J. Langhorst1, A. Westendorf2, M. Knott2, S. Schneider3, K. Goos4, U. Albrecht5, A. Rueffer6, R. Stange7, A. Michalsen7, G. Dobos8
1University Duisburg-Essen, Kliniken Essen-Mitte, Integrative Gastroenterology, Essen, Germany; 2Institute of Medical Microbiology, University of Duisburg-Essen, Essen, Germany; 3University of Hannover, Biometric Institute, Hannover, Germany;4Repha GmbH, Hannover, Germany; 5Mediconomics, Hannover, Germany; 6L+S Labor, Enterosan, Bad Bocklet – Grossenbrach, Germany; 7Charité, Immanuel Hospital, Berlin, Germany; 8University Duisburg-Essen, Kliniken Essen-Mitte, Internal and Integrative Medicine, Essen, Germany
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 ≤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), relapse-free time (268±22 days for mes and 240±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.