Evidence map›Paper›PMID 22927764›Full record

ArticleInternational journal of women's health2012

Impact of estradiol-valerate/dienogest on work productivity and activities of daily living in European and Australian women with heavy menstrual bleeding.

Radoslaw Wasiak, Anna Filonenko, David J Vanness, Kim U Wittrup-Jensen, Donald E Stull, Steven Siak, Ian Fraser

Registry-linked trialAbstract read
In one paragraph

Article in International journal of women's health, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00307801 (A Multicenter, Double-Blind, Randomized, Parallel-Group, Placebo-Controlled, 7 Cycle Duration), which is not on this map. Cited by 12 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
12citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT00307801 phase3completednot on this map

A Multicenter, Double-Blind, Randomized, Parallel-Group, Placebo-Controlled, 7 Cycle Duration (196 Days), Phase 3 Study of Oral Estradiol Valerate/Dienogest Tablets for the Treatment of Dysfunctional Uterine Bleeding.

TypeinterventionalSponsorBayerRan2006 to 2008Enrolled231ConditionsMetrorrhagiaArmsEstradiol valerate/Dienogest (Natazia, Qlaira, BAY86-5027), Placebo
3 · Its place in the literature

Who cites it

12 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Combined hormonal contraceptives for heavy menstrual bleeding.The Cochrane database of systematic reviews · 2019
    Pooled it
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  6. Observational
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

7 authors.

Radoslaw WasiakCentre for Health Economics and Science Policy, United BioSource Corporation, London, United Kingdom.
Anna Filonenko
David J Vanness
Kim U Wittrup-Jensen
Donald E Stull
Steven Siak
Ian Fraser

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe purpose of this study was to quantify the impact of estradiol-valerate/dienogest (E(2)V/DNG; Qlaira(®)/Natazia(®)) on work productivity and activities of daily living in European and Australian women with heavy menstrual bleeding.

methodsWomen aged 18-54 years with a confirmed diagnosis of heavy menstrual bleeding and no recognizable pathology were recruited across nine European countries (the Czech Republic, Finland, Germany, Hungary, The Netherlands, Poland, Sweden, UK, and Ukraine) and Australia. The women were randomized to receive either E(2)V/DNG (n = 149) or placebo (n = 82) for seven treatment cycles (196 days). The outcomes assessed included work productivity (ie, productivity while at work) and activities of daily living, measured on a Likert scale from 0 to 10 (with higher values denoting higher impairment levels) at baseline and at the end of the third and seventh cycles (days 84 and 196). The equivalent monetary value associated with the changes in work productivity and activities of daily living was also calculated.

resultsAcross all the countries, greater improvements from baseline to the end of treatment were observed with E(2)V/DNG treatment than placebo in work productivity (46.0% versus 15.1%) and activities of daily living (55.6% versus 30.8%). In 2008, savings associated with improvements in work productivity and activities of daily living due to E(2)V/DNG treatment (net of placebo improvement) were estimated to be between US$22-62 and US$18-56 per month (in purchasing power parity of US$), respectively.

conclusionE(2)V/DNG has a consistent positive impact on work productivity and activities of daily living in European and Australian women with heavy menstrual bleeding. These improvements were associated with a reduction in monetary burden of heavy menstrual bleeding compared with the placebo group, consistent with the response to treatment observed.

Indexed as

activities of daily livingdienogestestradiol valerateheavy menstrual bleedingwork productivity

Identifiers

PMID22927764
PMCPMC3422106

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.