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

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 ab...

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Published in:	British journal of cancer 2012-01, Vol.106 (1), p.45-52
Main Authors:	CASTANON, A, TRISTRAM, A, MESHER, D, POWELL, N, BEER, H, ASHMAN, S, RIECK, G, FIELDER, H, FIANDER, A, SASIENI, P
Format:	Article
Language:	eng
Subjects:	Adult Alphapapillomavirus - isolation & purification Anticarcinogenic Agents - adverse effects Anticarcinogenic Agents - pharmacology Anticarcinogenic Agents - therapeutic use Apoptosis - drug effects Biological and medical sciences Cervical Intraepithelial Neoplasia - drug therapy Cervical Intraepithelial Neoplasia - virology Clinical Study Double-Blind Method Female Female genital diseases Gynecology. Andrology. Obstetrics Humans Indoles - adverse effects Indoles - pharmacology Indoles - therapeutic use Medical sciences Middle Aged Placebos Tumors Uterine Cervical Neoplasms - prevention & control
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Summary:	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. We conducted a pragmatic double-blind, randomised controlled trial of 150 mg 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. 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. The results suggest that short-term DIM supplementation (150 mg day(-1)) is well tolerated, but is unlikely to have an effect on cytology or HPV infection. Uncertainty remains regarding its effect on CIN2+.
ISSN:	0007-0920 1532-1827