Post-laparoscopic oral contraceptive combined with Chinese herbal mixture in treatment of infertility and pain associated with minimal or mild endometriosis: a randomized controlled trial.

Shaomi Zhu,Lu Zhou,Wei Huang,Qiuyi Wang,Dong Liu,Guimei Feng,Qiushi Wang

doi:10.1186/1472-6882-14-222

Abstract

BackgroundEndometriosis 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.MethodsA 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.ResultsThe 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.ConclusionsCombination 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.Trial registrationChiCTR-TRC-11001820

Highlights

IntroductionThe 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
Endometriosis is a condition in which endometrial glands and stromal implants grow outside the uterus, causing chronic pelvic pain and infertility
A lot of studies have demonstrated no difference in pregnancy rates with preceding ovulation suppression with oral contraceptives, progestins, or danazol in infertile women with endometriosis, only a few trials have investigated whether laparoscopy combined with medical treatment is beneficial for the treatment of women with minimal/mild endometriosis [12]

Summary

Introduction

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. Current therapy for these women involves the use of surgical methods including laparoscopy, expectant treatment, induced ovulation, and assisted reproductive technology (ART) [3,4] and medication that induces a pseudomenopause or pseudopregnancy state. A Canadian RCT involving 341 women with minimal or mild disease followed up for 36 weeks after laparoscopy reported that surgery was more effective than no treatment and treatment with pharmaceutical agents alone [5]. There is a need to determine the usefulness of postoperative medical treatment in these cases, which is what our study set out to do

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Conclusion