‘’Study of the clinical efficacy of Bustilène cream for local use, in the treatment of mastodynia and premenstrual syndrome’’
• Doctor Brigitte Clavier, Gynecological and obstetric Clinic – University Hospital Center Charles-Nicolle – Rouen, France
• Doctor Valérie Saubry-Bobet, Clinic du Cèdre - Bois-Guillaume, France
Open-label preliminary study on 45 women.
This clinical study was conducted over a period optimally corresponding to 3 menstrual cycles.
- Primary endpoint: Reduction of breast pain, tension, heaviness, feelings of heat and inflammation, reduction of oedema.
- Secondary endpoint: rapidity of action, durability, cosmetic evaluation of the product.
Each patient received the tested product.
The patient must applied a small amount of cream onto each breast, twice a day, for about a fortnight preceding the presumed date of menstrual bleeding.
- C0 – 1st visit : Inclusion
- C1 – 2nd visit was held during the premenstrual period, about one week before
the presumed date of the menstrual bleeding.
- C2 – 3rd visit was held also about one week before the presumed date of the fourth period
Overall, between the inclusion visit C0 and the last visit C2 corresponding to an optimal treatment of 3 cycles, a marked improvement was observed for:
- Pain in 63% of cases
- Tension in 71% of cases
- Heaviness in 69% of cases
Results are identical on other parameters excepted for oedema where an improvement was observed in 100% of cases.
This study conducted in Rouen on a population of private practice patients and a population of patients attending the teaching hospital breast clinic demonstrated a number of interesting points:
• The diversity of the clinical symptoms and signs presented by the patients included.
• The very small number of patients who dropped out of the study for reasons related to the test product (texture, absence of improvement).
• The very rapid and indisputable efficacy of the product on subjective symptoms and the marked improvement of the breast examination performed by the clinician.
• Almost all patients (87%) were completely satisfied by the relief provided by the product and wanted to continue treatment.