NCCTG N10C2 (Alliance): A double-blind, placebo-controlled study of magnesium supplements to reduce menopausal hot flashes.

Abstract

Objective-Hot flashes (HFs) are a common symptom in breast cancer survivors that can negatively impact quality of life. Preliminary data suggested that magnesium might be an effective, low-cost treatment for HFs with minimal side effects.Methods-A four-arm, double-blind, placebo-controlled randomized trial was conducted. Postmenopausal women with a history of breast cancer and bothersome HFs were randomized into treatment groups of 800 or 1200 mg daily magnesium oxide, or corresponding placebo groups in 2:2:(1:1) ratios. HF frequency and scores (number times mean severity) were measured using a validated HF diary. A one-week baseline period preceded initiation of study medication. The primary endpoint was the intra-patient difference in average hot flash score between the baseline and the treatment periods, comparing each magnesium group to the combined placebo groups Correspondence and reprints requests to: using a gate-keeping procedure. Results were analyzed using repeated measures and growth curve models on weekly HF score, based on a modified intent-to-treat principle.Results-289 women enrolled between 12/2011 and 03/2013. The study groups were well balanced for baseline characteristics. Mean HF scores, 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 to placebo. No statistically significant difference occurred in other toxicities or quality of life measures. Conclusions-The results of this trial do not support the use of magnesium oxide for HFs. Keywords magnesium; hot flashes; breast cancer survivorshipPark et al.

Variation in menopausal vasomotor symptoms outcomes in clinical trials: a systematic review

“…Of these, 330 were excluded; 59 included fewer than 20 women per study arm and 54 were not an RCT; 126 did not clearly state a sample size calculation; 52 did not measure vasomotor symptoms as the primary outcome; 39 were secondary analysis. Following these exclusions, 214 RCT were included…”

“…However, they will still be used for the subsequent Delphi process. Other subjective vasomotor symptoms measurement tools included a 20‐item structured symptom checklist; two of the items asking about the presence of hot flushes and cold/night sweats, a 5‐point (from none to very severe) scoring system about the severity of hot flushes and night sweats, Interactive Voice Response System to record the number and severity of the hot flushes, and self‐reported surveys . Objective measures of vasomotor symptoms such as skin conductance were used in five trials in addition to subjective measures (Table ).…”

Menopausal hot flashes: The role of magnesium and select endocrine factors

“…In the phase II trial (n = 25), treatment with 400-800 mg of magnesium oxide was successful in reducing hot flashes. The larger randomized control study (n = 289) using treatment with 800 or 1200 mg of magnesium oxide yielded some improvement in symptoms, with 1200 mg doses being slightly more effective, but this improvement was not significant in comparison to placebo [15]. 3.…”

Magnesium in the gynecological practice: a literature review

“…Another common symptom of menopause is the occurrence of hot flashes. Two recent analyses [40,41] focused on the efficacy of magnesium oxide supplements to reduce the incidence of hot flashes in women with a history of breast cancer. The results provided discordant results, with the larger analysis being carried out by the North Central Cancer Treatment Group reporting no difference between the treatment and the placebo arm.…”