Routine clinical administration of 4-week alverine citrate and simeticone combination relief global IBS symptoms

DOI: 10.4236/ojgas.2014.41006   PDF   HTML     4,299 Downloads   6,164 Views   Citations


Introduction: The primary treatment aim for irritable bowel syndrome (IBS) is to relieve overall symptoms which can significantly impair the patient’s quality of life (QOL); however, it generally requires a high pill burden that may be improved by administration of combinatorial formulations. Thus, the effectiveness of alverine citrate and simeticone combination (ACS) for global symptom relief for IBS was investigated in this non-interventional study. Patients and Methods: ROME III IBS patients (n = 640; 52.3% male: mean age: 43.6 ± 12.5 years) with abdominal pain and discomfort ≥60 of 0-100 visual analogue scale (VAS) were included in a prospective, multicenter, non-interventional study at 26 Chinese sites from December 2010 to January 2012. Patients received alverine citrate (60 mg) with simeticone (300 mg) (ACS) 3× daily for 4 weeks. Pain/discomfort and bloating/distension were assessed by VAS. Global symptoms and QOL were assessed by 7-point and 5-point Likert scales, respectively. Post-treatment bowel function was assessed by Bristol Stool Form Scale (BSFS) and treatment-related adverse events (AEs) were recorded. Results: Of 640 patients, 540 (84.4%) completed the study, and 100 (15.6%) withdrew. In total, 87.5% reported bloating at baseline. After 4-week ACS treatment, 89.1% reported global symptom improvement. Furthermore, 4-week ACS treatment reduced pain and bloated VAS scores significantly from 78.4 ± 9.9 to 32.1 ± 21.0 and from 63.2 ± 27.2 to 22.6 ± 20.9, respectively (both p < 0.001), decreased diarrhea or constipation occurrence from 67.2% to 10.2% (p < 0.001), and reduced IBS impact on QOL with only 2 treatment-related AEs. Conclusion: Routine clinical administration of ACS for IBS over a 4-week period provides effective relief of IBS symptoms and improves QOL in IBS patients.

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Wang, X. , Feng, Y. , Li, J. , Tian, Z. , Wei, D. , Qi, L. , Fang, L. and Wu, K. (2014) Routine clinical administration of 4-week alverine citrate and simeticone combination relief global IBS symptoms. Open Journal of Gastroenterology, 4, 32-39. doi: 10.4236/ojgas.2014.41006.

Conflicts of Interest

The authors declare no conflicts of interest.


[1] Tack, J., Fried, M., Houghton, L.A., Spicak, J. and Fisher, G. (2006) Systematic review: The efficacy of treatments for irritable bowel syndrome—A European perspective. Alimentary Pharmacology & Therapeutics, 24, 183-205.
[2] Frank, L., Kleinman, L., Rentz, A., Ciesla, G., Kim, J.J. and Zacker, C. (2002) Health-related quality of life associated with irritable bowel syndrome: Comparison with other chronic diseases. Clinical Therapeutics, 24, 675-689; discussion 674.
[3] Dong, Y.Y., Zuo, X.L., Li, C.Q., Yu, Y.B., Zhao, Q.J. and Li, Y.Q. (2010) Prevalence of irritable bowel syndrome in Chinese college and university students assessed using ROME III criteria. World Journal of Gastroenterology, 16, 4221-4226.
[4] Xiong, L.S., Chen, M.H., Chen, H.X., Xu, A.G., Wang, W.A. and Hu, P.J. (2004) A population-based epidemiologic study of irritable bowel syndrome in Guangdong province. Zhonghua Yi Xue Za Zhi, 84, 278-281.
[5] Hulisz, D. (2004) The burden of illness of irritable bowel syndrome: Current challenges and hope for the future. Journal of Managed Care Pharmacy, 10, 299-309.
[6] Ford, A.C. and Talley, N.J. (2012) Irritable bowel syndrome. BMJ, 345, e5836.
[7] Gastrointestinal Motility Group, Chinese Society of Gastroenterology, Chinese Medical Association (2008) Consensus on management of irritable bowel syndrome (2007 Edition, Changsha). Chinese Journal of Digestion, 28, 38-40.
[8] Spiller, R., Aziz, Q., Creed, F., Emmanuel, A., Houghton, L., Hungin, P., Jones, R., Kumar, D., Rubin, G., Trudgill, N. and Whorwell, P. (2007) Guidelines on the irritable bowel syndrome: Mechanisms and practical management. Gut, 56, 1770-1798.
[9] Drossman, D.A., Morris, C.B., Schneck S., Hu, Y.J., Norton, N.J., Norton, W.F., et al. (2009) International survey of patients with IBS: symptom features and their severity, health status, treatments, and risk taking to achieve clinical benefit. Journal of Clinical Gastroenterology, 43, 541-550.
[10] Coelho, A.M., Jacob, L., Fioramonti, J. and Bueno, L. (2001) Rectal antinociceptive properties of alverine citrate are linked to antagonism at the 5-HT1A receptor subtype. Journal of Pharmacy and Pharmacology, 53, 1419-1426.
[11] Bouvier, M., Grimaud, J.C., Abysique, A. and Chiarelli, P. (1992) Effects of alverine on the spontaneous electrical activity and nervous control of the proximal colon of the rabbit. Gastroentérologie Clinique et Biologique, 16, 334-338.
[12] Hayase, M., Hashitani, H., Suzuki, H., Kohri, K. and Brading, A.F. (2007) Evolving mechanisms of action of alverine citrate on phasic smooth muscles. British Journal of Pharmacology, 152, 1228-1238.
[13] Brecevic, L., Bosan-Kilibarda, I. and Strajnar, F. (1994) Mechanism of antifoaming action of simethicone. Journal of Applied Toxicology, 14, 207-211.
[14] Bueno, L., Beaufrand, C., Theodorou, V. and Andro-Delestrain, M.C. (2013) Influence of simethicone and alverine on stress-induced alterations of colonic permeability and sensitivity in rats: Beneficial effect of their association. Journal of Pharmacy and Pharmacology, 65, 567-673.
[15] Barthet, M., Mambrini, P., Salducci, J., Bouvier M., Chiarelli, P., Grimaud J.C., et al. (1996) Efficacité de l’association citrate d’alvérine+siméthicone dans le traitement du syndrome de l’intestin irritable. Les Actualités en Gastroentérologie, 10, S1-S7.érologie
[16] Danne, O., Pospai, D. and Mignon, M. (1996) Efficacité comparée du citrate d’alvérine (nouvelle formule) et de la mébévérine chez les adultes atteints de troubles fonctionnels intestinaux. Le Concours Médical, 118, I-VIII.
[17] Wittmann, T., Paradowski, L., Ducrotté, P., Bueno, L. and Andro Delestrain, M.C. (2010) Clinical trial: The efficacy of alverine citrate simeticone combination on abdominal pain discomfort in irritable bowel syndrome a randomized, double-blind, placebo-controlled study. Ali-mentary Pharmacology & Therapeutics, 31, 615-624.
[18] ROME Foundation (2012) ROME III diagnostic criteria for functional gastrointestinal disorders. Appendix A: ROME III diagnostic criteria for FGIDs.
[19] Hammerle, C.W. and Surawicz, C.M. (2008) Updates on treatment of irritable bowel syndrome. World Journal of Gastroenterology, 14, 2639-2649.
[20] Rajagopal, S. (2006) The placebo effect. The Psychiatrist, 30, 185-188.
[21] Pitz, M., Cheang, M. and Bernstein, C.N. (2005) Defining the Predictors of the Placebo Response in Irritable Bowel Syndrome. Clinical Gastroenterology and Hepatology, 3, 237-247.
[22] Patel, S.M., Stason, W.B., Legedza, A., Ock, S.M., Kaptchuk, T.J., Conboy, L., et al. (2005) The placebo effect in irritable bowel syndrome trials: A meta-analysis. Neurogastroenterology & Motility, 17, 332-340.
[23] Dorn, S.D., Kaptchuk, T.J., Park, J.B., Nguyen, L.T., Canenguez, K., Nam, B.H., et al. (2007) A meta-analysis of the placebo response in complementary and alternative medicine trials of irritable bowel syndrome. Neuroga-stroenterology & Motility, 19, 630-637.
[24] Houghton, L.A. and Whorwell, P.J. (2005) Towards a better understanding of abdominal bloating and distension in functional gastrointestinal disorders. Neuroga-stroenterology & Motility, 17, 500-511.
[25] Zhong, Y.Q., Liu, J., Li, S.S. and Zen, Z.Y. (2009) A randomized controlled study of compound alverine citrate in treating patients with diarrhea-predominant irritable bowel syndrome. Chinese Journal of Gastroenterology, 14, 324-327.
[26] Yao, X., Yang, Y.S., Cui, L.H., Zhao, K.B., Zhang, Z.H., Peng, L.H., et al. (2012) Subtypes of irritable bowel syndrome on ROME III criteria: A multicenter study. Journal of Gastroenterology and Hepatology, 27, 760-765.
[27] Ford, A.C. (2009) Alverine citrate, simeticone, and ROME III irritable bowel syndrome. Alimentary Pharmacology & Therapeutics, 31, 767-768; author reply 768- 769.
[28] McFarland, L.V. and Dublin, S. (2008) Meta-analysis of probiotics for the treatment of irritable bowel syndrome. World Journal of Gastroenterology, 14, 2650-2661.
[29] Shi, J., Tong, Y., Shen, J.G. and Li, H.X. (2008) Effectiveness and safety of herbal medicines in the treatment of irritable bowel syndrome: A systematic review. World Journal of Gastroenterology, 14, 454-462.
[30] Mangel, A.W. and Fehnel, S.E. (2011) End points in irritable bowel syndrome. Expert Review of Gastroenterology & Hepatology, 5, 293-295.

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