Low-dose oral contraceptive pill for dysmenorrhea associated with endometriosis: a placebo-controlled, double-blind, randomized trial
Low-dose oral contraceptive pill for dysmenorrhea associated with endometriosis: a placebo-controlled, double-blind, randomized trial
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DOI：
10.1016/j.fertnstert.2007.08.051
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发表时间：
2008-11-01
影响因子：
6.7
通讯作者：
Terakawa, Naoki
中科院分区：
文献类型：
--
作者：
Harada, Tastuku;Monzoeda, Mikio;Terakawa, Naoki
目的：评估低剂量口服避孕药（OCP）对子宫内膜异位症相关痛经患者的疗效。设计：双盲、随机、安慰剂对照试验。地点：日本的临床试验地点。患者：100 名患有子宫内膜异位症相关痛经的患者。大多数入组患者有子宫内膜异位症的放射学证据，而不是手术诊断。 干预措施：患者被随机分配接受单相 OCP（炔雌醇加炔诺酮）或安慰剂。受试者在试验过程中根据需要使用常用的止痛药物。主要结果指标：经过四次循环治疗后，我们使用零至三分言语评定量表和视觉模拟量表来衡量日常生活中因痛经而导致的残疾严重程度，以及患者使用镇痛药的情况。结果：两组治疗结束时言语评定量表评估的痛经总分均显着下降。从第一个周期到治疗结束，OCP 组的痛经明显比安慰剂组轻。 OCP 组的 24.5%（49 人中的 12 人）和安慰剂组的 34.0%（47 人中的 16 人）在基线时出现非经期盆腔疼痛。 OCP 组子宫内膜异位囊肿（直径大于 3 厘米）的体积显着减小，但安慰剂组则没有。没有发生与使用 OCP 相关的严重不良事件。结论：本研究首次明确证明 OCP 可以有效且安全地治疗与子宫内膜异位症相关的疼痛。 （Fertil Steril(R) 2008；90:1583-8。(C)2008，美国生殖医学会。）
Objective: To evaluate the efficacy of a low-dose oral contraceptive pill (OCP) for patients with dysmenorrhea associated with endometriosis.Design: A double-blind, randomized, placebo-controlled trial. Settings: Clinical trial sites in Japan.Patient(s): One hundred patients with dysmenorrhea associated with endometriosis. Most enrolled patients had radiologic evidence of endometriosis rather than surgical diagnosis.Intervention(s): Patients were randomly assigned to receive either monophasic OCP (ethinylestradiol plus norethisterone) or placebo. Participants used their usual pain medications as needed during the trial.Main Outcome Measure(S): After four cyclic treatments, we used a zero- to three-point verbal rating scale and a visual analogue scale to measure the severity of disability because of dysmenorrhea in daily life, and the patients' use of analgesics.Result(s): Total dysmenorrhea scores assessed by the verbal rating scale were significantly decreased at the end of treatment in both groups. From the first cycle through the end of treatment, dysmenorrhea in the OCP group was significantly milder than in the placebo group. Nonmenstrual pelvic pain was present at baseline in 24.5% (12 of 49) of the OCP group and 34.0% (16 of 47) of the placebo group. The volume of endometrioma (larger than 3 cm in diameter) was significantly decreased in the OCP group, but not in the placebo group. No serious adverse events related to using OCPs occurred.Conclusion(s): The present study clearly demonstrated for the first time that OCPs could be used to effectively and safely treat pain associated with endometriosis. (Fertil Steril(R) 2008;90:1583-8. (C)2008 by American Society for Reproductive Medicine.)