Adequate Relief in a Treatment Trial with IBS Patients: a Prospective Assessment

Overview

Journal Am J Gastroenterol

Specialty Gastroenterology

Date 2009 Mar 19

PMID 19293784

Citations 20

Authors

Maria C F Passos

Anthony J Lembo

Lisa A Conboy

Ted J Kaptchuk

John M Kelly

Mary T Quilty

Catherine E Kerr

Eric E Jacobson

Rong Hu

Elizabeth Friedlander

Douglas A Drossman

Affiliations

Soon will be listed here.

Abstract

Objectives: Adequate relief (AR) of irritable bowel syndrome (IBS) symptoms (IBS-AR) has been used as a primary end point in many randomized controlled trials of IBS and is considered by the Rome III committee to be an acceptable primary end point. However, controversy exists on whether baseline severity confounds the effect of the treatment outcome. The aim (1) is to compare a subjective report of IBS-AR with global assessment of improvement (IBS-GAI), change in IBS symptom severity scale (IBS-SSS), and IBS quality of life (IBS-QOL); (2) to explore whether initial IBS symptom severity influences the ability of these outcome measures to detect differences post treatment; and (3) to determine whether psychological symptoms influence the sensitivity of these measures, in a randomized controlled treatment trial.

Methods: A total of 289 adult IBS patients were recruited to a treatment trial. Baseline IBS-SSS scores were used to classify IBS severity as mild (<175), moderate (175-300), or severe (>300). Questionnaires were completed at baseline and after 3 weeks of treatment with sham acupuncture or wait-list control.

Results: IBS baseline severity (IBS-SSS) significantly affected the proportion of patients who reported IBS-AR at 3 weeks (mild, 70%; moderate, 49.7%; severe, 38.8%) (P<0.05). However, once the patients who reported IBS-AR at baseline (28.0%) were excluded from the analysis, baseline severity no longer affected the proportion of patients reporting IBS-AR. Baseline severity did not have a significant effect on patients reporting moderate or significant improvement on the IBS-GAI (mild, 30%; moderate, 25.3%; severe, 18.8%) (P=NS). Psychological symptoms had no significant correlations with responders after adjusting for baseline severity.

Conclusions: These data suggest that IBS-AR as an end point is inversely related to baseline symptom severity. However, if patients who report AR at screening were excluded from study participation, baseline symptom severity was no longer confounded with a report of AR at the study end point.

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References

Beck A, Ward C, Mendelson M, Mock J, ERBAUGH J . An inventory for measuring depression. Arch Gen Psychiatry. 1961; 4:561-71. DOI: 10.1001/archpsyc.1961.01710120031004. View

Camilleri M, Mayer E, Drossman D, Heath A, Dukes G, McSorley D . Improvement in pain and bowel function in female irritable bowel patients with alosetron, a 5-HT3 receptor antagonist. Aliment Pharmacol Ther. 1999; 13(9):1149-59. DOI: 10.1046/j.1365-2036.1999.00610.x. View

Vanner S, Depew W, Paterson W, DaCosta L, Groll A, Simon J . Predictive value of the Rome criteria for diagnosing the irritable bowel syndrome. Am J Gastroenterol. 1999; 94(10):2912-7. DOI: 10.1111/j.1572-0241.1999.01437.x. View

Irvine E, Whitehead W, Chey W, Matsueda K, Shaw M, Talley N . Design of treatment trials for functional gastrointestinal disorders. Gastroenterology. 2006; 130(5):1538-51. DOI: 10.1053/j.gastro.2005.11.058. View

Mangel A, Hahn B, Heath A, Northcutt A, Kong S, Dukes G . Adequate relief as an endpoint in clinical trials in irritable bowel syndrome. J Int Med Res. 1998; 26(2):76-81. DOI: 10.1177/030006059802600203. View

Camilleri M, Northcutt A, Kong S, Dukes G, McSorley D, Mangel A . Efficacy and safety of alosetron in women with irritable bowel syndrome: a randomised, placebo-controlled trial. Lancet. 2000; 355(9209):1035-40. DOI: 10.1016/S0140-6736(00)02033-X. View

Kellow J, Lee O, Chang F, Thongsawat S, Mazlam M, Yuen H . An Asia-Pacific, double blind, placebo controlled, randomised study to evaluate the efficacy, safety, and tolerability of tegaserod in patients with irritable bowel syndrome. Gut. 2003; 52(5):671-6. PMC: 1773630. DOI: 10.1136/gut.52.5.671. View

Talley N . Irritable bowel syndrome. Intern Med J. 2006; 36(11):724-8. PMC: 1761148. DOI: 10.1111/j.1445-5994.2006.01217.x. View

Gordon S, Ameen V, Bagby B, Shahan B, Jhingran P, Carter E . Validation of irritable bowel syndrome Global Improvement Scale: an integrated symptom end point for assessing treatment efficacy. Dig Dis Sci. 2003; 48(7):1317-23. DOI: 10.1023/a:1024159226274. View

10.

Tack J, Muller-Lissner S, Bytzer P, Corinaldesi R, Chang L, Viegas A . A randomised controlled trial assessing the efficacy and safety of repeated tegaserod therapy in women with irritable bowel syndrome with constipation. Gut. 2005; 54(12):1707-13. PMC: 1774790. DOI: 10.1136/gut.2005.070789. View

11.

Francis C, Morris J, Whorwell P . The irritable bowel severity scoring system: a simple method of monitoring irritable bowel syndrome and its progress. Aliment Pharmacol Ther. 1997; 11(2):395-402. DOI: 10.1046/j.1365-2036.1997.142318000.x. View

12.

Tack J, Fried M, Houghton L, Spicak J, Fisher G . Systematic review: the efficacy of treatments for irritable bowel syndrome--a European perspective. Aliment Pharmacol Ther. 2006; 24(2):183-205. DOI: 10.1111/j.1365-2036.2006.02938.x. View

13.

Thompson W . Irritable bowel syndrome: a management strategy. Baillieres Best Pract Res Clin Gastroenterol. 1999; 13(3):453-60. DOI: 10.1053/bega.1999.0039. View

14.

Lembo A, Ameen V, Drossman D . Irritable bowel syndrome: toward an understanding of severity. Clin Gastroenterol Hepatol. 2005; 3(8):717-25. DOI: 10.1016/s1542-3565(05)00157-6. View

15.

Drossman D, Patrick D, Whitehead W, Toner B, Diamant N, Hu Y . Further validation of the IBS-QOL: a disease-specific quality-of-life questionnaire. Am J Gastroenterol. 2000; 95(4):999-1007. DOI: 10.1111/j.1572-0241.2000.01941.x. View

16.

Lembo T, Wright R, Bagby B, Decker C, Gordon S, Jhingran P . Alosetron controls bowel urgency and provides global symptom improvement in women with diarrhea-predominant irritable bowel syndrome. Am J Gastroenterol. 2001; 96(9):2662-70. DOI: 10.1111/j.1572-0241.2001.04128.x. View

17.

Nyhlin H, Bang C, Elsborg L, Silvennoinen J, Holme I, Ruegg P . A double-blind, placebo-controlled, randomized study to evaluate the efficacy, safety and tolerability of tegaserod in patients with irritable bowel syndrome. Scand J Gastroenterol. 2004; 39(2):119-26. DOI: 10.1080/00365520310006748. View

18.

Patrick D, Drossman D, Frederick I, DiCesare J, Puder K . Quality of life in persons with irritable bowel syndrome: development and validation of a new measure. Dig Dis Sci. 1998; 43(2):400-11. DOI: 10.1023/a:1018831127942. View

19.

Whitehead W, Palsson O, Levy R, Feld A, VonKorff M, Turner M . Reports of "satisfactory relief" by IBS patients receiving usual medical care are confounded by baseline symptom severity and do not accurately reflect symptom improvement. Am J Gastroenterol. 2006; 101(5):1057-65. DOI: 10.1111/j.1572-0241.2006.00535.x. View

20.

Camilleri M, Chey W, Mayer E, Northcutt A, Heath A, Dukes G . A randomized controlled clinical trial of the serotonin type 3 receptor antagonist alosetron in women with diarrhea-predominant irritable bowel syndrome. Arch Intern Med. 2001; 161(14):1733-40. DOI: 10.1001/archinte.161.14.1733. View