A double-blind randomized study of the treatment of endometriosis with nafarelin or nafarelin plus norethisterone

Abstract

The objective of this study was to compare the efficacy of nafarelin 200 micrograms (Group A), nafarelin 400 micrograms (Group B) and the combination of nafarelin 200 micrograms and norethisterone 1.2 mg (Group C) daily, in treating symptoms of endometriosis, American Fertility Society score and adverse events during 6 months of treatment. A prospective, randomized, double-blind parallel group study was performed in two centers and 49 women with endometriosis diagnosed laparoscopically were included. The patients were seen monthly for physical examination and records were taken for bleeding pattern, symptom score and adverse events. A control laparoscopy was performed at the end of 6 months of treatment. All patients were followed 6 months after treatment. At 3 and 6 months the pelvic examination total score had decreased significantly in all three groups. The total endometriosis score was significantly reduced in Groups B and C. After 2 months the total symptom score showed a significant decrease in Groups B and C. The frequency of hot flushes during the first month of treatment was lowest in Group C, but during the rest of treatment there were no differences between the groups. Best bleeding control was obtained in Group C. We conclude that nafarelin 200 micrograms daily has as good an effect on endometriosis symptoms as nafarelin 400 micrograms daily, and the addition of norethisterone 1.2 mg results in fewer hot flushes and better bleeding control.

Review Article on Evalution of Endometriosis Disorder

“…besides, GnRH agonist contains a worse adverse effect profile all told reviewed studies66 As a effect the hypoestrogenic adverse effects of GnRH agonists, clinicians should prescribe hormonal add-back therapy (i.e., the mix of low dose estrogen and progestogen or tibolone) with opening of the GnRH agonist therapy to forestall bone loss and hypoestrogenic symptoms. 67,68,70 However, due to lack of enormous randomized controlled trials, it remains unclear which kind of add-back therapy should be used. due to the severe adverse effects of GnRH agonists, women should be counseled thoroughly before starting this treatment.…”

Selection of key recommendations for the management of women with endometriosis by an international panel of patients and professionals

“…GPP VIII -Prescribe hormonal add-back therapy to coincide with the start of GnRH agonist therapy, to prevent bone loss and hypoestrogenic symptoms during treatment. This is not known to reduce the effect of treatment on pain relief (Bergqvist, Jacobson, and Harris 1997;Mäkäräinen, Rönnberg, and Kauppila 1996;Moghissi et al 1998;Taskin et al 1997).…”

Endometriosis: A review of the diagnosis and pain management

“…In addition, GnRH agonist is found to have a worse side effect profile in all the studies reviewed (27). As a result of the hypoestrogenic adverse effects of GnRH agonist, clinicians are recommended to prescribe hormonal add-back therapy (combination of low dose oestrogen and progestogen or tibolone) together with the start of the GnRH agonist therapy to prevent bone loss and hypoestrogenic symptoms (28,29,30). However, due to the lack of large randomized controlled trials, it remains unclear as to which type of add-back therapy should be used.…”