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Otilonium bromide in irritable bowel syndrome: a dose-ranging randomized double-blind placebo-controlled trial.
World J Gastroenterol 2014; 20(34):12283-91WJ

Abstract

AIM

To examine the efficacy and safety of otilonium bromide (OB) in treatment-sensitive functional irritable bowel syndrome (IBS) clinical parameters.

METHODS

Ninety-three patients (44.8 ± 12.6 years, 69% female) with IBS symptoms complying with Rome II criteria participated in this double-blind, placebo-controlled, randomised, dose-ranging phase I/II study. Patients were administered OB 20 mg (n = 24), 40 mg (n = 23) and 80 mg (n = 23) tid or placebo (n = 23) in 4 parallel groups for 4 wk. Primary efficacy variables included abdominal discomfort, intestinal habits, number of daily evacuations and stool consistency. Secondary efficacy measures included return to regular intestinal habits and global discomfort. Safety was also assessed.

RESULTS

Baseline clinical characteristics were similar among the 4 groups. Although individual parameters such as intensity and frequency of abdominal discomfort, bloating or pain were reduced by OB over the 4 wk, no significant differences were observed between groups. Similarly, no difference was observed between OB treatment or placebo for mucus in stool and incomplete or difficulty of evacuation. However, evacuation frequency was significantly reduced after 4 wk by 80 mg OB compared to placebo (-8.36% for placebo vs -41.9% for 80 mg OB, P < 0.01). While 21.7% of patients in the placebo group experienced regular intestinal habits after 4 wk, this improvement was greater for patients treated with 40 mg OB (P < 0.01 vs placebo). Furthermore, a dose-dependent reduction in frequency of diarrhoea (χ(2)-test for trend = 11.5, P < 0.001) and an increase in normal stool frequency was observed. Combining individual variables into a global discomfort index revealed significant improvement among increasing OB doses, favouring 40 mg (P = 0.013) and 80 mg OB (P = 0.001) over placebo. No difference was observed between frequency of adverse events for placebo vs OB.

CONCLUSION

This dose-ranging study demonstrates that OB at 40 and 80 mg can improve individual and global clinical symptoms of IBS compared to placebo over a 4-wk period.

Authors+Show Affiliations

Danuta Chmielewska-Wilkoń, Department of Gastrointestinal Endoscopy, Gabinet Endoskopii Przewodu Pokarmowego, Szewska, 31-009 Krakow, Poland.Danuta Chmielewska-Wilkoń, Department of Gastrointestinal Endoscopy, Gabinet Endoskopii Przewodu Pokarmowego, Szewska, 31-009 Krakow, Poland.Danuta Chmielewska-Wilkoń, Department of Gastrointestinal Endoscopy, Gabinet Endoskopii Przewodu Pokarmowego, Szewska, 31-009 Krakow, Poland.

Pub Type(s)

Clinical Trial, Phase I
Clinical Trial, Phase II
Comparative Study
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

25232263

Citation

Chmielewska-Wilkoń, Danuta, et al. "Otilonium Bromide in Irritable Bowel Syndrome: a Dose-ranging Randomized Double-blind Placebo-controlled Trial." World Journal of Gastroenterology, vol. 20, no. 34, 2014, pp. 12283-91.
Chmielewska-Wilkoń D, Reggiardo G, Egan CG. Otilonium bromide in irritable bowel syndrome: a dose-ranging randomized double-blind placebo-controlled trial. World J Gastroenterol. 2014;20(34):12283-91.
Chmielewska-Wilkoń, D., Reggiardo, G., & Egan, C. G. (2014). Otilonium bromide in irritable bowel syndrome: a dose-ranging randomized double-blind placebo-controlled trial. World Journal of Gastroenterology, 20(34), pp. 12283-91. doi:10.3748/wjg.v20.i34.12283.
Chmielewska-Wilkoń D, Reggiardo G, Egan CG. Otilonium Bromide in Irritable Bowel Syndrome: a Dose-ranging Randomized Double-blind Placebo-controlled Trial. World J Gastroenterol. 2014 Sep 14;20(34):12283-91. PubMed PMID: 25232263.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Otilonium bromide in irritable bowel syndrome: a dose-ranging randomized double-blind placebo-controlled trial. AU - Chmielewska-Wilkoń,Danuta, AU - Reggiardo,Giorgio, AU - Egan,Colin Gerard, PY - 2014/02/10/received PY - 2014/04/29/revised PY - 2014/06/02/accepted PY - 2014/9/19/entrez PY - 2014/9/19/pubmed PY - 2015/5/16/medline KW - Acute treatment KW - Irritable bowel syndrome KW - Otilonium bromide KW - Spasmolytic SP - 12283 EP - 91 JF - World journal of gastroenterology JO - World J. Gastroenterol. VL - 20 IS - 34 N2 - AIM: To examine the efficacy and safety of otilonium bromide (OB) in treatment-sensitive functional irritable bowel syndrome (IBS) clinical parameters. METHODS: Ninety-three patients (44.8 ± 12.6 years, 69% female) with IBS symptoms complying with Rome II criteria participated in this double-blind, placebo-controlled, randomised, dose-ranging phase I/II study. Patients were administered OB 20 mg (n = 24), 40 mg (n = 23) and 80 mg (n = 23) tid or placebo (n = 23) in 4 parallel groups for 4 wk. Primary efficacy variables included abdominal discomfort, intestinal habits, number of daily evacuations and stool consistency. Secondary efficacy measures included return to regular intestinal habits and global discomfort. Safety was also assessed. RESULTS: Baseline clinical characteristics were similar among the 4 groups. Although individual parameters such as intensity and frequency of abdominal discomfort, bloating or pain were reduced by OB over the 4 wk, no significant differences were observed between groups. Similarly, no difference was observed between OB treatment or placebo for mucus in stool and incomplete or difficulty of evacuation. However, evacuation frequency was significantly reduced after 4 wk by 80 mg OB compared to placebo (-8.36% for placebo vs -41.9% for 80 mg OB, P < 0.01). While 21.7% of patients in the placebo group experienced regular intestinal habits after 4 wk, this improvement was greater for patients treated with 40 mg OB (P < 0.01 vs placebo). Furthermore, a dose-dependent reduction in frequency of diarrhoea (χ(2)-test for trend = 11.5, P < 0.001) and an increase in normal stool frequency was observed. Combining individual variables into a global discomfort index revealed significant improvement among increasing OB doses, favouring 40 mg (P = 0.013) and 80 mg OB (P = 0.001) over placebo. No difference was observed between frequency of adverse events for placebo vs OB. CONCLUSION: This dose-ranging study demonstrates that OB at 40 and 80 mg can improve individual and global clinical symptoms of IBS compared to placebo over a 4-wk period. SN - 2219-2840 UR - https://www.unboundmedicine.com/medline/citation/25232263/Otilonium_bromide_in_irritable_bowel_syndrome:_a_dose_ranging_randomized_double_blind_placebo_controlled_trial_ L2 - http://www.wjgnet.com/1007-9327/full/v20/i34/12283.htm DB - PRIME DP - Unbound Medicine ER -