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

Purpose

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 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.

Results

Primary outcome criterion (p = 0.19), relapse rates (CAI>4) (mes 22/49 patients vs herb 25/47 patients; p = 0.54), relapse-free time (268 ± 22 days for mes and 240 ± 23 days (p = 0.40) 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+T_reg mes p=non significant (ns); herb p=0.02; CD4+CD25+ T_reg high mes p=ns; herb p=0.008).

Conclusion

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.