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Area of Science:

  • Gastroenterology
  • Pharmacology
  • Clinical Trials

Background:

  • Opioid analgesics impair anal sphincter function, contributing to opioid-induced bowel dysfunction (OIBD).
  • The efficacy of opioid antagonism with prolonged-release (PR) naloxone versus laxatives in mitigating this inhibition is not well-established.

Purpose of the Study:

  • To compare the effects of combined PR oxycodone/naloxone versus PR oxycodone plus macrogol 3350 on anal sphincter function and gastrointestinal symptoms.
  • To evaluate the impact of opioid antagonism on OIBD management.

Main Methods:

  • A randomized, double-blind, crossover trial involving 20 healthy men.
  • Participants received either PR oxycodone/naloxone or PR oxycodone plus macrogol 3350 for 5 days.
  • Evaluations included anal sphincter function (resting pressure, distensibility, relaxation), Patient Assessment of Constipation Symptom (PAC-SYM) scores, stool frequency, and consistency.

Main Results:

  • Both treatments reduced sphincter relaxation, but PR oxycodone/naloxone showed significantly greater improvement compared to macrogol (17.6% increase; P < 0.001).
  • No significant differences were observed in resting anal pressure or anal canal distensibility between the groups.
  • PR oxycodone/naloxone resulted in lower PAC-SYM abdominal symptom scores and fewer bowel movements compared to macrogol.

Conclusions:

  • PR oxycodone/naloxone significantly improves internal anal sphincter relaxation compared to macrogol in the context of opioid treatment.
  • These findings suggest that OIBD may necessitate specific therapies targeting the multifaceted gastrointestinal effects of opioids, rather than solely relying on laxatives.