Randomised clinical trial: Otilonium bromide improves frequency of abdominal pain, severity of distention and time to relapse in patients with irritable bowel syndrome

Alimentary Pharmacology and Therapeutics

Volumn 34, Issue 4, 2011, Pages 432-442

  Clave P ^a,b,c   Acalovschi, M ^d   Triantafillidis, J K ^e   Uspensky, Y P ^f   Kalayci, C ^g   Shee, V ^h   Tack, J ⁱ  

^a UNIVERSITAT AUTÒNOMA DE BARCELONA   (Spain)

^b Fundacio de Gastroenterologia Dr F Vilardell   (Spain)

^c INSTITUTO DE SALUD CARLOS III   (Spain)

^d Spitalul Clinic Adulti   (Romania)

^e GENERAL HOSPITAL OF NIKEA   (Greece)

^f NORTH WESTERN STATE MEDICAL UNIVERSITY NAMED AFTER I I MECHNIKOV   (Russian Federation)

^g MARMARA UNIVERSITY   (Turkey)

^h HOSPITAL PULIDO VALENTE   (Portugal)

ⁱ UNIVERSITY HOSPITALS LEUVEN   (Belgium)

Author keywords

[No Author keywords available]

Indexed keywords

OTILONIUM BROMIDE; PLACEBO;

ABDOMINAL PAIN; ADULT; AGED; ARTICLE; BLOATING; CONTROLLED STUDY; DISEASE SEVERITY; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; FEMALE; FLATULENCE; FOLLOW UP; HUMAN; INFECTION; IRRITABLE COLON; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; NAUSEA; PAIN ASSESSMENT; PHASE 4 CLINICAL TRIAL; PRIORITY JOURNAL; QUALITY OF LIFE; RANDOMIZED CONTROLLED TRIAL; RELAPSE; SCORING SYSTEM; XEROSTOMIA;

ABDOMINAL PAIN; ADULT; AGED; CALCIUM CHANNELS, L-TYPE; DILATATION, PATHOLOGIC; DOUBLE-BLIND METHOD; FEMALE; FOLLOW-UP STUDIES; HUMANS; IRRITABLE BOWEL SYNDROME; MALE; MIDDLE AGED; MUSCLE, SMOOTH; QUATERNARY AMMONIUM COMPOUNDS; QUESTIONNAIRES; SEVERITY OF ILLNESS INDEX; STATISTICS AS TOPIC; TIME FACTORS;

EID: 79960563170     PISSN: 02692813     EISSN: 13652036     Source Type: Journal    
DOI: 10.1111/j.1365-2036.2011.04730.x     Document Type: Article

References (24)

1. Longstreth GF, Thompson WG, Chey WD, Houghton LA, Mearin F, Spiller RC,. Functional bowel disorders. Gastroenterology 2006; 130: 1480-91. Erratum in: Gastroenterology 2006; 131 (2): 688.
2. Camilleri M, Heading RC, Thompson WG,. Consensus report: clinical perspectives, mechanisms, diagnosis and management of irritable bowel syndrome. Aliment Pharmacol Ther 2002; 16: 1407-30. (Pubitemid 34953582)
3. Dorn SD, Morris CB, Hu Y, et al. Irritable bowel syndrome subtypes defined by Rome II and Rome III criteria are similar. J Clin Gastroenterol 2009; 43: 214-20.
4. Hungin APS, Whorwell PJ, Tack J, MearÃn F,. The prevalence, patterns and impact of irritable bowel syndrome: an international survey of 40 000 subjects. Aliment Pharmacol Ther 2003; 17: 643-50. (Pubitemid 36418887)
5. Drossman DA, Camilleri M, Mayer EA, Whitehead WE,. AGA technical review on irritable bowel syndrome. Gastroenterology 2002; 123: 2108-31. (Pubitemid 35408332)
6. Kanazawa M, Palsson OS, Thiwan SI, et al. Contributions of pain sensitivity and colonic motility to IBS symptom severity and predominant bowel habits. Am J Gastroenterol 2008; 103: 2550-61.
7. Ford AC, Talley NJ, Spiegel BM, et al. Effect of fibre, antispasmodics, and peppermint oil in the treatment of irritable bowel syndrome: systematic review and meta-analysis. BMJ 2008; 13: 337. Erratum in BMJ 2009; 338: b881.
8. Lesbros-Pantoflickova D, Michetti P, Fried M, Beglinger C, Blum AL,. Meta-analysis: the treatment of irritable bowel syndrome. Aliment Pharmacol Ther 2004; 20: 1253-69. (Pubitemid 40040072)
9. Battaglia G, Morselli-Labate AM, Camarri E, et al. Otilonium bromide in irritable bowel syndrome: a double-blind, placebo-controlled, 15-week study. Aliment Pharmacol Ther 1998; 12: 1003-10. (Pubitemid 28454384)
10. Poynard T, Regimbeau C, Benhamou Y,. Meta-analysis of smooth muscle relaxants in the treatment of irritable bowel syndrome. Aliment Pharmacol Ther 2001; 15: 355-61. (Pubitemid 32187557)
11. Gallego D, Aulí M, Aleu J, et al. Effect of otilonium bromide on contractile patterns in the human sigmoid colon. Neurogastroenterol Motil 2010; 22: e180-91.
12. Czimmer J, Sütõ G, Király A, Mõzsik G,. Otilonium bromide enhances sensory thresholds of volume and pressure in patients with irritable bowel syndrome. J Physiol Paris 2001; 95: 153-6. (Pubitemid 33020230)
13. Tack J, Fried M, Houghton LA, Spicak J, Fisher G,. Systematic review: the efficacy of treatments for irritable bowel syndrome-a European perspective. Aliment Pharmacol Ther 2006; 24: 183-205. (Pubitemid 43972890)
14. Committee for Proprietary Medicinal Products (CPMP). Points to consider on the evaluation of medicinal products for the treatment of irritable bowel syndrome. CPMP/EWP/785/97 (London, 19 March 2003).
15. Patrick DL, Drossman DA, Frederick IO, DiCesare J, Puder KL,. Quality of life in persons with irritable bowel syndrome: development and validation of a new measure. Dig Dis Sci 1998; 43: 400-11. (Pubitemid 28124621)
16. Glende M, Morselli-Labate AM, Battaglia G, Evangelista S,. Extended analysis of a double-blind, placebo-controlled, 15-week study with otilonium bromide in irritable bowel syndrome. Eur J Gastroenterol Hepatol 2002; 14: 1331-8. (Pubitemid 36054922)
17. Strege PR, Sha L, Beyder A, et al. T-type Ca(2+) channel modulation by otilonium bromide. Am J Physiol Gastrointest Liver Physiol 2010; 298: G706-13.
18. Evangelista S,. Otilonium bromide: a selective spasmolytic for the gastrointestinal tract. J Int Med Res 1999; 27: 207-22. (Pubitemid 30064249)
19. 14C-otilonium bromide in the rat: evidence for selective tropism for large intestine after oral administration. Drug Metab Dispos 2000; 28: 643-7. (Pubitemid 30390402)
20. Posserud I, Syrous A, Lindström L, Tack J, Abrahamsson H, Simrén N,. Altered rectal perception in irritable bowel syndrome is associated with symptom severity. Gastroenterology 2007; 133: 1113-23. (Pubitemid 47494459)
21. Sutton JA, Kilminster SG, Mould GP,. The clinical pharmacology of single doses of otilonium bromide in healthy volunteers. Eur J Clin Pharmacol 1997; 52: 365-9. (Pubitemid 27341936)
22. Narducci F, Bassotti G, Granata MT, et al. Colonic motility and gastric emptying in patients with irritable bowel syndrome. Effect of pretreatment with octylonium bromide. Dig Dis Sci 1986; 31: 241-6. (Pubitemid 16123968)
23. Musial F, Klosterhalfen S, Enck P., Placebo responses in patients with gastrointestinal disorders. World J Gastroenterol 2007; 13: 3425-9. (Pubitemid 47162015)
24. Price DD, Craggs J, Verne GN, Perlstein WM, Robinson ME,. Placebo analgesia is accompanied by large reductions in pain-related brain activity in irritable bowel syndrome patients. Pain 2007; 127: 63-72. (Pubitemid 44959430)