Abstract
Background
Polyethylene glycol (PEG) is a commonly used osmotic laxative. PEG with electrolytes is mixed with water, but PEG without electrolytes can also be mixed with, for example, juice, coffee or tea, making it more palatable. Laxatives, including PEG, are commonly used by the elderly, particularly those living in institutions. Few clinical studies, however, have investigated the use of PEG in this population.
Objective
To test whether PEG 4000 without electrolytes (hypotonic PEG) is at least as effective and safe as PEG 4000 with electrolytes (isotonic PEG) in elderly institutionalized constipated patients. The acceptability of the treatments was also compared.
Methods
This randomized, double-blind, parallel-group study was conducted at ten private assisted-living facilities or communal nursing homes in Finland. Eligible patients were required to have used isotonic PEG at a stable dose without any other treatment for constipation (except for Plantago ovata seeds) for at least 2 weeks prior to a run-in period. After the 1-week run-in, 62 patients (mean age 86 years; range 66–99 years) were randomly either switched to receive hypotonic PEG or continued to receive isotonic PEG, both dissolved in water, 12g once or twice daily or once every other day, for 4 weeks. Stool frequency, stool consistency, stool straining and gastrointestinal symptoms were recorded. Safety laboratory tests were conducted before and after the treatment period. Acceptability was assessed at the end of the study.
Results
At week 4, mean (SD) weekly stool frequencies in the hypotonic and isotonic PEG groups were 8.5 (4.5) and 8.4 (3.6), respectively. The mean stool frequency ratio (95% CI) was 0.90 (0.74, 1.10); thus, the PEG products were considered equally effective. At week 4, the proportion of patients with soft or normal stool consistency was higher in the hypotonic PEG group than in the isotonic PEG group (70% vs 52%), but this difference was not statistically significant. There were no differences between the groups in stool straining or gastrointestinal symptoms. In the safety laboratory tests, no clinically significant differences between the groups were detected, although plasma sodium level was statistically significantly lower in the hypotonic PEG group at the end of the study (137.7 vs 138.9mmol/L, respectively; p=0.012). Most patients were willing to continue their study treatment (85% in the hypotonic PEG and 63% in the isotonic PEG group; p=0.070). Compared with only 12% of the patients receiving hypotonic PEG, however, 31% of the patients in the isotonic PEG group rated the taste of the study treatment as bad or very bad (p=0.101).
Conclusion
Hypotonic PEG solution is as effective as isotonic PEG in the treatment of constipation in elderly institutionalized patients. Both treatments appear safe, well tolerated and, when dissolved in water, well accepted by the majority of the patients. When desired, switching from isotonic to hypotonic PEG can safely take place in elderly individuals without compromising efficacy.
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References
Hosia-Randell H, Suominen M, Muurinen S, et al. Use of laxatives among older nursing home residents in Helsinki, Finland. Drugs Aging 2007; 24(2): 147–54
Gallagher PF, O’Mahony D, Quigley EM. Management of chronic constipation in the elderly. Drugs Aging 2008; 25(10): 807–21
Harari D, Gurwitz JH, Avorn J, et al. Constipation: assessment and management in an institutionalized elderly population. J Am Geriatr Soc 1994 Sep; 42(9): 947–52
Monane M, Avorn J, Beers MH, et al. Anticholinergic drug use and bowel function in nursing home patients. Arch Intern Med 1993 Mar 8; 153(5): 633–8
Phillips C, Polakoff D, Maue SK, et al. Assessment of constipation management in long-term care patients. J Am Med Dir Assoc 2001 Jul–Aug; 2(4): 149–54
Talley NJ, Fleming KC, Evans JM, et al. Constipation in an elderly community: a study of prevalence and potential risk factors. Am J Gastroenterol 1996 Jan; 91(1): 19–25
Wolfsen CR, Barker JC, Mitteness LS. Constipation in the daily lives of frail elderly people. Arch Fam Med 1993 Aug; 2(8): 853–8
Ramkumar D, Rao SS. Efficacy and safety of traditional medical therapies for chronic constipation: systematic review. Am J Gastroenterol 2005 Apr; 100(4): 936–71
Corazziari E, Badiali D, Bazzocchi G, et al. Long term efficacy, safety, and tolerability of low daily doses of isosmotic polyethylene glycol electrolyte balanced solution (PMF-100) in the treatment of functional chronic constipation. Gut 2000 Apr; 46(4): 522–6
DiPalma JA, DeRidder PH, Orlando RC, et al. A randomized, placebo-controlled, multicenter study of the safety and efficacy of a new polyethylene glycol laxative. Am J Gastroenterol 2000 Feb; 95(2): 446–50
Attar A, Lemann M, Ferguson A, et al. Comparison of a low dose polyethylene glycol electrolyte solution with lactulose for treatment of chronic constipation. Gut 1999 Feb; 44(2): 226–30
Chaussade S, Minic M. Comparison of efficacy and safety of two doses of two different polyethylene glycol-based laxatives in the treatment of constipation. Aliment Pharmacol Ther 2003 Jan; 17(1): 165–72
Cleveland MV, Flavin DP, Ruben RA, et al. New polyethylene glycol laxative for treatment of constipation in adults: a randomized, double-blind, placebo-controlled study. South Med J 2001 May; 94(5): 478–81
DiPalma JA, Cleveland MV, McGowan J, et al. A randomized, multicenter, placebo-controlled trial of polyethylene glycol laxative for chronic treatment of chronic constipation. Am J Gastroenterol 2007 Jul; 102(7): 1436–41
DiPalma JA, Cleveland MV, McGowan J, et al. An open-label study of chronic polyethylene glycol laxative use in chronic constipation. Aliment Pharmacol Ther 2007 Mar 15; 25(6): 703–8
DiPalma JA, Cleveland MB, McGowan J, et al. A comparison of polyethylene glycol laxative and placebo for relief of constipation from constipating medications. South Med J 2007 Nov; 100(11): 1085–90
Szojda MM, Mulder CJ, Felt-Bersma RJ. Differences in taste between two polyethylene glycol preparations. J Gastrointestin Liver Dis 2007 Dec; 16(4): 379–81
Corazziari E, Badiali D, Habib FI, et al. Small volume isosmotic polyethylene glycol electrolyte balanced solution (PMF-100) in treatment of chronic nonorganic constipation. Dig Dis Sci 1996 Aug; 41(8): 1636–42
Mathey MF, Siebelink E, de Graaf C, et al. Flavor enhancement of food improves dietary intake and nutritional status of elderly nursing home residents. J Gerontol A Biol Sci Med Sci 2001 Apr; 56(4): M200–5
Cohen R, de La Rocque F, Lecuyer A, et al. Study of the acceptability of antibiotic syrups, suspensions, and oral solutions prescribed to pediatric outpatients. Eur J Pediatr 2009 Jul; 168(7): 851–7
Powers JL. Properties of azithromycin that enhance the potential for compliance in children with upper respiratory tract infections. Pediatr Infect Dis J 1996 Sep; 15(9 Suppl.): S30–7
Pashankar DS, Bishop WP. Efficacy and optimal dose of daily polyethylene glycol 3350 for treatment of constipation and encopresis in children. J Pediatr 2001 Sep; 139(3): 428–32
Pashankar DS, Loening-Baucke V, Bishop WP. Safety of polyethylene glycol 3350 for the treatment of chronic constipation in children. Arch Pediatr Adolesc Med 2003 Jul; 157(7): 661–4
Acknowledgements
This study was funded by Orion Corporation, Orion Pharma, Finland. The authors would like to thank the study investigators, Jari Ahvenainen, Jussi Ripsaluoma and Sirkka-Liisa Kaistinen, and the study coordinating nurse, Mervi Nissinen, for their work in conducting the clinical study. Ulla Sairanen, Tarmo Laine, Sangita Kurl, Tiina Pettersson and Pertti Happonen are employees of Orion Pharma and may hold stock in the company. Lauri Seinelä, the coordinating investigator of the study, received payment for the work in this role and has received compensation as a speaker at seminars organized by Orion.
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Seinelä, L., Sairanen, U., Laine, T. et al. Comparison of Polyethylene Glycol with and without Electrolytes in the Treatment of Constipation in Elderly Institutionalized Patients. Drugs Aging 26, 703–713 (2009). https://doi.org/10.2165/11316470-000000000-00000
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DOI: https://doi.org/10.2165/11316470-000000000-00000