OA07.03. Randomized, double-blind, double-dummy trial of myrrh, chamomile, coffee charcoal compared to mesalazine in maintaining remission in ulcerative colitis

Abstract

Background: 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). Methods: A total of 96 patients (51 female) with UC in remission (not longer than 12 month) were included in a randomized, double-blind, double-dummy, multicenter, non inferiority study comparing mesalazine 500 mg (3x1/d) to 100 mg myrrh, 70 mg chamomile extract and 50 mg coffee charcoal (3 x 4/d) over a time period of 12 month. 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 (less-than or equal to)1 point. Furthermore, relapse rates, relapse-free times, safety, a comprehensive activity index (CAI, CRP and fecal Lactoferrin, Calprotectin and PMN-Elastase), an endoscopic activity index and Health-related Quality of life (HrQoL) was assessed. Peripheral CD4+CD25+ reg T-cells were investigated in a subgroup at each time point and during a flare. Results: Primary outcome criterion (p = 0.191), relapse rates (CAI >4) (mes 22/49 pts vs herb 25/47 pts; p = 0.540), relapsefree time (268(plus or minus)22 days for mes and 240(plus or minus)23 days (p = 0.397) for the herb), the comprehensive activity index and HrQoL did not show a significant difference. Of notice, peripheral CD4+CD25+ regulatory T-cells showed a distinct different pattern at time points pre-flare and flare for the two treatment modalities (CD4+CD25+Treg mes p = non significant (ns); herb p = 0.0208; CD4+CD25+Treghigh mes p = ns; herb p = 0.008). Conclusions: The herbal preparation shows efficacy and safety in maintaining remission non-inferior to mesalazine in ulcerative colitis. It appears to offer an alternative option for maintenance therapy. Regulatory T-cell pattern might give first evidence to suggest a different mechanism of action.