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Abstract：
BACKGROUND: Endometrial cancer is the second most frequent genital malignancy in women, which is showing a constant rise all over world. Endometrial hyperplasia is the precursor of endometrial cancer. Levonorgestrel intrauterine system is the first line management in patients with endometrial hyperplasia without atypia. Metformin has shown to reverse endometrial hyperplasia, but its effectiveness and safety in endometrial hyperplasia is uncertain.
OBJECTIVE: To compare the efficacy in terms of histopathological response, clinical response and safety at the end of 6 months in patients with endometrial hyperplasia without atypia managed with Levonorgestrel intrauterine system alone versus patients managed with Levonorgestrel intrauterine system plus metformin.
METHODS: The randomized control trial was conducted on 51 cases of endometrial hyperplasia without atypia. Twenty-five subjects were prescribed metformin 500mg twice daily with Levonorgestrel intrauterine system and 26 subjects, with Levonorgestrel intrauterine system only for 6 months. At the end of 6 months, endometrial sampling was performed for histopathological response.
RESULTS: Clinical response was observed in 23 of 25 subjects in metformin group and 22 of 24 in Levonorgestrel only group. The metformin group responded significantly with amenorrhea (p= 0.0053), while Levonorgestrel only group responded with regular cycles (p=0.027). At the end of study, of 46 subjects available for histopathological evaluation, 100% subjects in metformin group and 95.45% in Levonorgestrel only group (p=0.47826) showed complete response. The metformin group had a significant reduction in body mass index at end of study [P = 0∙023, 95% confidence interval (-1.7802, -0.1418)].
CONCLUSIONS: No significant difference in regression of endometrial hyperplasia was observed on adjunctive use of metformin but a significant reduction in BMI was observed. Use of metformin in obese patients may improve the treatment response.
OBJECTIVE: To compare the efficacy in terms of histopathological response, clinical response and safety at the end of 6 months in patients with endometrial hyperplasia without atypia managed with Levonorgestrel intrauterine system alone versus patients managed with Levonorgestrel intrauterine system plus metformin.
METHODS: The randomized control trial was conducted on 51 cases of endometrial hyperplasia without atypia. Twenty-five subjects were prescribed metformin 500mg twice daily with Levonorgestrel intrauterine system and 26 subjects, with Levonorgestrel intrauterine system only for 6 months. At the end of 6 months, endometrial sampling was performed for histopathological response.
RESULTS: Clinical response was observed in 23 of 25 subjects in metformin group and 22 of 24 in Levonorgestrel only group. The metformin group responded significantly with amenorrhea (p= 0.0053), while Levonorgestrel only group responded with regular cycles (p=0.027). At the end of study, of 46 subjects available for histopathological evaluation, 100% subjects in metformin group and 95.45% in Levonorgestrel only group (p=0.47826) showed complete response. The metformin group had a significant reduction in body mass index at end of study [P = 0∙023, 95% confidence interval (-1.7802, -0.1418)].
CONCLUSIONS: No significant difference in regression of endometrial hyperplasia was observed on adjunctive use of metformin but a significant reduction in BMI was observed. Use of metformin in obese patients may improve the treatment response.
摘要：
背景：子宫内膜癌是女性第二常见的生殖器恶性肿瘤，这在全世界都显示出不断的上升。子宫内膜增生是子宫内膜癌的前兆。左炔诺孕酮宫内节育系统是无异型子宫内膜增生患者的一线治疗方法。二甲双胍有逆转子宫内膜增生的作用,但其在子宫内膜增生中的有效性和安全性尚不确定。
目的：比较组织病理学反应方面的疗效，与单用左炔诺孕酮宫内节育器联合二甲双胍治疗的子宫内膜增生患者相比,单用左炔诺孕酮宫内节育器系统治疗6个月末的临床疗效和安全性.
方法：对51例无异型子宫内膜增生患者进行随机对照试验。25名受试者服用二甲双胍500mg，每日两次，左炔诺孕酮宫内节育系统和26名受试者，左炔诺孕酮宫内节育系统仅6个月。在六个月结束时，子宫内膜取样是为了观察组织病理学反应.
结果：在二甲双胍组25名受试者中的23名和仅左炔诺孕酮组24名受试者中的22名观察到临床反应。二甲双胍组对闭经有显著反应(p=0.0053),而仅左炔诺孕酮组有规律的周期反应(p=0.027)。在研究结束时,在46名可用于组织病理学评估的受试者中，二甲双胍组100％的受试者和左炔诺孕酮组95.45％的受试者（p=0.47826）显示完全反应。二甲双胍组的体重指数在研究结束时显著降低[P=0·023,95%置信区间(-1.7802,-0.1418)]。
结论：辅助使用二甲双胍对子宫内膜增生的消退无显著差异，但BMI显著降低。在肥胖患者中使用二甲双胍可以改善治疗反应。
目的：比较组织病理学反应方面的疗效，与单用左炔诺孕酮宫内节育器联合二甲双胍治疗的子宫内膜增生患者相比,单用左炔诺孕酮宫内节育器系统治疗6个月末的临床疗效和安全性.
方法：对51例无异型子宫内膜增生患者进行随机对照试验。25名受试者服用二甲双胍500mg，每日两次，左炔诺孕酮宫内节育系统和26名受试者，左炔诺孕酮宫内节育系统仅6个月。在六个月结束时，子宫内膜取样是为了观察组织病理学反应.
结果：在二甲双胍组25名受试者中的23名和仅左炔诺孕酮组24名受试者中的22名观察到临床反应。二甲双胍组对闭经有显著反应(p=0.0053),而仅左炔诺孕酮组有规律的周期反应(p=0.027)。在研究结束时,在46名可用于组织病理学评估的受试者中，二甲双胍组100％的受试者和左炔诺孕酮组95.45％的受试者（p=0.47826）显示完全反应。二甲双胍组的体重指数在研究结束时显著降低[P=0·023,95%置信区间(-1.7802,-0.1418)]。
结论：辅助使用二甲双胍对子宫内膜增生的消退无显著差异，但BMI显著降低。在肥胖患者中使用二甲双胍可以改善治疗反应。
