Pilot trial: pregabalin on colonic sensorimotor functions in irritable bowel
syndrome.
Author(s): Iturrino J(1), Camilleri M(2), Busciglio I(1), Burton D(1), Zinsmeister AR(3).
Affiliation(s): Author information:
(1)Clinical Enteric Neuroscience Translational and Epidemiological Research
(CENTER), College of Medicine, Mayo Clinic, Rochester, MN, United States;
Division of Gastroenterology and Hepatology, College of Medicine, Mayo Clinic,
Rochester, MN, United States.
(2)Clinical Enteric Neuroscience Translational and Epidemiological Research
(CENTER), College of Medicine, Mayo Clinic, Rochester, MN, United States;
Division of Gastroenterology and Hepatology, College of Medicine, Mayo Clinic,
Rochester, MN, United States. Electronic address: camilleri.michael@mayo.edu.
(3)Department of Health Sciences Research, Division of Biomedical Statistics and
Informatics, College of Medicine, Mayo Clinic, Rochester, MN, United States.
Publication date & source: 2014, Dig Liver Dis. , 46(2):113-8
BACKGROUND: In prior studies, pregabalin reduced rectal or colonic pain in
patients with irritable bowel syndrome and healthy adults, suggesting reduction
of afferent function.
AIM: To assess effects of pregabalin on colonic compliance, sensory and motor
functions in patients with constipation-predominant irritable bowel syndrome.
METHODS: In a pilot, double-blind, placebo-controlled, parallel-group study, we
tested oral pregabalin, 200mg, in 18 patients with constipation-predominant
irritable bowel syndrome. With a barostatically controlled polyethylene balloon
in the left colon, we assessed sensation thresholds and colonic compliance using
ascending method of limits, sensation ratings over 4 levels of distension,
fasting and postprandial colonic tone and phasic motility. Analysis of covariance
(adjusted for the corresponding pre-drug response) was used to compare placebo
and pregabalin. After 45% participants completed studies, we conducted an interim
analysis to assess the conditional power to detect pre-specified treatment
effects given the observed variation and treatment group differences based on the
planned sample size for the trial.
RESULTS: Pregabalin did not significantly affect colonic compliance, sensation
thresholds, sensation ratings, fasting or postprandial tone or motility index.
The study was stopped for futility to detect an effect on visceral pain with the
planned design and sample size.
CONCLUSION: Pregabalin, 200mg, might not reduce distension-related colonic pain
in constipation-predominant irritable bowel syndrome patients.
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