T1394 Mesalazine Treatment for Intestinal Immune Activation in Patient with Irritable Bowel Syndrome: A Randomized Controlled Pilot Trial

Background and aim IBS still needs a perfect therapy.Depression is a common disorder in IBS.Several trials showed the benefit of antidepressants in IBS.We looked for the effect of a SSRI, fluvoxamine vs a TCA, amitryptiline in depressed females with IBS.Methods Subjects: 80 female pts with IBS filling the Rome II criteria and with depression scores on the Beck Depression Inventory were selected in a tertiary center.Protocol: The pts were randomized in 2 groups: group I received fluvoxamine 50 mg at bedtime 4 weeks; group II received amitryptiline 25 mg at bedtime 4 weeks.Both groups were comparable in respect to age and depression score.Pts were avoided other medication for digestive symptoms during the trial.The effect of the drugs was assessed for 4 main symptoms with a symptom score looking for intensity and frequency of symptoms according to a validated scale from 0 to 4, thus allowing values from 0 to 16. Results From the 80 pts, 72 finished the study (36 in each leg), the other quit due to insatisfaction with the study drugs.Symptom score for abdominal pain was decreased from 11.7+3.1 to 5.3+3.3(p=0.020) in group I and from 12.5+4.0 to 6.2+4.5 (p=0.038) in group II.Bloating score was improved from 8.9+3.2 to 5.4+2.1 (p=0.040) in group I and from 7.7+2.7 to 4.6+3.2 in group II (p=0.035).Diarrhea and constipation scores were not significantly changed.BDI scores were similarly decreased by both drugs, from 21.3+6.2 to 14.7+6.0 in group I (p=0.015) and from 24.2+5.9 to 16.0+7.2 in group II (p=0.008).Less side-effects were recorded in group I vs group II (dry mouth: 4 vs 10 cases, dizzines: 3 vs 7cases, somnolence 8 vs 13 cases).Conclusions Fluvoxamine and amitryptiline similarly improve digestive symptoms: pain and bloating as well as depression scores in females with IBS and depression.However fluvoxamine produces less secondary effects but there number is still high.