TY - JOUR
T1 - North Central Cancer Treatment group N10C2 (Alliance)
T2 - A double-blind placebo-controlled study of magnesium supplements to reduce menopausal hot flashes
AU - Park, Haeseong
AU - Qin, Rui
AU - Smith, Thomas J.
AU - Atherton, Pamela J.
AU - Barton, Debra L.
AU - Sturtz, Keren
AU - Dakhil, Shaker R.
AU - Anderson, Daniel M.
AU - Flynn, Kathleen
AU - Puttabasavaiah, Suneetha
AU - Le-Lindqwister, Nguyet Anh
AU - Padula, Gilbert D.A.
AU - Loprinzi, Charles L.
N1 - Publisher Copyright:
© 2014 by The North American Menopause Society.
PY - 2015/6/6
Y1 - 2015/6/6
N2 - Hot 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. Methods A 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. Results Two 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. Conclusions The results of this trial do not support the use of magnesium oxide for hot flashes.
AB - Hot 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. Methods A 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. Results Two 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. Conclusions The results of this trial do not support the use of magnesium oxide for hot flashes.
KW - Breast cancer survivorship
KW - Hot flashes
KW - Magnesium
UR - http://www.scopus.com/inward/record.url?scp=84930485391&partnerID=8YFLogxK
U2 - 10.1097/GME.0000000000000374
DO - 10.1097/GME.0000000000000374
M3 - Article
C2 - 25423327
AN - SCOPUS:84930485391
SN - 1072-3714
VL - 22
SP - 627
EP - 632
JO - Menopause
JF - Menopause
IS - 6
ER -