Clinical studie on treatment

Treatment attempts with Bye Mouth Ulcer!™ on patients with recurrent aphthous ulcers (1995)

Dimethicone (50 mg/10 ml) in the form of a hydroxyethyl cellulose dispersion was

administered in treatment attempts on 12 patients (6 women, 6 men) with acute

recurrent aphthous ulcers (K.H.). The dispersion was to be applied at least four times a

day in order to completely cover the aphthous ulcers. The patient could conduct

additional applications in the event that pain reoccurs. The observation period during

which the patient was examined by a physician four times a day amounted to seven

days. In particular, the course of the pain was recorded prior to and after the application

as well as the development of pain over the entire examination period, in part by the

physician himself, in the case of immediate application, or by means of a patient diary for

the long term. A questionnaire and a visual analogue scale were used to conduct a

qualitative and semi-quantitative evaluation.

While 17 aphthous ulcers were present in 12 patients at the beginning of the treatment

attempts, the number declined over the course of the treatment, until only 7 aphthous

ulcers remained on day 7. At this point in time, the size of the remaining aphthous

ulcers indicated no tendency towards reducing. The pain development analysis revealed

a reduction in discomfort over the entire treatment period. The reduction in pain caused

by the acute treatment itself was particularly impressive. Absence of pain occurred in

approximately 50% of cases after the physician applied the complex of film-forming

substances. This effect already took place within the first 8 minutes, with a single

exception. Absence of pain was always achieved within 10 minutes, with a single

exception.

The amelioration of the pain symptoms was not linked to the morphological development

of the aphthous ulcers. The size of the aphthous ulcers occasionally increased

temporarily during treatment.

If the physician first rated the effectiveness of the dimethicone complex of film-forming

substance as “very good” at 50% of the aphthous ulcers on the 4th day, it was 95% on

day 7. The long-term course of the symptomatology also showed a marked reduction which could be read in the values of the visual analogue scale.

The attending physician as well as the patient overwhelmingly rated the tolerance as

“very good”. No side effects could be detected in this small patient collective.

Under critical appraisal of the data from these treatment attempt, it was determined that

the pain abatement over the entire period of treatment could also be attributed to a selfhealing effect, but the reliable onset of action immediately once the dispersion was applied to the aphthous ulcer could not. It must thus be an effect of the dispersion,

although the mechanism of action based on these treatment attempts must remain open.