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ROCHESTER, Minn., Feb. 3 - Patients with inflammatory bowel disease can use once-forbidden non-steroidal anti-inflammatory drugs (NSAIDS) safely, at least in certain circumstances, according to two studies.

In a randomized, placebo-controlled pilot study, researchers at the Mayo Clinic here showed that patients whose inflammatory bowel disease (IBD) is in remission can use Celebrex (celecoxib) safely for short periods of time.

In the other study, researchers in England, Iceland, and Sweden showed that non-selective non-steroidal anti-inflammatory drugs are more likely to cause disease flares than drugs that selectively target either of the cyclooxygenase enzymes, Cox-1 or Cox-2.

Both studies appear in the February issue of the journal Clinical Gastroenterology and Hepatology.

"In the past, physicians have considered ulcerative colitis and Crohn's disease as contraindications for prescribing NSAIDs," said Joshua Korzenik, M.D., co-author, with Daniel Podolsky, M.D., both of Massachusetts General Hospital, of an accompanying editorial.

The new information represents "an important advance," said Dr. Korzenik, both for patients who need pain relief and for their gastroenterologists, who are concerned with the safety of painkilling medications.

In the Mayo Clinic study, William Sandborn, M.D., and colleagues randomized 22 patients with ulcerative colitis that was in remission to get either 200 mg of Celebrex twice daily or a placebo for 14 days.

The study found no significant differences:

• 3% of patients getting Celebrex had a disease exacerbation, compared with 4% in the placebo group.
• 11% of patients in each group had a bowel-related adverse event
• 5% of patients in the Celebrex group and 3% of patients in the placebo group withdrew because of adverse events.

The study has limitations, Dr. Sandborn and colleagues noted. The duration was short, it did not include patients who were in exacerbation, and patients in the study were on maintenance therapy with 5-aminosalicylate medications and/or azathioprine or 6-mercaptopurine. Also, the researchers did not attempt to evaluate how well Celebrex worked for pain relief in these patients.

Several members of the study team are employed by Pfizer, which makes Celebrex.

In the European study, researchers led by Ingvar Bjarnason, M.D., of Sahlgrenska University Hospital in Gothenburg, Sweden, tried to tease out exactly how NSAIDs contribute to disease flares in the people with IBD.

The researchers enrolled 209 patients with quiescent Crohn's disease and ulcerative colitis in a two-part study. In the first part, 109 patients were given either the non-NSAID acetaminophen, or the conventional NSAIDs, naproxen, diclofenac, and indomethacin, over a four-week period, and monitored for relapse. The acetaminophen group served as a control.

In the second part of the study, 100 patients (in groups of 20) were assigned acetaminophen (as a control), naproxen, nabumetone, nimesulide, or low-dose aspirin. Naproxen and nabumetone are non-selective Cox inhibitors, nimesulide (not available in the U.S.) is a selective Cox-2 inhibitor, and low-dose aspirin selectively targets Cox-1.

The study found:

• In the first part, no patients taking acetaminophen relapsed, but relapse rates for patients taking non-selective NSAIDs ranged from 17% to 28%.
• Relapses occurred between two and nine days of starting the medication.
• In the second part, 10 patients had a clinical relapse - one each in the acetaminophen and nimesulide groups and four each in the naproxen and nabumetone groups.
• The number of patients who relapsed on naproxen and nabumetone versus acetaminophen, aspirin, and nimesulide was statistically significant (p<0.01).
• No patient taking low-dose aspirin had a relapse.

The researchers concluded that most patients with quiescent IBD can tolerate NSAIDs for a period of four weeks, but a significant minority will suffer a relapses within about a week.

The findings suggested, Dr. Bjarnason said, that "if a patient with IBD requires an NSAID for pain relief, then these drugs should not be withheld on the belief that they will cause worsening of disease symptoms."

The results also suggested, the researchers said, that selective inhibition of either of the COX enzymes is less likely to cause problems than blocking both of them.

However, neither study is exhaustive, noted Drs. Korzenik and Podolsky in their editorial. They added that "these studies are important as small steps forward in the care of IBD patients" and need to be supplemented with both longer studies and studies of other subgroups of IBD patients.