J Neurogastroenterol Motil.  2019 Oct;25(4):563-575. 10.5056/jnm18194.

A Randomized Double-blind Placebo-controlled Trial on the Effect of Magnesium Oxide in Patients With Chronic Constipation

• Mori S
• Tomita T
• Fujimura K
• Asano H
• Ogawa T
• Yamasaki T
• Kondo T
• Kono T
• Tozawa K
• Oshima T
• Fukui H
• Kimura T
• Watari J
• Miwa H

• KMID: 2460486
• DOI: http://doi.org/10.5056/jnm18194

Abstract

BACKGROUND/AIMS
Magnesium oxide (MgO) has been frequently used as a treatment for chronic constipation (CC) since the 1980s in Japan. The aim of this study is to evaluate its therapeutic effects of MgO in Japanese CC patients.
METHODS
We conducted a randomized, double-blind placebo-controlled study. Thirty-four female patients with mild to moderate constipation were randomly assigned to either placebo (n = 17) or MgO group (n = 17) 0.5 g × 3/day for 28 days. Primary endpoint was overall improvement over the 4-week study period. Secondary endpoints were changes from baseline in spontaneous bowel movement (SBM), response rates of complete spontaneous bowel movement (CSBM), stool form, colonic transit time (CTT), abdominal symptom, and quality of life.
RESULTS
One patient failed to complete the medication regimen and was omitted from analysis: data from 16 placebo and 17 MgO patients were analyzed. The primary endpoint was met by 25.0% of placebo vs 70.6% of MgO group (P = 0.015). MgO significantly improved SBM changes compared to placebo (P = 0.002). However, MgO did not significantly improved response rates of CSBM compared to placebo (P = 0.76). In addition, MgO significantly improved Bristol stool form scale changes (P < 0.001) and significantly improved CTT compared to the placebo group (P < 0.001). MgO significantly improved the Japanese version of the patient assessment of constipation quality of life (P = 0.003).
CONCLUSION
Our placebo-controlled study demonstrated that MgO was effective treatment for improving defecation status and shortened CTT in Japanese CC patients with mild to moderate symptoms.

Keyword

Constipation; Defecation; Double-blind method; Japan; Magnesium oxide

MeSH Terms

Asian Continental Ancestry Group
Colon
Constipation*
Defecation
Double-Blind Method
Female
Humans
Japan
Magnesium Oxide*
Magnesium*
Quality of Life
Therapeutic Uses
Magnesium
Magnesium Oxide
Therapeutic Uses