Paroxetine to treat irritable bowel syndrome not responding to high-fiber diet: a double-blind, placebo-controlled trial.
OBJECTIVE
The purpose of the trial was to determine whether a high-fiber diet (HFD) alone or in combination with paroxetine or placebo was effective treatment for patients with irritable bowel syndrome (IBS).


METHODS



METHODS
Trial of HFD alone (Group 1) followed by a randomized, double-blind trial of HFD with paroxetine or placebo (Group 2).


METHODS
Gastroenterology office in a 524-bed university-affiliated community hospital in Pittsburgh.


METHODS
Men and women, aged 18-65 yr, previously diagnosed with IBS but otherwise healthy.


METHODS
Institution of HFD in 98 participants consuming low- or average-fiber diets. Allocation of paroxetine to 38 and placebo to 43 symptomatic participants consuming HFDs.


METHODS
Overall well-being, abdominal pain, and abdominal bloating (Groups 1 and 2); food avoidance, work functioning, and social functioning (Group 2).


RESULTS
In Group 1, overall well-being improved in 26% patients, and abdominal pain and bloating decreased in 22% and 26% patients, respectively, with an HFD. In Group 2, overall well-being improved more with paroxetine than with placebo (63.3%vs 26.3%; p= 0.01), but abdominal pain, bloating, and social functioning did not. With paroxetine, food avoidance decreased (p= 0.03) and work functioning was marginally better (p= 0.08). Before unblinding, more paroxetine recipients than placebo recipients wanted to continue their study medication (84%vs 37%; p < 0.001).


CONCLUSIONS
The difference in overall well-being found in our paroxetine/placebo trial is greater than that found in previously published drug/placebo trials for IBS. Moreover, the difference in well-being applied to nondepressed recipients of paroxetine.
Tabas
Gary
G
University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania, USA.
Beaves
Mary
M
Wang
Jiping
J
Friday
Paul
P
Mardini
Houssam
H
Arnold
George
G
D000293:Adolescent; D000328:Adult; D000368:Aged; D004043:Dietary Fiber / Q000009:adverse effects; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D043183:Irritable Bowel Syndrome / Q000175:diagnosis* / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D017374:Paroxetine / Q000008:administration & dosage*; D011336:Probability; D012016:Reference Values; D018570:Risk Assessment; D017367:Selective Serotonin Reuptake Inhibitors / Q000008:administration & dosage*; D016896:Treatment Outcome
D004043:Dietary Fiber; D017374:Paroxetine; D017367:Selective Serotonin Reuptake Inhibitors