Randomised clinical trial: a herbal preparation of myrrh, chamomile and coffee charcoal compared with mesalazine in maintaining remission in ulcerative colitis--a double-blind, double-dummy study.

Abstract

BACKGROUND:

The herbal treatment with myrrh, dry extract of chamomile flowers and coffee charcoal has anti-inflammatory and antidiarrhoeal potential and might benefit patients with UC. Aminosalicylates are used as standard treatment for maintaining remission in ulcerative colitis (UC).

AIM:

To compare the efficacy of the two treatments in maintaining remission in patients with ulcerative colitis.

METHODS:

We performed a randomised, double-blind, double-dummy study over a 12-month period in patients with UC. Primary endpoint was non-inferiority of the herbal preparation as defined by mean Clinical Colitis Activity Index (CAI-Rachmilewitz). Secondary endpoints were relapse rates, safety profile, relapse-free times, endoscopic activity and faecal biomarkers.

RESULTS:

A total of 96 patients (51 female) with inactive UC were included. Mean CAI demonstrated no significant difference between the two treatment groups in the intention-to-treat (P = 0.121) or per-protocol (P = 0.251) analysis. Relapse rates in total were 22/49 patients (45%) in the mesalazine treatment group and 25/47 patients (53%) in the herbal treatment group (P = 0.540). Safety profile and tolerability were good and no significant differences were shown in relapse-free time, endoscopy and faecal biomarkers.

CONCLUSIONS:

The herbal preparation of myrrh, chamomile extract and coffee charcoal is well tolerated and shows a good safety profile. We found first evidence for a potential efficacy non-inferior to the gold standard therapy mesalazine, which merits further study of its clinical usefulness in maintenance therapy of patients with ulcerative colitis. EudraCT-Number 2007-007928-18.

• Authors: J Langhorst, I Varnhagen, S B Schneider, U Albrecht, A Rueffer, R Stange, A Michalsen, G J Dobos
• Journal: Alimentary pharmacology & therapeutics (Aliment Pharmacol Ther) Vol. 38 Issue 5 Pg. 490-500 (Sep 2013) ISSN: 1365-2036 [Electronic] England
• PMID: 23826890 (Publication Type: Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
• Copyright: © 2013 John Wiley & Sons Ltd.

Chemical References

• Anti-Inflammatory Agents, Non-Steroidal
• Coffee
• Plant Extracts
• Plant Preparations
• Terpenes
• Charcoal
• Mesalamine
• myrrh oil

Topics

• Adult
• Anti-Inflammatory Agents, Non-Steroidal (therapeutic use)
• Chamomile (chemistry)
• Charcoal (chemistry)
• Coffee
• Colitis, Ulcerative (drug therapy)
• Double-Blind Method
• Female
• Humans
• Male
• Mesalamine (therapeutic use)
• Middle Aged
• Plant Extracts (therapeutic use)
• Plant Preparations (therapeutic use)
• Remission Induction
• Terpenes (chemistry)
• Treatment Outcome