Objectives Imiquimod could be offered as a non-surgical treatment alternative to LLETZ in treatment of high-grade CIN, for women who wish to avoid surgery. Short term effectiveness of imiquimod is 60–70%. In the current study, we present the two-year follow-up results after successful initial imiquimod treatment, compared to LLETZ treatment.

Methods We performed a multi-center, non-randomized trial, in which women with a histological diagnosis of CIN 2/3 were treated with either imiquimod during 16 weeks or underwent LLETZ. All women who had initial successful treatment were included in further analysis.

Follow-up consisted of regular pap smears according to Dutch guidelines during two years. Successful treatment was defined as no histologic CIN 2/3 diagnosis during follow-up.

Results A total of 84 women were included in the analysis (27 from the imiquimod group and 57 from the LLETZ group). CIN2/3 was diagnosed in one woman (2%) in LLETZ group and two women in the imiquimod group (7%), all underwent additional LLETZ treatment (p=0.26). For both entire groups, HPV status at 2 year follow-up was similar. CIN grade at inclusion, HPV status at short term follow-up, age, parity and smoking were not identified as factors associated with successful treatment.

Conclusions Disease recurrence of high-grade CIN two years after successful treatment with imiquimod is infrequent and is not statistically different from LLETZ treatment. This indicates a lasting effectiveness of imiquimod treatment.