Clinical trial: The efficacy of alverine citrate/simeticone combination on abdominal pain/discomfort in irritable bowel syndrome - A randomized, double-blind, placebo-controlled study

Alimentary Pharmacology and Therapeutics

Volumn 31, Issue 6, 2010, Pages 615-624

  Wittmann, T ^a   Paradowski, L ^b   DucrottE P ^c   Bueno, L ^d   Andro Delestrain, M C ^e  

^a UNIVERSITY OF SZEGED   (Hungary)

^b WROCLAW MEDICAL UNIVERSITY   (Poland)

^c ROUEN UNIVERSITY HOSPITAL   (France)

^d CEMAGREF   (France)

^e Mayoly Spindler   (France)

Author keywords

[No Author keywords available]

Indexed keywords

ALVERINE CITRATE; PLACEBO; SIMETHICONE;

ABDOMINAL DISCOMFORT; ABDOMINAL PAIN; ADULT; ANALGESIA; ANXIETY; ARTICLE; ASTHENIA; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DEPRESSION; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG FATALITY; DRUG INDUCED HEADACHE; DRUG SAFETY; DRUG WITHDRAWAL; EYE SWELLING; FECES ANALYSIS; FEMALE; HUMAN; INTERACTIVE VOICE RESPONSE SYSTEM; IRRITABLE COLON; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; NAUSEA; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; TREATMENT OUTCOME; UPPER ABDOMINAL PAIN; VERTIGO; VISUAL ANALOG SCALE;

ABDOMINAL PAIN; ADOLESCENT; ADULT; AGED; ANTIFOAMING AGENTS; DOUBLE-BLIND METHOD; DRUG COMBINATIONS; FEMALE; HUMANS; IRRITABLE BOWEL SYNDROME; MALE; MIDDLE AGED; PARASYMPATHOLYTICS; PROPYLAMINES; SIMETHICONE; TREATMENT OUTCOME;

EID: 76449112444     PISSN: 02692813     EISSN: 13652036     Source Type: Journal    
DOI: 10.1111/j.1365-2036.2009.04216.x     Document Type: Article

References (36)

1. American College of Gastroenterology Functionnal Gastrointestinal Disorders Task Force. Evidence-based position statement on the management of irritable bowel syndrome in North America. Am J Gastroenterol 2002 97 (Suppl. S1 5.
2. Tack J, Fried M, Houghton LA, Spicak J, Fischer G. Systematic review: the efficacy of treatments for irritable bowel syndrome - a European perspective. Aliment Pharmacol Ther 2006 24 : 183 205.
3. Dapoigny M. Irritable bowel syndrome: epidemiology/economic burden. Gastroenterol Clin Biol 2009 33 (Suppl. 1 3 8.
4. Drossman DA. The Functional Gastrointestinal Disorders and the Rome III Process. Gastroenterology 2006 130 : 1377 1390.
5. Paré P, Gray J, Lam S, et al. Health-related quality of life, work productivity, and health care resource utilization of subjects with irritable bowel syndrome: baseline results from LOGIC (Longitudinal Outcomes Study of Gastrointestinal Symptoms in Canada), a naturalistic study. Clin Ther 2006 28 : 1726 1735.
6. Brun-Strang C, Dapoigny M, Lafuma A, Wainsten JP, Fagnani F. Irritable bowel syndrome in France: quality of life, medical management, and costs: the Encoli study. Eur J Gastroenterol Hepatol 2007 19 : 1097 1103.
7. Mulak A, Bonaz B. Irritable bowel syndrome: a model of the brain-gut interactions. Med Sci Monit 2004 10 : RA55 62.
8. Camilleri M, Talley NJ. Pathophysiology as a basis for understanding symptom complexes and therapeutic targets. Neurogastroenterol Motil 2004 16 : 135 142.
9. Talley NJ. Irritable bowel syndrome. Intern Med J 2006 36 : 724 728.
10. Mayer EA. Irritable bowel syndrome. N Engl J Med 2008 358 : 1692 1699.
11. Canavan JB, Bennett K, Feely J, O'Moráin CA, O'Connor HJ. Significant psychological morbidity occurs in irritable bowel syndrome: a case-control study using a pharmacy reimbursement database. Aliment Pharmacol Ther 2009 29 : 440 449.
12. Bouin M, Plourde V, Boivin M, et al. Rectal distension testing in patients with irritable bowel syndrome : sensitivity, specificity, and predictive values of pain sensory threshold. Gastroenterology 2002 122 : 1771 1777.
13. Kaptchuck TJ, Kelley JM, Conboy LA, et al. Components of placebo effect: randomized controlled trial in patients with irritable bowel syndrome. Br Med J 2008 336 : 999 1003.
14. Duracinsky M, Chassagny O. How can an effective drug to treat irritable bowel syndrome be successfully developed? Gastroenterol Clin Biol 2009 33 (Suppl. 1 S26 34.
15. Bouvier M, Grimaud JC, Abysique A, Chiarelli P. Effects of alverine on the spontaneous electrical activity and nervous control of the proximal colon of the rabbit. Gastroenterol Clin Biol 1992 16 : 334 338.
16. Labie I, Kraff N, Bueno L, Garcia-Villar R. Influence du citrate d'alvérine sur la viscérosensibilité rectale du rat. Act Med Int - Gastroenterol 1998 12 : 313 316.
17. Abysique A, Lucchini S, Orsoni P, Mei N, Bouvier M. Effect of alverine citrate on intestinal mechanoreceptor responses to chemical and mechanical stimuli. Aliment Pharmacol Ther 1999 13 : 561 566.
18. 1A receptor subtype. J Perioper Pract 2001 53 : 1419 1426.
19. Hayase M, Hashitani H, Suzuki H, Kohri K, Brading AF. Evolving mechanisms of action of alverine citrate on phasic smooth muscles. British J Pharmacol 2007 152 : 1228 1238.
20. Irvine EJ, Whitehead WE, Chey WD, et al. Design of treatment trials for functional gastrointestinal disorders. Gastroenterology 2006 130 : 1538 1551.
21. 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. Available at: http://www.emea.europa.eu/pdfs/human/ ewp/078597en.pdf. Accessed January 3, 2010.
22. Corazziari E, Bytzer P, Delvaux M, et al. Consensus report: clinical trial guidelines for pharmacological treatment of irritable bowel syndrome. Aliment Pharmacol Ther 2003 18 : 569 580.
23. Camilleri M, Mangel AW, Fehnel SE, Drossman DA, Mayer EA, Talley NJ. Primary endpoints for irritable bowel syndrome trials: a review of performance of endpoints. Clin Gastroenterol Hepatol 2007 5 : 534 540.
24. Longstreth GF, Thompson WG, Chey WD, Houghton LA, Mearin F, Spiller RC. Functional bowel disorders. Gastroenterology 2006 130 : 1480 1491.
25. Bengtsson M, Ohlsson B, Ulander K. Development and psychometric testing of the visual analogue scale for irritable bowel syndrome (VAS-IBS). BMC Gastroenterol 2007 7 : 16.
26. Chassagny O, Bonaz B, Bruley des Varannes S, et al. Acute exacerbation of pain in irritable bowel syndrome: efficacy of phloroglucinol/ trimethylphloroglucinol - a randomized double-blind, placebo-controlled study. Aliment Pharmacol Ther 2007 25 : 1115 1123.
27. Schoenfeld P, Talley NJ. Measuring successful treatment of irritable bowel syndrome is "Satisfactory Relief" enough? Am J Gastroenterol 2006 101 : 1066 1068.
28. Jones R, Latinovic R, Charlton J, et al. Physical and psychological co-morbidity in irritable bowel syndrome: a matched cohort study using the General Practice Research Database. Aliment Pharmacol Ther 2006 24 : 879 886.
29. 3 receptor antagonist: a pilot study. Aliment Pharmacol Ther 2008 28 : 344 352.
30. Quade D. Rank analysis of covariance. J Am Stat Assoc 1967 62 : 1187 1200.
31. Poynard T, Regimbeau C, Benhamou Y. Meta-analysis of smooth muscle relaxants in the treatment of irritable bowel syndrome. Aliment Pharmacol Ther 2001 15 : 355 361.
32. Spiller R, Aziz Q, Creed F, et al. Guidelines on the irritable bowel syndrome mechanisms and practical management. Gut 2007 56 : 1770 1798.
33. Hungin APS, Whorwell PJ, Tack J, Mearin F. The prevalence, patterns and impact of irritable bowel syndrome: an international survey of 40 000 subjects. Aliment Pharmacol Ther 2003 17 : 643 650.
34. Ersryd A, Posserud I, Abrahamsson H, Simren M. Subtyping the irritable bowel syndrome by predominant bowel habit: Rome II versus Rome III. Aliment Pharmacol Ther 2007 26 : 953 961.
35. Garrigues V, Mearin F, Badía X, et al. Change over time of irritable bowel syndrome: a prospective, observational 1-year follow up study (RITMO study). Aliment Pharmacol Ther 2007 25 : 323 332.
36. Hungin APS, Chang L, Locke GR, Dennis EH, Barghouth V. Irritable bowel syndrome in the United States: symptom patterns and impact. Aliment Pharmacol Ther 2005 21 : 1365 1375.