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  3. Single blind, randomised trial of efficacy and acceptability of oral Picolax versus self administered phosphate enema in bowel preparation for flexible sigmoidoscopy screeningCommentary: participants should have been told they were being randomisedCommen…
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Single blind, randomised trial of efficacy and acceptability of oral Picolax versus self administered phosphate enema in bowel preparation for flexible sigmoidoscopy screeningCommentary: participants should have been told they were being randomisedCommentary: opportunity for patient partnership was lost

BMJ 2000; 320 doi: https://doi.org/10.1136/bmj.320.7248.1504 (Published 03 June 2000) Cite this as: BMJ 2000;320:1504

Abstract

Objective: To compare the acceptability and efficacy of two methods of self administered bowel preparation for flexible sigmoidoscopy screening: a single phosphate enema and a single sachet of Picolax.

Design: Single blind, randomised trial.

Setting: Endoscopy units of two general hospitals.

Participants: 1442 men and women aged 55-64 years who had agreed to be screened by flexible sigmoidoscopy.

Main outcome measures: Attendance rates, compliance with allocated preparations, adverse effects, quality of bowel preparation, procedure time, and yield of neoplasia.

Results: Compliance with the enema was higher than with the Picolax (608 (84%) v 566 (79%); difference 6%, 95% confidence interval 2% to 10%). Almost half of those who refused Picolax used an enema at home. Wind, incontinence, and sleep disturbance were more frequent in the Picolax group than the enema group; bottom soreness was more frequent in the enema group. Around 30% (187) found the diet restriction required by Picolax difficult; 78% (471) found the enema easy to administer. The quality of preparation was better with the enema; the proportion of procedures complete to the descending colon was greater and the mean duration of the procedure was shorter. There was no significant difference in polyp detection rates.

Conclusion: A single phosphate enema self administered around one hour before leaving home is a more acceptable and effective method of preparing the distal bowel for flexible sigmoidoscopy than Picolax.

Footnotes

  • Accepted 16 March 2000

Single blind, randomised trial of efficacy and acceptability of oral Picolax versus self administered phosphate enema in bowel preparation for flexible sigmoidoscopy screening

  1. Wendy S Atkin, deputy director (atkin{at}icrf.icnet.uk)a,
  2. Andrew Hart, senior registrar in gastroenterologyb,
  3. Robert Edwards, statisticianc,
  4. Claire F Cook, statisticiana,
  5. Jane Wardle, professord,
  6. Peter McIntyre, consultant gastroenterologiste,
  7. Roger Aubrey, hospital practitionere,
  8. Clare Baron, data managera,
  9. Stephen Sutton, reader in social and health psychologyd,
  10. Jack Cuzick, headc,
  11. Asha Senapati, consultant surgeonf,
  12. John M A Northover, directora
  1. Imperial Cancer Research Fund Colorectal Cancer Unit, St Mark's Hospital, Northwick Park, Harrow HA1 3UJ
  2. Leicester General Hospital, Leicester LE5 4PW
  3. mperial Cancer Research Fund Department of Mathematics, Statistics and Epidemiology, Lincoln's Inn Fields, London WC2A 3PX
  4. Imperial Cancer Research Fund Health Behaviour Unit, Department of Epidemiology and Public Health, University College, London W1E 6BT
  5. Queen Elizabeth II Hospital, Welwyn Garden City AL7 4HQ,
  6. Queen Alexandra Hospital, Portsmouth
  7. Institute of Public Health, Panum Institute, University of Copenhagen, 2200 N, Denmark
  8. PASS Direct, Dumfries DG1 2AT
  1. Correspondence to: W Atkin
  • Accepted 16 March 2000

Abstract

Objective: To compare the acceptability and efficacy of two methods of self administered bowel preparation for flexible sigmoidoscopy screening: a single phosphate enema and a single sachet of Picolax.

Design: Single blind, randomised trial.

Setting: Endoscopy units of two general hospitals.

Participants: 1442 men and women aged 55-64 years who had agreed to be screened by flexible sigmoidoscopy.

Main outcome measures: Attendance rates, compliance with allocated preparations, adverse effects, quality of bowel preparation, procedure time, and yield of neoplasia.

Results: Compliance with the enema was higher than with the Picolax (608 (84%) v 566 (79%); difference 6%, 95% confidence interval 2% to 10%). Almost half of those who refused Picolax used an enema at home. Wind, incontinence, and sleep disturbance were more frequent in the Picolax group than the enema group; bottom soreness was more frequent in the enema group. Around 30% (187) found the diet restriction required by Picolax difficult; 78% (471) found the enema easy to administer. The quality of preparation was better with the enema; the proportion of procedures complete to the descending colon was greater and the mean duration of the procedure was shorter. There was no significant difference in polyp detection rates.

Conclusion: A single phosphate enema self administered around one hour before leaving home is a more acceptable and effective method of preparing the distal bowel for flexible sigmoidoscopy than Picolax.

Footnotes

  • Funding The studies were funded by the Imperial Cancer Research Fund, the Medical Research Council, NHS Research and Development, and Key Med.

  • Competing interests Pharmax paid WSA a speaker's fee and contributed to the costs of meetings between trial investigators in the UK flexible sigmoidoscopy trial.

  • Accepted 16 March 2000

Commentary: participants should have been told they were being randomised

  1. Henrik R Wulff, professor of clinical theory and ethics (H.R.Wulff{at}medphil.ku.dk)
  1. Imperial Cancer Research Fund Colorectal Cancer Unit, St Mark's Hospital, Northwick Park, Harrow HA1 3UJ
  2. Leicester General Hospital, Leicester LE5 4PW
  3. mperial Cancer Research Fund Department of Mathematics, Statistics and Epidemiology, Lincoln's Inn Fields, London WC2A 3PX
  4. Imperial Cancer Research Fund Health Behaviour Unit, Department of Epidemiology and Public Health, University College, London W1E 6BT
  5. Queen Elizabeth II Hospital, Welwyn Garden City AL7 4HQ,
  6. Queen Alexandra Hospital, Portsmouth
  7. Institute of Public Health, Panum Institute, University of Copenhagen, 2200 N, Denmark
  8. PASS Direct, Dumfries DG1 2AT

    Footnotes

    • Competing interests None declared.

      Commentary: opportunity for patient partnership was lost

      1. Marie Taylor, manager
      1. Imperial Cancer Research Fund Colorectal Cancer Unit, St Mark's Hospital, Northwick Park, Harrow HA1 3UJ
      2. Leicester General Hospital, Leicester LE5 4PW
      3. mperial Cancer Research Fund Department of Mathematics, Statistics and Epidemiology, Lincoln's Inn Fields, London WC2A 3PX
      4. Imperial Cancer Research Fund Health Behaviour Unit, Department of Epidemiology and Public Health, University College, London W1E 6BT
      5. Queen Elizabeth II Hospital, Welwyn Garden City AL7 4HQ,
      6. Queen Alexandra Hospital, Portsmouth
      7. Institute of Public Health, Panum Institute, University of Copenhagen, 2200 N, Denmark
      8. PASS Direct, Dumfries DG1 2AT

        Footnotes

        • Competing interests None declared.

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