Role of a medical device for intra-vaginal use in improving the quality of the colposcopic examination and the anatomical/pathological reading of the cytological test and biopsy

Acta Biomed. 2014 Aug 20;85(2):121-6.

Abstract

To evaluate the efficacy of a vaginal suppository in overcoming unsatisfactory colposcopy and/or possible change in terms of diagnosis in women who have had abnormal cervical cytology, 98 females were enrolled and treated for 10 days with Kramegin®, a vaginal product in tablets containing Lactobacillus acidophilus, lactic acid and Krameria triandra extract. Seventy-eight of 98 females completed the study. Seventy-fife of 78 volunteers served for the statistical analysis. According to the results got, diagnoses were modified in almost 62% of cases; cervical conization was reduced in 58% of cases; regression for HSIL (to LSIL) was 35% higher than expected; need of follow-up decreased by 36% and treatment was well tolerated in about 96% of cases. Use of Kramegin® before colposcopy can be considered a good tool to increase the possibility of turning unsatisfactory colposcopy into satisfactory and seems to indicate a possible role in reducing cervical lesion progression. Deeper clinical investigations are mandatory to confirm this possible result.

Publication types

  • Clinical Trial

MeSH terms

  • Adult
  • Aged
  • Biopsy / methods
  • Biopsy / standards*
  • Colposcopy / methods
  • Colposcopy / standards*
  • Equipment Design
  • Female
  • Humans
  • Middle Aged
  • Predictive Value of Tests
  • Pregnancy
  • Quality Improvement*
  • Suppositories
  • Vagina
  • Vaginitis / diagnosis
  • Vaginitis / drug therapy*

Substances

  • Suppositories