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.
Aliment Pharmacol Ther
; 38(5): 490-500, 2013 Sep.
Article
em En
| MEDLINE
| ID: mdl-23826890
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.
Texto completo:
1
Base de dados:
MEDLINE
Métodos Terapêuticos e Terapias MTCI:
Terapias_biologicas
/
Aromoterapia
/
Plantas_medicinales
Assunto principal:
Terpenos
/
Extratos Vegetais
/
Colite Ulcerativa
/
Carvão Vegetal
/
Anti-Inflamatórios não Esteroides
/
Mesalamina
/
Camomila
/
Preparações de Plantas
Tipo de estudo:
Clinical_trials
/
Guideline
Idioma:
En
Revista:
Aliment Pharmacol Ther
Ano de publicação:
2013
Tipo de documento:
Article
País de afiliação:
Alemanha