Low dose intranasal nafarelin for the treatment of endometriosis

Jacobson, J.; Harris, S.; Bullingham, R. E. S.

doi:10.3109/00016349409013417

Cited by 10 publications

(6 citation statements)

References 3 publications

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“…46 At the beginning of therapy, 5 of the subjects (20%) had mild pain, and 80% had moderate or severe pain. By the end of 6 months of therapy, 22 (88%) had no pain or mild pain, and 6 months later, 19 patients (76%) had no pain or mild pain.…”

Section: Danazolmentioning

confidence: 99%

Medical and Surgical Therapies for Pain Associated with Endometriosis

Winkel

Scialli

2001

Journal of Women's Health & Gender-Based Medicine

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Endometriosis is a common condition for which a number of treatments have been proposed. Medical treatments are based on the hormonal responsiveness of endometriosis implants. These therapies include progestins (with or without estrogens), androgens, and gonadotropin-releasing hormone (GnRH) analogs. Surgical treatments may include hysterectomy with oophorectomy or organ-sparing surgery involving ablation or resection of visible lesions of endometriosis and restoration of pelvic anatomy. There are no studies that directly compare the effectiveness or adverse effects of medical therapy and surgical therapy. Studies on medical therapy compare different treatments with placebo or with other active treatments. Hormone-based therapies for endometriosis show 80%-100% effectiveness in relief of pelvic pain over a 6-month course of therapy. Serious adverse outcomes after medical therapy are unusual. Studies on surgical therapy are largely anecdotal, with noncomparative reports on a variety of surgical methods. A few comparative surgical studies have been reported. Because of the noncomparative nature of many of the surgical studies, the use of combinations of surgical procedures and techniques in the reported studies, and the reporting of results from surgeons with an unusually high level of technical skill, the gynecological practitioner has little basis in the literature for assessing the optimum surgical approach. Surgical complications are believed to be underreported and may be related to how aggressive a surgical procedure is undertaken.

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Section: Danazolmentioning

confidence: 99%

Medical and Surgical Therapies for Pain Associated with Endometriosis

Winkel

Scialli

2001

Journal of Women's Health & Gender-Based Medicine

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“…Of the 1664 records screened, 14 studies regarding clinical outcomes associated with the three considered alternative modalities for GnRH agonist use were eventually included: intermittent oestrogen deprivation therapy, n = 2 ( Adamson et al , 1997 ; Hornstein et al , 1997 ); low-dose or ‘draw-back’ therapy, n = 8 ( Hull and Barbieri, 1994 ; Jacobson et al , 1994 ; Bergqvist et al , 1997 ; Uemura et al , 1999 ; Tahara et al , 2000 ; Akira et al , 2009 ; Tang et al , 2017 ; Harada et al , 2022 ); and extended-interval dosing regimen, n = 4 ( Tse et al , 2000 ; Wong and Tang, 2004 ; Kang et al , 2010 ; Liu et al , 2016 ). Six studies were RCTs (double blind, n = 2), whereas eight adopted a prospective cohort design (non-comparative, n = 6; comparative, n = 2).…”

Section: Resultsmentioning

confidence: 99%

Mitigating the economic burden of GnRH agonist therapy for progestogen-resistant endometriosis: why not?

Vercellini

Bandini

Buggio

et al. 2023

Human Reproduction Open

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STUDY QUESTION Is it possible to reduce the cost of GnRH agonist treatment for endometriosis by using non-standard dosing regimens? SUMMARY ANSWER An extended-interval dosing regimen of a 3.75 mg depot formulation of triptorelin injected every 6 weeks instead of every 4 weeks reduces the cost by one-third without compromising the effect on pain relief. WHAT IS KNOWN ALREADY Cost constitutes a limit to prolonged GnRH agonists use. Alternative modalities to reduce the economic burden of GnRH agonist treatment have been anecdotally attempted. STUDY DESIGN, SIZE, DURATION A systematic review was conducted to evaluate and compare the effect of three alternative modalities for GnRH use in women with endometriosis, i.e. intermittent oestrogen deprivation therapy, reduced drug dosage, and extended-interval dosing regimens of depot formulations. A PubMed and Embase search was initially conducted in October 2022 and updated in January 2023 using the following search strings: (endometriosis OR adenomyosis) AND (GnRH-agonists OR gonadotropin-releasing hormone agonists OR triptorelin OR leuprorelin OR goserelin OR buserelin OR nafarelin). Full-length articles published in English in peer-reviewed journals since 1 January 1980, and reporting original data on GnRH agonist treatment of pain symptoms associated with endometriosis were selected. PARTICIPANTS/MATERIALS, SETTING, METHODS Information was extracted on study design, GnRH-agonist used, dosage, total duration of therapy, side effects, treatment adherence, and pelvic pain relief. Reviews, commentaries, conference proceedings, case reports, and letters to the editor were excluded. MAIN RESULTS AND THE ROLE OF CHANCE Of the 1664 records screened, 14 studies regarding clinical outcomes associated with the 3 considered alternative modalities for GnRH agonist use were eventually included (intermittent oestrogen deprivation therapy, n = 2; low-dose or ‘draw-back’ therapy, n = 8; extended-interval dosing regimen, n = 4). Six studies were randomized controlled trials (RCTs) (double blind, n = 2) and eight adopted a prospective cohort design (non-comparative, n = 6; comparative, n = 2). A total of 776 women with endometriosis were recruited in the above studies (intermittent oestrogen deprivation therapy, n = 77; low-dose or ‘draw-back’ therapy, n = 528; extended-interval dosing regimen, n = 171). Robust data demonstrating cost saving without detrimental clinical consequences were available for the extended-interval dosing regimen only. In particular, the 3.75 mg triptorelin depot preparation inhibits ovarian function for a longer period compared with the 3.75 mg leuprorelin depot preparation, allowing injections every 6 instead of 4 weeks. Based on the cost indicated by the Italian Medicine Agency for the 3.75 mg triptorelin depot preparation, this would translate in a yearly saving of €744.60 (€2230.15–€1485.55; −33.4%). LIMITATIONS, REASONS FOR CAUTION The quality of the evidence reported in the selected articles was not formally evaluated and a quantitative synthesis could not be performed. Some studies were old and the tested therapeutic approaches were apparently obsolete. Only cost containment associated with GnRH analogue use, and not cost-effectiveness, has been addressed. WIDER IMPLICATIONS OF THE FINDINGS Consuming less resources without negatively impacting on health outcomes carries ethical and practical implications for individuals and the community, as this approach may result in overall increased healthcare access. STUDY FUNDING/COMPETING INTEREST(S) This study was supported by the Italian Ministry of Health (Ricerca Corrente 2023, IRCCS Ca' Granda Ospedale Maggiore Policlinico Milano). E.S. discloses payments from Ferring for research grants and honoraria from Merck-Serono for lectures. All other authors declare they have no conflict of interest. REGISTRATION NUMBER N/A.

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“…The median durations of the disease symptoms were 1.5 years (range 0.1-16) in the nafarelin 200 pg group, 0.8 years (range 0.1-10) in the nafarelin 400 pg group and 0.5 years (range 0. [2][3][4][5][6][7][8][9][10][11][12][13][14][15][16] in the nafarelin 200 pg plus norethisterone 1.2 mg group. There were no significant differences between groups concerning symptom scores or pelvic examination scores.…”

Section: Resultsmentioning

confidence: 99%

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

Bergqvist

Jacobson

Harris³

1997

Gynecological Endocrinology

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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.

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Low dose intranasal nafarelin for the treatment of endometriosis

Cited by 10 publications

References 3 publications

Medical and Surgical Therapies for Pain Associated with Endometriosis

Medical and Surgical Therapies for Pain Associated with Endometriosis

Mitigating the economic burden of GnRH agonist therapy for progestogen-resistant endometriosis: why not?

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

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