UNASSIGNED: The present double-blindplacebo-controlled clinical trial was conducted on 100 women with nonatypical endometrial hyperplasia in the age range of 30 to 45 years. Participants were randomly assigned to receive 50 mg of isoflavone (n = 50) or placebos (n = 50) daily for three months. Both groups received the standard treatment of nonatypical endometrial hyperplasia. Endometrial biopsy and blood samples were taken at the baseline and three months after the intervention. The incidence of drug side effects was assessed as well.
UNASSIGNED: After three months, 88.4% of isoflavone-administered subjects had a significant histological improvement compared to 68.9% subjects in the placebo group (P=0.02). There were no significant differences between the two groups in the changes of serum estradiol levels and the incidence of drug side effects.
UNASSIGNED: The findings of the present study demonstrated that the coadministration of 50 mg of isoflavones and medroxyprogesterone acetate increases the treatment efficacy in women with nonatypical endometrial hyperplasia. Clinical Trial Registration. This trial was registered on the Iranian website for clinical trial registration (https://www.irct.ir/trial/53553).
UNASSIGNED:本双盲安慰剂对照临床试验是对100名年龄在30至45岁之间的子宫内膜非非典型增生妇女进行的。参与者被随机分配接受50mg异黄酮(n=50)或安慰剂(n=50),每天三个月。两组均接受非非典型子宫内膜增生的标准治疗。在基线和干预后三个月采集子宫内膜活检和血液样本。还评估了药物副作用的发生率。
未经批准:三个月后,与安慰剂组的68.9%受试者相比,88.4%的异黄酮给药受试者具有显著的组织学改善(P=0.02)。两组患者血清雌二醇水平变化及药物副作用发生率差异无统计学意义。
UNASSIGNED:本研究的结果表明,50mg异黄酮和醋酸甲羟孕酮的共同给药可提高子宫内膜非非典型增生妇女的治疗效果。临床试验注册。该试验已在伊朗网站上注册,用于临床试验注册(https://www.irct.ir/trial/53553).