Jay Pravda, Michael J Weickert and Lawrence D Wruble
Objectives: In many patients, Ulcerative Colitis (UC) is poorly controlled; patients frequently fail to achieve remission or relapse on current therapies. Multiple disease mechanisms have been postulated but resulting therapies fail to deliver complete histological and clinical remission in a majority of patients. This case series reports clinical experience treating patients with active UC, not responding to conventional therapies, with a combination enema and oral therapy, to test whether it could induce remission in refractory, moderate to severe disease.
Methods: A four-component enema consisting of approved medications and generally regarded as safe ingredients, and oral dihydrolipoic acid, was administered daily for up to eight weeks. Thirty-six patients with UC experiencing a current flare not responding to other UC medications were treated. Patients were assessed at the initiation of treatment and two follow-up visits, visit 1 (average 26 days) and visit 2 (average 54 days), for symptoms and by endoscopic and histologic examination.
Results: Thirty-five (of 36) patients had moderate to severe disease at the initial pre-treatment assessment. At visit 1, 71% of patients achieved histological remission, 65% were in complete mucosal remission, 94% patients had a clinical response and 71% of patients achieved clinical remission. By visit 2, 85% of patients achieved histological remission, 85% were in complete mucosal remission, 97% of patients had a clinical response and 87% of patients achieved clinical remission. The regimen was well tolerated.
Conclusions: A combination oral/enema regimen was effective at inducing clinical, endoscopic and histological remission in moderate to severe UC patients experiencing a flare that was not controlled by their existing UC medications.
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