Abstract
Objectives
To assess the tolerance and potential nutritional consequences of long-term repeated doses of PEG 4000 (10 to 30 g/day) in elderly patients with chronic constipation as compared to lactulose (10-30 g/ day).
Design
Single blind, randomised, multicentre, parallel group comparative study.
Setting
Community-dwelling patients and nursing homes residents aged 70 years and older with a history of chronic constipation.
Treatment intervention
PEG 4000 (10-30 g/day) or lactulose (10-30 g/day) for six months.
Assessments
Clinical nutritional status (Mini Nutritional Assessment), blood and stool samples were taken at baseline and after three and six months for assay of nutritional and absorption parameters. A patient diary documented digestive symptoms and adverse events were recorded. Information on efficacy (stool frequency and consistency) was collected as a secondary outcome measure.
Results
Of the 316 patients screened, 245 eligible patients constituted the ITT population (PEG 4000: N = 118; lactulose group: N = 127). The proportion of patients receiving PEG 4000 with abnormal levels of electrolytes, nutritional markers or vitamins did not significantly change in the six months after initiating laxative treatment and do not differ between the two groups. After a D-xylose challenge test, the proportion of patients with abnormally low xylosaemia (suggesting malabsorption) varied from 24.6% at baseline to 35.8% after six months in the PEG 4000 group and from 29.1% to 42.4% in the lactulose group, with no significant between-group or within-group differences. The proportion of patients with poor nutritional status (MNA score <17) varied from 8.5% at baseline to 9.8% after 6 months in the PEG 4000 group and from 3.9% to 5.0% in the lactulose group. No changes in stool fat or total or soluble stool nitrogen were observed in the minority of patients for whom stool analysis was performed. A significantly higher stool frequency p <0.05) and improved stool consistency p <0.05) was observed in the PEG 4000 group compared to the lactulose group at each monthly evaluation period.
Conclusions
After six months of treatment with PEG 4000, no clinically relevant changes in biochemical and nutritional parameters and no unanticipated treatment-related adverse events were detected, demonstrating the good clinical tolerance of PEG 4000 in this population of elderly constipated patients. This tolerance was associated with a better clinical efficacy of PEG 4000 compared to lactulose.
Similar content being viewed by others
References
Dagogo-Jack S. Glycemic control and chronic diabetes complications. In: Umpierrez 1. Thompson WG, Longstreth GF, Drossman DA, Heaton KW, Irvine EJ, et al. Functional bowel disorders and functional abdominal pain. Gut 45 Suppl 1999;2: II43–47.
Longstreth GF, Thompson WG, Chey WD, Houghton LA, Mearin F, et al. Functional bowel disorders. Gastroenterology 2006; 130: 1480–1491.
Peppas G, Alexiou VG, Mourtzoukou E, Falagas ME. Epidemiology of constipation in Europe and Oceania: a systematic review. BMC Gastroenterol 2008; 8: 5.
Higgins PD, Johanson JF. Epidemiology of constipation in North America: a systematic review. Am J Gastroenterol 2004; 99: 750–759.
Rantis PC, Vernava AM, Daniel GL, Longo WE. Chronic constipation—is the work-up worth the cost? Dis Colon Rectum 1997; 40: 280–286.
Frexinos J, Denis P, Allemand H, Allouche S, Los F, et al. [Descriptive study of digestive functional symptoms in the French general population]. Gastroenterol Clin Biol 1998; 22: 785–791.
Locke GR, Pemberton JH, Phillips SF. American Gastroenterological Association Medical Position Statement: guidelines on constipation. Gastroenterology 2000; 119: 1761–1766.
Sandler RS, Jordan MC, Shelton BJ. Demographic and dietary determinants of constipation in the US population. Am J Public Health 1990; 80: 185–189.
Harari D, Gurwitz JH, Minaker KL. Constipation in the elderly. J Am Geriatr Soc 41: 1130-1140.
Schaefer DC, Cheskin LJ. Constipation in the elderly. Am Fam Physician 58: 907-914.
Rey E, Barcelo M, Jimenez Cebrian MJ, Alvarez-Sanchez A, Diaz-Rubio M, et al. A nation-wide study of prevalence and risk factors for fecal impaction in nursing homes. PLoS One 2014;9: e105281.
Cheskin LJ, Kamal N, Crowell MD, Schuster MM, Whitehead WE. Mechanisms of constipation in older persons and effects of fiber compared with placebo. J Am Geriatr Soc 1995; 43: 666–669.
Gattuso JM, Kamm MA. Adverse effects of drugs used in the management of constipation and diarrhoea. Drug Saf 1994; 10: 47–65.
Piche T, Dapoigny M, Bouteloup C, Chassagne P, Coffin B, et al. [Recommendations for the clinical management and treatment of chronic constipation in adults]. Gastroenterol Clin Biol 2007; 31: 125–135.
Hammer HF, Santa Ana CA, Schiller LR, Fordtran JS. Studies of osmotic diarrhea induced in normal subjects by ingestion of polyethylene glycol and lactulose. J Clin Invest 1989; 84: 1056–1062.
Lee-Robichaud H, Thomas K, Morgan J, Nelson RL. Lactulose versus Polyethylene Glycol for Chronic Constipation. Cochrane Database Syst Rev 2010;: CD007570.
Brandt LJ, Prather CM, Quigley EM, Schiller LR, Schoenfeld P, et al. Systematic review on the management of chronic constipation in North America. Am J Gastroenterol 2005;100 Suppl 1: S5–S21.
Bharucha AE, Dorn SD, Lembo A, Pressman A. American Gastroenterological Association medical position statement on constipation. Gastroenterology 2013; 144: 211–217.
Lindberg G, Hamid SS, Malfertheiner P, Thomsen OO, Fernandez LB, et al. World Gastroenterology Organisation global guideline: Constipation—a global perspective. J Clin Gastroenterol 2011; 45: 483–487.
Pare P, Bridges R, Champion MC, Ganguli SC, Gray JR, et al. Recommendations on chronic constipation (including constipation associated with irritable bowel syndrome) treatment. Can J Gastroenterol 2007;21 Suppl B: 3B–22B.
Remes Troche JM, Chavez Barrera JA, Gonzalez Ortiz B, Heller Rouassant S, Montijo Barrios E, et al. [Guidelines for diagnosis and treatment of constipation in Mexico. D) Evaluation and treatment of constipation in pediatric population.]. Rev Gastroenterol Mex 2011; 76: 155–168.
Drossman DA, Richter JE, Talley NJ, Thomson WG, Corazziari E, et al. The functional gastrointestinal disorders: diagnosis, pathophysiology and treatment. Boston: Little & Brown, 1994.
Folstein MF, Folstein SE, McHugh PR. «Mini-mental state». A practical method for grading the cognitive state of patients for the clinician. J Psychiatr Res 1975; 12: 189–198.
Yesavage JA, Brink TL, Rose TL, Lum O, Huang V, et al. Development and validation of a geriatric depression screening scale: a preliminary report. J Psychiatr Res 1982; 17: 37–49.
Katz S, Downs TD, Cash HR, Grotz RC. Progress in development of the index of ADL. Gerontologist 1970; 10: 20–30.
Lawton MP, Brody EM. Assessment of older people: self-maintaining and instrumental activities of daily living. Gerontologist 1969; 9: 179–186.
Rubenstein LZ, Harker JO, Salva A, Guigoz Y, Vellas B. Screening for undernutrition in geriatric practice: developing the short-form mini-nutritional assessment (MNA-SF). J Gerontol A Biol Sci Med Sci 2001;56: M366–372.
Denis P, Lerebours E. Etude de la tolérance au long cours du Forlax® chez 16 patients traités en moyenne depuis 17 mois pour une constipation chronique. Méd Chir Digestives 1996; 25: 1–4.
Bosshard W, Dreher R, Schnegg JF, Bula CJ. The treatment of chronic constipation in elderly people: an update. Drugs Aging 2004; 21: 911–930.
Gallagher P, O’Mahony D. Constipation in old age. Best Pract Res Clin Gastroenterol 2009; 23: 875–887.
Xing JH, Soffer EE. Adverse effects of laxatives. Dis Colon Rectum 2001; 44: 1201–1209.
Belsey JD, Geraint M, Dixon TA. Systematic review and meta analysis: polyethylene glycol in adults with non-organic constipation. Int J Clin Pract 2010; 64: 944–955.
Seinelä L, Sairanen U, Laine T, Kurl S, Pettersson T, et al. Comparison of polyethylene glycol with and without electrolytes in the treatment of constipation in elderly institutionalized patients: a randomized, double-blind, parallel-group study. Drugs Aging 2009; 26: 703–713.
Sanders JF. Lactulose syrup assessed in a double-blind study of elderly constipated patients. J Am Geriatr Soc 1978; 26: 236–239.
Passmore AP, Wilson-Davies K, Stoker C, Scott ME. Chronic constipation in long stay elderly patients: a comparison of lactulose and a senna-fibre combination. BMJ 1993; 307: 769–771.
Lederle FA, Busch DL, Mattox KM, West MJ, Aske DM. Cost-effective treatment of constipation in the elderly: a randomized double-blind comparison of sorbitol and lactulose. Am J Med 1990; 89: 597–601.
Author information
Authors and Affiliations
Corresponding author
Rights and permissions
About this article
Cite this article
Chassagne, P., Ducrotte, P., Garnier, P. et al. Tolerance and long-term efficacy of polyethylene glycol 4000 (Forlax®) compared to lactulose in elderly patients with chronic constipation. J Nutr Health Aging 21, 429–439 (2017). https://doi.org/10.1007/s12603-016-0762-6
Received:
Accepted:
Published:
Issue Date:
DOI: https://doi.org/10.1007/s12603-016-0762-6