ArticleThe EPMA journal2015
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.
Article in The EPMA journal, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers.
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Who cites it
13 citing papers in PubMed, 26 citations in OpenAlex.
- Efficacy and safety of an adsorbent and anti-oxidative vaginal gel on CIN1 and 2, on high-risk HPV, and on p16/Ki-67: a randomized controlled trial.Archives of gynecology and obstetrics · 2021Trial
- Integrated Lipidomics and Network Pharmacology Reveal the AMPK-Mediated Therapeutic Mechanism of 3,3'-Diindolylmethane in Hepatic Lipid Metabolism.Antioxidants (Basel, Switzerland) · 2025Article
- Review
- Bacterial Metabolites: A Link between Gut Microbiota and Dermatological Diseases.International journal of molecular sciences · 2023Review
- Synthetic Methodologies and Therapeutic Potential of Indole-3-Carbinol (I3C) and Its Derivatives.Pharmaceuticals (Basel, Switzerland) · 2023Review
- Indole-3-carbinol in vitro antiviral activity against SARS-Cov-2 virus and in vivo toxicity.Cell death discovery · 2022Article
- Natural Bioactives: Back to the Future in the Fight against Human Papillomavirus? A Narrative Review.Journal of clinical medicine · 2022Review
- 3,3'-Diindolylmethane Exhibits Significant Metabolism after Oral Dosing in Humans.Drug metabolism and disposition: the biological fate of chemicals · 2021Article
- The interplay between the vaginal microbiome and innate immunity in the focus of predictive, preventive, and personalized medical approach to combat HPV-induced cervical cancer.The EPMA journal · 2021Review
- Phytochemicals in Gynecological Cancer Prevention.International journal of molecular sciences · 2021Review
- Indoles Derived From Glucobrassicin: Cancer Chemoprevention by Indole-3-Carbinol and 3,3'-Diindolylmethane.Frontiers in nutrition · 2021Review
- An Adsorptive and Antioxidant Vaginal Gel Clears High-Risk HPV- and p16/Ki-67-Associated Abnormal Cytological Cervical Findings: AFrontiers in medicine · 2021Article
- Topical therapies for the treatment of cervical intraepithelial neoplasia (CIN) 2-3: A narrative review.Gynecologic oncology reports · 2020Review
Corrections and comments
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Authors and funding
9 authors at 4 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundThe 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.
methodsA 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).
resultsThe 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.
conclusionsThus, 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 registrationID: ChiCTR-INR-15007497 (2 December 2015).
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