Reproductive Endocrinology Research Center, Research Institute for Endocrine Sciences, Shahid Beheshti University of Medical Sciences, No 24, Parvane Street, Yaman Street, Velenjak, P.O.Box: 19395-4763, Tehran, Iran.
Endocrine Research Center, Research Institute for Endocrine Sciences, Shahid Beheshti University of Medical Sciences, Tehran, Iran.
J Ovarian Res. 2019 Aug 30;12(1):78. doi: 10.1186/s13048-019-0554-9.
Reduction of the body iron stores can improve hyperandrogenemia and insulin resistance. This study aimed to compare clinical and para-clinical responses to the treatment of phlebotomy using oral contraceptive pills (OCs) containing cyproterone acetate in women with PCOS.
In this randomized clinical trial, 64 patients with PCOS were randomly assigned to the phlebotomy and OCs groups (n = 32 in each group). The intervention group, using a single treatment procedure, underwent venesection of 450 mL of whole blood at the early follicular phase of the spontaneous or progesterone-induced menstrual cycle. The control group received OCs pills for 3 months from the 1th day of spontaneous or progesterone-induced menstrual cycle onwards for 3 weeks, followed by a pill-free interval of 7 days. The women were evaluated after the 3-month intervention. The primary outcome measure was a change in the HOMA-IR and free androgen index (FAI). Secondary outcomes were changes in the Ferriman-Gallwey (FG) score and other clinical, biochemical and hormonal changes from the baseline (pre-treatment) to week 12.
In the phlebotomy group, 27 (84.3%) and in the OCs group 30 (93.7%) of the women completed the 3-month follow-up. The median HOMA-IR significantly decreased from 3.5 to 2.7 in the phlebotomy, and from 3.1 to 2.8 in the OCs group, and the changes were comparable between the groups. Median changes in the FAI significantly decreased in both groups, but the differences were not statistically significant between the groups (P = 0.061). With regard to secondary outcomes, mean FG scores in both groups significantly decreased [from 16.8 (6) to 13.3 (7.4), P < 0.028] in the phlebotomy group and [from 14.3 (7) to 9.8 (7.6) in the OCs group, P = 0.001] after 3 months of treatment, but such changes had no statistically significant differences between the groups. During treatment, menstrual cycles became regular in all women in the OCs group and in 12.27 (44.4%) of the women in the phlebotomy group, and the difference was statistically significant (P = 0.001). Despite no statistically significant differences in lipid profiles between the groups at the baseline, triglycerides were significantly higher in the OCs group compared to the phlebotomy at end of follow up (p = 0.019).
Both treatment modalities had similar beneficial effects on insulin resistance and on androgenic profiles. However, OCs was reported more effective in treating menstrual irregularities and phlebotomy had less adverse effects on triglyceride concentrations.
Code: IRCT2013080514277N1 .
减少体内铁储存可以改善高雄激素血症和胰岛素抵抗。本研究旨在比较使用含有醋酸环丙孕酮的口服避孕药（OC）进行放血治疗对多囊卵巢综合征（PCOS）妇女的临床和临床前反应。
在这项随机临床试验中，将 64 名 PCOS 患者随机分为放血和 OC 组（每组 32 名）。干预组采用单次治疗程序，在自然或孕激素诱导的月经周期的早卵泡期抽取 450 毫升全血。对照组从自然或孕激素诱导的月经周期第 1 天开始服用 OC 药丸 3 个月，持续 3 周，然后停药 7 天。女性在 3 个月干预后进行评估。主要结局指标是 HOMA-IR 和游离雄激素指数（FAI）的变化。次要结局是从基线（治疗前）到第 12 周时 Ferriman-Gallwey（FG）评分和其他临床、生化和激素变化。
在放血组中，27 名（84.3%）和 OC 组中 30 名（93.7%）妇女完成了 3 个月的随访。HOMA-IR 中位数从放血组的 3.5 降至 2.7，OC 组从 3.1 降至 2.8，两组间的变化相当。两组的 FAI 中位数均显著降低，但组间差异无统计学意义（P=0.061）。关于次要结局，两组的平均 FG 评分均显著降低[放血组从 16.8（6）降至 13.3（7.4），P<0.028]，OC 组从 14.3（7）降至 9.8（7.6），P=0.001]治疗 3 个月后，但组间无统计学差异。在治疗过程中，OC 组所有妇女的月经周期变得规律，放血组有 12.27%（44.4%）的妇女出现这种情况，差异具有统计学意义（P=0.001）。尽管两组基线时血脂谱无统计学差异，但治疗结束时 OC 组的甘油三酯明显高于放血组（P=0.019）。
两种治疗方法对胰岛素抵抗和雄激素谱均有类似的有益作用。然而，OC 被报道在治疗月经不规律方面更有效，而放血对甘油三酯浓度的不良影响较小。
代码：IRCT2013080514277N1。
