Department of Obstetrics and Gynecology, West China Second University Hospital of Sichuan University, Renminnanlu 3 Duan 20hao, Chengdu, Sichuan 610041, China.
BMC Complement Altern Med. 2014 Jul 5;14:222. doi: 10.1186/1472-6882-14-222.
Endometriosis affects fertility negatively. The study aims to evaluate whether laparoscopic surgery combined with oral contraceptive or herbs were more effective than laparoscopic alone in improving fecundity and pelvic pain in women with minimal/mild endometriosis.
A randomized controlled trial (RCT) was conducted in 156 infertile women with minimal/mild endometriosis. After laparoscopic surgery, patients were randomized to three groups: in Group A (n = 52) oral contraceptive (OC) was administered one pill a day, continuous for 63 days without intervals, in Group B (n = 52) OC was administered as above and then Dan'e mixture was added 30 g/day for the latter 30 days, and in control Group C (n = 52) patients tried to get pregnant after surgery without complementary treatment. The follow-up periods were 12 months in Group C and 14 months in complementary medical treatment Group A and B. The pregnant women were further followed up, and labor and pregnancy outcomes were assessed. Primary outcome was pregnancy rate (PR) and live birth rate (LBR). Secondary outcomes included changes of pelvic pain visual analog scale scores and side effects. Analyses were done as intention-to-treat.
The PR was 46.80% (73/156), and the LBR was 69.86% (51/73). Of the 73 pregnancies, 60 occurred within 12 months of follow-up and 7 of the remaining 13 patients underwent assisted reproductive technology for >1 year. No significant difference was observed in PR and LBR among the three groups. Patients given medical treatment (OCs or OCs plus herbal medicine) had significantly decreased pain scores compared with the laparoscopy alone group.
Combination of laparoscopy with OCs or OCs and herbal medicine does not have more advantages than laparoscopy alone in improving fertility of women with minimal/mild endometriosis.
ChiCTR-TRC-11001820.
子宫内膜异位症会对生育能力产生负面影响。本研究旨在评估腹腔镜手术联合口服避孕药或草药是否比单独腹腔镜手术更能提高轻度/局限性子宫内膜异位症患者的生育能力和盆腔疼痛。
对 156 名患有轻度/局限性子宫内膜异位症的不孕妇女进行了一项随机对照试验（RCT）。腹腔镜手术后，患者被随机分为三组：A 组（n=52）每天口服一粒避孕药，连续服用 63 天，无间隔；B 组（n=52）以同样的方式服用避孕药，然后在最后 30 天加用丹莪妇康煎膏 30g/天；C 组（n=52）手术后不进行补充治疗尝试自然受孕。C 组的随访期为 12 个月，A 组和 B 组的补充治疗组为 14 个月。对妊娠妇女进行进一步随访，评估分娩和妊娠结局。主要结局是妊娠率（PR）和活产率（LBR）。次要结局包括盆腔疼痛视觉模拟评分的变化和副作用。分析采用意向治疗。
PR 为 46.80%（73/156），LBR 为 69.86%（51/73）。73 例妊娠中，60 例发生在 12 个月随访内，其余 13 例中的 7 例在 1 年以上接受了辅助生殖技术。三组间 PR 和 LBR 无显著差异。接受药物治疗（避孕药或避孕药加草药）的患者疼痛评分明显低于单独腹腔镜手术组。
与单独腹腔镜手术相比，腹腔镜手术联合口服避孕药或避孕药加草药在提高轻度/局限性子宫内膜异位症患者的生育能力方面没有更多优势。
ChiCTR-TRC-11001820。
