Title:  Method and composition for treatment of headache using magnesium

United States Patent:  6,218,192

Assignee:  Research Foundation of the State University of New York (Albany, NY)

Filed:  February 17, 1995

A method of treating headache is provided using a water soluble magnesium salt. Specifically, a method of treating a headache is provided for an individual having a serum ionized magnesium concentration of 0.44 mmoles/L to 0.53 mmoles/L and having at least one headache symptom by administering an amount of a water soluble magnesium salt sufficient to inhibit at least one headache symptom in the individual within 24 hours and to raise the serum ionized magnesium concentration in the individual to within a normal ionized magnesium concentration range of 0.54 mmoles/L to 0.67 mmoles/L. Headache symptoms which may be inhibited include: pain, aura, photophobia, nausea, unilateral pain and phonophobia.

SUMMARY OF INVENTION

The present invention relates to a method for preparing biological samples, including collection and storage conditions, prior to testing for ionized Mg²⁺ concentrations under conditions which minimize or prevent exchange of gases between the biological sample and atmospheric air and in which air and O₂ is substantially excluded from the biological sample, preferably under anaerobic conditions, prior to measuring ionized Mg²⁺.

Another aspect of the invention is a method for determining ionized Mg²⁺ concentrations in a biological sample, collected and maintained under anaerobic conditions or conditions which minimize or prevent exchange of gases between the biological sample and atmospheric air and in which O₂ is substantially excluded from the biological sample, the Mg²⁺ concentration being measured using an ion selective electrode with a neutral carrier based membrane.

Another aspect of the invention is a method for determining ionized Ca²⁺ :Mg²⁺ ratios in a biological sample, collected and maintained under anaerobic conditions or conditions which minimize or prevent exchange of gases between the biological sample and atmospheric air and in which O₂ is substantially excluded from the biological sample, the Ca²⁺ and Mg²⁺ concentrations being measured using ion selective electrodes with a neutral carrier based membrane.

An additional aspect of the invention is a method for diagnosing or prognosing disease states such as headache, cardiac diseases, hypertension, idiopathic intracranial hypertension, diabetes, lung diseases, abnormal pregnancy, pre-eclampsia, eclampsia, head trauma, fetal growth retardation, and the like, in a patient using a method of determining ionized Mg²⁺ concentrations or ionized Ca²⁺ :Mg²⁺ ratios.

A further aspect of the invention is a method of maintaining normal ionized Mg²⁺ concentrations in a patient in need of such maintenance comprising administration of Mg²⁺ in the form of a pharmaceutical composition or dietary supplement. Another aspect of the invention is a method of maintaining normal ionized Ca²⁺ /ionized Mg²⁺ molar ratios in an individual comprising administration of an effective amount of Ca²⁺ and Mg²⁺ in the form of a pharmaceutical composition or dietary supplement.

Another object of the present invention is a method and composition for treatment of headaches using a magnesium salt. The composition may be provided in a kit form along with a self-injection device.

Another aspect of the invention is a pharmaceutical composition or dietary supplement for preventing or treating magnesium deficiencies, the composition comprising as the active ingredient(s) a concentration of bioavailable magnesium or bioavailable calcium and magnesium, wherein the concentration(s) provides a normal physiological molar ratio of ionized Ca²⁺ /Mg²⁺ in the body fluids, such body fluids comprising whole blood, serum, plasma, cerebral spinal fluid or the like.

Claim 1 of 7 Claims

What is claimed is:

1. A method of treating a headache in an individual having a serum ionized magnesium concentration of 0.44 m moles/L to 0.53 mmoles/L, wherein said serum ionized magnesium concentration of said individual is below a normal serum ionized magnesium concentration range of 0.54 mmoles/L to 0.67 mmoles/L, said method consisting of:

administering to said individual having said serum ionized magnesium concentration of 0.44 mmoles/l to 0.53 mmoles/L and having at least one headache symptom, an amount of a water soluble magnesium salt, wherein said amount of said water soluble magnesium salt inhibits said at least one headache symptom in said individual within 24 hours and raises said serum ionized magnesium concentration in said individual to within said normal ionized magnesium concentration range of 0.54 mmoles/L to 0.67 mmoles/L.

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