Abstract

JIMENEZ ARCEO, Anne et al. Efficacy and safety of propomiel in aphthous stomatitis. Multimed [online]. 2019, vol.23, n.4, pp. 656-669. ISSN 1028-4818.

Aphthous stomatitis, a clinical entity whose main manifestation is the appearance of canker sores. The search for effective medications to treat it is a "challenge for the medical community." A randomized phase IIb therapeutic clinical trial was carried out. Patients carrying the disease were used in the experimental design and wished to cooperate with the trial. The proposed objective was to evaluate the efficacy and safety of Propomiel in relation to the conventional treatment of Foot-and-Mouth Disease. The sample comprised 102 patients, two groups of 51 patients each were formed; in group A (experimental) propomiel was applied and in group B (control) 0.2% aqueous chlorhexidine. The variables that were taken into account: age group, sex, pain, healing, time, therapeutic effect, adverse events and severity of adverse events. It was determined possible existence of significant differences between both therapeutics by means of the homogeneity test, X2 test or Fisher exact probability test with a 95% reliability (p <0.05). The results showed the majority of patients 19-34 years of age and female sex, as well as in absence and painful intensity; after the first 3 applications, 100% of the patients had improved (experimental group) and 86.27 (control group). After 5 days, 98.04% of the lesions had healed (group A) and 90.20% (group B). There were no adverse events. It is concluded that propomel treatment in aphthous stomatitis demonstrated therapeutic efficacy and safety without significant differences with respect to 0.2% aqueous chlorhexidine.

Keywords : Aphthous Stomatitis; Drug Therapy.

        · abstract in Spanish | Portuguese     · text in Spanish     · Spanish ( pdf )