Clinical Drug Investigation

, Volume 24, Issue 10, pp 569–576

A Randomised, Controlled Comparison of Low-Dose Polyethylene Glycol 3350 plus Electrolytes with Ispaghula Husk in the Treatment of Adults with Chronic Functional Constipation

  • Hui-Ji Wang
  • Xiao-Mei Liang
  • Zhong-Lin Yu
  • Li-Ya Zhou
  • San-Ren Lin
  • Mike Geraint
Original Research Article

Abstract

Objective: To compare the efficacy and safety of polyethylene glycol (PEG) 3350 plus electrolytes (PEG+E; Movicol®) with that of ispaghula husk (psyllium; Konsyl®) in the treatment of constipation.

Patients: Male or female adults with chronic functional constipation.

Methods: This was a randomised, controlled, open-label, parallel-group trial. Study treatment was either PEG+E 13.8g/sachet dissolved in water twice daily or ispaghula husk 3.5g/sachet dissolved in water twice daily for a period of 2 weeks. Assessments were at baseline and after 1 and 2 weeks’ therapy and by patient daily diary card. The primary outcome measures were weekly defaecation rate, stool consistency according to the Bristol Stool Form scale, time to first defaecation, and overall efficacy, which combined defaecation rate, stool consistency and difficulty on defaecation. Adverse effects were recorded and laboratory assessments were performed before and at the end of the treatment period.

Results: Sixty-three patients were randomised to each treatment group. Treatment was highly effective in 50/63 patients in the PEG+E group compared with 26/63 in the ispaghula husk group, and the overall efficacy rates were 92% and 73%, respectively (p = 0.005). PEG+E increased the mean weekly defaecation rate from 1.18 (SD 0.77) at baseline to 7.95 (SD 3.49) after 1 week and 8.48 (SD 3.55) after 2 weeks. In the ispaghula husk group the mean weekly defaecation rate increased from 1.33 (SD 0.68) at baseline to 5.33 (SD 2.81) after 1 week and to 5.71 (SD 2.49) after 2 weeks. The treatment differences for defaecation rates were all statistically significant (p < 0.001). Two weeks of treatment with PEG+E or ispaghula husk normalised stools in 55/63 (87.3%) and 42/63 (66.7%) of patients (p < 0.001). The incidence of adverse effects did not differ between groups and none were serious or required any treatment. Laboratory evaluations found no adverse effect from either treatment.

Conclusion: The present study demonstrated that low-dose PEG 3350 plus electrolytes is more effective and more rapid in its onset of action than ispaghula husk, and is equally well tolerated.

References

  1. 1.
    Wald A. Constipation. Adv Gastroenterol 2000; 84: 1231–46Google Scholar
  2. 2.
    Thompson WG, Longstreth GF, Drossman DA, et al. Functional bowel disorders and functional abdominal pain. Gut 1999; 45Suppl. II: 1143–7Google Scholar
  3. 3.
    Brunton LL. Agents affecting gastrointestinal water flux and motility; emesis and antiemetics; bile acids and pancreatic enzymes. In Goodman and Gilman’s The pharmacological basis of therapeutics. 9th ed. 1996: 917-936Google Scholar
  4. 4.
    Pulin Y, Zengjin L, Hong Z, et al. A survey of the current status and distribution of elderly constipation in China. Chin J Geriatr 2001; 20(2): 132–4Google Scholar
  5. 5.
    Lewis SJ, Heaton KW. Stool form as a useful guide to intestinal transit time. Scand J Gastroenterol 1997; 32: 920–4PubMedCrossRefGoogle Scholar
  6. 6.
    Koch A, Voderholzer WA, Klauser AG, et al. Symptoms in chronic constipation. Dis Colon Rectum 1997; 40: 902–6PubMedCrossRefGoogle Scholar
  7. 7.
    Cleveland MV, Flavin DP, Ruben RA, et al. New polyethylene glycol laxative for treatment of constipation in adults: a randomised, double-blind, placebo-controlled study. South Med J 2000; 94: 478–81Google Scholar
  8. 8.
    Attar A, Lemann M, Ferguson A. Comparison of a low dose polyethylene glycol electrolyte solution with lactulose for treatment of chronic constipation. Gut 1999; 44: 226–30PubMedCrossRefGoogle Scholar
  9. 9.
    Culberts P, Gillett H, Ferguson A. Highly effective oral therapy (polyethylene glycol/electrolyte solution) for faecal impaction and severe constipation. Clin Drug Invest 1998; 16: 225–360Google Scholar

Copyright information

© Adis Data Information BV 2004

Authors and Affiliations

  • Hui-Ji Wang
    • 1
  • Xiao-Mei Liang
    • 1
  • Zhong-Lin Yu
    • 1
  • Li-Ya Zhou
    • 2
  • San-Ren Lin
    • 2
  • Mike Geraint
    • 3
  1. 1.Beijing Friendship HospitalBeijingPeople’s Republic of China
  2. 2.The Third Hospital of Peking UniversityBeijingPeople’s Republic of China
  3. 3.Norgine Ltd, HarefieldMiddlesexUK

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