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Print ArticleInflammatory Bowel Disease Health Center
This article is from the WebMD News Archive
Steroid May Delay Return of Crohn's Disease
Sept. 15, 2005 -- A steroid called budesonide may lengthen remission from Crohn's disease, an inflammatory bowel disease.
"Budesonide capsules are a treatment option for Crohn's disease that has been shown in studies not only to be very effective in relieving symptoms, but also in extending the time before patients experience a recurrence," says researcher William Sandborn, MD, in a news release.
Crohn's disease is a chronic disease that causes inflammation of the digestive tract. The disease is believed to be caused by an abnormal immune system response within the bowel lining, causing inflammation and injury.
People with the disease may have mild to severe disease marked by periods of remission and periods of active flare-ups causing symptoms.
"This disease is recurring in nature, so extending the time a patient can be symptom-free or with diminished symptoms is an important feature of treatment," Sandborn notes.
Sandborn and colleagues checked four trials of budesonide in people whose Crohn's disease was in remission.
The key finding: Crohn's was significantly slower to return to patients taking 6 daily milligrams of budesonide.
Keeping Crohn's at Bay
The four trials were done at 95 centers in North America and Europe in the 1990s.
All participants were already in remission from Crohn's disease. Their remission had begun after taking either the steroids budesonide or prednisolone or a fake drug (placebo) in the first phase of the trials.
A total of 380 patients were assigned to take budesonide pills or the placebo for 12 months. Some patients took 6 daily milligrams of budesonide; others got a daily 3 milligram dose. No one knew who got which treatment.
Compared with those taking the placebo, patients taking 6 milligrams of budesonide per day had significantly lower relapse rates after three and six months. That difference had narrowed by nine and 12 months, the study shows.
How Long Did Crohn's Relief Last?
Budesonide didn't permanently hold off Crohn's.
Here are the average lengths of time before relapse for each group:
- Budesonide (6 milligrams/day): 268 days
- Budesonide (3 milligrams/day): 170 days
- Placebo: 154 days
Side Effects
Side effects occurred at similar frequencies in all three groups, the researchers note. Most side effects were mild or moderate.
Abdominal pain, respiratory infection, headache, diarrhea, and nausea were the most common adverse effects. Steroid-related adverse events included easy bruising and acne.
None of the few serious side effects seen in the trials was considered to be caused by budesonide, and none was fatal, write Sandborn and colleagues.
They note that in another study, patients taking budesonide pills in varying doses (up to 9 daily milligrams) stayed in remission for more than two years and didn't have a significant drop in bone mineral density, which chronic steroid therapy can do.
However, budesonide isn't free of side effects, and it's not for everyone.
Unusual but serious side effects can include chest pain, vision problems, unusually fast heartbeat, sleep problems, mental or mood changes, changes in menstrual periods, and increased hair growth.
Elderly users may be more sensitive to budesonide. The drug should only be used when clearly needed during pregnancy.
Doctors can help patients weigh budesonide's risks and benefits.
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