Abstract | BACKGROUND: AIM: METHODS: 195 irritable bowel syndrome with constipation patients received daily doses of 16 [8 microg twice daily (b.d.)], 32 (16 microg b.d.) or 48 microg (24 microg b.d.) lubiprostone or placebo b.d. for 3 months. Gastrointestinal parameters were recorded in diaries daily by patients. RESULTS: After 1 month, lubiprostone showed significantly greater improvements in mean abdominal discomfort/ pain scores vs. placebo (P = 0.023). After 2 months, all lubiprostone groups showed significantly greater improvements in mean abdominal discomfort/ pain scores (P < or = 0.039). After 3 months of treatment, the improvement in each lubiprostone arm was greater than placebo, but the test for trend was no longer significant. Treatment with lubiprostone showed significantly higher rates of gastrointestinal adverse events (P = 0.020), especially diarrhoea and nausea. CONCLUSION:
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Authors | J F Johanson, D A Drossman, R Panas, A Wahle, R Ueno |
Journal | Alimentary pharmacology & therapeutics
(Aliment Pharmacol Ther)
Vol. 27
Issue 8
Pg. 685-96
(Apr 2008)
ISSN: 1365-2036 [Electronic] England |
PMID | 18248656
(Publication Type: Clinical Trial, Phase II, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
- Fatty Acids
- Gastrointestinal Agents
- Lubiprostone
- Alprostadil
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Topics |
- Adolescent
- Adult
- Aged
- Aged, 80 and over
- Alprostadil
(administration & dosage, adverse effects, analogs & derivatives)
- Constipation
(drug therapy)
- Dose-Response Relationship, Drug
- Double-Blind Method
- Fatty Acids
(administration & dosage, adverse effects)
- Female
- Gastrointestinal Agents
(administration & dosage, adverse effects)
- Humans
- Irritable Bowel Syndrome
(drug therapy)
- Lubiprostone
- Male
- Middle Aged
- Quality of Life
- Treatment Outcome
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