Mueller-Lissner, S., Kamm, M.A., Wald, A., Hinkel, U., Koehler, U., Richter, E., & Bubeck, J. (2010). Multicenter, 4-week, double-blind, randomized, placebo-controlled trial of sodium picosulfate in patients with chronic constipation. American Journal of Gastroenterology, 105, 897–903.

DOI Link

Study Purpose

To evaluate the effectiveness of sodium picosulfate for constipation.

Intervention Characteristics/Basic Study Process

Patients were randomized to receive either sodium picosulfate or matching placebo drops as treatment. If the study treatment was not effective, 10 mg bisacodyl was used as rescue medication. Patients were allowed to titrate the number of study drug drops to best meet their bowel function needs.

Sample Characteristics

  • The study reported on a sample of 202 women.
  • Mean patient age was 50.8 years in the treatment group and 51.9 years in the placebo group.
  • The sample comprised healthy patients with functional constipation.
  • Mean duration of constipation was 13.2 years.

Setting

  • Multi-site
  • Outpatient
  • 45 general practices in Germany

Study Design

This was a double-blind, placebo-controlled, parallel-group, randomized clinical trial.

Measurement Instruments/Methods

  • Diary to record bowel symptoms
  • SF-36®, version 2
  • Patient Assessment of Constipation Quality of Life (PAC-QOL) questionnaire
  • Rome III diagnostic criteria

Results

  • The mean number of complete spontaneous bowel movements (BMs) increased from 0.9 to 3.4 in the sodium picosulfate group, compared to an increase from 1.1 to 1.7 in the placebo group (p < 0.0001).
  • The mean number of complete spontaneous BMs per week compared to baseline increased by more than one in 65.5% of patients (p < 0.0001).
  • After 24 hours, more patients in the intervention group had a complete spontaneous BM compared to the control group (69% versus 53%).

Conclusions

The use of laxative with sodium picosulfate in patients with chronic constipation may improve complete spontaneous BMs.

Limitations

  • The study was performed on a very general population. One should be cautious in interpreting these data for patients with cancer.
  • The SF-36 looks at general functional status and is not a great tool for measuring quality of life.

Nursing Implications

Nurses need to be aware of other agents for the treatment of constipation, as well as the pharmacodynamics in which these agents work.