@article {Naik786, author = {R. Naik and S. Nixon and A. Lopes and K. Godfrey and M. H. Hatem and J. M. Monaghan}, title = {A randomized phase II trial of indole-3-carbinol in the treatment of vulvar intraepithelial neoplasia}, volume = {16}, number = {2}, pages = {786--790}, year = {2006}, doi = {10.1136/ijgc-00009577-200603000-00050}, publisher = {BMJ Specialist Journals}, 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.}, issn = {1048-891X}, URL = {https://ijgc.bmj.com/content/16/2/786}, eprint = {https://ijgc.bmj.com/content/16/2/786.full.pdf}, journal = {International Journal of Gynecologic Cancer} }