Abstract
Methods A total of 96 patients (51 female) with UC in remission (not longer than 12 months) were included in a randomized, double-blind, double-dummy, multicenter, non inferiority study comparing mesalazine 500 mg (3x1/d) to 100mg myrrh, 70mg chamomile extract and 50mg coffee charcoal (3 x 4/d) over a time period of 12 months. As primary outcome criterion, non-inferiority of the herbal preparation was defined and accepted, if the difference in the colitis activity index (Colitis Activity Index CAI Rachmilewitz) (calculated at six time points during the 12 month interval) averaged over all visits was ≤ 1 point. Furthermore, relapse rates, relapse-free times, safety, a comprehensive activity index (CAI, CRP and fecal Lactoferrin, Calprotectin and PMN-Elastasis), an endoscopic activity index and Health-related Quality of life (HrQoL) were assessed. Peripheral CD4+CD25+ reg T-cells were investigated in a subgroup at each time point and during a flare.
Highlights
Randomized, double-blind, doubledummy trial of myrrh, chamomile, coffee charcoal compared to mesalazine in maintaining remission in ulcerative colitis
We compared the efficacy of the herbal preparation of myrrh, chamomile extract and coffee charcoal with a mesalazine therapy in maintaining remission in ulcerative colitis (UC)
Peripheral CD4+CD25+ reg T-cells were investigated in a subgroup at each time point and during a flare
Summary
We compared the efficacy of the herbal preparation of myrrh, chamomile extract and coffee charcoal (herb) with a mesalazine (mes) therapy in maintaining remission in ulcerative colitis (UC). Randomized, double-blind, doubledummy trial of myrrh, chamomile, coffee charcoal compared to mesalazine in maintaining remission in ulcerative colitis From International Research Congress on Integrative Medicine and Health 2012 Portland, Oregon, USA.
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