Help deciphering this study re: Magnesium and Hot Flashes

Hi farmerlucy:

Near the top of the record in red font, it notes: "The study has been completed."

At the bottom of the record, under "More Information", there is a link to a PubMed abstract, which can be followed to this NIH version of the published results:

http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3085555/pdf/nihms277868.pdf

The clinicaltrial.gov record also includes the "study objectives":

OBJECTIVES:

Primary

• To determine if magnesium oxide supplement will decrease the frequency and severity of hot flashes by 50% in menopausal women with cancer.

Secondary

• To evaluate the effect of magnesium oxide on overall quality of life.
• To evaluate the toxicities of magnesium oxide when administered at commonly used supplement doses.

The paper appears to include a discussion of findings for both the primary and secondary objectives:

"The primary objective was to determine if magnesium oxide supplements would decrease the frequency and severity of hot flashes (the hot flash score) by 50% as done in trials conducted at the Mayo Clinic [12]. Secondary objectives were to evaluate the effect on overall quality of life and toxicities." Please see the paper linked above for the results of these assessments.

Study results are also entered in the clinicaltrial.gov record under the "Study Results" tab at the top of the screen:

▲

Study Results Tab

This was a Phase II "pilot" study in a small number of patients, and the discussion of the paper mentions: "A phase III randomized controlled trial is planned to further evaluate effectiveness of magnesium supplementation for hot flash symptoms in a larger patient population, with biologic correlates to determine mechanism of action."

I did a quick and dirty search of clinicaltrials.gov (query: "magnesium oxide" and "hot flashes") and found another Phase II trial, but not a Phase III one:

https://clinicaltrials.gov/ct2/show/NCT01439945?term=magnesium+oxide+and+hot+flashes&rank=1

This second trial is completed, but no results or publication are posted in the record.

BarredOwl

And if "they" think it will help, I am doubtful. I've been taking Mg and STILL getting hot flashes...less often, but then, I've been off the cancer meds for almost 4 years