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

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)

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

“…Due to the fact that no information is given concerning the distribution of CIN1 and CIN2, the groups are not comparable. Because of this lack of important information in this study a statement of the treatment efficacy is difficult [ 32 ]. Two other randomized controlled trials, however only for CIN2 and more ( +), showed significant treatment results.…”

The efficacy of vaginal suppository based on myrtle in patients with cervicovaginal human papillomavirus infection: A randomized, double‐blind, placebo trial

“…In their study, 78 patients aged 18–39, with CIN1/2 from 90 to 180 days, received a medication depending on the improvement. The rate of CIN regression, based on histology, was 100% in the 200‐mg dose group, 95% at a dose of 100 mg, and 61% in the placebo group (Ashrafian et al, ). Although complete response in our study was 52%, but the time for intervention was also lower (3 months against 6 months).…”

Phytochemicals in Gynecological Cancer Prevention

“…In the group of women receiving DIM at a dose of 200 mg/day and 100 mg/day, a 100% (CI 95% = 82.35–100.00%) and 90.5% (CI 95% = 69.62–98.83%) regression of CIN lesions on histological examination were observed, respectively. However, in the placebo group, only 61.1% of the patients had a regression of the lesions on histological examination (CI 95% = 35.75–82.70%) [ 129 ]. The presented results indicate a significant potential of I3C and its DIM derivative in the chemoprevention of cervical cancer.…”