Effects of tibolone and continuous combined hormone replacement therapy on bleeding rates, quality of life and tolerability in postmenopausal women

Huber, Johannes; Palacios, Santiago; Berglund, Lars; Hänggi, W.; Sathanandan, S.M.; Christau, S.; Helmond, F.A.

doi:10.1111/j.1471-0528.2002.01338.x

Cited by 62 publications

(33 citation statements)

References 34 publications

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“…Previous studies assessing the relation between use of HT and quality of life in postmenopausal women all used different questionnaires with only a little overlap. [27][28][29][30][31][32] It is difficult to determine to what extent results of studies using different questionnaires can be compared. Decrease in estrogen levels might, as mentioned before, lead to climacteric symptoms, but also to decreases in physical and cognitive functioning and may therefore have serious implications on quality of life.…”

Section: Discussionmentioning

confidence: 99%

A randomized, placebo-controlled trial on the effects of soy protein containing isoflavones on quality of life in postmenopausal women

et al. 2005

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Objective: Postmenopausal estrogen decline is implicated in several age-related physical and psychological changes in women, including decreases in perceived quality of life (QoL). A number of trials with hormone therapy showed beneficial effects of the intervention on parameters of quality of life. However, because of known or suspected serious side-effects of conventional hormone therapy there is a need for alternatives.Design: We conducted a double-blind randomized placebo-controlled trial with soy protein, containing 52 mg genistein, 41 mg daidzein, and 6 mg glycitein (aglycone weights), or milk protein (placebo) daily for 1 year. For this trial, we recruited 202 postmenopausal women aged 60 to 75 years.Results: At baseline and at final visit, participants filled in the Short Form of 36 questions (SF-36), the Questionnaire on Life Satisfaction Modules (QLS M ), and the Geriatric Depression Scale (GDS). For the placebo group scores on all dimensions of the SF-36 and the QLS M decreased during the intervention year, except for the dimension ''role limitations caused by physical problems.'' The soy group showed increases on two dimensions of the SF-36 (''social functioning'' and ''role limitations caused by physical problems'') and on one dimension of the QLS M . There were however no statistically significant differences in changes of scores between the two intervention groups. For the GDS similarly, no significant differences were found between the groups.Conclusion: In conclusion, the findings in this randomized trial do not support the presence of a marked effect of soy protein substitution on quality of life (health status, life satisfaction, and depression) in elderly postmenopausal women.

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Section: Discussionmentioning

confidence: 99%

A randomized, placebo-controlled trial on the effects of soy protein containing isoflavones on quality of life in postmenopausal women

et al. 2005

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“…7 As a result, tibolone is clinically associated with a high amenorrhoea rate and relatively few irregular bleedings. 8,9 Estrogenic effects on the breast are low due to inhibition of the local enzyme systems, which impair the local formation of active estrogens. 10 Clinically, this results in few breast complaints in women using tibolone and no or limited increase in breast density.…”

Section: Introductionmentioning

confidence: 99%

“…10 Clinically, this results in few breast complaints in women using tibolone and no or limited increase in breast density. 8,11 Continuous combined estrogen plus progestogen preparations also offer efficacious treatment without regular monthly bleeding. However, relatively high rates of irregular bleeding, especially during the first 3 months of treatment, have been reported with continuous combined 17b estradiol (2 mg) plus norethisterone acetate (1 mg) (E 2 /NETA, Kliogest Ò ; Nova Nordisk, Copenhagen, Denmark), as well as with other continuous combined HT regimens.…”

Section: Introductionmentioning

confidence: 99%

“…However, relatively high rates of irregular bleeding, especially during the first 3 months of treatment, have been reported with continuous combined 17b estradiol (2 mg) plus norethisterone acetate (1 mg) (E 2 /NETA, Kliogest Ò ; Nova Nordisk, Copenhagen, Denmark), as well as with other continuous combined HT regimens. 8,9 The occurrence of vaginal bleeding during treatment, especially in the first 3 months, leads to poor adherence and causes early discontinuation. 9,[12][13][14] In addition, adverse effects related to treatment such as breast pain and tenderness cause some women to discontinue treatment, may induce fear and anxiety and additional medical examinations.…”

Section: Introductionmentioning

confidence: 99%

“…[16][17][18][19] Higher dose estrogen-progestogen combinations compare unfavourably with tibolone with respect to bleeding and breast-related adverse events (AEs), whereas lower dose regimens have not been compared with tibolone. 8,9,[20][21][22] Therefore, the aim of the present study was to compare the occurrence of vaginal bleeding, efficacy and tolerability of 2.5 mg tibolone with 1 mg E 2 and 0.5 mg NETA.…”

Section: Introductionmentioning

confidence: 99%

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Tibolone and low‐dose continuous combined hormone treatment: vaginal bleeding pattern, efficacy and tolerability

Hammar

Weijer

et al. 2007

BJOG

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ObjectivesThe primary objective was to compare the vaginal bleeding pattern during administration of tibolone and low-dose continuous combined estradiol plus norethisterone acetate (E 2 / NETA). The secondary objectives were efficacy on vasomotor symptoms and vaginal atrophy.Design A randomised, double-blind, double-dummy, group comparative intervention trial.Setting Multicentre study executed in 32 centres in 7 European countries.Sample Five hundred and seventy-two healthy symptomatic postmenopausal women, aged 45-65 years.Methods Participants were randomised to receive 2.5 mg tibolone or 1 mg 17b estradiol plus 0.5 mg norethisterone acetate (E 2 / NETA) daily for 48 weeks.Main outcome measures Prevalence of vaginal bleeding, hot flushes and adverse events.Results The incidence of bleeding was significantly lower in the tibolone group during the first 3 months of treatment (18.3 versus 33.1%; P < 0.001) when compared with the E 2 /NETA group. This effect on the bleeding pattern was sustained throughout the study, although reaching statistical significance again only in 7-9 months of treatment (11 versus 19%; P < 0.05). In both treatment groups, vasomotor symptoms and vaginal atrophy were significantly reduced to a similar extent when compared with baseline. The prevalence of breast pain/tenderness was significantly lower with tibolone compared with E 2 /NETA (3.2 versus 9.8%; P < 0.001).Conclusion Tibolone reduces menopausal symptoms to a similar extent as conventional low-dose continuous combined hormone therapy but causes significant less vaginal bleeding in the first 3 months of treatment. This constitutes an important argument for woman adherence to therapy.

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Short and long term effects of tibolone in postmenopausal women

Formoso

Perrone

Maltoni

et al. 2012

Cochrane Database of Systematic Reviews

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Effects of tibolone and continuous combined hormone replacement therapy on bleeding rates, quality of life and tolerability in postmenopausal women

Abstract: The vaginal bleeding rate during cycles 4-6 was significantly lower in women using tibolone. Both treatments improved QoL, wellbeing, climacteric symptoms and urogenital symptoms. Breast tenderness was significantly less frequent with tibolone.

Cited by 62 publications

References 34 publications

A randomized, placebo-controlled trial on the effects of soy protein containing isoflavones on quality of life in postmenopausal women

A randomized, placebo-controlled trial on the effects of soy protein containing isoflavones on quality of life in postmenopausal women

Tibolone and low‐dose continuous combined hormone treatment: vaginal bleeding pattern, efficacy and tolerability

Short and long term effects of tibolone in postmenopausal women

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