THE EFFICACY AND SAFETY OF DIINDOLYLMETHANE IN THE VAGINAL SUPPOSITORY DOSAGE FORM IN THE TREATMENT OF CERVICAL INTRAEPITHELIAL NEOPLASIA

DOI: https://doi.org/None

L.A. Ashrafyan (1), G.T. Sukhikh (2), V.I. Kiselev (3), I.A. Apolikhina (2), M.A. Paltsev (4), V.M. Drukh (3), I.N. Kuznetsov (5), E.L. Muyzhnek (6) 1 -Russian Scientific Center of Roentgenoradiology, Profsoyuznaya str., 86, Moscow, 117997, Russian Federation; 2 -Research Center for Obstetrics, Gynecology and Perinatology, Oparina str., 4, Moscow, 117997, Russian Federation; 3 -Peoples’ Friendship University of Russia, Miklukho-Maklaya str., 6, Moscow, 117198, Russian Federation; 4 -Russian Academy of Sciences, Leninsky av., 14, Moscow, 119991, Russian Federation; 5 -Moscow State University of Medicine and Dentistry named after A.I. Evdokimov, Delegatskaya Str., 20, bld. 1, Moscow, 127473, Russian Federation; 6 -ZAO «MiraxBioPharma», Kutuzovsky av., 12, Moscow, 121248, Russian Federation

The aim of the study. The clinical study of the efficacy and safety of the novel pharmaceutical composition Cervicon-DIM on the base of diindolylmethane (DIM) in vaginal suppository form in the course of the conservative treatment of cervical intraepithelial neoplasia (CIN) I–II. Methods. 78 women of childbearing age participated in the study. The study was multicenter randomized placebo-controlled double-blind and was performed in parallel groups. The efficacy of the therapy was evaluated in CIN I–II patients after intravaginal administration of the «CerviconDIM» in a dose of 100–200 mg/day. The evaluation of the efficacy was based on the histological examination of bioptates of uterine cervixResults. On the main criteria of the assessment – the proportion of patients with complete regression of CIN after 90–180 days of treatment with the preparation, the efficacy of the treatment with the active preparation (100 mg/day and 200 mg/day) in both groups was significantly higher than in the placebo group. The efficacy was 90,5% (95% CI: 69,62–98,83%), 100,0% (95% CI: 82,35–100,0%) and 61,1% (95% CI: 35, 75–82,70%), respectively. In the placebo group adverse events occurred in 22% of patients (95% CI: 7,5–43,7%). In the group with therapy with Cervicon-DIM (100 mg/day) adverse events were reported in 40,0% of patients (95% CI: 21,1–61,3%). In the group with therapy with Cervicon-DIM (200 mg/ day), adverse events were reported in 42,0% of patients (95% CI: 22,1–63,4%). Differences in efficiacy between treatment and placebo groups are significant. There were no serious adverse events in all groups. Conclusion. Thus, the use of vaginal suppository based on DIM can be efficient and is not accompanied by significant side effects in CIN I-II female patients.
Keywords: 
cervical intraepithelial neoplasia, CIN I, CIN II, diindolylmethane, DIM, Cervicon-DIM, clinical study
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