Barish, C.F., Drossman, D., Johanson, J.F., & Ueno, R. (2010). Efficacy and safety of lubiprostone in patients with chronic constipation. Digestive Diseases and Sciences, 55, 1090–1097.

DOI Link

Study Purpose

To assess the efficacy and safety of lubiprostone in the treatment of patients with chronic constipation.

Intervention Characteristics/Basic Study Process

Patients had a washout period, followed by a two-week prerandomization period. Patients were randomized to receive either oral lubiprostone 24-mcg capsules (n = 119) or placebo (n = 118) twice daily with food and at least 8 oz of water. Patients were instructed to keep daily diaries to record their medication administration, use of medication rescues, and occurrences of bowel movements (BMs) (date and time). Study assessments were scheduled after one week (office visits), two weeks (telephone evaluation), four weeks (end-of-treatment office visit), and two weeks following the end of treatment.

Sample Characteristics

  • The study reported on a sample of 237 patients who met the Rome II criteria for functional constipation.
  • Mean patient age was 46.2 years (SD = 12.13) for the lubiprostone group and 45.4 years (SD = 13.24) for the placebo group.
  • The study comprised 104 women and 15 men in the lubiprostone group, and 105 women and 13 men in the placebo group.
  • Constipation severity was 3 (SD = 0.82) in the lubiprostone group and 3 (SD = 0.76) in the placebo group. 
  • Stool consistency was 2.7 (SD = 0.83) in the lubiprostone group and 2.8 (SD = 0.77) in the placebo group.
  • All were normal patients with constipation.

Setting

  • Multi-site
  • United States

Study Design

This was a randomized, double-blinded, placebo-controlled study.

Measurement Instruments/Methods

  • Daily BM diary
  • Five-point scale of stool consistency
  • Five-point scale of stool straining

Results

  • Lubiprostone was an effective treatment for chronic constipation, with more than 60% of patients having a spontaneous BM within 24 hours of their first dose.
  • Patients taking lubiprostone also experienced significant improvement in spontaneous BM frequency, stool consistency, straining, severity, and abdominal bloating.
  • Patients' global treatment effectiveness was significantly higher in the lubiprostone group compared with the placebo group.
  • Fewer patients receiving lubiprostone required rescue medication.
  • Nausea was the most common adverse side effect reported, occurring in 25 patients in the lubiprostone group compared to five patients in the placebo group.

Conclusions

Lubiprostone was an effective treatment for chronic constipation.

Limitations

  • The sample comprised more women than men.
  • Nausea was reported as toxicity to the drug, but also was reported in the placebo group. In addition, nausea may also be seen in patients who have issues with constipation.
  • The sample did not include patients specifically with cancer or related opioid-induced constipation. Therefore, applicability to that population is unclear.

Nursing Implications

Lubiprostone has been shown to be effective in the management of chronic constipation and is used for patients with chronic constipation related to irritable bowel syndrome. However, additional studies are warranted in patients with cancer, as well as the palliative care population, in which patients are receiving chemotherapy agents, antiemetics, and narcotics that contribute to their constipation.