the effect of the treatments on GI symptoms, distress and quality of life, and assess costs of both approaches. The results will be used to design a larger study.

The clinical trial will be conducted out of the Erie County Medical Center, a UB teaching hospital.

Additional researchers on the study from UB are Susan Krasner, Ph.D., clinical assistant professor of anesthesiology and medicine; Michael Sitrin, M.D., UB professor of medicine, and Leonard Katz, M.D., emeritus professor of medicine.

Kenneth Holroyd, M.D., of Ohio University, James Jaccard, M.D., of Florida International University, and Brian Yates, M.D., of American University, will serve as consultants.

The University at Buffalo is a premier research-intensive public university, the largest and most comprehensive campus in the State University of New York.