New Drug Therapies Look Promising for Bowel Diseases
HealthDay News
TUESDAY, May 23 (HealthDay News) -- For bowel disorders such as Crohn's disease and irritable bowel syndrome, long-term treatments with new compounds look promising, researchers report.
And, for those with moderate to severe Crohn's disease, which often does not respond to conventional treatment, the new biologic therapies, which target the specific cause of the inflammation causing the disease instead of suppressing the entire immune system as traditional medications do, also look good, experts said.
The experts shared their assessments Monday at the annual Digestive Disease Week meeting, in Los Angeles.
More than one million people in the United States have inflammatory bowel diseases, said Dr. Maria Abreu, director of the Inflammatory Bowel Disease Center at Mount Sinai Medical Center in New York City, who chaired the panel.
While all the treatments are "tremendously important," adalimumab (Humira), a medicine already approved for the treatment of rheumatoid arthritis and psoriatic arthritis, may be a "front runner" for bowel disease patients, she said. Not all the treatments discussed are yet on the market.
Inflammatory Bowel Disease (IBD) includes the diseases ulcerative colitis, an inflammation in the lining of the rectum and colon causing frequent emptying and diarrhea, as well as Crohn's disease, an inflammation of the gastrointestinal tract that most often affects the lower part of the small intestine. Swelling leads to pain and diarrhea. Irritable Bowel Syndrome is mainly a problem that affects the large intestine, leading to cramping, bloating, diarrhea and constipation.
In patients with arthritis as well as Crohn's disease, some similar inflammatory proteins are increased. This lead researchers to test arthritis medicines for these gastrointestinal tract diseases.
In Monday's session, researchers reported results of a series of studies.
Adalimumab (Humira) provided remission from Crohn's disease in patients with moderate to severe disease, said Dr. Jean-Frederic Colombel, the lead author of the study and a researcher at Centre Hospitalier Universitaire de Lille, in France. In the study, which included 854 patients and continued for 56 weeks, 46 percent of those on the drug achieved remission, compared to just 17 percent on placebo.
Natalizumab (Tysabri), a drug approved for multiple sclerosis, was voluntarily taken off the market last year, when it was potentially linked to deadly brain infections called progressive multifocal leukoencephalopathy (PML). But it's expected back on the market, after the manufacturer submitted more data to the U.S. Food and Drug Administration to prove safety, and an FDA advisory panel recommended reintroduction of the drug.
Dr. Stephan Targan is director of the inflammatory bowel disease center at Cedars-Sinai Medical Center in Los Angeles, and the lead author of a study of Tysabri treatment for more than 500 Crohn's disease patients. He reported that a higher proportion of patients in the Tysabri group responded to the therapy at weeks eight and 12 than those in a placebo group -- 48 percent vs. 32 percent, respectively. More than 25 percent of the Tysabri group had remission by weeks eight and 12, compared to 16 percent of those taking a placebo. The drug dampens the immune response that causes the inflammation characteristic of Crohn's disease.
Another study of Tysabri, which included 2,248 patients with either Crohn's disease, multiple sclerosis or rheumatoid arthritis, found the risk of developing the PML brain infection was very low, according to Dr. William Sandborn of the Mayo Clinic, who led the study. Before the voluntary recall of the drug, three patients were identified with the infection, and four more infections were initially reported in post-marketing reviews. Sandborn's analysis, in which his team checked spinal fluid and blood, found no additional cases among the patients studied, and the four post-marketing cases did not have the infection after all.
Another biologic treatment, which is called certolizumab pegol and is in phase III clinical trials, helped those with moderate to severe Crohn's disease. The 659 patients were assigned to the drug or placebo; at week four, 20 percent of those on the drug achieved remission and response, compared to 10 percent on a placebo.
Lubiprostone (Amitiza), approved in January 2006 by the FDA for chronic constipation, also helped patients with IBS, said Dr. John F. Johanson, lead study author and a researcher with Rockford Gastroenterology Associates, in Illinois. About 50 patients were assigned to each of four groups -- either a placebo or one of three drug doses. All those on the drug showed improvement, compared to those on a placebo, and those who took the highest dose improved the most.
Teduglutide is a naturally occurring hormone under study that governs the growth and maintenance of cells lining the gastrointestinal tract. Dr. Alan Buchman, a researcher at Northwestern University's Feinberg School of Medicine, led a study in which three different doses of the drug or a placebo were given to 100 people with Crohn's disease. Half of the drug-treated patients responded after two weeks, and more than one-third also achieved remission then, too. After eight weeks, 61 percent of the treatment group responded, and 56 percent also had remission.
Therapy, Hypnosis for Irritable Bowel?
Cognitive Behavioral Therapy, Hypnosis May Help Patients With Irritable Bowel Syndrome (IBS)
WebMD Medical News
May 24, 2006 -- Some people may cope better with irritable bowel syndrome (IBS) with help from cognitive behavioral therapy and hypnosis, three new studies show.
The studies were presented in Los Angeles, at Digestive Disease Week 2006, an international meeting of doctors, researchers, and academics.
One of the studies used cognitive behavioral therapy to teach IBS patients new ways to handle their condition. The other two studies tested hypnosis in IBS patients who hadn't been helped by other treatments.
Cognitive behavioral therapy and hypnosis were each linked to improvements in gastrointestinal symptoms, the studies show.
Not 'Hocus-pocus'
The hypnosis researchers included Magnus Simren, MD, of Sahlgrenska University Hospital's internal medicine department in Gothenburg, Sweden.
Hypnotherapy is already used to treat IBS patients, mainly at a few highly specialized gastrointestinal centers, Simren told reporters in a conference call. His team used two more common settings: a university hospital and a county hospital.
Exactly how hypnosis helps IBS isn't clear. Simren, a gastroenterologist, admits having his doubts that patients would give it a try.
"When I started with this, I was a little bit afraid that patients would be hesitant, that they would think this is hocus-pocus. But they are very open-minded to this," he says.
"When I speak to the patient, I tell them that this is a way that you can get control over your symptoms," says Simren. "They are quite satisfied with that explanation."
Hypnosis Studies
Simren's hypnosis studies had a combined total of 135 IBS patients. The patients' average age was 41; most were women.
In both studies, participants were split into two groups. One group got 12 weekly one-hour hypnotherapy sessions focused on gut-related problems. For comparison, the second group didn't get hypnosis.
In one study, the comparison group got 12 weeks of attention from doctors and nutritionists. In the other study, the comparison group got no special care.
The patients rated their gastrointestinal symptoms, quality of life, and depression at the study's start, immediately after 12 weeks of treatment, and again six and 12 months later.
During the hypnosis sessions, patients were guided into a "relaxational trance," says Simren, in which patients imagined calming images like a gently flowing river.
Simren didn't hypnotize any of the patients. The hypnosis sessions were conducted by trained hypnotherapists.
Symptoms Lessened With Hypnosis
"The hypnotherapy groups improved significantly in both studies regarding gastrointestinal symptoms and the control groups did not," Simren says.
Significant improvement (meaning improvement not likely due to chance) in gastrointestinal symptoms was seen in 52% of the hypnotherapy groups, compared with 32% of the comparison groups.
The improvements were mainly seen with symptoms of abdominal pain, distension, and bloating, rather than for bowel habits, the study shows.
"We believe that with this study we have really demonstrated that this can be performed outside highly specialized GI centers," Simren says, adding that hypnotherapy seems to have a "good effect" with symptom relief sustained after a year.
The long-term results were "promising," says Simren. "So it was good in the short-term; it also seemed to work in the long run with these patients."
Learning to Cope With IBS
Another team of researchers tested cognitive behavioral therapy on 59 IBS patients, most of whom were women.
The researchers included Jeffrey Lackner, PsyD, of the University of Buffalo, which is part of the State University of New York.
"Our work was based on a couple of beliefs," Lackner told reporters, in a teleconference. "One is that at this point, there are no pharmacological treatments or drug therapies that seem to be satisfactory for the full range of symptoms. And so the real burden of managing IBS really rests on the shoulders of patients on a day-to-day basis."
"Managing symptoms really comes down to having a set of skills," Lackner says. Those skills are often taught over 10 to 20 weeks, which is "very impractical for a significant proportion of patients," says Lackner, noting a shortage of therapists trained in cognitive behavior therapy for IBS patients.
Therapy Study
Lackner and colleagues randomly split participants into three groups:
- 10 weekly sessions of cognitive behavior therapy.
- 4 weekly sessions of cognitive behavior therapy with a manual to use at home.
- Wait list for cognitive behavior therapy (comparison group).
Both therapy groups covered the same material and had 60% to 75% achieving "adequate relief and describing their symptoms as improved significantly," Lackner says. The comparison group showed no improvement.
"What we found, just in a nutshell, was that whether patients are treated with a 10-session treatment or a four-session treatment they achieved clinically significant improvement in symptom relief, in quality of life, and they were satisfied," Lackner says.
The four-session treatment was about 2.5 times as efficient as the lengthier treatment, Lackner notes.
No 'Head Shrinking'
"While we have a psychological treatment, our treatment is not shrinking heads," Lackner says.
"Our treatment is teaching patients to manage their illness. This is what is done with cardiac rehabilitation. This is done with diabetes management, arthritis management. We need to use that same approach for IBS."
The therapy covered information on IBS, muscle relaxation training, developing a flexible set of problem-solving skills for IBS, and curbing worry about IBS.
For instance, Lackner says someone with IBS going on a date might worry that their date will think they're "weird" if they have to go to the bathroom during the date.
"We encourage them to say [to themselves], 'Listen, I don't really know what's going to happen four hours down the road. I can only deal with the evidence, the information I have available to me and I'll deal with that when it comes up."
The bottom line: "Our goal is to try to teach them to control that worried thinking in a way that reduces their symptoms," says Lackner. He and his colleagues developed the at-home workbook used in the study.
