[Comparative study of the short-term acceptability and tolerance of a new oral formulation of magnesium (TX 1341) and a reference magnesium].
This open, randomized study on 2 parallel groups compared the acceptability, digestive tolerance and observance of TX 1341, a new chewable magnesium tablet (OROMAG, Laboratoire Théramex) to that of a reference magnesium (MAG2, Laboratoire Théraplix). 179 patients warranting a magnesotherapy were treated for 10 weeks either by 3 chewable lactate and citrate of magnesium tablets (TX 1341) each containing 120 mg of magnesium-element, or by 3 drinkable ampoules of pidolate of magnesium (each of 122 mg of magnesium-element). Acceptability was assessed at the end of the study by a semi-quantitative scale at four levels and digestive tolerance by closed questionnaire submitted before and after treatment. 72.7% of patients treated by TX 1341 find the treatment agreeable against 46.1% with the reference magnesium (p < 0.01). The number of drops out linked to treatment is not significantly different in the two groups and they are virtually all linked to digestive problems. The two medications significantly lower the number of cases of constipation without noticeably increasing the number of cases of diarrhea. The comparison of the number of digestive symptoms which appeared under treatment only underline one significant difference between the 2 groups (p < 0.05): the appearance of 5 times less the number of abdominal pains with TX 1341 (2 cases). Cases of irregular intake are significantly higher with the reference drug than with TX 1341 (respectively 23.7% and 8.5%; p < 0.01).
Zartarian
M
M
Hôpital de l'Archet l, Service d'Endocrinologie, CHU Nice.
Perez
J P
JP
Gelas
B
B
Thomas
J L
JL
D000284:Administration, Oral; D000328:Adult; D002626:Chemistry, Pharmaceutical; D005260:Female; D005767:Gastrointestinal Diseases / Q000139:chemically induced; D006801:Humans; D017616:Magnesium Compounds / Q000737:chemistry / Q000627:therapeutic use*; D008275:Magnesium Deficiency / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D010342:Patient Acceptance of Health Care; D011446:Prospective Studies; D011761:Pyrrolidonecarboxylic Acid / Q000031:analogs & derivatives* / Q000627:therapeutic use; D011795:Surveys and Questionnaires; D013607:Tablets
D017616:Magnesium Compounds; D013607:Tablets; D011761:Pyrrolidonecarboxylic Acid