Metformin versus levonorgestrel-releasing intrauterine system in the management of endometrial hyperplasia: a randomized clinical trial

Abstract

Background Endometrial hyperplasia is one of the common causes of bleeding in perimenopausal women. Variable treatment options aim to induce regression. The current study evaluated the regression rate of endometrial hyperplasia after treatment with levonorgestrel intrauterine system (LNG- IUS) versus Metformin. Methods This randomized clinical trial was conducted at the obstetrics and gynecology department of Suez Canal University hospital. We recruited women diagnosed with endometrial hyperplasia without atypia. Patients were allocated into two groups. Group one included patients treated with levonorgestrel-releasing intrauterine system and group two treated with Metformin. The rate of regression of hyperplasia in both groups after six months of intervention was the main outcome measure. Results Significant regression of hyperplasia was noted in the LNG-IUS group (96% versus 64%, p-value 0.009). There was a significant decrease in the endometrial thickness after treatment in both groups (17.65 ± 4.62 and 5.3 ± 2.01 in the LNG- IUS with a p-value < 0.001) (19.57 ± 6.84 and 11.22 ± 7.51 in the metformin group with a p-value < 0.001). Factors that correlated with the Δ endometrial thickness included parity in the LNG- IUS group (p-value 0.019) and age and BMI in the metformin group (p-value 0.043 and 0.004 respectively). Conclusion Metformin had a regressive effect on endometrial hyperplasia; however, it was not significant as that achieved with the levonorgestrel intrauterine system. Trial registrations PACTR201908498370196. Date of registration: 21/8/2019. Date of first patient enrollment: 25/8/2019. URL: https://pactr.samrc.ac.za/Researcher/TrialRegister.aspx?TrialID=9335