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- W2979258345 abstract "Purpose: Recent studies suggest that methane (CH4) decreases intestinal transit, and that methanogenesis is associated with a higher prevalence of slow transit constipation and irritable bowel syndrome (IBS-C). Lubiprostone, a ClC2 secretagogue is effective for the treatment of constipation and IBS-C. Whether CH4 production can be reduced by a secretagogue, and if this effect improves constipation is not known. Aim: To investigate the effects of lubiprostone on intestinal CH4 production and bowel symptoms in patients with chronic constipation and methanogenic flora, by performing a randomized, double-blind, placebo-controlled study. Methods: Patients with chronic constipation (Rome III) and baseline CH4>3 ppm, underwent a five hour lactulose breath test at baseline and after treatment. H2 and CH4 levels were assessed (Quintron breath analyzer). Patients were randomized (2:1) to receive either lubiprostone 24 μg BID or placebo for 4 weeks. Primary outcome measures were a change in CH4 production as assessed by the area under the curve (AUC) of breath CH4 output over 5 hours and the number of complete spontaneous bowel movements (CSBMs)/week. Results: Forty-one patients (M:F=4:37, mean age=44 years) were enrolled; 25 received lubiprostone and 12 placebo. 34 completed and 7 withdrew from adverse events all randomized to lubiprostone (2-chest tightness and shortness of breath, 2-lost to follow-up, and 3-other medical problems. In the lubiprostone group, the mean AUC of CH4 was lower but not significantly different than placebo (Table 1; mean + sd). The mean change in AUC from baseline to end of treatment did not differ significantly between lubiprostone and placebo (Trt*Time interaction effect, p=0.849). The mean number of CSBMs/week over the four weeks of treatment was significantly greater in lubiprostone compared to placebo (3.6±0.6 versus 1.2±0.5, p=0.012) (Table 1). There was a 37±36% mean increase in CSBMs from baseline in the lubiprostone group but in contrast there was a 57±19% mean decrease in CSBMs in the placebo group (p=0.023).Table: [1729]Conclusion: Lubiprostone was significantly more effective than placebo in improving constipation and bowel symptoms. Although there was a trend towards a decrease in CH4 production with lubiprostone this was not significant either from a Type II error (sample size) or suggesting that the drug may not have effects on methane production or that the effects of lubiprostone on constipation are independent of CH4. Acknowledgement: Study supported by an investigator initiated unrestricted grant from Takeda Pharmaceuticals of North America. Disclosure: Dr. Summers - Grant/Research Support: Takeda Pharmaceuticals. This research was supported by an industry grant from Takeda Pharmaceuticals." @default.
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- W2979258345 date "2012-10-01" @default.
- W2979258345 modified "2023-10-18" @default.
- W2979258345 title "Effects of Lubiprostone on Methanogenesis and Bowel Function in Chronic Constipation" @default.
- W2979258345 doi "https://doi.org/10.14309/00000434-201210001-01729" @default.
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