Perimenopausal women in estrogen vasomotor trials: contribution to placebo effect and efficacy outcome

Simon, James A.; Stevens, Rm; Ayres, Stacey A.; Phelps, Ken V.

doi:10.1080/cmt.4.1.19.27

Cited by 18 publications

(11 citation statements)

References 18 publications

(21 reference statements)

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“…Perimenopausal women may have contributed to a higher placebo response than postmenopausal women [66]. The mean placebo effect in all included trials dealing with soy supplements was 27%, which is in line with reported average values by Sloan et al of 20 to 30% after 4 wks [23].…”

Section: Discussionsupporting

confidence: 65%

Efficacy of isoflavones in relieving vasomotor menopausal symptoms – A systematic review

Jacobs¹,

Wegewitz

Sommerfeld

et al. 2009

Molecular Nutrition Food Res

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This review assessed the efficacy of isoflavone supplements to reduce vasomotor symptoms in menopausal women by reviewing all published randomized controlled trials. Systematic literature searches were carried out in 70 databases. Randomized and placebo controlled studies were included if they investigated the treatment of isoflavone supplements derived from soy or red clover on vasomotor symptoms in peri- or postmenopausal women for at least 12 wks. Data were analyzed concerning outcome and methodological quality of the study. Twenty-three trials met the inclusion criteria, thereof 17 investigated soy isoflavones and 6 red clover isoflavones. Without exception, selected trials examining the effect of red clover isoflavones were already assessed in several meta-analyses and were therefore excluded from this evaluation. As the soy isoflavone studies were very heterogeneous concerning interventions and outcome measures, meta-analysis could not be performed and trials were systematically assessed in a structured approach. Included soy isoflavone studies had numerous quality deficiencies and did not consistently show a reduction of flushes after treatment with soy isoflavones. Therefore, there is no conclusive evidence, but only some indication of a benefit of soy isoflavones on hot flush frequency or severity.

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Section: Discussionsupporting

confidence: 65%

Efficacy of isoflavones in relieving vasomotor menopausal symptoms – A systematic review

Jacobs¹,

Wegewitz

Sommerfeld

et al. 2009

Molecular Nutrition Food Res

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“…Therefore, it is important to subtract the placebo effect when interpreting the results of these studies. There is evidence to suggest that women who are perimenopausal may contribute to a higher placebo response rate in trials of hot flashes [30]. Fourth, several risk factors for the occurrence and severity of VMS, such as obesity, race, and smoking, have been neglected in evaluating the efficacy.…”

Section: Discussionmentioning

confidence: 99%

Efficacy and Safety of Desvenlafaxine Treatment for Hot Flashes Associated with Menopause: A Meta-Analysis of Randomized Controlled Trials

Sun

Yanqing

Zhang³

2013

Gynecol Obstet Invest

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Vasomotor symptoms, such as daytime hot flashes and nighttime awakenings due to hot flashes, are commonly associated with menopausal women. The aim of this study was to assess desvenlafaxine in moderate to severe hot flashes in postmenopausal women. Electronic databases were searched for relevant randomized controlled trials that compared desvenlafaxine to placebo for postmenopausal women affected with hot flashes. The main outcomes were mean differences (MD) or standardized mean differences (SMD) and 95% confidence interval (CI) for change of the hot flashes. Six randomized controlled trials were identified in the meta-analysis. Pooled change of moderate and severe hot flashes frequency reduced SMD of -0.49 (95% CI -0.91 to -0.07) in desvenlafaxine 100 mg and -0.36 (95% CI -0.54 to -0.19) in desvenlafaxine 150 mg at week 12. Desvenlafaxine 100 mg reduced moderate and severe hot flashes frequency SMD of -0.74 (95% CI -1.05 to -0.44) within 26 weeks. There is no evidence for an increased risk of cardiovascular, cerebrovascular, or hepatic events associated with desvenlafaxine 100 mg/day. The meta-analysis suggests that treatment with desvenlafaxine 100 mg/day is associated with a significant reduction of moderate to severe hot flashes in postmenopausal women. Desvenlafaxine appears both safe and effective for treating hot flushes for up to 12 months.

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“…In the perimenopause, an assessment of hot flashes is complicated by the natural fluctuations in symptom frequency and severity during this transition. One study has shown that perimenopausal women show a higher placebo response in HT trials than postmenopausal women [10]. Studies included both naturally and surgically menopausal women.…”

Section: Population Being Studiedmentioning

confidence: 99%

The role of complementary and alternative medicine in management of menopausal symptoms

Kessel

Kronenberg

2004

Endocrinology and Metabolism Clinics of North America

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Perimenopausal women in estrogen vasomotor trials: contribution to placebo effect and efficacy outcome

Cited by 18 publications

References 18 publications

Efficacy of isoflavones in relieving vasomotor menopausal symptoms – A systematic review

Efficacy of isoflavones in relieving vasomotor menopausal symptoms – A systematic review

Efficacy and Safety of Desvenlafaxine Treatment for Hot Flashes Associated with Menopause: A Meta-Analysis of Randomized Controlled Trials

The role of complementary and alternative medicine in management of menopausal symptoms

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