Evidence map›Paper›PMID 15309425›Full record

Trial reportEuropean journal of nutrition2004

Soymilk or progesterone for prevention of bone loss--a 2 year randomized, placebo-controlled trial.

Eva Lydeking-Olsen, Jens-Erik Beck-Jensen, Kenneth D R Setchell, Trine Holm-Jensen

Abstract readClinical TrialRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in European journal of nutrition, 2004. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 49 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
49citing papers in PubMed, 4 pooled it
9.9field-weighted citation impact, top 1% of its field
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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

49 citing papers in PubMed, 4 syntheses or guidelines pooled it, 178 citations in OpenAlex.

  1. Pooled it
  2. Isoflavone intervention and its impact on bone mineral density in postmenopausal women: a systematic review and meta-analysis of randomized controlled trials.Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA · 2024
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  9. The effect of soy isoflavone on bone mineral density in postmenopausal Taiwanese women with bone loss: a 2-year randomized double-blind placebo-controlled study.Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA · 2012
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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

4 authors at 3 institutions in 2 countries.

Eva Lydeking-OlsenInstitute for Optimum Nutrition, Teglgaardstraede 4, 1st. floor, 1452, Copenhagen K, Denmark. forskning@optinut.dk
Jens-Erik Beck-Jensen
Kenneth D R Setchell
Trine Holm-Jensen
Children's Hospital & Medical Center · USCopenhagen University Hospital · DKOptimum Therapeutics (United States) · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundGiven concerns over the use of hormone replacement therapy (HRT), women are seeking natural alternatives to cope with the symptoms and effects of menopause. The bone sparing effects of soy protein and its isoflavones is well established in animal studies, while 5 previous human studies on soy and bone have yielded variable outcomes due in part to their short duration of study. Progesterone has been suggested as a bone-trophic hormone, but the effect of long-term, low dose transdermal progesterone is unknown.

aimThe aim of the study was to compare for the first time the long-term effects of soymilk, with or without isoflavones with natural transdermal progesterone, or the combination, on bone mineral density in the lumbar spine and hip.

methodsPostmenopausal, Caucasian women with established osteoporosis or at least 3 risk-factors for osteoporosis, were randomly assigned, double-blind to one of four treatment-groups: soymilk containing isoflavones (soy+, n = 23), transdermal progesterone (TPD+, n = 22), or the combination of soy+ and TDP+,(n = 22) or placebo (isoflavone-poor soymilk, soy/ and progesterone-free-cream TDP/, n = 22). All subjects received comparable intakes of calcium, minerals and vitamins. Bone mineral content (BMC) and density (BMD) were measured in lumbar spine and hip by using dual-energy X-ray absorptiometry (DEXA) at baseline and after 2 years.

findingsThe percentage change in lumbar spine BMD and BMC respectively, did not differ from zero in the soy+ group (+1.1%, +2.0%) and TDP+ group (/1.1%, +0.4 %) but significant bone loss occurred in the control group (/4.2%,/4.3 %) and the combined treatment group (/2.8%, /2.4 %). No significant changes occurred for femoral neck BMD or BMC.

interpretationDaily intake of two glasses of soymilk containing 76 mg isoflavones prevents lumbar spine bone loss in postmenopausal women. Transdermal progesterone had bone-sparing effects but when combined with soy milk a negative interaction between the two treatments occurs resulting in bone-loss to a greater extent than either treatment alone.

Indexed as

Absorptiometry, PhotonAdministration, CutaneousAnalysis of VarianceBone and BonesBone DensityDouble-Blind MethodDrug InteractionsFemaleFemur NeckHumansIsoflavonesLongitudinal StudiesLumbar VertebraeMiddle AgedOsteoporosis, PostmenopausalPatient ComplianceIsoflavonesProgesterone

Identifiers

PMID15309425
OpenAlexW1999785937

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

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.