Do combinations of 1 mg estradiol and low doses of NETA effectively control menopausal symptoms?

Baerug, U; Winge, T; Nordland, G; Faber-Swensson, E; Heldaas, Knut; Norling, B.; Larsen, S.V.; Arce, Joan‐Carles

doi:10.3109/13697139809085544

Cited by 46 publications

(28 citation statements)

References 17 publications

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“…The results of this study confirm previous reports suggesting a low incidence of bleeding with lower dose combinations, especially with the E 2 1 mg/NETA 0.5 mg [26,27]. The favorable bleeding profile seen with these lower dose combinations, especially in particular the E 2 1 mg/NETA 0.5 mg combination, would be expected to facilitate long-term adherence to treatment.…”

Section: Discussionsupporting

confidence: 81%

“…Combinations of 17b-estradiol 1 mg and low doses of norethisterone acetate have been shown to provide adequate vasomotor symptom relief in most women and appear to be associated with a lower incidence of bleeding than higher-dose combinations [26,27]. However, the effect of these lower-dose combinations on preserving bone mass has not been established.…”

Section: Introductionmentioning

confidence: 98%

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A Combination of Low Doses of 17β-Estradiol and Norethisterone Acetate Prevents Bone Loss and Normalizes Bone Turnover in Postmenopausal Women

et al. 2000

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The effects of 17 beta-estradiol (E2) 1 mg combined with low doses of norethisterone acetate (NETA) on postmenopausal bone loss and turnover were investigated in a 2-year, randomized, double-masked, placebo-controlled trial. A total of 135 postmenopausal women with a lumbar spine bone mineral density (BMD) T-score between -2 and +2 were randomized to daily treatment with an oral tablet of either placebo, E2 1 mg/NETA 0.25 mg, or E2 1 mg/NETA 0.5 mg. Significant (p < 0.001) increases in BMD at the lumbar spine (L1-4) were observed with E2 1 mg/NETA 0.25 mg (5.2%) and E2 1 mg/NETA 0.5 mg (5.4%) compared with placebo (-0.9%). The total hip BMD increased significantly in the E2 1 mg/NETA 0.25 mg (3.1%) and E2 1 mg/NETA 0.5 mg groups (3.3%) compared with placebo. At the femoral trochanter, the increase in BMD in the E2 1 mg/NETA 0.5 mg group (6.3%) was significantly different from the placebo group (0.8%), while that in the E2 1 mg/NETA 0.25 mg group (3.3%) was not. No statistical differences were found between the active groups and placebo for the change in BMD at the femoral neck. Significant increases in BMD at the distal radius and total body were found for both E2 1 mg/NETA 0.25 mg (0.9% and 2.5%, respectively) and E2 1 mg/NETA 0.5 mg (2.1% and 3.0%, respectively) compared with placebo (-0.7% and 0.4%, respectively). At the end of the treatment, urinary pyridinoline type I collagen C-telopeptide had decreased by 65% and 60% in the E2 1 mg/NETA 0.25 mg and E2 1 mg/NETA 0.5 mg groups, respectively, while the mean serum concentrations of osteocalcin had decreased by 39% and 34%, bone-specific alkaline phosphatase by 32% and 29%, and C-terminal propeptide of type I collagen by 21% and 19% had decreased by 34-39%, 29-32%, and 19-21% in the E2 1 mg/NETA 0.25 mg and E2 1 mg/NETA 0.25 mg groups, respectively. In conclusion, combinations of E2 1 mg and NETA 0.25 or 0.5 mg prevent bone loss in postmenopausal women at the lumbar spine, hip, distal radius and total body, and normalize bone turnover.

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Section: Discussionsupporting

confidence: 81%

Section: Introductionmentioning

confidence: 98%

A Combination of Low Doses of 17β-Estradiol and Norethisterone Acetate Prevents Bone Loss and Normalizes Bone Turnover in Postmenopausal Women

et al. 2000

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“…The Greene Climacteric Scale is a standardized instrument widely used for the evaluation of menopausal symptoms in epidemiologic (14 -16) and clinical studies (17)(18)(19)(20)(21)(22). It comprises 21 questions that measure physical and psychological symptoms associated with menopause, further grouped in 3 independent subscales called factors: psychological, somatic, and vasomotor.…”

Section: Protocolmentioning

confidence: 99%

Efficacy of estrogen plus progestin on menopausal symptoms in women with systemic lupus erythematosus: A randomized, double‐blind, controlled trial

Cravioto¹,

Durand-Carbajal²,

Jiménez-Santana³

et al. 2011

Arthritis Care & Research

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Objective. To define the effects of continuous sequential estrogen plus progestin therapy on menopausal symptoms in women with systemic lupus erythematosus (SLE).Methods. We performed a randomized, double-blind, 24-month clinical trial involving 106 women with SLE who were in the menopausal transition or early or late postmenopause. Patients received continuous sequential estrogen plus progestin (n ‫؍‬ 52) or placebo (n ‫؍‬ 54). Menopausal symptoms were assessed using the Greene Climacteric Scale at 0, 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24 months. A new factor analysis of the scale reduced 21 items to 5 factors. The primary outcome was improvement of menopausal symptoms throughout the followup period. Results were analyzed by the intent-to-treat principle. Results. At baseline, demographic and disease characteristics were similar in both groups. Fifteen of 21 menopausal symptoms had a prevalence of >50%, with a similar distribution between groups. Vasomotor factor scores decreased over time in both groups (P ‫؍‬ 0.002), but in the estrogen plus progestin group the reduction was more pronounced than in the placebo group (1.5-2.0 versus 0.35-0.8 points on a scale of 0 -6; P ‫؍‬ 0.03). Maximum effects were observed among the most symptomatic women. Psychological, subjective-somatic, and organic-somatic factors scores also improved along time (P < 0.001), but the treatment and placebo arms improved to a similar degree. Thromboses occurred in 3 patients receiving estrogen plus progestin and in 1 patient receiving placebo. Conclusion. Menopausal symptoms are highly prevalent in peri-and postmenopausal lupus patients. Estrogen plus progestin improved vasomotor symptoms at a clinically significant level, but not other menopausal symptoms. Given the thrombotic risks of menopausal hormone therapy, this should be used only in women with significant vasomotor symptoms.

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“…Dose response studies in the 1980s suggested that the minimum bone-sparing dose of CEE was 0.625 mg or 2 mg estradiol or 50 micrograms of transdermal estradiol. Effective relief of menopausal symptoms can be achieved, however, by lower doses and more recently the trend has been for starting at a dose of 1 mg estradiol 4 or 0.3 mg CEE. 5 Progestogen is added to oestrogen to prevent endometrial hyperplasia and carcinoma but New developments in HRT: low-dose therapy David …”

Section: Low Dosementioning

confidence: 99%

New developments in HRT: low-dose therapy

Sturdee

2005

The Obstetrician &Amp; Gynaecologist

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Hormone therapy for postmenopausal women has been available for over 60 years. Never during all these years have its merits and potential risks come under such scrutiny as in the past 2‐3 years. The culmination or premature termination of large randomised control trials and one large observational study have partly contradicted some of the previously accepted benefits. Since oral conjugated equine oestrogens were first produced, many other routes of administration have been introduced and their relative merits debated. Much recent emphasis, especially from regulatory authorities, has been on limiting the duration and, in particular, the dose of both oestrogen and progestogen. Traditionally, doses of 0.625‐1.25 mg conjugated equine oestrogens and 2 mg estradiol were considered necessary for adequate symptom control and bone protection. Now much lower doses have been shown to be effective and progestogen has been shown to have a further additive effect. Progestogen is given solely to protect the endometrium from the proliferative effects of oestrogen, so it is logical to give this direct to the endometrial cavity by an intrauterine system. A smaller experimental version of the widely used levonorgestrel‐releasing intrauterine system may provide a low‐dose alternative for progestogen administration.

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Do combinations of 1 mg estradiol and low doses of NETA effectively control menopausal symptoms?

Abstract: The combinations of 1 mg E2/0.25 mg NETA and 1 mg E2/0.5 mg NETA rapidly relieve vasomotor symptoms and are efficacious in the majority of menopausal women, including those with severe hot flushes.

Cited by 46 publications

References 17 publications

A Combination of Low Doses of 17β-Estradiol and Norethisterone Acetate Prevents Bone Loss and Normalizes Bone Turnover in Postmenopausal Women

A Combination of Low Doses of 17β-Estradiol and Norethisterone Acetate Prevents Bone Loss and Normalizes Bone Turnover in Postmenopausal Women

Efficacy of estrogen plus progestin on menopausal symptoms in women with systemic lupus erythematosus: A randomized, double‐blind, controlled trial

New developments in HRT: low-dose therapy

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