Introduction. Endometriosis is a chronic disease caused by the growth of functional endometrial-like tissue outside the uterus. Conservative laparoscopic surgery is considered the gold standard treatment. Postoperative administration of hormonal treatment is used to prolong the symptom-free period and to prevent recurrence. Objectives.The aim of our study was to compare the effect of a low-dose oral contraceptive (OC) containing dienogest Vs Gonadotrophin-releasing hormone analogue (GnRH-a) administered after conservative laparoscopic surgery in women complaining of chronic pelvic pain (CPP) for pelvic endometriosis. Materials & methods. A multi-center prospective randomized study was conducted in the Ob/Gyn Department of the Universities of Naples, Messina and Palermo (Italy). We enrolled 78 patients who underwent laparoscopic conservative surgery for CPP due to endometriosis (stage III-IV according to rAFS score), and randomly divided in two groups. We performed clinical gynaecological examination, transvaginal ultrasound and serum dosage of CA125 in all patients before the surgery and at 3, 6 and 9 months follow up. In order to assess the severity of the symptoms, we administered a Visual Analogue Scale (VAS) before surgery and at each follow up, and a questionnaire to investigate health-related quality of life (QoL) before surgery and at 9 months follow up. Pre-treatment evaluations of age, BMI, rAFS stages, VAS and QoL scores in the two groups did not show statistically significant differences, allowing post-treatment analysis. During laparoscopic surgery, we identified and removed all the endometriotic lesions. At hospital discharge, group 1’s patients were treated with OC containing dienogest + estradiol valerate without interruption for 6 months, whereas group 2’s patients were treated with GnRH-a every month for 6 months. The efficacy of postoperative therapy was assessed by the lack of recurrences and by improvement of endometriosis-related pelvic pain and QoL. Results. We reported no statistically significant difference between the two groups for endometriosis recurrence. Side effects at 3, 6, 9 months follow-up in both groups were headache, decreased libido, spotting, vaginal dryness, vasomotor symptoms, weight gain: the last two were more severe in group 2 respect to group 1. At 3, 6 and 9-month of follow-up, VAS score data did not show statistically significant differences between the two groups. At 9 month follow up our questionnaire showed an improvement in QoL with both treatment (no statistically significant difference between the two groups). Conclusion. We evidenced that both therapies were equally effective in preventing endometriosis and CPP recurrence. GnRH-a showed more side effects than OC, and they could be administered for a short period. OC containing dienogest are more tolerated but equally effective: for these reasons, we recommended them for a cheap and safe long term prevention of endometriosis recurrence.
Control of symptoms relapse after conservative surgery for endometriosis: advantages of using dienogest plus estradiol valerate.
LAGANA', ANTONIO SIMONE;GRANESE, ROBERTA
2013-01-01
Abstract
Introduction. Endometriosis is a chronic disease caused by the growth of functional endometrial-like tissue outside the uterus. Conservative laparoscopic surgery is considered the gold standard treatment. Postoperative administration of hormonal treatment is used to prolong the symptom-free period and to prevent recurrence. Objectives.The aim of our study was to compare the effect of a low-dose oral contraceptive (OC) containing dienogest Vs Gonadotrophin-releasing hormone analogue (GnRH-a) administered after conservative laparoscopic surgery in women complaining of chronic pelvic pain (CPP) for pelvic endometriosis. Materials & methods. A multi-center prospective randomized study was conducted in the Ob/Gyn Department of the Universities of Naples, Messina and Palermo (Italy). We enrolled 78 patients who underwent laparoscopic conservative surgery for CPP due to endometriosis (stage III-IV according to rAFS score), and randomly divided in two groups. We performed clinical gynaecological examination, transvaginal ultrasound and serum dosage of CA125 in all patients before the surgery and at 3, 6 and 9 months follow up. In order to assess the severity of the symptoms, we administered a Visual Analogue Scale (VAS) before surgery and at each follow up, and a questionnaire to investigate health-related quality of life (QoL) before surgery and at 9 months follow up. Pre-treatment evaluations of age, BMI, rAFS stages, VAS and QoL scores in the two groups did not show statistically significant differences, allowing post-treatment analysis. During laparoscopic surgery, we identified and removed all the endometriotic lesions. At hospital discharge, group 1’s patients were treated with OC containing dienogest + estradiol valerate without interruption for 6 months, whereas group 2’s patients were treated with GnRH-a every month for 6 months. The efficacy of postoperative therapy was assessed by the lack of recurrences and by improvement of endometriosis-related pelvic pain and QoL. Results. We reported no statistically significant difference between the two groups for endometriosis recurrence. Side effects at 3, 6, 9 months follow-up in both groups were headache, decreased libido, spotting, vaginal dryness, vasomotor symptoms, weight gain: the last two were more severe in group 2 respect to group 1. At 3, 6 and 9-month of follow-up, VAS score data did not show statistically significant differences between the two groups. At 9 month follow up our questionnaire showed an improvement in QoL with both treatment (no statistically significant difference between the two groups). Conclusion. We evidenced that both therapies were equally effective in preventing endometriosis and CPP recurrence. GnRH-a showed more side effects than OC, and they could be administered for a short period. OC containing dienogest are more tolerated but equally effective: for these reasons, we recommended them for a cheap and safe long term prevention of endometriosis recurrence.Pubblicazioni consigliate
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