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Double-blind Randomized Placebo-Controlled Multicenter Clinical Trial (Phase IIa) on Diindolylmethane's Efficacy and Safety in the Treatment of CIN: Implications for Cervical Cancer Prevention

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Double-blind Randomized Placebo-Controlled Multicenter Clinical Trial (Phase IIa) on Diindolylmethane's Efficacy and Safety in the Treatment of CIN: Implications for Cervical Cancer Prevention

Levon Ashrafian et al. EPMA J.

Abstract

Background: The article presents the results of a clinical trial on the efficacy and safety of a novel pharmaceutical composition in the form of vaginal suppositories containing diindolylmethane in the course of cervical intraepithelial neoplasia (CIN) I-II conservative treatment. It offers an attractive drug therapy for more personalized prevention of cervical cancer.

Methods: A total of 78 women of reproductive age were included. This was a multicenter, randomized, placebo-controlled, double-blind, parallel-group trial with efficacy determined by histological evaluation of cervical biopsies. The efficacy of active drug treatment (100 and 200 mg/day) in both treatment groups was significantly higher in comparison with the placebo group, according to the primary efficacy end point (proportion of patients with complete CIN regression after 90-180 days of the study drug treatment).

Results: The efficacies were 100.0 % (confidence interval (CI) 95 %: 82.35-100.00 %), 90.5 % (CI 95 %: 69.62-98.83 %), and 61.1 % (CI 95 %: 35.75-82.70 %), for the high dose, low does, and placebo, respectively. Adverse events in the placebo group were reported in 22 % of patients (CI 95 %: 7.5-43.7 %); in the first treatment group (100 mg/day), adverse events were reported in 40.0 % of patients (CI 95 %: 21.1-61.3 %); in the second treatment group (200 mg/day), adverse events were reported in 42.0 % of patients (CI 95 %: 22.1-63.4 %). The differences in side effects between treatment groups treated with the active drug and placebo were statistically significant. No serious adverse events were reported in any of the groups.

Conclusions: Thus, the use of diindolylmethane in the form of intravaginal suppositories can be effective in patients with CIN I-II and is not accompanied by clinically significant side effects. This approach could be a better option for young women with CIN I-II as it takes in attention their reproductive plans.

Trial registration: ID: ChiCTR-INR-15007497 (2 December 2015).

Keywords: CIN I; CIN II; Cervical intraepithelial neoplasia; Clinical trial; Diindolylmethane; Predictive preventive personalized medicine; Targeted prevention.

Figures

Fig. 1
Fig. 1
Effectiveness of the therapy according to the data of histological examination (90–180 days of treatment)

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References

    1. Soutter WP, Sasieni P, Panoskaltsis T. Long-term risk of invasive cervical cancer after treatment of squamous cervical intraepithelial neoplasia. Int J Cancer. 2006;118(8):2048–55. doi: 10.1002/ijc.21604. - DOI - PubMed
    1. Ferlay J, Soerjomataram I, Ervik M, Dikshit R, Eser S, Mathers C, et al. Cancer incidence and mortality worldwide: IARC CancerBase, 11. Lyon, France: International Agency for Research on Cancer; 2013. GLOBOCAN 2012 v1.0. 2012.
    1. Burd EM. Human papillomavirus and cervical cancer. Clin Microbiol Rev. 2003;16(1):1–17. doi: 10.1128/CMR.16.1.1-17.2003. - DOI - PMC - PubMed
    1. Schmitz M, Driesch C, Jansen L. Non-random integration of the HPV genome in cervical cancer. PLoS One. 2012;7(6):e39632. doi: 10.1371/journal.pone.0039632. - DOI - PMC - PubMed
    1. Munoz N, Kato I, Bosch FX, Eluf-Neto J, De Sanjosé S, Ascunce N, et al. Risk factor for HPV DNA detection in middle-aged women. Sex Transm Dis. 1996;23(6):504–10. doi: 10.1097/00007435-199611000-00012. - DOI - PubMed

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