Evidence map›Paper›PMID 25423327›Full record

Trial reportMenopause (New York, N.Y.)2015

North Central Cancer Treatment Group N10C2 (Alliance): a double-blind placebo-controlled study of magnesium supplements to reduce menopausal hot flashes.

Haeseong Park, Rui Qin, Thomas J Smith, Pamela J Atherton, Debra L Barton, Keren Sturtz, Shaker R Dakhil, Daniel M Anderson, Kathleen Flynn, Suneetha Puttabasavaiah and 3 more

Open access · greenAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Menopause (New York, N.Y.), 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed, 2 pooled it
1.2field-weighted citation impact, top 23% 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

8 citing papers in PubMed, 2 syntheses or guidelines pooled it, 21 citations in OpenAlex.

  1. Does the placebo effect on hot flashes depend on the placebo dose?Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2021
    Pooled it
  2. Variation in menopausal vasomotor symptoms outcomes in clinical trials: a systematic review.BJOG : an international journal of obstetrics and gynaecology · 2020
    Pooled it
  3. Review
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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

13 authors at 10 institutions in 1 country.

Haeseong ParkFrom the 1Virginia Commonwealth University, Richmond, VA; 2Alliance Statistics and Data Center, Mayo Clinic Rochester, Rochester, MN; 3Johns Hopkins Medical Institutions, Baltimore, MD; 4University of Michigan School of Nursing, Ann Arbor, MI; 5Colorado Cancer Research Program, Denver, CO; 6Wichita Community Clinical Oncology Program, Wichita, KS; 7Metro-Minnesota Community Clinical Oncology Program, St Louis Park, MN; 8Michigan Cancer Research Consortium, Ann Arbor, MI; 9Illinois Oncology Research Association Community Clinical Oncology Program, Peoria, IL; 10Grand Rapids Clinical Oncology Program, Grand Rapids, MI; and 11Mayo Clinic, Rochester, MN.
Rui Qin
Thomas J Smith
Pamela J Atherton
Debra L Barton
Keren Sturtz
Shaker R Dakhil
Daniel M Anderson
Kathleen Flynn
Suneetha Puttabasavaiah
Nguyet Anh Le-Lindqwister
Gilbert D A Padula
Charles L Loprinzi
Virginia Commonwealth University · USAlliance Data (United States) · USAlliance for Clinical Trials in Oncology · USIowa Oncology Research Association · USJohns Hopkins University · USMetro-Minnesota Community Oncology Research Consortium · USMichigan Cancer Research Consortium · USUniversity of Colorado Denver · USUniversity of Michigan–Ann Arbor · USWichita Clinic · US

Funding

Member Site CoreU10CA180821 · NCI · BRIGHAM AND WOMEN'S HOSPITAL · PI Evanthia Galanis · 2014 to 2026
$177.3M
CANCER AND LEUKEMIA GROUP B MINORITY SATELLITE SUPPLEMENU10CA031946 · NCI · UNIVERSITY OF CHICAGO · PI BERTAGNOLLI, MONICA M · 1985 to 2013
$158.4M
Women's Cancer ProgramP30CA015083 · NCI · MAYO CLINIC ROCHESTER · PI AKHILESH PANDEY · 1985 to 2026
$151.3M
Collaborations and NCORP Collective ManagementUG1CA189823 · NCI · MAYO CLINIC ROCHESTER · PI Evanthia Galanis, Olwen Hahn · 2014 to 2026
$120.6M
Statistics CoreU10CA180882 · NCI · MAYO CLINIC ROCHESTER · PI Sumithra Jay Mandrekar · 2014 to 2026
$115.0M
TRANSLATIONAL RESEARCHU10CA025224 · NCI · MAYO CLINIC ROCHESTER · PI BUCKNER, JAN C · 1985 to 2013
$85.0M
CANCER &LEUKEMIA GROUP B STATISTICAL CENTERU10CA033601 · NCI · UNIVERSITY OF NEBRASKA MEDICAL CENTER · PI SARGENT, DANIEL J. · 1985 to 2013
$69.4M
SUPPLEMENTU10CA037404 · NCI · MAYO CLINIC ROCHESTER · PI LOPRINZI, CHARLES L · 1985 to 2014
$34.8M
COMMUNITY CLINICAL ONCOLOGY PROGRAMU10CA035431 · NCI · VIA CHRISTI REGIONAL MEDICAL CENTER · PI DAKHIL, SHAKER R · 1985 to 2014
$24.0M
W METRO-MINNEAPOLIS COMMUNITY CLINICAL ONCOLOGY PROGRAMU10CA035267 · NCI · PARK NICOLLET INSTITUTE · PI LEACH, JOSEPH · 1985 to 2014
$23.2M
UPSTATE CAROLINA COMMUNITY CLINICAL ONCOLOGY PROGRAMU10CA035119 · NCI · SPARTANBURG REGIONAL MEDICAL CENTER · PI BEARDEN, JAMES D · 1985 to 2013
$21.5M
MICHIGAN CANCER RESEARCH CONSORTIUM CCOPU10CA063848 · NCI · SAINT JOSEPH MERCY HEALTH SYSTEM · PI STELLA, PHILIP J · 1994 to 2014
$17.2M
NCI NIH HHS CA-25224NCI NIH HHS CA31946NCI NIH HHS CA33601NCI NIH HHS CA-35090NCI NIH HHS CA-35101NCI NIH HHS CA-35103NCI NIH HHS CA-35113NCI NIH HHS CA-35195NCI NIH HHS CA-35267NCI NIH HHS CA-35415NCI NIH HHS CA-35448NCI NIH HHS CA-37404NCI NIH HHS CA-37417NCI NIH HHS CA-63848NCI NIH HHS CA-63849NCI NIH HHS N01 CA035119NCI NIH HHS N01 CA035431NCI NIH HHS P30 CA015083NCI NIH HHS U10 CA025224NCI NIH HHS U10 CA031946NCI NIH HHS U10 CA033601NCI NIH HHS U10 CA035090NCI NIH HHS U10 CA035101NCI NIH HHS U10 CA035103NCI NIH HHS U10 CA035113NCI NIH HHS U10 CA035119NCI NIH HHS U10 CA035195NCI NIH HHS U10 CA035267NCI NIH HHS U10 CA035415NCI NIH HHS U10 CA035431NCI NIH HHS U10 CA035448NCI NIH HHS U10 CA037404NCI NIH HHS U10 CA037417NCI NIH HHS U10 CA063848NCI NIH HHS U10 CA063849NCI NIH HHS U10 CA180821NCI NIH HHS U10 CA180882NCI NIH HHS UG1 CA189805NCI NIH HHS UG1 CA189808NCI NIH HHS UG1 CA189823NCI NIH HHS UG1 CA189825
6 · The paper itself

Abstract

objectiveHot flashes are a common symptom in breast cancer survivors that can negatively impact quality of life. Preliminary data suggested that magnesium might be used as an effective low-cost treatment of hot flashes with minimal adverse effects.

methodsA four-arm, double-blind, placebo-controlled, randomized trial was conducted. Postmenopausal women with a history of breast cancer and bothersome hot flashes were randomized into treatment groups of magnesium oxide 800 or 1,200 mg daily or corresponding placebo groups at a 2:2:(1:1) ratio. Hot flash frequency and hot flash score (number × mean severity) were measured using a validated hot flash diary. A 1-week baseline period preceded initiation of study medication. The primary endpoint was intrapatient difference in mean hot flash score between baseline and treatment periods, comparing each magnesium group with the combined placebo groups using a gatekeeping procedure. Results were analyzed using repeated-measures and growth curve models on weekly hot flash scores based on a modified intent-to-treat principle.

resultsTwo hundred eighty-nine women enrolled between December 2011 and March 2013. Study groups were well balanced for baseline characteristics. Mean hot flash scores, mean hot flash frequencies, and associated changes during the treatment period were similar for each group. An increased incidence of diarrhea and a corresponding lower incidence of constipation were reported in magnesium arms compared with placebo. No statistically significant difference in other toxicities or quality-of-life measures was observed.

conclusionsThe results of this trial do not support the use of magnesium oxide for hot flashes.

Indexed as

Dietary SupplementsMenopauseBreast NeoplasmsDouble-Blind MethodFemaleHot FlashesHumansMagnesium OxideMiddle AgedQuality of LifeTreatment OutcomeMagnesium Oxide

Identifiers

PMID25423327
PMCPMC4442087
OpenAlexW2026705709

What OpenQuestion holds

Textmetadata
LicenceTDM
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.