Efficacy of Rhizophora mangle aqueous bark extract (RMABE) in the treatment of aphthous ulcers: a pilot study.
OBJECTIVE
Rhizophora mangle aqueous bark extract (RMABE) (CIKRON-H), has been used as antiseptic and skin wound healing promoter. The present study was a randomised, single-blinded, placebo control trial conducted to asses the efficacy of RMABE in treating oral aphthous ulcers.


METHODS
Patients (n = 32) with aphthous ulcers were randomised to received placebo solution or RMABE topically, once a day, from Monday to Friday, until they healed. The efficacy of the treatment was evaluated by physician clinical observations (time to heal, change in condition), the quality of the patient's life and the tolerability through recording adverse effects.


RESULTS
No demographic differences were noted between the two groups at base-line. Seven days after treatment, 12 of the 17 patients in the RMABE group (71%) were completely healed of their aphthous ulcers, with repaired mucosa and no symptoms of ulcers, compared with one in 15 patients in the placebo group (7%) (p < 0.0001). The time taken for the signs and symptoms of ulcers to diminish was also higher in the placebo than in RMABE-treatment group (erythema: placebo 10.54 +/- 1.24, RMABE 4.94 +/- 0.72 days, p = 0.0003; ardour: placebo 7.00 +/- 0.76, RMABE 2.93 +/- 0.49 days, p = 0.0001; and pain: placebo 7.43 +/- 1.21, RMABE 2.92 +/- 0.23 days, p = 0.0011). No subject showed any sign of adverse effects.


CONCLUSIONS
These observations demonstrate that the R. mangle aqueous bark extract reduced the time to repair mucosal tissue, erythema, ardour and pain persistence. There was no evidence any adverse effects. This is the first time that the R. mangle extract has been reported to have mouth mucosa healing properties.
de Armas
Elizabeth
E
Centro Nacional de Sanidad Agropecuaria (CENSA), Carretera de Jamaica y Autopista Nacional, San José de Las Lajas, La Habana, Cuba.
Sarracent
Yamina
Y
Marrero
Eva
E
Fernández
Octavio
O
Branford-White
Christopher
C
D000328:Adult; D005260:Female; D006801:Humans; D008297:Male; D008517:Phytotherapy; D010865:Pilot Projects; D010919:Placebos; D024301:Plant Bark / Q000737:chemistry*; D010936:Plant Extracts / Q000494:pharmacology / Q000627:therapeutic use*; D043982:Rhizophoraceae / Q000737:chemistry*; D013281:Stomatitis, Aphthous / Q000188:drug therapy* / Q000473:pathology / Q000503:physiopathology; D013997:Time Factors; D014945:Wound Healing / Q000187:drug effects
D010919:Placebos; D010936:Plant Extracts