Volume 173, 15 September 2015, Pages 225–230
Abstract
Ethnopharmacological relevance
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.
Aim of the study
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).
Materials and 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.
Results and discussion
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.
Graphical abstract
Keywords
- Minor recurrent aphthous stomatitis;
- Pilot study;
- Aphthae;
- Gumboils;
- Mouth ulcer;
- Ageratina pichinchensis
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