Abstract
Objective: This is a Prospective randomized analytical study carried out in department of obstetrics and Gynecology, Hi-Tech Medical College & Hospital, Bhubaneswar, in a tertiary care center to compare the efficacy and safety of dienogest (DNG) with depot leuprolide acetate (LA) in patients with chronic pelvic pain following laparoscopic surgery for endometriosis.
Materials & Method: 242 patients with chronic pelvic pain following laparoscopic surgery for endometriosis were chosen. Prospective randomized trial was done in laproscopic treated patient of endometriosis with chronic pelvic pain with Dienogest (2 mg/day, orally) or depot LA (3.75 mg/4 weeks, intramuscularly) for 12 weeks. The study was conducted over 3year period i.e. from 01.04.2016 to 31.03.2019 in Hi-Tech Medical College & Hospital, Bhubaneswar. A visual analogue scale was used to test the intensity of pain before and after the end of treatment.
Results: There was highly significant reduction in pelvic pain, back pain and dyspareunia in both groups with mean of difference in dienogest group (28.7±5.3,19.0±4.3 and 20.0 ± 3.08 mm, respectively) and in LA group (26.2 ± 3.01, 19.5 ± 3.01 and 17.9 ± 2.9 mm, respectively). The most frequent drug-related adverse effects in dienogest group were vaginal bleeding and weight gain (64.5 and 10.8%, respectively) which were significantly higher than LA group (21.5 and 3.3%, respectively). While the most frequent drug-related adverse effects in LA group were hot flushes and vaginal dryness (46.3 and 15.7%, respectively) which were significantly higher than dieno- gest group (15.7 and 3.3%, respectively).
Conclusion: Daily dienogest is as effective as depot LA for relieving endometriosis-associated pelvic pain, low back pain and dyspareunia. In addition, dienogest has accept- able safety, tolerability and lower incidence of hot flushes. Thus, it may offer an effective and well-tolerated treatment in endometriosis
Keywords: Endometriosis, Chronic Pelvicpain, Laproscopy, Leuprolide acetate (LA), Dienogest (DNG).
References
- Dunselman GA, Vermeulen N, Becker C, et al. ESHRE guide- line: management of women with endometriosis. Hum Reprod. 2014;29(3):400–12.
- Meuleman C, Vandenabeele B, Fieuws S, et al. High prevalence of endometriosis in infertile women with normal ovulation and normospermic partners. Fertil Steril. 2009;92(1):68–74.
- Smorgick N, As-Sanie S, Marsh CA, et al. Advanced stageendometriosis in adolescents and young women. J PediatrAdo- lesc Gynecol.2014;27(6):320–3.
- Guo SW. Recurrence of endometriosis and its control. Hum Reprod Update. 2009;15(4):441–61.
- Vercellini P, Crosignani PG, Abbiati A, et al. The effect of sur-gery for symptomatic endometriosis: the other side of the Hum Reprod Update.2009;15(2):177–88.
- Singh SS, Suen MW. Surgery for endometriosis: beyond medical FertilSteril.2017;107:549–54.
- Muzii L, Marana R, Angioli R, et al. Histologic analysis of specimens from laparoscopic endometrioma excision performed by different surgeons: does the surgeon matter? FertilSteril.2011;95:2116–9.
- Vercellini P,SomiglianaE, Vigano`P,et al. Post-operative endometriosis recurrence: a plea for prevention based on patho- genetic, epidemiological and clinical evidence. ReprodBiomed2010;21:259–65.
- Vercellini P, Somigliana E, Daguati R, et al. Post-operative oral contraceptive exposure and risk of endometrioma recurrence. Am J Obstet Gynecol.2008;198:504–5.
- Becker CM, Gattrell WT, Gude K, et al. Reevaluating response and failure of medical treatment of endometriosis: a systematic review. FertilSteril.2017;108(1):125–36.
- Lee DY, Lee JY, Seo JW, et al. Gonadotropin-releasing hormone agonist with add–back treatment is as effective and tolerable as dienogest in preventing pain recurrence after laparoscopic sur- gery for endometriosis. Arch Gynecol Obstet. 2016;294(6):1257–63.
- Zito G, Luppi S, Giolo E, et al. Medical treatments for endometriosis-associated pelvic pain. BioMed Res 2014; 2014:191967.
- Rahmioglu N, Missmer SA, Montgomery GW, et al. Insights into assessing the genetics of endometriosis. Curr Obstet Gynecol Rep.2012;1(3):124–37.
- Fauconnier A, Fritel X, Chapron C. Endometriosis and pelvic pain: epidemiological evidence of the relationship and implica- tions. Gynecol Obstet Fertil.2009;37(1):57–69.
- Takae S, Kawamura K, Sato Y, et al. Analysis of late-onset ovarian insufficiency after ovarian surgery: retrospective study with 75 patients of post-surgical ovarian insufficiency. PLoS2014;9(5):e98174.
- Vercellini P, Frattaruolo MP, Somigliana E, et al. Surgical versus low-dose progestin treatment for endometriosis-associated severe deep dyspareunia II: effect on sexual functioning, psychological status and health-related quality of life. Hum Reprod. 2013;28:1221–30.
- Strowitzki T, Marr J, Gerlinger C, et al. Dienogest is as effective as leuprolide acetate in treating the painful symptoms of endometriosis: a 24-week, randomized, multicentre, open-label trial. Hum Reprod.2010;25(3):633–41.
- Harada T, Momoeda M, Taketani Y, et al. Dienogest is as effective as intranasal buserelin acetate for the relief of pain symptoms associated with endometriosis—a randomized, double- blind, multicenter, controlled trial. FertilSteril. 2009;91(3):675–81.
- Caruso S, Iraci M, Cianci S, et al. Quality of life and sexual function of women affected by endometriosis-associated pelvic pain when treated with dienogest. J Endocrinol Invest. 2015;38:1211.
- Harada T, Momoeda M, Taketani Y. Dienogest is as effective as intranasal buserelin acetate for the relief of pain symptoms associated with endometriosis—a randomized, double-blind, multicenter, controlled trial. FertilSteril. 2009;91:675–81.
- Strowitzki T, Faustmann A, Christoph G, et al. Dienogest in the treatment of endometriosis-associated pelvic pain: a 12-week, randomized, double-blind, placebo-controlled study. Eur J Obstet Gynecol Reprod Biol.2010;151:193–8.
- Ko¨hlerG, Faustmann TA, Gerlinger C, et al. Adose-ranging study to determine the efficacy and safety of dienogest 1, 2, and 4 mg daily in the treatment of endometriosis. Int J Gynaecol Obstet.2010;108:21–5.
- Irahara M, Harada T, Momoeda M, et al. Hormonal and histo- logical study on irregular genital bleeding in patients with endometriosis during treatment with dienogest, a novel progestational therapeutic agent.Reprod MedBiol.2007;6:223–8.
- Seitz C, Gerlinger C, Marr J, et al. A double-blind placebo- controlled trial investigating the efficacy of 12 weeks of dieno- gest 2 mg/day for the treatment of endometriosis-associated FertilSteril.2008;90:S140.
- Strowitzki T, Marr J, Gerlinger C, et al. Dienogest is as effective as leuprolide acetate in treating the painful symptoms of endometriosis: a 24-week, randomized, multicentre, open-label trial. Hum Reprod.2010;25:633–41.
- Momoeda M, Taketani Y, Terakawa N, et al. A randomized, double-blind, multicenter, parallel, dose–response study of die- nogest in patients with endometriosis. Jpn Pharmacol 2007;35:769–83.
- Momoeda M, Harada T, Terakawa N. Long-term use ofdienogest for the treatment of endometriosis. J Obstet Gynaecol 2009;35(6):1069–76.
- Kitawaki J, Kusuki I, Yamanaka K, et al. Maintenance therapy with dienogest following gonadotropin-releasing hormone ago- nist treatment for endometriosis-associated pelvic pain. Eur J Obstet Gynecol Reprod Biol.2011;157(2):212–6.
Corresponding Author
Dr Ramakanta Sahoo
Final year PG Student, Department of Obstetrics and Gynecology, Hi-Tech Medical College & Hospital, Bhubaneswar, Odisha, India
DOI: https://dx.doi.org/10.18535/jmscr/v7i4.61
