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
Bastian, H.Lehmann.; Rindum, J.; Lindeberg, H.
Oral Surgery, Oral Medicine, Oral Pathology, Oral Radiology, and Endodontics 98(4): 423-428
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. 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. 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. The chewing gum medication is clinically promising.