Effect of mesalazine on mucosal immune biomarkers in irritable bowel syndrome: a randomized controlled proof‐of‐concept study
Open accessAbstract
Summary: Background Intestinal immune infiltration contributes to symptoms in patients with irritable bowel syndrome (IBS). Aim To assesses the effect of mesalazine (mesalamine) on mucosal immune cells in patients with IBS, through a pilot study. Methods A randomized, double‐blind, placebo‐controlled trial in 20 patients with IBS in tertiary care setting. Patients were randomized to receive placebo or 800 mg mesalazine three times daily for 8 weeks. The primary endpoint was a significant reduction in total colonic immune cells on biopsies obtained at the end of treatment compared to baseline. Secondary endpoints included effects on subsets of immune cells, inflammatory mediators and symptom severity. Intention‐to‐treat analysis was performed. Results Mesalazine markedly reduced immune cells as compared with placebo ( P = 0.0082); this effect was ascribed to a marked inhibition of mast cells ( P = 0.0014). Mesalazine significantly increased general well‐being ( P = 0.038), but had no significant effects on abdominal pain ( P = 0.084), bloating ( P = 0.177) or bowel habits. No serious drug‐related adverse events were reported during the study. Conclusions Mesalazine is an effective and safe approach to reduce mast cell infiltration and may improve general well‐being in patients with IBS. These results support the hypothesis that immune mechanisms represent potential therapeutic targets in IBS.
Integrity signals
Registry
Cites
Statistics
Claims the paper makes
Claims other papers make about this one
Each is checked against this paper’s own text: does it say what the citing paper says it does?
A small, double-blind, randomized study of 20 IBS patients showed that mesalamine 2.4 g/day for 8 wk failed to show improvement in IBS symptoms despite a reduction in the number of total immune cells in colonic biopsies and improvement in general well-being.
“A small, double-blind, randomized study of 20 IBS patients showed that mesalamine 2.4 g/day for 8 wk failed to show improvement in IBS symptoms despite a reduction in the number of total immune cells in colonic biopsies and improvement in general well-being (45, 177).”
From Intestinal microbiota and immune function in the pathogenesis of irritable bowel syndrome (2013) · cites this paper as [45]
Cites
Longstreth, G. F., Thompson, W. G., Chey, W. D., Houghton, L. A., Mearin, F., & Spiller, R. C. (2006) · Gastroenterology · doi:10.1053/j.gastro.2005.11.061 · Cited by 4,856 · see citing works
Biologic basis for interleukin-1 in disease.
Dinarello, C. (1996) · Blood · doi:10.1182/blood.v87.6.2095.bloodjournal8762095 · Cited by 3,380 · see citing works
Functional bowel disorders and functional abdominal pain
Thompson, W. G., Longstreth, G. F., Drossman, D. A., Heaton, K. W., Irvine, E. J., & Müller-Lissner, S. A. (1999) · Gut · doi:10.1136/gut.45.2008.ii43 · Cited by 2,440 · see citing works
Inflammatory bowel disease: clinical aspects and established and evolving therapies
Baumgart, D. C., & Sandborn, W. J. (2007) · The Lancet · doi:10.1016/s0140-6736(07)60751-x · Cited by 1,921 · see citing works
Metcalfe, D. D., Baram, D., & Mekori, Y. A. (1997) · Physiological Reviews · doi:10.1152/physrev.1997.77.4.1033 · Cited by 1,723 · see citing works
Barbara, G., Stanghellini, V., De Giorgio, R., Cremon, C., Cottrell, G. S., Santini, D., Pasquinelli, G., Morselli-Labate, A. M., Grady, E. F., Bunnett, N. W., et al. (2004) · Gastroenterology · doi:10.1053/j.gastro.2003.11.055 · Cited by 1,475 · see citing works
Self-citationO’Mahony, L., McCarthy, J., Kelly, P., Hurley, G., Luo, F., Chen, K., O’Sullivan, G. C., Kiely, B., Collins, J. K., Shanahan, F., et al. (2005) · Gastroenterology · doi:10.1053/j.gastro.2004.11.050 · Cited by 1,448 · see citing works
Enck, P., Aziz, Q., Barbara, G., Farmer, A. D., Fukudo, S., Mayer, E. A., Niesler, B., Quigley, E. M. M., Rajilić-Stojanović, M. D., Schemann, M., et al. (2016) · Nature Reviews Disease Primers · doi:10.1038/nrdp.2016.14 · Cited by 1,057 · see citing works
Self-citationMast Cell-Dependent Excitation of Visceral-Nociceptive Sensory Neurons in Irritable Bowel Syndrome
Barbara, G., Wang, B., Stanghellini, V., de Giorgio, R., Cremon, C., Di Nardo, G., Trevisani, M., Campi, B., Geppetti, P., Tonini, M., et al. (2007) · Gastroenterology · doi:10.1053/j.gastro.2006.11.039 · Cited by 783 · see citing works
Self-citationImmune Activation in Patients With Irritable Bowel Syndrome
Liebregts, T., Adam, B., Bredack, C., Röth, A., Heinzel, S., Lester, S., Downie–Doyle, S., Smith, E., Drew, P., Talley, N. J., et al. (2007) · Gastroenterology · doi:10.1053/j.gastro.2007.01.046 · Cited by 660 · see citing works
Role for protease activity in visceral pain in irritable bowel syndrome
Cenac, N., Andrews, C. N., Holzhausen, M., Chapman, K., Cottrell, G., Andrade-Gordon, P., Steinhoff, M., Barbara, G., Beck, P., Bunnett, N. W., et al. (2007) · Journal of Clinical Investigation · doi:10.1172/jci29255 · Cited by 591 · see citing works
Self-citationPiche, T., Barbara, G., Aubert, P., Bruley des Varannes, S., Dainese, R., Nano, J. L., Cremon, C., Stanghellini, V, De Giorgio, R., Galmiche, J. P., et al. (2009) · Gut · doi:10.1136/gut.2007.140806 · Cited by 540 · see citing works
Self-citationRousseaux, C., Lefebvre, B., Dubuquoy, L., Lefèbvre, P., Romano, O., Auwerx, J. H., METZGER, D., Wahli, W., Desvergne, B., Naccari, G. C., et al. (2005) · The Journal of Experimental Medicine · doi:10.1084/jem.20041948 · Cited by 528 · see citing works
Gwee, K.-A. (2003) · Gut · doi:10.1136/gut.52.4.523 · Cited by 415 · see citing works
Diarrhoea-predominant IBS patients show mast cell activation and hyperplasia in the jejunum
Guilarte, M., Santos, J., de Torres, I., Alonso, C., Vicario, M., Ramos, L., Martinez, C., Casellas, F., Saperas, E., & Malagelada, J. R. (2007) · Gut · doi:10.1136/gut.2006.100594 · Cited by 385 · see citing works
Cremon, C., Gargano, L., Morselli-Labate, A. M., Santini, D., Cogliandro, R. F., De Giorgio, R., Stanghellini, V., Corinaldesi, R., & Barbara, G. (2009) · The American Journal of Gastroenterology · doi:10.1038/ajg.2008.94 · Cited by 342 · see citing works
Self-citationMayer, E. A. (2008) · New England Journal of Medicine · doi:10.1056/nejmcp0801447 · Cited by 243 · see citing works
New pathophysiological mechanisms in irritable bowel syndrome
Barbara, G., GIORGIO, R. D., Stanghellini, V., Cremon, C., Salvioli, B., & Corinaldesi, R. (2004) · Alimentary Pharmacology & Therapeutics · doi:10.1111/j.1365-2036.2004.02036.x · Cited by 221 · see citing works
Self-citationEfficacy of alosetron in irritable bowel syndrome: a meta‐analysis of randomized controlled trials
Cremonini, F., Delgado‐Aros, S., & Camilleri, M. (2003) · Neurogastroenterology & Motility · doi:10.1046/j.1365-2982.2003.00389.x · Cited by 219 · see citing works
Piche, T., Saint-Paul, M. C., Dainese, R., Marine-Barjoan, E., Iannelli, A., Montoya, M. L., Peyron, J. F., Czerucka, D., Cherikh, F., Filippi, J., et al. (2008) · Gut · doi:10.1136/gut.2007.127068 · Cited by 198 · see citing works
Clinical Determinants of Health-Related Quality of Life in Patients With Irritable Bowel Syndrome
Spiegel, B. M. R., Gralnek, I. M., Bolus, R. R., Chang, L., Dulai, G. S., Mayer, E. A., & Naliboff, B. D. (2004) · Archives of Internal Medicine · doi:10.1001/archinte.164.16.1773 · Cited by 198 · see citing works
Dunlop, S., Jenkins, D., Neal, K. R., Næsdal, J., Borgaonker, M., Collins, S. M., & Spiller, R. E. (2003) · Alimentary Pharmacology & Therapeutics · doi:10.1046/j.1365-2036.2003.01640.x · Cited by 178 · see citing works
Functional gastrointestinal disorders and mast cells: implications for therapy
Barbara, G., Stanghellini, V., GIORGIO, R. D., & Corinaldesi, R. (2005) · Neurogastroenterology & Motility · doi:10.1111/j.1365-2982.2005.00685.x · Cited by 176 · see citing works
Self-citationFunctional GI disorders: from animal models to drug development
Mayer, E. A., Bradesi, S., Chang, L., Spiegel, B. M. R., Bueller, J. A., & Naliboff, B. D. (2007) · Gut · doi:10.1136/gut.2006.101675 · Cited by 162 · see citing works
INVESTIGATION AND TREATMENT OF ENDOCRINOLOGICAL DISORDERS
Wootton, I. D. P., Strong, J. A., Whitby, L. G., Doar, J. W. H., Sewell, P. F. J., Wilde, C. E., Pennington, G. W., & Ross, E. J. (1972) · The Lancet · doi:10.1016/s0140-6736(72)90608-3 · Cited by 150 · see citing works
Tegaserod for the treatment of irritable bowel syndrome
Evans, B., Clark, W., Moore, D., & Whorwell, P. J. (2004) · Cochrane Database of Systematic Reviews · doi:10.1002/14651858.cd003960.pub2 · Cited by 97 · see citing works
LUNARDI, C., BAMBARA, L. M., BIASI, D., CORTINA, P., PEROLI, P., NICOLIS, F., FAVARI, F., & PACOR, M. L. (1991) · Clinical & Experimental Allergy · doi:10.1111/j.1365-2222.1991.tb00848.x · Cited by 72 · see citing works
Effect of aminophenols (5-ASA and 4-ASA) on colonic interleukin-1 generation.
Rachmilewitz, D., Karmeli, F., Schwartz, L. W., et al. (1992) · Gut · doi:10.1136/gut.33.7.929 · Cited by 65 · see citing works
Fox, C. C., Moore, W. C., & Lichtenstein, L. M. (1991) · Digestive Diseases and Sciences · doi:10.1007/bf01300753 · Cited by 60 · see citing works
Bissonnette, É. Y., Enciso, J. A., & Befus, A. D. (1996) · The Journal of Immunology · doi:10.4049/jimmunol.156.1.218 · Cited by 49 · see citing works
5-Aminosalicylic acid inhibits the impaired epithelial barrier function induced by gamma interferon.
Paolo, M. C., Merrett, M. N., Crotty, B. J., & Jewell, D. P. (1996) · Gut · doi:10.1136/gut.38.1.115 · Cited by 44 · see citing works
Effect of Drugs on Colonic Eicosanoid Accumulation in Active Ulcerative Colitis
Eliakim, R., Karmeli, F., Chorev, M., et al. (1992) · Scandinavian Journal of Gastroenterology · doi:10.3109/00365529209000172 · Cited by 32 · see citing works
Stefanini, G. F. (1986) · The Lancet · doi:10.1016/s0140-6736(86)90673-2 · Cited by 20 · see citing works
Andrews, C. N., Petcu, R., Griffiths, T. A. M., Bjarnason, J., Chapman, K., Cellars, L., Vergnolle, N., & Rioux, K. P. (2008) · Gastroenterology · doi:10.1016/s0016-5085(08)62558-5 · Cited by 8 · see citing works
Flagged first, then by citations
Cited by
Sorted by citations
Intestinal barrier function in health and gastrointestinal disease
Camilleri, M., Madsen, K., Spiller, R., Van Meerveld, B. G., & Verne, G. N. (2012) · Neurogastroenterology & Motility · doi:10.1111/j.1365-2982.2012.01921.x · Cited by 908 · see citing works
Pathogenesis of IBS: role of inflammation, immunity and neuroimmune interactions
Öhman, L., & Simrén, M. (2010) · Nature Reviews Gastroenterology & Hepatology · doi:10.1038/nrgastro.2010.4 · Cited by 617 · see citing works
The role of mast cells in functional GI disorders
Wouters, M. M., Vicario, M., & Santos, J. (2016) · Gut · doi:10.1136/gutjnl-2015-309151 · Cited by 308 · see citing works
The immune system in irritable bowel syndrome
Barbara, G., Cremon, C., Carini, G., Bellacosa, L., Zecchi, L., Giorgio, R. D., Corinaldesi, R., & Stanghellini, V. (2011) · Journal of Neurogastroenterology and Motility · doi:10.5056/jnm.2011.17.4.349 · Cited by 211 · see citing works
Self-citationSwan, C., Duroudier, N. P., Campbell, E., Zaitoun, A., Hastings, M., Dukes, G. E., Cox, J., Kelly, F. M., Wilde, J., Lennon, M. G., et al. (2013) · Gut · doi:10.1136/gutjnl-2011-301213 · Cited by 165 · see citing works
Intestinal microbiota and immune function in the pathogenesis of irritable bowel syndrome
Ringel, Y., & Maharshak, N. (2013) · American Journal of Physiology-Gastrointestinal and Liver Physiology · doi:10.1152/ajpgi.00207.2012 · Cited by 115 · see citing works
Quigley, E. M. M. (2011) · Gastroenterology Clinics of North America · doi:10.1016/j.gtc.2010.12.009 · Cited by 67 · see citing works
Tuteja, A. K., Fang, J. C., Al-Suqi, M., Stoddard, G. J., & Hale, D. C. (2012) · Scandinavian Journal of Gastroenterology · doi:10.3109/00365521.2012.694903 · Cited by 41 · see citing works
- Authors
- CORINALDESI, R., STANGHELLINI, V., CREMON, C., GARGANO, L., COGLIANDRO, R. F., DE GIORGIO, R., BARTESAGHI, G., CANOVI, B., & BARBARA, G.
- Affiliations
- University of Bologna (IT)
- Corresponding author
- BARBARA, G.
- Venue
- Alimentary Pharmacology & Therapeutics
- Publisher
- Wiley
- Published
- 2009-07-10
- Volume
- 30
- Issue
- 3
- Pages
- 245-252
- ISSN
- 0269-2813 (ISSN-L)
- 1365-2036
- OpenAlex
- W2085068901
- Cited by
- 131
- References
- 34
- Citations by year
- 2026: 1 · 2025: 4 · 2024: 2 · 2023: 5 · 2022: 7 · 2021: 3 · 2020: 4 · 2019: 5 · 2018: 1 · 2017: 6 · 2016: 12 · 2015: 12 · 2014: 10 · 2013: 11 · 2012: 11
- FWCI
- 16.66
- Type
- journal article
- Language
- en
- Open access
- Licence
- Locations
- Alimentary Pharmacology & Therapeutics (publishedVersion)
- PubMed (publishedVersion)
- Archivio istituzionale della ricerca (Alma Mater Studiorum Università di Bologna) (submittedVersion)
- Institutional Research Information System University of Ferrara (University of Ferrara) (submittedVersion)
- INFM-OAR (INFN Catania) (submittedVersion, other-oa)
- Topics
- Health Sciences › Medicine › Gastroenterology › Gastrointestinal motility and disorders
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Genetics › Inflammatory Bowel Disease
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Molecular Biology › Gut microbiota and health
- Keywords
- 5-aminosalicylic acid, irritable bowel syndrome, mucosal immune cells, mast cells, colonic biopsy, intestinal inflammation, immune cell infiltration, inflammatory mediators, symptom severity, well-being
- MeSH terms
- Adolescent, Adult, Aged, Aged, 80 and over, Anti-Inflammatory Agents, Non-Steroidal, Double-Blind Method, Female, Humans, Intestinal Mucosa, Male, Middle Aged, Pilot Projects, Biomarkers, Treatment Outcome, Mesalamine, Irritable Bowel Syndrome, Young Adult
About these checks
Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
Statistics and arithmetic are recomputed, not judged.
Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.
What counts as a claim ›How we measure confidence ›How we check this ›
Are you an author, or do you see a problem with this page? Request a review
