Pilot study that evaluated the clinical effectiveness and safety of a phytopharmaceutical elaborated with an extract of Ageratina pichinchensis in patients with minor recurrent aphthous stomatitis.

BACKGROUND

The plant species Ageratina pichinchensis (Schauer) R.M.King & H.Rob. (Asteraceae) in a wild plant native to Mexico that is utilized in traditional medicine for the treatment of skin problems and for mouth ulcers.

OBJECTIVE

The objective of the present study was to evaluate the clinical effectiveness and therapeutic safety of a phytopharmaceutical elaborated with a unpigmented hexane-ethyl acetate extract of A. pichinchensis at a concentration of 5% in patients with a clinical condition of Minor Recurrent aphthous stomatitis (MiRAS).

METHODS

We conducted a double-blind, randomized, and controlled pilot study in which the experimental treatment was a phytopharmaceutical elaborated with a unpigmented hexane-ethyl acetate extract of A. pichinchensis at a 5% concentration and, as control treatment, we utilized Triamcinolone at 0.1%. Study participants were patients with a diagnosis of MiRAS, elderly males and females, with a disease evolution of no. >3 days. Lesion size was measured by means of a tracing sheet and pain, by the Visual analog scale (VAS). Output variables comprised clinical effectiveness, treatment adherence, therapeutic failure, and therapeutic success.

CONCLUSIONS

Fifty six patients participated in the study and we distributed these into two study groups (28 in each group). The results obtained did not show statistically significant differences between the experimental and the control treatments. Among patients treated with the A. pichinchensis extract, the time required for achieving the absence of pain was 4.0 days, while that of the control treatment was 4.1 days. In patients treated with A. pichinchensis, the time necessary for healing was 4.5 days and for the Triamcinolone 0.1%-treated group, this was 4.7 days. Greater clinical effectiveness was evidenced on days 2, 3, and 4 of treatment. During the first 7 follow-up days, there was clinical effectiveness in 92.8% of experimental-group and in 89.2% of control-group patients. At the end of the study, 100% therapeutic effectiveness was able to be scored.