A randomized phase II trial of indole-3-carbinol in the treatment of vulvar intraepithelial neoplasia. Issue 2 (1st March 2006)

• Record Type: Journal Article
• Authors: Naik, R.; Nixon, S.; Lopes, A.; Godfrey, K.; Hatem, M. H.; Monaghan, J. M.
• Is Part Of: International journal of gynecological cancer. Volume 16:Issue 2(2006)
• Page Start: 786
• Page End: 790
• Publication Date: 2006-03-01
• Subjects: vulvar intraepithelial neoplasia -- vulvar precancer -- indole-3-carbinol -- randomized -- trial; Generative organs, Female -- Cancer -- Periodicals; 616.99465
• DOI: 10.1136/ijgc-00009577-200603000-00050
• Languages: English
• ISSNs: 1048-891X

Abstract

Abstract : The aim of this study was to determine the potential therapeutic benefits of indole-3-carbinol (I3C) in the management of vulvar intraepithelial neoplasia (VIN). Women with histologically confirmed high-grade VIN were randomized to receive 200 and 400 mg/day of I3C. Symptomatology by visual analog scale and vulvoscopic appearance were assessed at recruitment, 6 weeks, 3 months, and 6 months. Tissue biopsy to determine histologic response was obtained at completion of the study period. Urine samples were obtained at each visit to determine 2-hydroxyestrone to 16-alpha-hydroxyestrone ratios. Data from 12 women were suitable for analysis. There was a significant improvement in symptomatology with the introduction of I3C (itch, P = 0.018; pain, P = 0.028). Lesion size and severity were also significantly reduced (size, P = 0.005; appearance, P = 0.046). In addition, there was a significant increase in 2-hydroxyestrone to 16-alpha-hydroxyestrone ratio following commencement of I3C, P = 0.05. However, tissue biopsy from the worst-affected vulval areas revealed no improvement in grade of VIN during the 6-month period, P = 0.317. There were no significant differences in results between those women taking 200 mg/day of I3C and those on 400 mg/day. This study has shown significant clinical improvement in symptomatology and vulvoscopic appearance of VIN with I3C therapy. Further clinical and scientific investigations are required to support these preliminary findings.