Efficacy of the novel pharmaceutical composition in suppository form comprising dim in patients with grade 1-2 cervical intraepithelial neoplasia (CIN 1-2)

Purpose of the study: To evaluate efficacy, optimal dose and the treatment duration of the novel pharmaceutical composition «Cervicon-DIM» in suppository form containing 3,3’-diindolylmethane (DIM) substance in patients with grade 1-2 cervical intraepithelial neoplasia (CIN 1-2). Materials and methods: 78 patients with CIN 1-2 were included and randomized to three groups. The patients in the first group received 100 mg DIM intravaginally per day. In the second group the patients received 200 mg DIM intravaginally per day. In the control group patients received placebo. The treatment lasted for 3 or 6 months. An assessment of the therapeutic response was performed using histologic examination (complete regression of cervical lesions war the major criterion of effectiveness). Results: We found a statistically significant difference in efficacy between the first experimental group (dose 100 mg DIM per day) and placebo after six months of treatment (90,5% versus 61,1%; р=0,036). We observed significant difference in efficacy between the second experimental group (dose 200 mg DIM per day) and the control group after three month of therapy (85,0% versus 52,6%; p=0,032) and six months of therapy (100% versus 61,1%; р=0,0361). Conclusions: Efficacy of the therapy of patients with CIN 1-2 by intravaginal application of the «Cervicon-DIM» at a dose of 100 mg DIM per day and 200 mg of DIM per day has been observed after three months of treatment. However, statistically significant difference in efficacy between the experimental drug and placebo was shown only at a dose of 200 mg of DIM per day. Both doses of the «Cervicon-DIM» were associated with a statistically significant increase in efficacy (compared with control) after six months therapy of patients with CIN 1-2. We recommend treatment for three months at a dose 200 mg of DIM per day. This regimen is expected to achieve high efficacy and minimize possible side effects.