Clinical Study

BJC Open article

British Journal of Cancer (2012) 106, 45–52. doi:10.1038/bjc.2011.496 www.bjcancer.com
Published online 10 November 2011

Effect of diindolylmethane supplementation on low-grade cervical cytological abnormalities: double-blind, randomised, controlled trial

A Castañon1, A Tristram2, D Mesher1, N Powell2, H Beer3, S Ashman2, G Rieck2, H Fielder3, A Fiander2,4 and P Sasieni1,4

  1. 1Centre for Cancer Prevention, Wolfson Institute of Preventive Medicine, Queen Mary University of London, Charterhouse Square, London EC1M 6BQ, UK
  2. 2Department Obstetrics & Gynaecology, School of Medicine, Cardiff University, Heath Park, Cardiff CF14 4XN, UK
  3. 3Cervical Screening Wales, 18 Cathedral Road, Cardiff CF11 9LJ, UK

Correspondence: Professor P Sasieni, E-mail: p.sasieni@qmul.ac.uk

4Joint last authors.

Received 2 August 2011; Revised 10 October 2011; Accepted 11 October 2011
Advance online publication 10 November 2011

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Abstract

Background:

  

Cervical screening identifies many women with low-grade abnormalities. In vitro and in vivo studies have shown that diindolylmethane (DIM) could potentially halt (cervical) carcinogenesis. We report on a randomised controlled trial of the effect of DIM in women with low-grade cervical cytological abnormalities.

Methods:

  

We conducted a pragmatic double-blind, randomised controlled trial of 150mg DIM (from BioResponse DIM) or placebo daily for 6 months in women with newly diagnosed, low-grade cytological abnormalities. Randomisation was in the ratio 2 (DIM) to 1 (placebo). All women were invited for colposcopy at 6 months with biopsy of any abnormality.

Results:

  

Of the 551 randomised women available for analysis, 9% on DIM and 12% on placebo had cervical intraepithelial neoplasia-2 (CIN2) or worse after 6-month supplementation (risk ratio (RR) 0.7 (95% confidence interval (CI): 0.4–1.2)), whereas 4.6% and 5.1%, respectively, had CIN3 or worse (RR 0.9 (95% CI: 0.4–2.0)). A total of 27.3% of women on DIM and 34.3% on placebo had no sign of disease (negative cytology, colposcopy and human papilloma virus (HPV) tests) at 6 months (RR 0.8 (95% CI: 0.6–1.0)). Of those HPV-positive at baseline, 69% (114 out of 166) of the DIM group were positive at 6 months compared with 61% (43 out of 71) of the placebo group: RR 1.1 (95% CI: 0.9–1.4). Diindolylmethane supplementation was well tolerated.

Conclusion:

  

The results suggest that short-term DIM supplementation (150mgday−1) is well tolerated, but is unlikely to have an effect on cytology or HPV infection. Uncertainty remains regarding its effect on CIN2+.

Keywords:

cervical intraepithelial neoplasia; chemoprevention; diindolylmethane (DIM); randomised, controlled trial; indole-3-carbinol (I3C); human papillomavirus (HPV); food supplement