Seguridad y actividad de la Solución de Bardana como coadyuvante en el manejo del prúrito vulvovaginal en Colombia: Ensayo clínico fase II

摘要

Genital itching is associated with allergic and infectious aetiologies, systemic causes or a primary reaction. Managing this syndrome is a challenge for gynaecologists and general practitioners. Objective: evaluating the safety and activity of a 1.2% burdock solution in external applications per day, for 5 days, as an adjuvant in managing vulvovaginitis to relieve itching. Methodology: this was an open, non-comparative, multicentre, phase II clinical trial involving patients suffering from genital pruritus. The evaluation was made in 14 Colombian cities; it included women aged over 18 suffering from genital itching (regardless of aetiology) who had been not been treated for vulvovaginitis or vulvovaginosis during the 30 days prior to their inclusion in the study and had not used any topical pharmaceutical product during the 8 days before beginning treatment recommended by the study. Patients were excluded who were suffering from psychiatric or mental disorders, difficult to control, pregnant or had a history of drug allergy. The patients' ages, itching intensity, presence of leukorrhoea (vulvar irritation) and associated infectious agents were classified. Results: 152 patients were included in the study after fulfilling the inclusion criteria; 2 of them were excluded for not attending the last control at the end of the treatment. 83.6% reported no itching by this time, or only minimum intensity, and 11.8% regarded it as just being slight. Itching initially classified by 30.5% of the patients as being severe at the start was only rated so by 2.6% on the second day; 1.3% still rated it as being severe at the end of therapy. Similar results were obtained in the subgroups suffering from single candida infection or single bacteria. Conclusion: the supplementary local use of a 2% topical burdock solution in women suffering from genital itching could be an effective management alternative.