A double-dummy, double-blind, placebo-controlled phase III study comparing the efficacy and efficiency of miconazole chewing gum with a known drug (Brentan gel) and a placebo in patients with oral candidosis.
OBJECTIVE
The purpose was to compare the therapeutic effect, the required overall treatment duration, and patients' subjective perception of treatment of candidosis with miconazole chewing gum 20 mg/piece (3.6 mg released) and 2% Brentan gel 2.5 g (50 mg released), both administered 4 times daily.


METHODS
Randomly selected patients (chewing gum: 96; gel: 28; placebo 16) were seen at baseline and at 4 and 6 weeks. They were evaluated clinically and with culture and cytology assays.


RESULTS
There was no significant difference between the 2 drugs after 6 weeks, but miconazole released in small doses from chewing gum was at least as effective as a larger gel dose. Both active drugs demonstrated efficiency and efficacy (P=1.9%). The hypothesis of equal proportions was rejected (P=.0001). Patients preferred the chewing gum. There was a statistically significant difference in patient preference for the chewing gum treatment.


CONCLUSIONS
The chewing gum medication is clinically promising.
Bastian
Henning Lehmann
HL
Department of Oral and Maxillofacial Surgery, Odense University Hospital, USA. henning.lehmann@ouh.fyns-amt.dk
Rindum
Judith
J
Lindeberg
Henning
H
D000328:Adult; D000935:Antifungal Agents / Q000008:administration & dosage*; D002180:Candidiasis, Oral / Q000188:drug therapy*; D002638:Chewing Gum; D016009:Chi-Square Distribution; D004311:Double-Blind Method; D005782:Gels / Q000008:administration & dosage; D006801:Humans; D008825:Miconazole / Q000008:administration & dosage*; D017060:Patient Satisfaction; D010919:Placebos; D016896:Treatment Outcome
D000935:Antifungal Agents; D002638:Chewing Gum; D005782:Gels; D010919:Placebos; D008825:Miconazole