Effectiveness and safety of natural mineral water rich in magnesium and sulfates for the intestinal function

A randomized, placebo-controlled, double-blind trial

Objective. The present randomized placebo-controlled double-blind trial was conducted to examine whether natural mineral water with a high content of magnesium sulfate and sodium sulfate (Donat Mg) contributes to improvement of the bowel function.

Methods. A total of 106 healthy subjects with functional constipations were randomized in groups to receive 500 ml natural mineral water for the 6-week course and a comparison group who took placebo water. Trial participants recorded in a diary each complete spontaneous bowel movement, the number of spontaneous bowel movements per week overall, consistency of stool, gastrointestinal symptoms and general wellbeing. The change in the number of complete spontaneous bowel movements was defined as the primary outcome of the trial.

Results. In 75 trial participants in groups that took 500 ml the change in the number of complete spontaneous bowel movements per week after 6 weeks., as a rule, was higher in the active treatment group compared with the placebo group (T2 = 1.8; P-value= 0.036; one-sided criterion). The average number of complete spontaneous bowel movements significantly increased during the trial, with significant differences between trial groups, taking into account the duration of the trial in general (F-criterion = 4,743; R time × group = 0,010, a two-sided criterion). Intake of mineral water, compared with placebo considerably improved the stool consistency at spontaneous bowel movements (p < 0.001), subjectively perceived signs of constipation significantly decreased (p = 0.005).

Conclusion. Daily intake of natural mineral water, rich in magnesium sulfate and sodium sulfate, has increased frequency of bowel movements and improved stool consistency in people with functional constipations. In addition, assessment of the participants in the trial of quality of life associated with the condition improved. Clinical trial registration number in the EudraCT database: No. 2012-005130-11. 

1. Norton C. Constipation in older patients: effects on quality of life. Br J Nurs, 2006. doi:10.12968/bjon.2006.15.4.20542.

2. Burkitt DP, Walker AR, Painter NS. Effect of dietary fibre on stools and the transit-times, and its role in the causation of disease. Lancet, 1972, 2(7792): 1408-1412.

3. Sun SX, Dibonaventura M, Purayidathil FW, Wagner JS, Dabbous O, Mody R (2011) Impact of chronic constipation on health-related quality of life, work productivity, and healthcare resource use: an analysis of the National Health and Wellness Survey. Dig Dis Sci, doi:10.1007/s10620-011-1639-5.

4. Drossman DA. The functional gastrointestinal disorders and the Rome III process. Gastroenterology, 2006. doi:10.1053/j. gastro.2006.03.008.

5. Schmidt FM, Santos VL.Prevalence of constipation in the general adult population: an integrative review. J Wound Ostomy Cont Nurs, 2014. doi:10.1097/01.WON.0000438019.21229.b7.

6. Peppas G, Alexiou VG, Mourtzoukou E, Falagas ME. Epidemiology of constipation in Europe and Oceania: a systematic review. BMC Gastroenterol, 2008. doi:10.1186/1471-230X-8-5.

7. Wyman JB, Heaton KW, Manning AP, Wicks AC. Variability of colonic function in healthy subjects. Gut, 1978, 19(2): 146-150.

8. Wenzl HH, Fine KD, Schiller LR, Fordtran JS. Determinants of decreased fecal consistency in patients with diarrhea. Gastroenterology, 1995, 108(6): 1729-1738.

9. Weaver LT. Bowel habit from birth to old age. J Pediatr Gastroenterol Nutr, 1988, 7(5): 637-640.

10. Muller-Lissner S, Tack J, Feng Y, Schenck F, Specht Gryp R. Levels of satisfaction with current chronic constipation treatment options in Europe – an internet survey. Aliment Pharmacol Ther, 2013. doi:10.1111/apt.12124

11. Vu MK, Nouwens MA, Biemond I, Lamers CB, Masclee AA. The osmotic laxative magnesium sulphate activates the ileal brake. Aliment Pharmacol Ther, 2000, 14(5): 587-595.

12. Stewart JJ, Gaginella TS, Olsen WA, Bass P. Inhibitory actions of laxatives on motility and water and electrolyte transport in the gastrointestinal tract. J Pharmacol Exp Ther, 1975, 192(2): 458-467.

13. Dupont C, Campagne A, Constant F. Efficacy and safety of a magnesium sulfate-rich natural mineral water for patients with functional constipation. Clin Gastroenterol Hepatol, 2014. doi:10.1016/j.cgh.2013.12.005

14. Constant F, Morali A, Arnaud MJ, Delabroise AM, Thirion F, Matisse N, Wagner M, Dohm JP, Vuillemin JL, Gay G. Treatment of idiopathic constipation in infants: comparative and randomized study of twa mineral waters (60 cases). J Pediatr Gastroenterol Nutr, 1999, 28(5): 551.

15. Gasbarrini G, Candelli M, Graziosetto RG, Coccheri S, Di Iorio F, Nappi G. Evaluation of thermal water in patients with functional dyspepsia and irritable bowel syndrome accompanying constipation. World J Gastroenterol, 2006, 12(16): 2556-2562.

16. Drossman DA. Rome III: the new criteria. Chin J Dig Dis, 2006. doi:10.1111/j.1443-9573.2006.00265.x.

17. Lewis SJ, Heaton KW. Stool form scale as a useful guide to intestinal transit time. Scand J Gastroenterol, 1997. doi:10.3109/00365529709011203

18. Dimenas E, Glise H, Hallerback B, Hernqvist H, Svedlund J, Wiklund I. Well-being and gastrointestinal symptoms among patients referred to endoscopy owing to suspected duodenal ulcer. Scand J Gastroenterol, 1995, 30(11): 1046-1052.

19. Ware JJr, Kosinski M, Keller SD. A 12-Item Short-Form Health Survey: construction of scales and preliminary tests of reliability and validity. Med Care, 1996, 34(3): 220-233.

20. Lee PH, Macfarlane DJ, Lam TH, Stewart SM. Validity of the international physical activity questionnaire short form (IPAQ-SF): a systematic review. Int J Behav Nutr Phys Act, 2011, doi:10.1186/1479-5868-8-115.

21. Chow S-C, Chang M. Adaptive design methods in clinical trials. Chapman & Hall/CRC, New York, 2012.

22. Lehmacher W, Wassmer G. Adaptive sample size calculations in group sequential trials. Biometrics, 1999, 55(4): 1286-1290.

23. Chang M. Adaptive design theory and implementation using SAS and R. Chapman & Hall/ CRC, New York, 2008.

24. Attaluri A, Donahoe R, Valestin J, Brown K, Rao SS. Randomised clinical trial: dried plums (prunes) vs. psyllium for constipation. Aliment Pharmacol Ther, 2011. doi:10.1111/j.1365-2036.2011.04594.x.

25. Talley NJ, Fullerton S, Junghard O, Wiklund I. Quality of life in patients with endoscopy-negative heartburn: reliability and sensitivity of disease-specific instruments. Am J Gastroenterol, 2001. doi:10.1111/j.1572-0241.2001.03932.x.

26. Mueller-Lissner S, Kamm MA, Wald A, Hinkel U, Koehler U, Richter E, Bubeck J. Multicenter, 4-week, double-blind, randomized, placebocontrolled trial of sodium picosulfate in patients with chronic constipation. Am J Gastroenterol, 2010. doi:10.1038/ajg.2010.41.

27. Donowitz M. Current concepts of laxative action: mechanisms by which laxatives increase stool water. J Clin Gastroenterol, 1979, 1(1): 77-84.

28. Izzo AA, Gaginella TS, Capasso F. The osmotic and intrinsic mechanisms of the pharmacological laxative action of oral high doses of magnesium sulphate. Importance of the release of digestive polypeptides and nitric oxide. Magnes Res, 1996, 9(2): 133-138.

29. Ikarashi N, Mochiduki T, Takasaki A, Ushiki T, Baba K, Ishii M, Kudo T, Ito K, Toda T, Ochiai W, Sugiyama K. Amechanism by which the osmotic laxative magnesium sulphate increases the intestinal aquaporin 3 expression in HT-29 cells. Life Sci, 2011. doi:10.1016/j.lfs.2010.11.013.

30. Ikarashi N, Ushiki T, Mochizuki T, Toda T, Kudo T, Baba K, Ishii M, Ito K, Ochiai W, Sugiyama K. Effects of magnesium sulphate administration on aquaporin 3 in rat gastrointestinal tract. Biol Pharm Bull, 2011, 34(2): 238-242.

31. Izzo AA, Gaginella TS, Mascolo N, Capasso F. Nitric oxide as a mediator of the laxative action of magnesium sulphate. Br J Pharmacol, 1994, 113(1): 228-232.

32. Moore EW. Physiological effects of the consumption of saline drinking water. In: A progress report to the 16th meeting of the subcommittee on sanitary engineering and environment. Appendix B. National Academy of Sciences, Washington, DC, 1952.

33. Heizer WD, Sandler RS, Seal E Jr, Murray SC, Busby MG, Schliebe BG, Pusek SN. Intestinal effects of sulfate in drinking water on normal human subjects. Dig Dis Sci, 1997, 42(5): 1055-1061.