Recognizable Patterns of Human Malformation

Abstract

<h3>Introduction</h3> Patients with a high output ileostomy often have hypomagnesaemia. Oral magnesium therapy may be unsuccessful. Topical magnesium therapy may offer a novel mode of replacement. This phase II clinical study using BetterYou magnesium oil spray primarily aimed to determine if the spray will maintain or increase serum magnesium in these patients. <h3>Methods</h3> Outpatients with an ileostomy formed more than 6 months prior to inclusion and having chronic hypomagnesaemia (serum magnesium level less than &lt;0.66 mmol/L) at enrolment and either: (a) a further outpatient serum magnesium (Mg⁺²) level &lt;0.66 mmol/L in the last 3 months, or (b) needing regular intravenous magnesium infusions at least once every 6 weeks for more than 18 weeks, were recruited. Exclusion criteria included severe hypomagnesaemia (&lt;0.25 mmol/L), diuretic use, and medication alterations (including supplements and magnesium infusions) within 4 weeks of enrolment. Recruits applied 10 sprays twice daily for 6 weeks, delivering a topical elemental magnesium dose of 150 mg/day. Serum and whole cell Mg⁺² levels were measured at enrolment, and at weeks 1, 3 and 6. Vitamin D levels were measured at enrolment; 24 hour urinary magnesium levels were measured at enrolment and week 6. Treatment response is defined as a serum Mg⁺² level rise &gt;0.10 mmol/L at week 6, or the avoidance of a planned magnesium infusion during the trial without a fall in serum Mg⁺². Patients with serum Mg⁺² &lt;0.25 mmol/L or requiring additional magnesium supplementation during the study were withdrawn. <h3>Results</h3> 7 patients entered the study. 6 patients completed it; 1 was withdrawn at week 4 due to hospitalisation for Crohn’s disease. All 6 patients had normal enrolment vitamin D levels (&gt;45 nmol/L), and 5 of 6 had 24 hour urinary magnesium levels below the minimum detection limit (&lt;0.28 mmol/L). 1 of the 6 patients avoided their planned six-weekly magnesium infusion, maintaining a stable serum Mg⁺² level (0.59 mmol/L at enrolment, 0.62 mmol/L at week 6) and increased 24-urinary magnesium output. 2 of the remaining 5 patients were treatment successes, with a serum Mg⁺² rise of 0.27 and 0.13 respectively. No patient had a fall in serum Mg⁺² of greater than 0.07 mmol/L between enrolment and week 6. Serum and whole cell Mg⁺² correlation is strong and near linear (Pearson’s r=0.92, p&lt;0.01). All 6 patients complained of muscle cramping at enrolment; 5 reported significant improvement or complete resolution of cramping by week 3. <h3>Conclusions</h3> 3 of 6 patients were treated successfully with BetterYou magnesium oil spray. Serum magnesium is a reliable surrogate for whole cell magnesium.