Gonadotrophin‐releasing hormone analogue or dienogest plus estradiol valerate to prevent pain recurrence after laparoscopic surgery for endometriosis: a multi‐center randomized trial

Abstract

Objectives. To evaluate the efficacy of dienogest + estradiol valerate (E2V) and gonadotrophin-releasing hormone analogue (GnRH-a) in reducing recurrence of pain in patients with chronic pelvic pain due to laparoscopically diagnosed and treated endometriosis. Design. Multi-center, prospective, randomized study. Setting. Three university departments of obstetrics and gynecology in Italy. Population. Seventy-eight women who underwent laparoscopic surgery for endometriosis combined with chronic pelvic pain. Methods. Post-operative administration of dienogest + E2V for 9 months (group 1) or GnRH-a monthly for 6 months (group 2). Main outcome measures. A visual analogue scale was used to test intensity of pain before laparoscopic surgery at 3, 6 and 9 months of follow up. A questionnaire to investigate quality of life was administered before surgery and at 9 months of follow up. Results. The visual analogue scale score did not show any significant differences between the two groups (p = 0.417). The questionnaire showed an increase of scores for all women compared with pre-surgery values, demonstrating a marked improvement in quality of life and health-related satisfaction with both treatments. No significant differences were found between the groups. The rate of apparent endometriosis recurrence was 10.8% in group 1 and 13.7% in group 2 (p = 0.962). Conclusion. Both therapies seemed equally efficacious in preventing endometriosis-related chronic pelvic pain recurrence in the first 9 months of follow-up.Abbreviations: CA125, cancer antigen 125; CPP, chronic pelvic pain; E2V, estradiol valerate; EHP, Endometriosis Health Profile; GnRH-a, gonadotrophin-releasing hormone analogues; OC, oral contraceptive; QoL, quality of life; VAS, visual analogue scale.

Endometriosis: Epidemiology, Diagnosis and Clinical Management

“…Non-steroidal anti-inflammatory drugs (NSAIDs) and low-dose combined oral contraceptive pills (COCPs) such as ethyl estradiol and progestins are the first choice drugs [91]. If patients do not respond to NSAIDs in three months a second line of treatments is used which includes progestins (oral, injectable and intra-uterine), androgens, and gonadotropin releasing hormone agonists (GnRH) which reduce moderate to severe pain of endometriosis [92–94]. …”

Endometriosis: where are we and where are we going?

“…Of the progestins, the 19-nortestosterone derivatives are less androgenic and offer better side effect profiles (Angioni et al 2014). In a RCT, dienogest significantly decreases endometriosis-related pain similar to gonadotropin releasing hormone agonists (GnRHa), both as initial and post-operative therapy, without the negative side effect profile of GnRHa (Angioni et al 2014, Andres Mde et al 2015, Granese et al 2015, Strowitzki et al 2015). Levonorgestrel, delivered through an intrauterine system after conservative surgery, significantly decreases dysmenorrhea, dyspareunia, and non-cyclic pelvic pain compared to expectant management in a RCT of 55 patients (Tanmahasamut et al 2012, Imai et al 2014).…”

“…It decreases pain and endometriotic nodules in comparison to placebo (Leone Roberti Maggiore et al 2014, Brown & Farquhar 2015). A multi-center RCT comparing GnRHa to OCPs as post-surgical therapy reports both groups increase quality of life scores (Granese et al 2015). Although GnRHa is proven effective, a severe side effect is decreased bone mineral density (BMD); therefore, estrogens or progestins are given for bone protection (Leone Roberti Maggiore et al 2014, Zito et al 2014).…”

Renal endometriosis mimicking complicated cysts of kidney: report of two cases

“…The recurrence of symptoms, usually correlated with patients' menstrual cycles, may lead to the adoption of medical approaches, including hormonal therapies such as GnRH agonists and oral contraceptives, while surgical therapeutic strategies, in particular laparoscopic management, should be considered for large renal endometriomas or persistent obstructive uropathy (6,27,28). These surgical procedures should to be performed by a surgical team experienced in general, gynaecological, adrenal and urological laparoscopic surgery also in urgency setting because we well know the possible intraoperative complications of this kind of surgery as bowel, bladder, ureteric and vascular injuries (29)(30)(31)(32)(33)(34)(35).…”